IRB Manual: IRB Review Process and Considerations
All projects defined by the IRB as “research” involving “human participants” must be reviewed and approved by the IRB before any research activities involving potential participants are initiated. This includes honors theses, culminating graduate research papers, and Masters or Doctoral theses involving human participants, and the IRB reviews projects that involve more than minimal risk samples, topics, or procedures (see below).
Exempt versus Research Needing Review
As will be discussed further in Chapter 9, some projects that the IRB reviews fit into the federal category of “Exempt”. This status should not be confused with “Not Research.” In the former case, the study meets the IRB’s definition for research needing review, but the review has determined that the study meets the criteria for Exempt(ion) from Continuing Review. In the latter case, “Not Research,” the project does not need IRB review in the first place because, in the judgment of the IRB, it does not fit the definition of human participants research.
Criteria for Research Needing Review
Please note that the process of determining whether or not a given project is “research” is often a nebulous undertaking. The IRB has spent considerable time working to define “research” as clearly and consistently as possible, in light of the federal regulations and balancing the need to oversee potential risks for human participants with the desire to avoid over-regulation of minimal risk projects. In some cases, the question simply requires a judgment call, which according to regulation, must be made by the IRB. In questionable cases, investigators are encouraged to simply email the IRB Administrator and ask if review is required.
The considerations involved in determining if a project needs review are: 1) does it meet the IRB’s definition of research; 2) does it involve interaction with or information about living human beings; and/or 3) does the project involve more than minimal risk or vulnerable populations?
1. How does the IRB define “research”?
The first criterion for assessing if a given project requires review involves determining if the project meets the regulatory definition of research. Research is defined in the federal regulations at 45 CFR 46.102(d) as “a systematic investigation, including research development, pilot studies, testing and evaluation, designed to develop or contribute to generalizable (or transferable) knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.”
Generalizable knowledge is typically interpreted by the IRB to include research findings or data that are intended to contribute to the existing body of knowledge on the topic. A strong indicator of the intention to contribute to general knowledge is when the results are intended for public dissemination or presentation. Public dissemination of knowledge may involve many formats, including broadcast email, poster presentation, scholarly paper, public bulletin board, web publication, or report to external sponsor.
Data collection activities that are conducted solely for institutional purposes, even if the results will be accessible by the public, are not typically considered research by the IRB, unless there is a dual, scholarly purpose involved or the researcher believes there may be in the future.
Research projects involving human participants that are conducted by students for the purpose of independent research papers, culminating graduate research papers, master’s theses, and dissertations are all considered research and must be reviewed by the IRB.
2. How does the IRB define human participants involvement?
The second criterion for determining if review is required is whether or not the project involves obtaining private information from or about living human beings. This may include obtaining information through interventions or interactions, or by accessing datasets or private records.
A. Obtaining private data FROM human beings. According to 45 CFR 46.2102 (f), “Intervention includes both physical procedures by which data are gathered (for example, veni-puncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place….”
Thus, for example, if you are planning to observe children in a public park but not expecting to interact with them in any way, the study does not need review. If you are planning to observe adults in a public restroom, those individuals are obviously expecting some degree of privacy and your study does need review.
B. Obtaining private data ABOUT human beings. This involves obtaining individual-level information from datasets or records that may have been compiled for some other purpose and now are going to be used for research purposes. There are several considerations involved in regard to secondary data studies, including individual level vs. aggregate data, identifiable data vs. de-identified, and publicly-available vs. privately-held datasets.
Individual level data means that the information is recorded for each individual, rather than compiled into aggregate statistics. And it means that the data is actually about the individual, not some other entity (such as the organization they may work for). For example, if you are asking school districts to provide you with the number of school psychologists they employ and what percentage have master’s degrees, IRB review is not needed. If you are asking principals what their opinion is about the number of school psychologists they employ, the data is now about the individual principals and the study does need review. If you want to ask the districts to provide you with private information about each psychologist (e.g., Birthdate, degree, number of years employed), then the study does need review.
Identifiable information is that which can either directly or indirectly identify an individual. Direct identifiers include name, address, telephone number, social security number, identification number, medical record number, license number, photographs, voice recording, and biometric information. Indirect identifiers are those items that taken together might enable a reasonably informed and determined person to deduce the identity of the participant, and include race, gender, age, zip code, IP address, and college major. Projects involving “de-identified” private datasets (e.g., a dataset you obtain from a state agency or another investigator) are commonly found Exempt from continuing review by the IRB, but they are considered research that must be reviewed. See Chapter 8 for a full discussion of exempt determinations.
Publicly-available datasets are defined by the IRB as data that have already been compiled and are now available in a library or on the internet, and no permissions are required to access them. Privately-held datasets are those for which some type of permission is necessary to access the data and studies involving these typically require IRB review. (The IRB has made an exception for a few well-known, commonly used repositories of secondary data, such as the InterUniversity Consortium for Political and Social Research-ICPSR.) Research involving data that is both completely de-identified and publicly available without permission is not reviewed by the IRB. If you do not need permission from anyone to access the data and the data is completely “de-identified,” you do not need to seek review.
3. Does the study involve more than minimal risk or vulnerable populations?
If a research project involves more risk than an individual might expect to encounter in the course of daily life, or involves groups or procedures that require special precautions, the study may need to be reviewed even if it does not fall within the above guidelines for research. For example, if your study involves children or other vulnerable populations, or you will be asking about sensitive topics that may cause psychological harm or embarrassment, or you will need to deceive the participants about the nature of the research, your study must be reviewed by the IRB even if it is a class project or other situation that would not normally be seen as formal research.
Examples of projects that the IRB does not typically review because they do not fit any of the above criteria are:
- Teacher and student evaluations used solely by the institution
- Class-related data collection projects (with adults and of no more than minimal risk) conducted solely for didactic purposes where the results are not disseminated outside the classroom
- Activities conducted for quality improvement/quality assurance intended solely for internal use and not designed to contribute to generalizable knowledge – these may include “institutional” surveys or other assessment projects that are less than minimal risk and are only intended for purposes of benchmarking or institutional assessment and are not publicly disseminated
- Data collection activities performed as a commercial service to inform business decisions regarding a specific process or product if the results will not be made public by the researchers, the business, and/or the sponsor (if other than the business)
- Journalism articles
- Theatrical productions
- Art exhibits
- Secondary datasets available online without permission (e.g., IPEDS data accessed through the National Center for Education Statistics website), or data obtained from well-known secondary public data sources that anyone can access but involve a standard registration process (e.g., data obtained from the ICPSR).
Examples of projects that typically are considered research needing review include:
- Oral history projects
- “Action” research conducted by graduate students or faculty in education settings
- Class or institutional projects that will be disseminated for a scholarly purpose, or that involve data collection on sensitive populations or subjects (e.g., minors and/or substance abuse, mental health, sexual identity), involve deception of potential participants, or otherwise present more than minimal risk to participants
- Taking blood or other biological samples from any person other than oneself, unless it is clearly for non-research purposes
- Secondary datasets obtained from a state agency, nonprofit organization, other university researchers, or other private source which are then going to be used for faculty or student research
It is possible that some activities will begin as non-research activities (such as course evaluations) and later spark a research question or otherwise evolve into research, at which time they fall under IRB jurisdiction, and it becomes necessary to obtain IRB approval to use data that has already been collected. When the intent of the activity becomes dissemination to a wider audience and contribution to the general knowledge base in a field, IRB approval is necessary.
Please note that retrospective approval cannot be granted for research studies that have already begun. Investigators must seek a determination and/or IRB review of projects that may fit the definition of research as described above, or risk being found in regulatory noncompliance, which typically results in a finding that the data be destroyed.
The University recognizes that some student projects conducted to fulfill course requirements involve activities that, in a different context, might be viewed as research. As a general rule, when those activities are conducted solely to fulfill a course requirement, an element of the definition of research (the intent to develop or contribute to generalizable knowledge) is lacking. However, it is also the case that some classroom research assignments could place participants at risk. Therefore, recognizing its role in the protection of human participants, the IRB has determined that some classroom assignmtents may require review by the IRB.
UNI considers classroom assignments involving research activities to be educational in nature, and not subject to IRB review, when all of the following criteria are true:
1. The project is limited to surveys, questionnaires, interview procedures, observation of public behavior, minimal risk experimental studies, or standard educational exercises directly related to the topic(s) being studied in an official University course. In general, audio and video recordings made as part of the interview procedure for the sole purpose of accuracy are allowed.
2. Surveys/questionnaires/interviews, if used, contain no sensitive personal questions (e.g., no questions about alcohol/drug use, sexual behavior/attitudes, criminal activity, medical history, grades/test scores) or other personal information that could "label" or "stigmatize" an individual.
3. The participants are not from a special population that requires extra protections (e.g., pregnant women, people in the criminal justice system, children under age 18, cognitively impaired individuals).
4. Either the information is recorded:
a) without any direct or indirect (e.g., race, gender, code number) identifier linking the participant to his/her data; or
b) no direct identifiers are recorded and any indirect identifiers could not be combined to ascertain the identity of some or all the participants; or
c) if direct or indirect identifiers are retained in the dataset, then the other data contained in the dataset could not reasonably harm the participant's reputation, employability, financial standing, or place the participant at risk of criminal or civil liability.
5. The results of the classroom assignment, including audio and video recordings, either do not leave the classroom, or, if the project involves gathering data from or about a company, agency, or organization, the data/results are shared only with that company, agency, or organization, and the company will not share the data or results with anyone else.
If any one of the foregoing criteria is not true, then the project must be sent to IRB for review. It is the responsibility of faculty to determine whether an assigned project involving human participants can be classified as a course-related student project. Faculty should contact the IRB Office if assistance in making this determination is needed. It is also the responsibility of faculty to discuss general principles of research ethics with the class prior to the initiation of the project and ensure that those are followed.
The IRB is willing to review class research projects submitted by students individually or in groups, in order to support the educational process, but please recognize the traffic issues involved. The reviewers cannot always respond to applications from multiple classes during the two or three week window that may have been planned by the instructor for IRB review. Therefore, please do take into account the volume of applications that may be under review at a given time, particularly at certain points in the semester.
The IRB strives to process all applications for IRB review as quickly and efficiently as possible. This is accomplished by the IRB office working with principal investigators to ensure that the applications are complete prior to being forwarded to a reviewer, by conducting as much communication as possible by email, by reviewers striving to complete their initial reviews of applications within 2 weeks of receiving all materials, and by investigators responding to reviewer comments within 2 weeks whenever possible.
To initiate an IRB review, the PI must select, download and complete the correct IRB application from the IRB website. There are three application forms: 1) the Application for Use of Existing Data should be used for studies that only involve review and analysis of data and records that already exist; 2) the Survey Application should be used only for survey research; and 3) the Standard Application should be used for all other studies, including mixed methods. Please note that forms are periodically revised and thus investigators should download a fresh form from the website each time they prepare an application. All applications must be typed; handwritten applications are not accepted.
Several of the questions on the application forms require the Principal Investigator (PI) to develop and attach supplementary documents. Applications missing items required to begin the review will be held at screening until those items are provided.
Supplementary documents that are required in order to begin the review are:
Recruitment materials for each sample and method, including scripts, flyers, letters, emails, etc. (See Chapter 10 for further detail.)
Consent materials for each sample and method, including scripts, forms, letters, electronic display text, etc. Depending on the sample, these may include materials for consent (for adults), assent (for minors), and/or permission (for parents or guardians). (See Chapter 10 for further detail.)
Data collection instruments, including interview questions, questionnaires, and tests, regardless of how well known they are. Qualitative interviews can be approved even if all of the questions cannot be specified in advance, as long as likely questions for each topic are provided. Links to an online test or survey will be accepted (provided there are no access issues) but it is preferred that they be included with the application materials.
Training documentation for the PI, Co-Investigators, and Faculty Advisor (if applicable). Certificates of training for all other key personnel must be on file before that individual becomes involved in the project. The UNI IRB accepts documentation from any legitimate training for this purpose, including those sponsored by UNI, which are provided online by a known training provider or training obtained while employed at another institution. For those who take the CITI training, a certificate will be automatically emailed to the IRB office from the CITI program. Training options offered or sponsored by UNI, such as the CITI program, are described on the IRB training page, along with instructions on how to access them.
Key personnel are those who have authority or responsibility for the design or management of the project, as well as those involved in recruitment, data collection and management activities, including those responsible for maintaining data privacy and confidentiality processes. Individuals who typically do not require training are staff involved only in the analysis or management of de-identified datasets, individuals providing video services, or individuals in the community who distribute written materials or make announcements about the study according to written script(s) provided by the research team. Any person who actually explains the study for recruitment purposes or attempts to answer questions about the research must receive training before doing so.
“On file” means the training certificate is in the IRB office, not in faculty or departmental offices. On file also does not refer to being in the database of a training provider, although the CITI training program automatically notifies the IRB office when someone has completed that program.
Previous IRB documentation for this project. When applicable, copies of IRB applications and/or IRB approval letters from other institutions for the current project are required at the time of submission.
Second language materials are required at the application stage. This refers to recruitment materials, consent documents, data collection instruments, or any other text that will be seen or heard by the participants. If participants are not fluent in English, these materials must be developed in (or translated into) the participants own first language, and must be made available to the IRB for review. The IRB may or may not choose to consult a speaker of that language for assistance, if the reviewer is not fluent.
Letters of cooperation from any external research site or cooperating organization will be required. These may come in during the review but at least one must be on file with the IRB before the application can be approved. These should not be confused with consent documents from individual participants (see Chapter 10). A letter of cooperation serves as documentation from the research site that the investigator has permission to conduct the research at that location. The letter typically must be from someone in authority at the organization, not a group counselor or teacher. Although the PI is encouraged to likewise have contact with others in the organization whose cooperation will be needed to carry out the research (e.g., teachers who will be distributing consent forms to students), only the top individual needs to document permission. An exception to this rule is that letters are occasionally permitted from coaches or professors in large or international institutions, when it makes more sense to seek the permission of someone closer to the research rather a central administrator. PIs are cautioned to check with central administration at colleges and universities, however, because they sometimes have their own rules about oversight of research conducted at their institutions.
When the research is being carried out at UNI, letters are only required from special departments or areas, primarily coaches of sports teams, directors of student clubs, and individual faculty or departments who are providing a dataset to the PI for analysis. Please note that some departments, such as the Registrar, may themselves require documentation of IRB review (or that IRB review is not needed) prior to providing a mailing list or contact information for potential participants.
A letter of cooperation may be submitted to the IRB as a formal signed hard copy letter or as an informal email or fax from the organization. Regardless of format, the letter must show the individual’s name, title, organization, and contact information. If by email, the email must show the originator’s email address (in the case of forwarded emails). The letter should also say something about what is being permitted (e.g., to allow the investigator access to recruit participants, to allow the investigator to carry out the data collection on site, to allow posting of a flyer, or to serve as a “conduit” for distributing recruitment materials). If the letters do not contain the required contact information or are not from a person in authority, the PI will be requested to seek another letter or email.
If the study requires multiple sites, the PI has the option to draft the “letter” of cooperation as a form and simply request signatures from the research sites. Also, the study may be approved as a multi-site project with only one letter of cooperation on file. The PI is then required to ensure that letters from each additional site are provided to the IRB before initiating any research at those locations. When an additional letter is received for a multi-site study, the IRB Administrator will send a confirmatory email to the PI authorizing the research to begin at that location.
Submission and Screening
When the application and all necessary attachments are complete, the application may be submitted by email or by hard copy to the IRB Office in the Office of Sponsored Programs, in 213 East Bartlett Hall.
Submission by Hard Copy: If by hard copy, the application must be signed by the PI, and if the PI is a student, it must also be signed by the Faculty Advisor. Only one copy is needed, which can be mailed or dropped off at 213 East Bartlett Hall, campus mail code 0394.
Submission by Email: If by email, it is preferred that the application and all its attachments be submitted as one pdf or Word file. The application must be emailed to the IRB Administrator by the Principal or Co-Investigator. If the PI is a student, the email must include a copy to any co-investigators and the student’s Advisor to indicate that the Advisor and other members of the team are aware of the submission and have approved its contents.
After submission, each new application is given an IRB protocol number for tracking purposes. Please use this number in all correspondence with the IRB whenever possible. The applications are then screened for completeness by the IRB Office in the order in which they are received. If questions are not answered or required supplementary documents are not attached, the application will be placed in a temporary file and an email will be sent to the PI requesting those additional items. The application will not be forwarded to a reviewer until the necessary documents are in place for the review to take place.
The items most commonly missing from submitted applications, thus requiring communications with the PI at the screening point, are:
- Training certificate for PI and/or Advisor
- Letter of cooperation from at least one research site (including schools)
- Additional consent or assent forms called for by the research design
- One or more of the data collection instruments listed in the application
- Recruitment materials that match procedures (e.g., verbal script)
- Written justification for requested waiver of documentation of consent
It is possible, under special circumstances, to request review of a study for which some of the materials are not yet available, because the project development is scheduled to take place over a period of time. In those cases, the PI may request a “concept” review or a review of all procedures except X, and receive approval to proceed with initial activities only. If this situation is approved by the IRB, the PI will be required to submit the materials for subsequent phases of the study as a modification request and receive approval for those components prior to implementation.
When the application is complete, it will be forwarded to the IRB Chair or other designated IRB member for initial review.
When the IRB Chair or designated reviewer receives the protocol, s/he conducts an initial review and makes a determination of whether the study requires full board approval. Studies that require full board review are typically those that are deemed to involve more than minimal risk, that do not meet the regulatory criteria for Expedited or Exempt review, and/or involve sensitive issues that the primary reviewer would like to have considered by the full board. If the study is referred for full committee review, the PI is so notified, the application is forwarded to all IRB members, and the protocol is scheduled for review at the next regularly scheduled IRB meeting.
Expedited and Exempt Reviews (No more than Minimal Risk)
If the study does not require full board review, the initial reviewer will undertake the review individually, consulting with other IRB members or special experts as needed and appropriate. Reviewers strive to complete the initial reading of each application within two weeks of receiving it, although this is not always possible, depending on schedules and volume. After initial review, the reviewer will email any questions, comments, or requests for adjustment to the PI, and if a student PI, to the Faculty Advisor. The PI is expected to respond within two weeks with answers to the questions posed by the reviewer, any questions the PI may have, further discussion as needed, and/or edited documents. It is not required that all changes requested by the reviewer be made exactly as requested without discussion. If the PI has questions or concerns, they should be shared with the reviewer, so that reviewer can help find solutions whenever possible.
Communications between the PI and the reviewer are most efficient if the following guidelines are followed by the investigator:
1. Respond directly to the reviewer, by “Reply All” email, not by starting a new email string.
2. Insert (or keep) the IRB protocol number in the Subject line.
3. Only return the items requested, not the entire application.
4. Respond to ALL items, not just some, and preferably in the same email, in the same order as listed in the review.
5. Mark any changes made to edited documents – don’t just edit them and return a clean copy (because then it takes so much extra time to find the changes made).
6. Always, always, copy the IRB Administrator on ALL communications.
7. If you have not heard from your reviewer in 2-3 weeks, check in with the IRB Administrator. Likely the cause is work overload, but it may be possible that a communication has gotten missed.
The primary reviewer may review and approve a study that does not require full board approval under one of two categories: Expedited or Exempt. The criteria for approving studies as Expedited or Exempt are outlined in the Federal regulations (45 CFR 46.110 or 45 CFR 46.101). Expedited approval means that the study must be reviewed again periodically, at least annually. Exempt approval means the study does not need standard continuing review and approval. In all cases, whether Full Board, Expedited, or Exempt, the PI must report any serious adverse events that arise during the study and must request review of any changes to the protocol before implementing them.
When the review and any discussion is complete, the reviewer will send an approval email to the PI and the Faculty Advisor, if the PI is a student, indicating that the study may proceed. It is highly unusual for a study at UNI to be disapproved. Most often, the reviewers have resolvable concerns regarding the procedures or participant materials and will recommend changes to the PI during the review process. In the rare event that the reviewer and PI cannot reach an agreement on the changes needed, the PI may request that the application be forwarded to the entire IRB for further review and discussion.
Full Board Review (More than Minimal Risk)
In the event that a study is reviewed by the full committee, the investigator will be invited but not required to attend the meeting. Investigators are encouraged to accept the invitation in order to save time in the process by discussing the study at the meeting and answering any questions that the IRB members have. Investigators who wish to attend the meeting must inform the IRB Administrator. Upon arrival, investigators or visitors should be seated in the reception area and wait to be called into the meeting at the appropriate time.
For full IRB review, a complete set of documents is sent to each IRB member who will review the protocol and supporting documentation in detail prior to the meeting. In preparing for the meeting, the Chair or other primary IRB reviewer may contact the investigator, co-investigators, other IRB members, or outside sources as necessary to insure a thorough evaluation of risks and benefits of the proposed research. The protocols undergoing initial review are presented and discussed individually by the IRB, in addition to those protocols undergoing continuing review.
After complete and individual discussion, each protocol is voted upon for one of four possible dispositions. The Board may vote to approve a study, table a study, approve a study with explicit conditions, or disapprove a study. A study may be tabled either because the Board did not have sufficient time, or expertise, or appropriate personnel present (i.e., absence of prisoner advocate for a study involving prisoners) to vote on the study or because the Board needed substantive clarification or modifications regarding the protocol or informed consent documents to determine whether to approve or disapprove the study. A study may be approved with explicit conditions when the convened IRB is able to stipulate specific revisions that require simple concurrence by the investigator. If the IRB approves a study with explicit conditions, then the primary IRB reviewer or Chair may subsequently approve the revised research protocol on behalf of the Board, after determining that the investigator has incorporated the specified explicit conditions into his or her project. In a rare circumstance, the study may be disapproved because the protocol describes a research activity that is deemed to have risks which outweigh potential benefits or the protocol is significantly deficient in several major areas. A principal investigator has the right to appeal the disapproval of his research protocol to the Board and asked to have the decision reconsidered.
If the protocol disposition is "Approved" or "Approved with Explicit Conditions" and the protocol requests inclusion of a vulnerable population(s), special determinations for the vulnerable population(s) may be made during the meeting as well. These will be documented in the minutes and communicated to the investigator(s).
The minutes will also document if the study was determined to be More than Minimal Risk or No More than Minimal Risk. Studies reviewed by the full board initially that are determined by the IRB to be no more than minimal risk may be subsequently reviewed through an expedited process if the IRB so decides.
If a waiver of consent or waiver of documentation of consent (see Chapter 10) is granted, whether by the full board or through Expedited or Exempt review, this will be noted in the IRB minutes (for full board studies), in the IRB database, and in the protocol file.
Administrative Closure (study closed by the IRB)
If an application remains pending for 30 days with no action or communication by the PI, the PI will be sent an email notification of the intent by the IRB office to close the file. The PI may respond at this point and request that the file be kept open longer if additional activity on the application is expected. If no response is received, the file is closed. If the PI subsequently decides to pursue the study at a later date, a new application for review must be submitted.
When a study is approved, the primary reviewer or Chair on behalf of the full committee will so notify the PI and Advisor, and the study may begin immediately upon receipt of the email. Subsequently, a formal letter of approval will be issued by the IRB Office to the PI, any Co-Investigators, and Faculty Advisor, if applicable. The letter will indicate the duration of approval, if applicable, and remind investigators they must report serious adverse events as they occur and request approval for modifications prior to implementing them. No portion of a study involving the participants, including recruitment/invitational activities or data collection, may be initiated prior to the email notification of approval from the IRB.
Duration of Approval
All Full Board and Expedited studies must be periodically reviewed again at least annually (see Chapter 13). There are times when the risks associated with a particular protocol are such that continuing review should take place more frequently than annually. In these cases, the IRB will specify that the PI report to the IRB either at a shorter time interval or after a specified number of participants (e.g., after each participant or after 3 participants) are enrolled. The PI's report must describe the observed effects of the research activities and/or how the participant(s) responded to the research interventions. Such a determination will be recorded in the IRB files (e.g., minutes), along with whether the reports will be reviewed by the full board or primary reviewer.
Appealing an IRB Decision
If the IRB makes a decision that an investigator believes to be unfair, unsubstantiated, or unduly restrictive on his/her proposed research, the investigator should first discuss the matter with the Chair of the IRB and the IRB Administrator. The investigator should be prepared to present reasons that he/she believes that the proposed research is in compliance with University policy and Federal regulations for the protection of human participants.
If the issue cannot be resolved satisfactorily by negotiation, the investigator may appeal the decision, in writing, to the IRB. In developing his/her appeal, the investigator is encouraged to seek the advice or opinion of an objective, qualified consultant (or consultants) to support the claim that the proposed research is in compliance with human participants policy and regulations.
The investigator must appear before the IRB to present his/her appeal and any supportive material or documentation obtained through consultation. Based upon this appeal, the IRB will issue a final determination on the proposed research.
General Principles of IRB Review
The IRB is responsible for protecting the rights of human participants engaged in research. This is achieved through a careful review of the proposed study, including the scientific design, methodology, study procedures, participant population, recruitment procedures, and consent processes. Through this review, the IRB seeks to balance the risks to the participants against the scientific knowledge to be gained and the potential benefits to society.
Federal guidelines grant the IRB autonomy in the interpretation of regulations for review of research studies. Thus, each IRB must apply its own discretion when deciding how a research proposal will be judged to meet the ethical criteria provided in the regulations. And, in the case of informed consent, 45 CFR 46 allows the IRB to waive the requirement for written consent in special circumstances. This means that each IRB must independently determine the nature of research risks and research benefits, the extent to which risks to participants are "reasonable" in relation to anticipated benefits, when research risks and benefits justify modification of the informed consent requirement, and what constitutes equitable participant selection.
No involvement of human participants in research, including initial contact and recruitment, is permitted until the IRB has reviewed and approved the planned procedures. It is the responsibility of the investigator to obtain approval from the IRB prior to the initiation of any research, including recruitment activities and pilot or pre-test studies.
IRB review is grounded in the following essential principles for participant rights and protections:
- All activities involving humans as research participants must provide for the safety, health, and welfare of every individual. Rights, including the right to privacy, must not be infringed. No participant in a research activity shall be exposed to unreasonable risk to health or well-being.
- An individual does not abdicate any rights by consenting to be a research participant. A participant has the right to withdraw from a research project at any time or can refuse to participate without loss of benefits to which the subject would otherwise be entitled. Further, a participant has the right to receive appropriate professional care, to enjoy privacy and confidentiality in the use of personal information, and to be free from undue embarrassment, discomfort, anxiety, and harassment.
- The direct or potential benefits to the participant, or the importance of the knowledge to be gained, must not preclude consideration of the inherent risks to the individual.
- The confidentiality of information received from participants in experiments or respondents to questionnaires or surveys shall be fully protected, both during and after the conduct of a research activity, within the limits of the law.
- Participation in projects must be voluntary. Informed consent must be obtained from all participants and must be documented (unless the requirement for documentation of consent is specifically waived by the IRB). Methods in accordance with the requirements of 45 CFR 46.116 and 46.117, appropriate to the risks of the research, must be used to obtain the participants’ informed consent.
- In research involving more than minimal risk or substantial stress or discomfort, such risk, stress, or discomfort shall be carefully explained to the participant before his or her participation and justified by the expected benefits of the research. The investigator shall be satisfied that the explanation has been understood by the participant; and the written consent of the participant (unless otherwise waived by the IRB), containing the substance of the explanation, shall be obtained and kept as a matter of record for 3 years.
Most investigators are able to readily identify the potential benefits of their proposed research to the knowledge base in their discipline as well as to society, since those are often the underlying motivations for undertaking the research. Identifying the potential benefits and risks to participants can be a little more challenging, and it is not uncommon for our judgment as researchers to become clouded by a strong desire to realize those benefits to society. It is also helpful to recognize the personal advancement that is the intended product of most research endeavors in an academic setting. With that in mind, it is particularly important to carefully consider the possible participant benefits and risks to ensure appropriate procedures and protections are established. All research can be said to carry some risk, including inconvenience at the very least, but much of the research done has little direct personal benefit to participants. Payments or incentives provided to participants who consent to the research are not considered benefits to the research – they are considered compensation for efforts. (See Chapter 11.) We seek their involvement primarily as volunteers in the hope that their contributions will lead to the broader benefits to society.
Benefits are only likely to accrue directly to participants if something beneficial is being provided to them as an aspect of the research. Experimental medical treatments may be of benefit to patients who are ill, as may new counseling services to those who are in need of psychological care. Children may likewise benefit from involvement in an experimental new approach to education. But some research does not involve experiments with new services or interventions, but instead are designed to simply examine outcomes of existing programs or methods. There may therefore be no benefits to participating in the research at all. However, if the risks from the research activities are likewise low, nonexistent, or sufficiently mitigated, the study can still be approved.
Risks of potential harm to participants can sometimes be subtle, and should involve an assessment of both the magnitude (severity) and likelihood (risk) of the potential harms. Death would be a very serious harm, for example, but the risk of its occurrence in relation to a given research project may be extremely low or nonexistent. More common are potential psychological or privacy harms that actually do have a reasonable chance of occurring as a result of research participation. Discussion of sensitive topics may cause emotional or psychological concerns, particularly in individuals with particular vulnerabilities. Employability or reputational harms could result from individuals sharing negative opinions or private information, and they could actually have a reasonable risk of occurrence if the data were to become known, unless the PI takes precautions to mitigate the risk of a potential breach of confidentiality. Mitigation of risks does not render potential harms nonexistent or less harmful; it merely reduces the likelihood they may occur. In almost all studies, participants run the risk that they will be inconvenienced and their valuable time used profitably or wasted, making it all the more important that the PI develop a sound design that has a reasonable chance of at least benefiting society through an increase in knowledge.
Further reading on this topic can be found in the IRB Guidebook, published by the Office of Human Research Protections (OHRP).
Who actually are the participants in a research project? The answer is obvious in most studies, but there are some interesting nuances that investigators should be aware of. Below are examples of when individuals are and are not considered participants in a study. This is important in part because anyone who is considered a participant must provide assent or consent in order to be included in the study.
1. When individuals provide any kind of information about themselves, they are obviously participants.
2. When individual-level information is included in a dataset (whether they can be identified or not) the individuals are typically participants. (See Chapter 7 to determine when IRB review is required.)
3. When an individual provides information about other individuals, the others are the participants. For example, when a principal provides information about individual teachers, such as their age, gender, and college degree, the teachers are the participants, not the principal. However, if the principal offers opinions about how well-prepared each of the teachers is, then the principal also becomes a participant. If the principal only provides aggregate data about the teachers (e.g., 50% have MA degrees), then there are no participants involved at all – it is not human subjects research.
4. Somewhat similar criteria as shown in item 3 can be applied to parents and children. If parents provide individual information about their children, the parents are only informants and the children are the participants. If they provide opinions about each of their children, both the parents and the children are participants. Providing aggregate data about the children would depend on how large the family is – if a small family, all would be participants. For a very large family, it could be argued that only the parents are the participants if no individual data could be inferred.
5. Multi-phase studies involving “helpers” versus participants can be a little tricky. Here are some examples:
a) In phase 1, a panel of teachers with special expertise is invited to review and suggest further developments for a new curriculum developed by the researchers. These teachers would be considered expert “helpers”. In phase 2, a second larger group of teachers is recruited to use the curriculum, likewise provide a critique and suggestions for development, and share outcome data from the children in their classes. This one is in a grey area - teachers are both expert commentators (helpers) as well as participant teachers, because their performance using the curriculum is being assessed as well as the curriculum. Unless the student outcome data provided by the teachers to the researchers is in aggregate (e.g., 50% of the students got A’s), the students are also now participants. In phase 3, another group of teachers are invited to use the curriculum and provide attitudinal data (opinions) about how well the curriculum worked as well as student outcome data. These teachers are only participants, not helpers.
b) In phase 1, a group of individuals is taped speaking English. In phase 2, these videos are shown in systematically varied ways to ESL students learning to speak English, and the students are asked to rate the confidence level of the speakers as well as take language tests assessing their own speaking abilities. The individuals taped in phase 1 are providing stimuli for the study – they are not participants. The students who are rating them and providing data about themselves are the participants in the study.
The purpose of this discussion has been to distinguish when individuals involved in a research project are or are not serving in the role of participants because participants must typically provide formal consent. However, there is some overlap between this discussion and the question of whether or not a given data collection activity involves participants at all and thus needs review by the IRB. That question is answered more fully in Chapter 7 – Which Projects Need Review.
Privacy and Confidentiality
In most research projects, it is incumbent upon the researcher to protect the privacy and confidentiality of those who volunteer to serve as participants in the study. First, it is important to understand the difference between the two concepts. Privacy is defined by Merriam-Webster as: a) “the quality or state of being apart from company or observation”, and b) “freedom from authorized intrusion”. Thus, privacy has to do with the privacy of the person. Confidentiality has more to do with the private or secret nature of information.
In regard to privacy, researchers must consider whether or not others are present when individuals are invited to participate in a study as well as when they are actually participating. During the recruitment process, it is important to provide ways for individuals to say “yes” or “no” to the study without others being aware of their choices. This is particularly important when the study topic is somewhat or very sensitive and/or when others’ knowledge might influence the decision that the potential participant might make. Recruiting potential participants in individual situations helps avoid this issue. Inviting participation by phone (if others are not in the background listening to the conversation) or by email may be good options. Researchers must strive for the degree of privacy that matches the sensitivity of the study. It would be completely inappropriate to recruit domestic abuse victims by visiting their homes. On the other hand, it is typically acceptable to ask students who are interested in participating in a study about reading habits to simply drop their surveys in a box at the front of the room. Similarly, if the study topic or population has the potential to harm an individual’s reputation or might simply embarrass them if they were overheard, obviously then interviews must be conducted in a private setting. Likewise, participants must not fill out sensitive questionnaires and then drop them in a box, or even sometimes hand them directly to the researcher. A better option is to have them sealed in an envelope first.
As noted, confidentiality pertains to what happens to the data or information collected or analyzed during the study. The fact of an individual’s participation should be kept confidential, as well as the data provided, unless there is a reason to do otherwise (see below). There are a variety of methods that researchers use to maintain confidentiality, which again should be tailored to the study’s potential risks. At the very least, if the study is at all sensitive, the names of participants should be kept in a separate electronic or physical file from the other data provided, and a password-protected master code list maintained to connect them. Researchers should always consider whether they actually need the names of participants in the first place – if not necessary for future contact or research purposes, the data should be anonymous.
It is beyond the scope of this discussion to examine all of the procedures that can be used to track, connect, and/or protect the privacy of individuals and confidentiality of data. It is simply important to note that all potential participants have a right to know what steps, if any, are being taken by the researchers to protect their privacy and confidentiality, in order to make an informed decision about whether or not to participate.
In some cases, even in sensitive studies, it may be appropriate for participants’ identities to be known. In some qualitative studies, for example, participants may be considered partners in the research and the researchers may wish to offer the option for participant names to be associated with the results. This is certainly acceptable – it simply needs to be documented one way or the other by each participant. Similarly, the researcher may wish for some reason pertinent to the study to NOT protect the identities of participants. This then needs to be clearly stated in the consent information for potential participants to consider when deciding whether or not to participate.
One final issue in regard to privacy and confidentiality is the question of direct versus indirect identifiers. Direct personal identifiers include information such as name, address, telephone number, social security number, identification number, medical record number, license number, photographs, and biometric information. Indirect personal identifiers include information such as race, gender, age, zip code, IP address, and major. Researchers must be aware that, even in anonymous studies with no direct identifiers, indirect identifiers can sometimes be combined to ascertain the identity of a participant. This is most common when one or more of the identifiers is relatively rare in the population (e.g., some racial/ethnic groups in some geographic areas in the state). When this is the case, caution must be used to guard that information to prevent identification, particularly in higher-risk studies. Different fields have various methods for doing this, but a common procedure is to not report certain information in the study results when identification becomes possible.
Researchers and the members of their team must be qualified to carry out the procedures outlined in their research design or obtain the oversight and/or participation of others who do have the qualifications. If questions arise, the IRB may request that the researchers document that they or their key personnel have the appropriate qualifications. This is typically only an issue when special procedures are being undertaken that require particular expertise, such as certain therapeutic procedures. All key personnel, however, should be trained in human subjects protections and research procedures that they are responsible for (e.g., how to invite participation in a study without introducing undue influence).
Initial Contact with and Recruitment of Participants
Participant recruitment is the process of inviting individuals from the target population to consider participating in the research project. The process begins with the initial contact with potential participants, whether that be in person, by email, over the telephone, or on the web, and whether it be directly by the investigator or by someone else acting on behalf of the investigator. During the recruitment process, potential participants receive information about the study that will help them decide if they wish to learn more and possibly become involved in the study. Therefore, the IRB must review these procedures before they are implemented and as a general rule, investigators may not have any contact whatsoever with potential participants prior to IRB review of the study.
In order to review the procedures, the PI must provide a copy of the information being provided to potential participants as part of the recruitment process. The recruitment language, whether it is the form of an email, an oral script, a letter, or a flyer, must be provided with the IRB application. The information provided at recruitment is typically not as extensive as that provided at the consent phase. Sometimes, the recruitment and consent processes occur simultaneously (such as in telephone interviews), in which case, this must be explained in the IRB application. Missing recruitment information, such as the recruitment email or script, is a common cause of delay in the review process.
In oral history projects or other studies in which the sample is very targeted and relatively small, the investigator may wish to have very preliminary contact with potential participants in order to determine the feasibility of the research prior to fully developing the study design and IRB application. In this situation, the investigator should first contact the IRB Administrator or Chair and confirm the appropriateness of the preliminary contact.
In service or educational programs, the service provider (who may also be the researcher) may sometimes need to invite participation in the program prior to inviting participation in the research aspects of the project. This is permissible, provided that a) the program is not part of the research; in other words, the service or training would take place with or without the research component; b) any information about the research is only referred to in the most general terms (e.g., “at a later date, you will receive an invitation to participate in research associated with this program, but your involvement in the program will not be affected by whether or not you decide to participate in the research”). Please refer to Chapter 11 for other special considerations pertaining to program evaluation, services research, workshops, and educational assessment activities.
Contact with and Recruitment of Research Sites
It is permissible, and in fact advisable, for researchers to have contact prior to IRB review with cooperating organizations and research sites regarding their willingness to play a role in the project. If external sites are involved in the study, the IRB will require documentation of permission from at least one research site prior to approving the study. See Chapter 8 for further details.
If the individual in authority at the prospective site is also a possible participant in the study, investigators should be careful not to confuse requesting permission to conduct the study at that site with inviting the individual’s participation as a possible subject in the study. This can happen, for example, when the purpose of the study is to interview school administrators, including superintendents and principals. In this case, the PI should wait and first submit for IRB review a special letter of invitation for the top administrator in each school or system that requests permission to conduct the study as well as a personal solicitation to participate as a subject. The IRB would then approve the study contingent on receiving letters of cooperation from each of the sites, and after receiving authorization to proceed from the IRB Administrator, the PI would then proceed to seek formal consent and otherwise collect data from that individual and all of the other administrators in that location. As with all consent documents, the consent form signed by the participant-administrators would not be provided to the IRB, only that initial letter/email of cooperation on behalf of the organization. A parallel situation could arise for studies involving other organizations or companies, and the same process should be considered in those circumstances as well.
An underlying ethical principle of the federal regulations is that human participants enter into research voluntarily and with adequate information. (See The Belmont Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research, 1979.) Thus, consent must be informed and voluntarily given. A participant’s consent is “informed” if he/she has a reasonable comprehension of that to which he/she is consenting. The investigator must use language appropriate to the participant’s ability to comprehend. Generally, consent information should be provided at no more than an 8th grade reading level. Information may not be withheld from participants simply to assure their participation in the research.
Consent should be considered a process, not an event. Although consent is typically documented by the participant signing a form, the form itself is not the consent (although it is often referred to in that way). The consent is the individual’s decision to participate and/or to continue participation. It is the researcher’s responsibility to ensure that the participant is consenting throughout the study procedures. Participants have the right to withdraw consent and terminate participation at any point, and researchers must be attuned to the participants’ state of mind and allow for this to occur, particularly when participants may find it difficult to express their feelings if they believe it will make the researcher unhappy.
Coercion and Undue Influence
Any legally competent adult can give consent; but said adult cannot give valid consent if he/she is under the influence of alcohol or drugs, or if the consent is obtained under duress or undue influence. To ensure that participants’ consent is voluntary, the IRB considers whether any undue pressures or coercion will be brought to bear on potential participants. Excessive compensation or no payment for withdrawals can be viewed by the participants as pressure to participate or continue participation. Other pressures may be more subtle as, for example, when individuals request that family members, friends, or colleagues participate in a study they are conducting. An indirect method of recruitment (e.g., email) may be best in these situations.
Undue influence occurs most commonly when the researchers is in a formal position of power over the potential participants –supervisor/employee, counselor/client, teacher/student. It is best to avoid these situations whenever possible. For example, investigators should try to avoid using their current students in their research projects. If current students must be used, it must be made clear to the participants that the decision to participate will have no effect upon their grades or other standing in the course. Typically this means that someone other than the investigator must recruit the participant and/or collect the data so that the investigator has no knowledge of who did or did not participate, or that consent to use student work be obtained after the close of the semester or school year when the instructor no longer has a differential power relationship with the participants. Investigators should be aware that the IRB will not approve a study when coercion or undue influence is present - even if no adequate alternative design is available - unless the IRB is satisfied that voluntary consent can be obtained and undue influence or coercion to participate has been mitigated by the study procedures.
The consent process involves the researcher or key personnel providing the consent information – the information participants need to make an informed decision – and then the individual decides whether or not to proceed. There are several “elements” of consent that reviewers are looking for in consent materials, which are all listed on an Informed Consent Checklist. Sample consent forms are also available to assist investigators in the preparation of their own consent materials. The samples reflect both requirements of the federal regulations and customary language adopted by the IRB. Use of the Checklist and samples will facilitate IRB review.
Consent information may be provided orally, in written form, and/or by electronic text or display, according to the nature of the study. Providing consent information in written form is the standard, preferred method, and thus researchers must provide a justification when proposing other methods. The justification is often inherent in the method, however. For example, oral consent makes more sense in telephone interviews, rather than mailing the consent information or asking participants to return a signed form. Likewise, online or email surveys will typically provide the consent information in the email text or on the webpage (electronic display). There are other situations, however, when a written consent process is not best for the participants, such as when language or literacy issues are present. Oral consent (assent) is obviously more appropriate for young children and for individuals with certain significant communication problems. In some communities and countries, there may be cultural concerns. In these cases, the investigator must explain the justification on the IRB application form when proposing an alternative to written, signed consent.
Waiver of Consent
Certain studies can only be undertaken if the potential participants are not aware of the nature of the study, or that the study is even taking place. In these cases, the PI must request a waiver of consent (or some of the elements of consent). It is also possible to request that the consent requirements be waived in cases where the research is important but consent would be impossible or highly impractical to obtain. This type of waiver is unusual and must not only be justified by the requirements of the study design, but also well-balanced by its benefits. Waivers can be requested by checking the appropriate box on the application form and providing a written justification on the form as to why the waiver is appropriate.
Documentation of Consent (Consent Forms)
The standard consent process is for the PI to develop and provide a written informed consent document to a potential participant that includes signatures lines for participants as well as the PI and Advisor (if the PI is a student). If the individual is interested in participating in the study, s/he signs the form as well as the PI (or other key personnel), the participant is provided a copy, and the PI or Advisor keeps it in a secure location, separate from the data, for at least 3 years. Each participant must be offered a copy of the consent form when written consent is obtained.
Researchers should not provide signed consent forms to the IRB. They should be kept in a private, locked filing cabinet and not provided to anyone outside of the study team, unless specifically requested by the IRB as part of a study audit or other review process. PIs should notify the IRB if an outside agency or court of law requests to see the consent forms.
Waiver of Documentation of Consent
The standard written informed consent agreement provides the PI with documented proof that participants gave informed consent, and it partially protects the PI and the University of Northern Iowa from later charges of misconduct. The IRB recommends that written documentation of informed consent be obtained whenever it is appropriate and possible to do so. However, if in the PI’s judgment obtaining signed consent is inappropriate or risky in itself, and thus the consent method being proposed is oral, electronic, or by mail, the PI may request a waiver of documentation of consent by checking the appropriate box on the IRB application and providing a justification as to why the alternate method is more appropriate. Note that this is not a waiver of consent, but a waiver of the standard requirement to obtain documentation of consent from the participant (the signatures on a form).
When a waiver of documentation of consent is granted, it is nevertheless highly advisable for investigators to document in some other fashion that consent was obtained. One alternative is to tape record the interview, or at least the informed consent procedures. A second procedure is to have a witness (e.g., a research assistant) record in written notes that the participant was fully informed, and gave consent. Under some circumstances the IRB will accept the most minimal documentation: a note in the PI’s own records stating that he/she followed informed consent procedure and obtained fully informed consent. If the researcher chooses to use this minimal documentation procedure, he/she should explain why no other form of documentation is appropriate. The greater the risk is to the participant, the greater the burden on the researcher to justify a less conventional means of documenting consent.
General Ethical Principles
A primary principle in human participants research is that a participant's decision to become involved in the research must be voluntary and free of undue influence or coercion, including potential undue influence through payments or rewards for participation. On a practical level, it is probably impossible for an IRB to determine what amount of money or type of reward would unduly influence a particular individual to accept a given degree of risk. Although our society generally accepts the premise that those assuming risk deserve reward, the application of this rule in establishing payment for participants in biomedical and behavioral experiments is still being debated. The appropriateness of proposed payments is therefore a matter each IRB must address for each study.
Clear cases of coercion (e.g., actual threats) are readily identifiable; it is more difficult to recognize undue inducement. An offer one could not refuse is essentially coercive (or "undue"). Undue inducements may be troublesome because: (1) offers that are too attractive may blind prospective participants to the risks or impair their ability to exercise proper judgment; and (2) they may prompt participants to lie or conceal information that, if known, would disqualify them from enrolling or continuing as participants in a research project.
When determining the appropriate level of renumeration, the principal investigator (PI) should take into consideration the participants' medical, employment, and educational status, as well as their financial, emotional and community resources. These considerations should be applied regardless of the form of payment, which may be offered by cash, gift card, gift (e.g., T-shirts or books), entry into a drawing, travel or child care reimbursement, course credit, or no-cost services or treatment.
Record Keeping and Payment Process When University Funds are Involved
Following approval of the study protocol by the IRB, the PI will need to work with the Office of Business Operations (OBO) and/or the Office of Research and Sponsored Programs (RSP, for externally funded projects) to set up the participant payment process, if the study involves direct payments to individuals from university funds. The appropriate process will depend on which type of compensation is planned and the dollar value of the compensation.
I. If individual payments to participants will not exceed $75 AND any recurring payments to individuals will not exceed $599 in any one year, investigators may choose to pay participants by cash, gifts or gift cards, or entry into a drawing. If the PI wants to pay cash to participants, or purchase gift cards to use for participant compensation, a cash advance should be requested using the OBO Cash Advance form. Purchase of gift cards with personal money for which the PI then requests reimbursement is acceptable, but not encouraged, particularly if the exact number of participants is not certain. The PI should not request that University checks be issued to pay participants because doing so requires that participant identity and contact information be revealed to others outside of the research team, which is not required for payments under the $75 individual - $599 annual threshold. If the PI wants to provide a gift, those should be purchased using standard departmental processes for doing so, and then provided to the participants after they complete the study task for which they are receiving payment.
When requesting a cash advance or reimbursement for purchase of gift cards, the cash advance or reimbursement form must be accompanied by the IRB Approval letter and the page from the IRB application that documents the number of planned participants. Investigators will not be limited to payments for the exact number of participants originally planned. The number may vary over the course of the study, but if significant changes to the sample size or a new sample population should be necessary, the PI must send an email to the IRB Administrator requesting approval for a study modification before proceeding further.
Investigators are cautioned to use appropriate financial tracking procedures when managing participant payment processes. If cash or gift cards are lost or stolen, the PI will be required to reimburse the University for the loss. In addition, in all cases, including anonymous studies, the PI must maintain a tracking list or spreadsheet with individual code numbers and payments to ensure that no one individual receives a total of $599 or more, which would require following the procedures listed below. If the study is not anonymous, the PI must also keep a master list linking code numbers and individual participant names and contact information, which must be kept in a password protected computer and/or locked filing cabinet. The tracking spreadsheet or other documentation with study and individual code numbers must be kept indefinitely to allow for an audit of expenditures if required. If the PI is a student, the tracking spreadsheet and master list must be turned over to the student’s Advisor for storage long-term.
II. If individual payments will exceed $75 OR any recurring payments to individuals may exceed a total of $599, investigators may choose to pay participants by University check, gifts or gift cards, or entry into a drawing. The use of cash payments is not allowed for these studies.
If compensation is by gift or gift card, the researchers must record the individual’s name, UNI ID#, address, and signature at the time of payment, using the OBO Acknowledgement of Payment Receipt form. The PI then retains this information in a confidential manner, except that a copy of all signed forms must be sent to OBO at the end of the study. If the compensation is by University check, participant name, ID, and contact information must be provided to OBO on a Request for Payment form and then checks will be issued.
As above, the PI must maintain a tracking spreadsheet of individual and study code numbers and payments to track how much individual participants are being paid for the study.The PI must also keep a master list linking code numbers and individual names, which must be kept in a password protected computer and/or locked filing cabinet.Tracking information must be retained per the document retention schedule. These items should be kept for the length of time identified for Request for Payments in order to allow for an audit of expenditure documentation if necessary.
In the event a PI wishes to propose a study that may include compensation that will go over the $75 - $599 thresholds, and will be either anonymous or include a waiver of consent signatures, the PI must request special approval for this in the IRB application. It is likely the request will only be approved if providing signatures will pose a significant risk to participants, compensation is strongly indicated for study success, and the study benefits are expected to be quite high. The IRB will also confer with the OBO before approving such a request.
UNI Employees and Students as Study Participants
In the event the participants are employees or students at UNI, regardless of the value or type of compensation, all names and contact information and UNI ID# of participants who elect to receive compensation must be provided to OBO, so that the dollar amount (or value) can be included in the individual’s tax statements as required by IRS. Participant signatures will also be required for any payments made over the $75 - $599 thresholds. This policy is applicable even if the actual payments to UNI employees or students come from another organization and UNI is just a co-sponsor of the study in some way (e.g., someone at UNI is a co-investigator). Again, a special request can be made for a waiver of this policy, but significant justification will be necessary for approval.
Informed Consent about Payments
In those studies where names, contact information and UNI ID# (but not their research data) must be submitted to OBO (all university employees and students and all non-employees who are eligible to receive an individual payment exceeding $75 and/or receive more than $599 in one year, either in one study or through multiple studies) the participants must be informed about this policy during the consent process, and that they will receive a tax form from the institution at the end of the year. They must also be informed that the business office has careful procedures in place to keep such information confidential, and that they may elect not to receive payments if they prefer not to have their identifying information provided to anyone outside the research team.
Research Using Existing or Secondary Data
Research that involves the use of existing data, documents, records and pathological specimens, or diagnostic specimens must be reviewed in advance of receiving or analyzing the data. If the data contain individual identifiers, the research may be eligible for an expedited review. If the data are recorded so that participants cannot be identified, either directly or through identifiers linked to the subject, the research may be reviewed by the IRB through Exempt procedures. See Chapter 4 for a discussion of direct versus indirect identifiers as well as which secondary data projects require review (most do).
Consent issues require special attention in secondary data projects. Ordinarily, when a person uses data collected by someone else for another purpose, the consent of the participants must be sought again. For example, if researcher A has interviewed a number of persons for project A, the interview cannot be released later to researcher B for project B. The participant who consented for his or her data to be used in project A might disapprove heartily of project B and thus might refuse to cooperate. The wording of the original consent form is critical. If a participant consented to allow his or her blood sample to be available to persons studying blood diseases, his or her sample could be shared with many researchers without additional consent. The original researchers who received consent can re-work the data without new consent provided it is for a related purpose and the original consent form informed participants of this possibility.
Having said that, if the data from the original research are truly anonymous or the data are pooled in a form ensuring anonymity, then consent for secondary use may be waived by the IRB. It is also possible to request that the IRB waive consent when it will be impossible or highly impractical to go back and obtain consent. Issues pertaining to waivers of consent and documentation of consent are discussed in Chapter 10.
Use of Biological Samples
The use of biological samples in research has become very sensitive due to the rapidly increasing technology available that allows identification of individuals through their DNA. Unless the biological samples are drawn from the researcher alone, informed consent will be required in most cases and the consent information must address how the biological samples will be drawn, handled, and stored, and for how long. Unless the participant consents to future research using them, the samples should be destroyed as soon as possible after data analysis is complete.
The IRB recognizes that ethnography and participant observation are different from experiments conducted in a laboratory or classroom, and that the standard written consent form may be inappropriate. The IRB also recognizes that such qualitative methods often involve casual conversations with dozens or hundreds of participants in various settings. The researcher should simply describe in the IRB application what methods will be used under which circumstances for disclosing that research is taking place and how other elements of the consent process will be addressed. Often a waiver of documentation of consent may be granted if written consent is inappropriate in a given situation.
Deception should be employed only when there are no viable alternative procedures. Where deception is a necessary part of a study, the IRB may require that a preliminary consent be obtained, if possible, in which the investigator informs the participant that the study activities or purpose cannot be described fully in advance. After the study, the participant should be informed of the deception and its purpose. The IRB recognizes that there are rare instances in which no consent can be obtained or debriefing done: for example, where debriefing would cause more harm to the participant than the deception itself.
Protections for Vulnerable Populations
Vulnerable populations include individuals who may be vulnerable to coercion or undue influence to participate in research projects. They may also include research populations, or be associated with populations, that are simply unable or have limited capacity to provide consent. Thus, Federal Regulations require additional protections for special participant populations, such as: (1) pregnant women (2) prisoners (3) children (4) physically or mentally impaired persons (5) economically or educationally disadvantaged persons (6) other potentially vulnerable groups, and (7) activities involving fetuses and human in vitro fertilization.
It is important to note that, in some cases, state and local laws will also be relevant in these considerations.
Children are defined as persons who have not yet attained the legal age for consent to treatment or procedures involved in research as determined by local law. Generally, the law considers any person under 18 years old to be a minor. Persons aged 18 and older may consent to participating in research and parental permission is not required. For participants aged 17 and under, however, the permission (consent) of at least one parent or guardian is required. Permission from parents is usually indicated in a form similar to a participant consent form, constructed to request "your child" to participate.
If a minor is age 7 or older, the minor's assent must also be obtained. An assent is defined as a minor’s affirmative agreement to participate in research. (Failure to object should not be construed as assent.) The aims and general nature of the project must be described in language that is appropriate to the minor’s age, experience, maturity, and condition. This explanation should also include a discussion of any discomforts and inconveniences the child may experience if he or she agrees to participate. Parental permission overrules a minor’s decision not to participate in therapeutic settings.
There are no particular requirements to obtain assent from children under age 7, provided parental permission is secured. However, early childhood professionals have developed appropriate methods for seeking the assent of young children in research that should be considered in the design. Sample assent and consent forms are available on the IRB forms page.
In certain cases where risk would be increased if parental permission is sought (e.g., studies of abuse) and where it would be unreasonable to require parental permission, the IRB may waive the requirement. Research on minors which involves more than minimal risk will be approved only if it is (i) of direct benefit to the participant or (ii) yields useful knowledge about a participant's problem or disorder. In the latter case, both parents must give consent. If a child is a ward of the state, the IRB requires that there be an advocate appointed to function as a guardian in the child's behalf.
Children are considered a vulnerable population because their physical and intellectual capacities are limited and as such, special considerations are necessary. The IRB reviewing research involving children as participants must consider the benefits, risks, and discomforts inherent in the proposed research and assess their justification in light of the expected benefits to the child-participant or to society as a whole. Thus, when the IRB reviews research involving children, it is required to classify such research as involving children in one of four categories. The four categories are:
- Research not involving greater than minimal risk.
- Research involving greater than minimal risk, but presenting the prospect of direct benefit to the participant.
- Research involving greater than minimal risk with no prospect of direct benefit to individual participants, but likely to yield generalizable knowledge about the participant’s disorder or condition.
- Research that is not otherwise approvable, but which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
If the IRB determines that the research involves greater than minimal risk, signatures from both parents are necessary. However, in some cases, the IRB may determine that it is acceptable for only one parent to provide permission when one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
According to 45 CFR 46.303(c), a prisoner is defined as any individual involuntarily confined or detained in a penal institution. This term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. It is important to note that this category of special protections also includes situations where a research participant may become a prisoner after the research has commenced.
Only certain types of research may be conducted utilizing prisoners as participants: (1) study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the participants; study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the participants; (2) research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; (3) and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults). (4) Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the participant.
Coercion is the IRB’s main focus when reviewing studies involving prisoners. Many factors will be taken into account regarding this issue before a study may be approved. When prisoner research is reviewed by the IRB, IRB membership in attendance at that meeting will include a prisoner representative with appropriate background and experience to serve in that capacity.
Research involving women who are or may become pregnant receives special attention from IRBs because of women’s additional health concerns during pregnancy and because of the need to avoid unnecessary risk to the fetus. Pregnancy is defined as the period from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e., has been delivered). In studies involving pregnant women, IRBs must also determine when the informed consent of the father is necessary. Additionally, because of the involvement of the fetus (who cannot give consent), the IRB must consider the need to prevent harm or injury to future members of society. At the same time, IRBs must also recognize that the inclusion of women in research study populations is important so that research findings can be generalizable and of benefit to all persons at risk of a disease, disorder, or condition under study. Therefore, pregnant women may be involved in several kinds of research which present differing IRB duties for each kind of research.
The three basic types of research are:
- Studies in which pregnancy is coincidental to participant selection. Any study where women of childbearing potential are possible participants could inadvertently include pregnant women. Depending on the research procedures, these participants may need to be notified that a particular treatment or procedure "may involve risks to the participant (or to the embryo or fetus if the participant is or becomes pregnant) that are currently unforeseeable." Non-pregnant participants may need to be advised to avoid pregnancy or nursing while involved or following the research.
- Studies directed primarily toward the mother’s health. As women’s health can be positively or negatively affected by pregnancy, some research may be undertaken to explore these issues. As such, a woman’s needs generally take precedence over those of the fetus. The IRB will, however, attempt to ensure that the risks to the fetus are minimized.
- Studies directed toward pregnancy. Many studies are directed to examine the normal and abnormal processes of pregnancy, labor, and delivery. In these cases, the IRB must determine that the risk to the fetus is "minimal." "Minimal" is defined as where the risk to the fetus is no more than that from established procedures routinely used in an uncomplicated pregnancy or in a pregnancy with complications comparable to those being studied. If the IRB cannot conclude that the risk is minimal, it can consult with the experts for advice. Basically, it must then be determined that the risks are far outweighed by the benefits to the participant and the importance of the knowledge to be gained.
A fetus is defined as the product of conception from the time of implantation until delivery. Once the fetus is delivered or expelled and is viable (likely to survive to the point of sustaining life independently, given the benefit of available medical therapy), it is designated as an infant and is thus subject to Federal Regulations governing research with children. The fetus should be treated respectfully and with dignity and its genetic heritage and vulnerability should be recognized, regardless of its life prospects. Because the fetus shares a unique relationship with its mother and cannot consent to be a research participant, special Federal Regulations are in place to guide fetal research.
In research, risks to the fetus may not be more than minimal (e.g., risks from ultrasound or changes in maternal diet) and if the risk to the fetus is deemed more than minimal, it must be justified by the anticipated benefit for the health of the mother or the particular fetus. It can be problematic, however, to determine what exactly is minimal risk for a fetus as compared to a child or adult; and the IRB will work closely with investigators to make this determination. However, if risk to the fetus is more than minimal and without anticipated medical benefit to the mother or fetus, special provisions apply, and the IRB must determine that data gained from such a study is not obtainable in any other research design or format.
Basic types of research involving fetuses include:
- Research directed toward the fetus in utero. The IRB can approve this kind of research if the purpose of the research is to meet the health needs of the fetus and will be conducted in such a way to minimize risk or if the research presents no more than minimal risk to the fetus and the purpose of this activity is the development of new knowledge that is unobtainable by any other way. As always, risks should be justified by a consideration of potential benefits.
- Research involving the fetus ex utero. If the fetus is judged viable outside of the uterus, then it is considered an infant and is thus governed by research regulations involving children. If a fetus is judged nonviable (unable to survive to the point of sustaining life independently), then research is forbidden.
- Research with dead fetuses, fetal material, and placenta. Research with dead fetuses, fetal material, or cells, tissues, or organs removed from a dead fetus are governed by state laws and regulations. Ethical considerations commonly held about respect for the dead should be observed if proposing such research.
Persons with Cognitive Impairment
A cognitively impaired person is defined as having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders), an organic impairment (e.g., dementia), or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. In addition, persons under the influence of or dependent on drugs or alcohol, suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.
Thus, the major ethical concern in research involving individuals with psychiatric, cognitive, or developmental disorders, or who are substance abusers is that their disorders may affect their capacity to understand the information presented and their ability to make a reasoned decision about participation. Also, many individuals with such disabilities may be residents of institutions responsible for their total care and treatment and this factor may have an impact on or further compromise these individuals’ ability to exercise free choice (voluntariness) in participating in research. (For example, these individuals may agree too readily to requests for their "cooperation" or may be vulnerable to perceived or actual pressures for fear of being denied services.) It is for these reasons that special protections must be considered by the IRB when reviewing research involving cognitively impaired persons.
When reviewing research involving cognitively impaired persons, the IRB must consider several issues:
Do such individuals comprise the only appropriate participant population? In other words, do the research questions focus on issues unrelated to their disorders or institutionalization?
Are there sufficient protections for privacy and confidentiality of information gathered?
How are issues of consent and competence addressed? As a general rule, there should be specific evidence of individuals’ incapacity to understand and to make a choice before they are deemed unable to consent. If cognitive impairment cannot be judged a priori, then mental status testing should be included in the research design. If a person is capable of understanding the nature of the project, consent should be obtained from both the participant and a parent, guardian, or advocate as appropriate. In instances where the person is not competent to consent, parental or guardian consent alone is sufficient. When individuals are deemed unable to consent, investigators and IRBs must consider state and local laws governing the selection of an appropriate representative to consent on behalf of these individuals. The IRB will consider the possibility of obtaining "assent" (see the discussion on involving children in research) from potential research participants when they are cognitively impaired.