UNI Information For Investigators

1. The IRB
   1. Definition & Responsibilities
   2. Members
   3. Meeting Schedule

2. Responsibilities of Researchers
   1. The Belmont Report
   2. Federalwide Assurance
   3. Federal Regulations

3. Mandatory Investigator Education

4. The Review Process
   1. General Criteria for Review
   2. Research in Collaboration with Other Institutions
   3. Research Conducted in Foreign Countries
   4. Research Using Existing or Secondary Data
   5. Classroom Research Training Activities
   6. Notification of Approval
   7. Changes in Protocols and Adverse Reactions
   8. Continuing Review of Ongoing Research

5. Guidelines for Protecting Human Participants in Research
   1. Definitions
      1. Research
      2. Human Participant/Subject
      3. Minimal Risk
   2. Informed Consent
   3. Special Protections for Vulnerable Populations
      1. Prisoners
      2. Children/Minors
      3. Pregnant Women
      4. Fetuses
      5. Cognitively Impaired
   4. IRB Forms (The current on-line version of the submission form must be used. No earlier versions or altered versions of the materials will be accepted)

Information for Investigators

This information is offered to inform UNI researchers about their responsibilities for all research projects involving the use of human participants and the role of the Institutional Review Board (IRB).

The IRB

Definition & Responsibilities

An Institutional Review Board (IRB) is a committee, required by federal regulation, which reviews all research protocols involving human participants. The UNI IRB (also known as the Human Participants Review Committee) supports the advancement of research through the careful application of federal regulations, state laws and University policy. The IRB is formally designated by UNI to review, approve the initiation of, and conduct periodic review of all research involving human participants. The primary purpose of this review is to assure the protection of the rights and welfare of human participants.

An 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
• Subject population
• Recruitment procedures; and,
• Consent processes

Through this review an IRB seeks to balance the risks to the participants against the scientific knowledge to be gained and the potential benefits to society.

The UNI IRB consists of:

• Institutional Official (Jill Trainer, Associate Vice President)
• IRB Administrator (Anita Kleppe, Grant Specialis, Office of Sponsored Programs); and,
• The fully convened IRB (Human Participants Review Committee)

The administrative staff is housed within the Office of Sponsored Programs. The Office of Sponsored Programs receives and processes research protocols and acts as a liaison between the Committee, investigator and the research community.

IRB Members

The fully convened IRB meets once monthly and is made up of the following members:

• Angela Burda, Ph.D. (Communication Sciences and Disorders)
• Phyllis Carlin, Ph.D. (Communication Studies)
• William Clohesy, Ph.D. (Philosophy & Religion)
• Belinda Creighton-Smith, MDiv (Prisoner Advocate)
• Susan Etscheidt (Co-chair), PhD (Special Education)
• David Goodson, M.S.W. (Prisoner Advocate)
• Helen Harton, Ph.D. (Psychology)
• John Henning, Ph.D. (Educational Psychology)
• Larry Hensley (Co-chair), Ed.D. (Health, Physical Education, & Leisure Services)
• Bruce Meisinger, MPP (Black Hawk County Health Department)
• Robert Roth, M.D. (community member)
• Anita Kleppe, M.S.W. (Office of Sponsored Programs, ex-officio)

Meeting Schedule

The meeting schedule for 2007-2008 is as follows:

Meeting Date	Completed Protocol Submission Cutoff (for full Board review)
July 12, 2007	June 28, 2007
August 9, 2007	July 26, 2007
September 13, 2007	August 30, 2007
October 11, 2007	September 27, 2007
November 8, 2007	October 25, 2007
December 13, 2007	November 29 2007
January 10, 2008	December 27, 2007
February 14, 2008	January 31, 2008
March 13, 2008	February 28, 2008
April 10, 2008	March 27, 2008
May 8, 2008	April 24, 2008
June 12, 2008	May 29, 2008

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Responsibilities of Researchers

Researchers proposing to use human participant participants in the course of their research study are required to submit an application to the IRB for review and approval before initiating each project. This requirement encompasses a variety of research activities that can range from the simple use of surveys or interview procedures to more complex uses such as treatment interventions. All research must be conducted in accordance with three documents.

• The Belmont Report. This report is a summary of the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

• Federalwide Assurance - FWA00002159. This contract between UNI and the Office of Human Research Protection (OHRP) of the Department of Health and Human Services assures that Investigators conducting human participants research at UNI will follow the ethical principles outlined in the Belmont report.

• The Code of Federal Regulations for the Protection of Human Subjects, Title 45, Part 46, and Title 21 CFR Part 50 and Title 21 CFR Part 56. These are federal regulations that describe general standards for the composition, operation, and responsibility of an Institutional Review Board. Compliance with these regulations is intended to protect the rights and welfare of human participants involved in research projects.

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Mandatory Investigator Education

To ensure that researchers understand the federal regulations, UNI policy requires that all principal investigators and key research personnel complete an on-line tutorial that provides information and training in human participants protections. The primary means of gaining certification is through the completion of a training module offered via the web by the National Institutes of Health.

Key research personnel include the PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way. Those responsible for recruiting participants and obtaining consent would be considered key personnel. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered key personnel if their involvement meets this definition. Consultants also may be considered key personnel if they meet this definition. This policy affects all new protocols, whether full-board, expedited, or exempt. There will be no exceptions.

Research "Key Personnel" are typically responsible for:

1. Day-to-day protocol decision-making related to the study conduct;
2. Participant recruitment, selection and eligibility;
3. Clarification of the complexities of the protocol to the participant and others;
4. Collecting participant information and entering data using procedures to maintain privacy and confidentiality;
5. Ensuring that the rights and welfare of participants are monitored throughout the study.

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The Review Process

An IRB review must occur in advance of all human participants research when any of the following criteria apply:

• the research is sponsored by this institution, or

• the research is conducted by or under the direction of any employee, student, or agent of this institution in connection with his or her institutional responsibilities, or

• the research is conducted by or under the direction of any employee, student, or agent of this institution using any property or facility of this institution, or

• the research involves the use of this institution's non-public information to identify or contact human research participants or prospective participants.

Research in Collaboration with Other Institutions

Research conducted in collaboration with other universities, research institutions, businesses, organizations, schools, or hospitals must be reviewed and approved by the IRB. This is in addition to review requirements imposed by the collaborating institution.

Research Conducted in Foreign Countries

Research conducted in a foreign countries by a UNI-affiliated researcher must be reviewed by the IRB and adhere to University and federal guidelines. The standards for ethical conduct in research must be incorporated into the research design while allowing for cultural differences.

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 analysis. 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.

Classroom Research Training Activities

Class assignments or projects may have a research component or constitute training in research methodology. Classroom projects that are minimal risk and used exclusively for instructional purposes need not undergo formal review by the IRB; however, instructors are responsible for the conduct of these projects and should follow federal guidelines and University regulations when designing and conducting class projects with human participants. If the data collected for a class assignment/project will be presented in any public forum or may be used in future research activities of the students, faculty, or staff at The University of Northern Iowa or by individuals in another institutional setting, an IRB review is required prior to data collection.

Notification of Approval

The IRB has the authority to approve, require modifications to (to secure approval), or disapprove research. During the initial review process, the IRB Chairperson determines whether a particular study is classified as Exempt, Expedited, or requires Full Board review. The IRB communicates its findings via an official letter to the Investigator. A researcher may begin a study only after notification of approval from the IRB.

Shortly after review, a notice is sent to each investigator whose protocol was reviewed. This notice is always sent to the PI whose signature appears on the protocol form. The notice will indicate what action was taken by the IRB (i.e., approved, approved pending modifications, exempt from continuing review or deferred for additional information), as well as the review interval (duration of the approval.) If the protocol is approved pending modifications or deferred for additional information, there will be an additional explanation about what information is needed in order to receive approval. In the case of an approval pending modifications, these are most commonly slight changes to the consent form or some additional information the IRB requires in the protocol. It is unlikely the protocol would be disapproved without discussion with the investigator regarding the IRB's concerns about the research. These concerns would also be described, at least initially, in the notice of action communication.

If the protocol is deferred by the full IRB and additional information is requested from the investigator, it will be reviewed at the first regularly scheduled meeting of the IRB after receipt of the requested information.

Another notice will be sent to the investigator after that meeting to inform him/her of the disposition of the protocol.

If the protocol is approved pending modifications, the requested information should be returned to the IRB office or IRB chair, as requested. As soon as possible after the material is received, it will be reviewed to ensure that it responds to the concerns of the IRB. An acknowledgement of the receipt of the requested information will then be sent to the investigator. Do not complete a new protocol form. Return just the information requested by the IRB. Include the PI name, protocol title and protocol number with the information. The modifications must be made and approved by the IRB before an investigator may begin to recruit participants for involvement in the research.

Changes in Protocols and Adverse Reactions

The investigator is responsible for ensuring that any changes to the protocol are submitted to the IRB for review before the changes are incorporated into the research. This can be done by sending a letter/memo, signed by the responsible faculty member and referencing the protocol number and title, which describes the proposed changes. The changes will be reviewed by the IRB chairperson, or at the next regularly scheduled meeting of the IRB and the investigator will be notified of the results of the review. Investigators should note that only those procedures specifically approved by the IRB may be initiated. Any changes or additions, such as review of student or medical records, or contacting participants again for follow-up research, must have either been included in the original procedure and consent form or receive specific approval from the IRB.

New information, which would affect the potential risk to participants, must be brought to the IRB's attention in a timely way. Any adverse reactions by participants to research interventions should be reported to the IRB immediately.

Continuing Review of Ongoing Research

The federal rules mandate that ongoing research must be reviewed by the IRB at least once a year (except in the case of exempt research). Most protocols are approved for one year, although the review interval may be less if the IRB determines that it is necessary, for whatever reason, to review the protocol on a shorter review cycle.

Approximately 45 days before the end of the review interval, the investigator will receive a notification that the IRB approval is about to expire. A continuing review form plus a copy of the consent form currently in use should be submitted if the research is still active. This notification is meant to assist the investigator in securing timely renewal of human participants IRB approval. It is the responsibility of the investigator to see that ongoing research is submitted for review however, before the approval lapses. If IRB approval lapses, the investigator must suspend any ongoing research interventions with participants and must not recruit any additional participants. If a study is completed before one year has elapsed, the investigator should complete the protocol closure form and submit it to the Human Participants Review Committee.

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Guidelines for Protecting Human Participants in Research

Definitions

Research: Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. This definition includes all activities where results are intended for presentation, publication, distribution, or use outside the specific instructional setting and includes pilot studies. Also included as research are student investigations within the campus instructional settings in which the data are to be used in future research activities of the investigators, faculty, or staff at The University of Northern Iowa or by individuals in another institutional setting.

Human Participant/Subject: A human participant/subject is a living individual about whom an investigator obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Although scientific concerns are primary in the design of research involving human participants, the rights of human participants should be considered from the outset. The principles, policies, and procedures used in human participants protection should be applied throughout the design of any research project.

Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Informed Consent

In addition to concerning itself with risk, the IRB must consider the participant's consent to participate in the research project. 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, the consent form should be written at the 8th grade reading level. Nondisclosure of information to participants must not be used simply to assure their participation in the research. It is desirable, but not mandatory, that the investigator, rather than an assistant, obtain the consent.

To ensure that participants' consent is voluntary, the IRB considers whether any undue pressures or coercion will be brought to bear on potential participants. Such pressure may be subtle as, for example, when a teacher asks his or her own students to become participants of his or her research. Excessive compensation or no payment for withdrawals is viewed by the IRB as pressure.

In order to obtain informed consent the investigator must provide a statement that includes the information listed on the Informed Consent Statement Checklist (provided below). Sample informed consent statements are available on this website to assist investigators in the preparation of their own consent forms. The samples reflect both requirements of the federal regulations and customary language adopted by the IRB. Use of the samples will facilitate IRB review. Each participant must be given a copy of the signed consent form when written consent is required.

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. This latter point is important in academic circumstances since students are often asked to volunteer as participants. Investigators should not use their current students. 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 rades. Typically this means that someone other than the investigator must 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 students .

Investigators should be aware that the IRB will not approve a study involving a researcher's current students 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 is not present.

The consent process for studies conducted in foreign countries or with illiterate populations, may be altered so that consent may be given orally and documented on tape. Such tapes must be treated in the same manner as paper consent forms. The full committee must review any other alteration to the consent process.

Special Challenges for Consent

Specific issues related to the federal regulations regarding vulnerable populations is presented in the following section. However, a general review of consent issues with minors and persons with cognitive impairment are also addressed in this section.

Children: Minors require special consideration. 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 consent of at least one parent or guardian is required. If a child is age 7 or older, the aims and general nature of the project must be described in language the child can comprehend, and the child's assent must be obtained. Children under age 7 need not be asked to assent; parental or guardian consent is sufficient. 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 must require that there be an advocate appointed to function as a guardian in the child's behalf.

Persons With Cognitive Impairment: Persons with cognitive impairment also require special consideration. They may or may not be able to give consent depending upon the severity of their impairment. If a person is capable of understanding the nature of the project, consent should be obtained from both the participant and a parent or guardian. In instances where the person is not competent to consent, parental or guardian consent alone is sufficient. If cognitive impairment cannot be judged a priori, then mental status testing should be included in the research design.

Secondary Data Sources: Secondary research is often a problem. 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.

If the data from the original research is truly anonymous or the data is pooled in a form ensuring anonymity, then consent for secondary use is not required.

Deception: Deception should be employed only when there are no viable alternative procedures. Where deception is a necessary part of an experiment, the IRB will generally require that a preliminary consent be obtained, in which the investigator informs the participant that the experiment cannot be described fully in advance. After the experiment, the participant should be informed of the deception and its purpose. We recognize that there are rare instances in which no consent can be obtained or debriefing done: for example, studies of public responses to various behaviors or where debriefing would cause more harm to the participant than the deception itself.

Ethonographic Research: 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 or in some cases potentially harmful. The IRB also recognizes that such qualitative methods often involve casual conversations with dozens or hundreds of participants. In most such cases, when the researcher is interacting in a way that is not unusual for that culture, no formal consent is needed. The issue of informed consent arises primarily in the case of individuals who will be interviewed at length and whose identity is known to the researcher. It is in these cases that risks are most likely to arise, both for the participant and for the researcher. In evaluating your plan for obtaining informed consent, the IRB will make its approval rest on your protection of participants’ rights relative to three main issues:

1. Risk. Please be explicit and complete in enumerating the potential risks that your project may entail. The IRB does not expect research to be risk free, but it has an obligation to evaluate the risks and benefits of each proposal, and it is often difficult for the IRB to assess risks in other cultures.

2. Degree to which participants are fully informed. The standard written informed consent agreement covers the most important points about which participants must be informed. If you are going to use a oral consent procedure, or if you choose to make up a written form that is more appropriate for your research population, you should still be sure to inform participants of these major points: what they will be asked to do, how long it will take, what risks they might be exposed to, how you will handle the interview in terms of confidentiality, and most importantly, that participation is fully voluntary and that they can end the interview and withdraw from the study at any time without penalty.

3. Documentation of consent. The standard written informed consent agreement provides you with documented proof that participants gave informed consent, and it partially protects you 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 your judgment obtaining written consent is inappropriate or risky in itself, please explain why, and explain what you will do to document consent. 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 your own records stating that you followed your informed consent procedure and obtained fully informed consent. If you choose to use this minimal documentation procedure, you 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.

Special Protections for Vulnerable Populations

What are "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:

• Prisoners
• Children/Minors
• Pregnant Women
• Fetuses
• Cognitively Impaired

In addition, it is important to note that, in some cases, state and local laws will also be relevant in these considerations. The next several pages will explore IRB requirements associated with each type of participant population.

Prisoners
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:

• 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;

• 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; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults) the study may proceed only after OHRP has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the federal Register

• research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the participant. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after OHRP has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register

Coercion is the IRB’s main focus when reviewing studies involving this population. 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.

Children/Minors
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 child. An assent is defined as a child’s affirmative agreement to participate in research. (Failure to object should not be construed as assent.)

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:

1. Research not involving greater than minimal risk.

2. Research involving greater than minimal risk, but presenting the prospect of direct benefit to the participant.

3. 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.

4. 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. (With this category, the IRB must consult a panel of experts for concurrence.)

The principal investigator should initially determine into which category the research falls and provide a rationale for this choice upon submission of the research study to the IRB. The final determination will be made by the IRB.

Consent Procedures with Children/Minors
In research with children, written parental permission is required. 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. In other cases, such as child abuse or treatment of venereal disease, parental permission may not be appropriate and here, the IRB can grant a "waiver of parental consent" if it is determined that the research will provide great benefit to the population being studied and that obtaining parental consent may put the participant at considerable risk. Permission from parents is usually indicated in a form similar to a participant consent form, constructed to request "your child" to participate.

Once parental permission has been obtained, the agreement of the child is often required by the IRB and this can be documented in an assent. An assent of the child requires that the child be given an explanation of the proposed research procedures in a language that is appropriate to the child’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 child's decision not to participate in therapeutic settings.

Pregnant Women
Research involving women who are or may become pregnant receives special attention from IRBs because of womens’ 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. The inclusion of women is also a NIH requirement. 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.

Fetuses
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 (see discussion below). 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 and investigators will work closely 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.

Cognitively Impaired Persons
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. When individuals are deemed unable to consent, investigators and IRBs must seek legal advice to 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.

IRB Forms

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