I. The proposal is Exempt from IRB review if all aspects of it fall within one or more of the following categories:
A. The data, documents, records, or specimens already exist and either:
1. the subjects cannot be identified in the research data or statistically, and no one can track the subjects' identities, or
2. the sources of data are publicly available.
B. For research not involving vulnerable subjects or sensitive topics, the researcher observes public behavior, conducts interviews or surveys, or uses educational tests and either:
1. subjects cannot be identified directly or statistically, or
2. the data could not harm subjects if they were made public, nor, if subjects give information about others, is inadvertent disclosure likely to harm others, or
3. federal statute completely protects all subjects' confidentiality, or
4. all respondents are candidates or elected or appointed public officials.
C. In an educational setting, the research or evaluation concerns normal educational practices.
D. Taste and food quality studies with safe and wholesome foods.
Research with vulnerable subjects or on sensitive topics or when subjects can be identified or if risks are more than minimal cannot be exempted. The complete protocol (all questions answered) must be submitted for review.
II. The criteria for eventual approval of expedited (i.e., subcommittee review) and Full Board review are the same, but certain categories of proposals:
A. Cannot be expedited:
1. Research involves more than minimal risk;
2. Subjects can be identified.
If you receive such a proposal under expedited conditions, please report to the Office of Grants and Contracts that you believe the proposal needs full board review.
B. May or may not be appropriately expedited:
1. Research with vulnerable subjects
2. Research on sensitive topics*
Recommend shifting to full board review if you think research raises issues of concern or interest to the entire IRB.
*Sensitive topics include: sexual orientation, sexually-transmitted diseases, incest, rape or date rape, sexual harassment, molestation, race relations, use of licit or illicit drugs, eating disorders, abortion, contraception or pregnancy, the subjects' own mental health (suicide, depression, compulsive behaviors), religion, illegal conduct, stressful experiences.
Only the full board may disapprove a protocol. Check "Full Board Review" if you believe the protocol should not be approved.
III. Criteria for Approval
In accordance with 45 CFR 46.111:
A. Risks to subjects are minimized.
Risks refers to magnitude of harm and probability of incurring harm. "Minimal risk" is keyed to experiences of a non-vulnerable person in ordinary daily life or in routine medical, dental, psychological examinations. [Scrutinize risks especially when the topics are "sensitive."]
B. Risks to subjects are reasonable in relation to benefits.
If more than minimal risks, does scientific merit outweigh risk? Are benefits maximized? Are risks minimized? [More restrictive standards apply for special/vulnerable populations.]
C. Selection of subjects is equitable.
[Scrutinize especially when populations are special/vulnerable.]
D. Informed consent is properly sought.
1. An explanation of the purpose of the research, duration and procedures to be used is provided at a language level the subject will comprehend.
2. Major deception (e.g.) intentionally misleading subjects about their status, giving false information about the researcher(s) or the project), and minor deception (e.g. withholding some information about the purpose of the study to avoid biasing the results) should be justified and plans for debriefing subjects should be outlined. If possible, consent forms should warn subjects that some deception is involved. [Scrutinize especially when populations are special/vulnerable; parental permission is required for children, child's assent is needed depending on the age and type of research.]
E. Informed consent is properly documented.
[If waiver from written consent is requested, decide whether oral consent should be witnessed.]
F. Subjects are monitored during data collection to ensure their safety.
G. Subject's privacy is adequately protected and data is maintained confidentially (when appropriate).
H. Vulnerable or special subjects are adequately protected from coercion or undue influence (e.g. excessive compensation or inequitable relationship between research and subject.) Special restrictions apply for children, prisoners, pregnant women or fetuses, etc. See federal regulations for more information.
IV. Other Considerations:
A. If genetic research and bloody/body tissue research have additional constraints, please consult the IRB Chair or the Director of Grants and Contracts.
B. In some instances (for example, projects involving particularly sensitive research), the IRB may require periodic reports from the researcher and may review the project more frequently than once a year.
C. The College employs the Department of Health and Human Services human subjects regulations. Proposals submitted to agencies other than HHS may require that different or additional human subjects regulations be applied to the research in accordance with that agency's guidelines. If such a proposal is being reviewed, you will be alerted to obtain other agency guidelines from the Office of Grants and Contracts.
Questions? Email firstname.lastname@example.org.