Institutional Review Board: Frequently Asked Questions
Physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research.
Psychological effects may be experienced during the research situation and/or later, as a result of participating. Includes anxiety, stress, fear, confusion, embarrassment, depression, guilt, shock, loss of self-esteem, altered behavior.
Alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling with negative consequences, or diminishing the subject's opportunities and powers in relation to others. Economic risks include payment by subjects for procedures, loss of wages or income, and damage to employability.
Risk of criminal prosecution or civil lawsuit when research methods reveal that the subject has or will engage in conduct for which the subject or others may be criminally or civilly liable.
Loss of Confidentiality
Confidentiality is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Risks include invasion of privacy, as well as the social, economic and legal risks outlined above.
Federal regulations define "minimal risk" as follows: "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." In broad terms, a project involves minimal risk if:
- The participant experiences no pain or physical danger;
- The participant experiences no emotional arousal or psychological stress beyond the levels normally to be expected in everyday life;
- The project neither induces nor attempts to induce long-term significant change in the participant's behaviors (including attitudes toward self and others);
- The data would not embarrass or socially disadvantage the participant, were confidentiality to be violated; and
- If the investigator conceals information about the specific purpose of the project, there is no reason to believe the subject would choose not to participate if s/he had known that information initially.
If you are planning to collect body fluids or tissue, a statement that indicates that persons at increased risk for Hepatitis B or C or HIV (AIDS) infections should not donate blood or other body fluids. In order to locate source subjects quickly, the informed consent document should contain the current address and telephone number of the subject. Compulsory screening of source subjects for infections should not be done except where such screening is required to protect the validity of the research data. In those cases where an investigator asserts that screening is necessary, the need for such testing must be justified to the IRB. A sample statement follows:
Persons who have ever had hepatitis B or C, who have tested positive for HIV or any AIDS virus, or persons who have AIDS should not donate body fluids or tissues. Persons at risk for getting and spreading any AIDS virus also should not donate body fluids or tissue and should not participate in this investigation. You are at risk if:
- You are a man who has had sex with another man since 1977, even one time.
- You have shared a needle, even one time, to inject drugs or medication.
- You have taken clotting factor concentrates for a bleeding disorder such as hemophilia.
- You have ever had a positive test for any AIDS virus or hepatitis B or C or any AIDS antibody.
- You have had sex with any person described above.
- You have had sex with a male or female prostitute since 1977.
No. Expedited review does not mean your protocol application is processed faster; rather, fewer reviewers are assigned to review your protocol. However, most protocol applications submitted by the deadline date are processed within 10-14 days.
- The study involves no more than minimal risk to subjects.
- The lack of a signed informed consent will not adversely affect the rights and welfare of subjects.
- The signed consent form would be the only document linking the identify of the subject to the study.
- Obtaining signed informed consent would be impractical.
However, all subjects must be informed of the nature and purpose of the study, what will be asked of them for participation, any risks or benefits of participation, that participation is voluntary, and who to contact for more information, whether or not signed informed consent is necessary.