West Virginia University Office of Research Integrity & Compliance Human Research Protections Program

Office of Research Integrity and Compliance Human Subject Research & the IRB Animal Research & the ACUC Biological Safety & the IBC Responsible Conduct of Research Conflict of Interest in Research Export Control

What’s Special about IRB Review of Social and Behavioral Science Research and the Welfare of Subjects? Welfare includes not only physical well-being, but emotional, political, cultural, educational, and economic well-being Social and behavioral science researchers are interested in emotional, cultural, political, educational, and economic behavior Collecting data about these areas from individuals may harm the welfare not only of the individual subjects, but of the groups to which they belong Researchers are sometimes ignorant of or oblivious to these risks of harm

IRB Review The regulations were designed with social and behavioral sciences in mind, and work pretty well. Many IRB’s however, are more experienced with reviewing bio-medical research and have less experience with social and behavioral science research. Those who volunteer to take part in soc/beh research are still deserving of the protections provided by the regulations – a clear understanding of the purpose, procedures, benefits and risks of the research, and a clear understanding both of voluntariness and their ability to stop participating in the research at any time The regulations allow IRBs an enormous degree of empowerment, discretion and flexibility in implementing the elements of individual informed consent – to the extent of waiving written consent or waiving individual informed consent completely, if the circumstances warrant.

There are some differences between social/behavioral scientific research and biomedical research.

Differences in Risks of Harm? Most common sources of risk are breach of confidentiality and invasion of privacy May be just as serious but different time frame May be less amenable to measurement May be less predictable May be more elusive (i.e., psycho-social screening) May be less remediable

Differences in Risks of Harm (continued) May provoke increased risks of deductive disclosure of stigmatizing characteristics Possible risk of group harms from studies of behavior More often involves deliberate deception than biomedical research For most soc/beh scientists it is a matter of acknowledging these risks and letting the IRB know what they are going to do about it.

Records-Based Research Points To Consider: Consent as default position Document waiver of consent Document waiver of elements of consent Check federal and state laws Require Coding, encryption Require destruction of identifiers ASAP Research data should not be entered into non-research records

Survey/Interview Research Points To Consider: Disclose recordings and provide option to review and delete Disclose researcher’s position Conduct interviews privately Disclose reporting obligations Internet Random digit dialing This is an invasion of privacy although it can be considered

Research in School Settings Points to Consider: Approval from school system, principal, teacher Permission from parents/assent from minors Make sure that participation does not deprive minors of other benefits or standard care, e.g. having to skip recess to participate Make sure that participation/non-participation doesn’t stigmatize minors

Research in School Settings (continued) Keep data out of school records Consent to access school records Research conducted privately Make sure assent and parental permissions make clear the limits of privacy and confidentiality 45 CFR 46 does not mandate confidentiality. It stipulates that confidentiality limits be specified.

Suggestions of IRBs A Mixed Message: Always base decisions of rational evaluation of risks Recognize that most social/behavioral research poses no more than minimal risks of harm Allow waivers of written consent when appropriate Hold social science and behavioral researchers to same standards as biomedical researchers Invite active researchers to sit on IRB