Questions regarding the definition of "human subject"

February 18, 2020 Yvonne Higgins

Submitter:  Director of research integrity at a university

Question 1:

An investigator is asking individuals to review the bank records of other individuals. For the purposes of this case study, you can presume that the activity meets the definitions of “research” and that the individuals who are reviewing the bank records are “human subjects.” The issue is whether Are the individuals whose bank records are being analyzed (the bank clients) human subjects?  

Response 1:

Based on the information provided, I think the bank clients would be considered human subjects “about whom an investigator obtains, uses, studies, analyzes or generates identifiable private information…” §46.102(e)(1)(ii).

This kind of research may be exempt under the Common Rule; but that determination would require knowing more details about the study design and data collected.

Question 2:

An investigator is asking individuals about the sexual history of their friends. For the purposes of this case study, you can presume that the activity meets the definitions of “research” and that the interviewees are “human subjects.” Are the friends (whose sexual history is being described) human subjects?

Response 2:

This one is a little more nuanced than the previous case.  Based on the limited information above, the friends are human subjects.  This opinion is informed by the case a while back involving a researcher who interviewed students at VCU. The interview included questions about the students’ parents. The father of one of the students filed a complaint with OHRP; and OHRP determined that the parents were “secondary subjects” of the research.

Based on the limited information provided, this study may qualify for exemption under the newly revised category §46.104(2) (i) or (iii).  I’d be inclined to go with iii which would require a limited review by the IRB to determine that there are adequate provisions in place to protect the privacy of subjects and to maintain the confidentiality of data.  (My somewhat conservative opinion is that one could argue that the circle of friends about whom one could provide a sexual history could be small enough that the friends could be identified.)

§46.104(2)(i) the information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

§46.104(2)(iii) the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7). [adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.]

About the Author

Yvonne Higgins

Yvonne has contributed to the cause of ethics and responsibility in human research for more than 20 years. During that time, she has served as Vice President of Quality Management for Copernicus Group IRB, Executive Director of the human research protections program (HRPP) and Institutional Review Boards (IRBs) at the University of Pennsylvania, Co-Chair of the workshop and didactic planning committee for PRIM&R’s Advancing Ethical Research annual conference, and Public Health Analyst within the US Department of Health and Human Services Office for Human Research Protections (OHRP).

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