Is it possible to make a PI’s name or institution confidential on a consent form?

January 16, 2020 Lindsay Abraham, JD, CIP

Question:  

Is it possible to omit the Principal Investigator’s name and/or affiliate institution on the consent form distributed to subjects in order to maintain confidentiality?
- Researcher

Response: 

In short, the answer to the question is no. Human research participants have right to know whom to contact for answers to questions about the research and whom to contact in the event of a research-related injury. This requirement is grounded in the ethical principles of respect for persons and informed consent as well as the federal regulations.

Required elements that must be included in consent forms are covered in 45 CFR §46.116 and 21 CFR §50.25. Both regulations require that the consent form include a statement describing how confidentiality of records identifying the subject will be maintained, as well as an explanation for whom to contact for answers regarding questions about the research, including whom to contact in the event of a research-related injury.

For research involving drugs, devices, or biologics regulated by the Food and Drug Administration (FDA), the FDA expands on the requirement in both a draft guidance from 2014 and a formalized guidance from 1998 that cover informed consent.  Both guidance documents affirm that the consent form should specifically explain who will have access to research records.

If protected health information is being collected, and the entity is required to comply with the Health Insurance Portability and Accountability Act (HIPAA), 45 CFR §164.508 also applies, and section (c)(ii) requires the authorization include “The name or other specific identification of the person(s), or class of persons, to whom the covered entity may make the requested use or disclosure.”  These regulatory requirements lead to the conclusion that any and all entities or persons receiving or accessing the information should be specifically listed in the consent form, and that would by necessity include both the investigator and the institution.

The consent form also must contain information regarding who to contact regarding questions about the research as well as whom to contact in the event of a research related injury. The FDA guidance previously referenced also states that this should include a specific name and contact information. While a Sponsor may be able to answer questions about the research and might be an appropriate contact to list for that purpose, if there is a research related injury, subjects generally should reach out to the institution and/or investigator conducting the research for questions or assistance, thus should be listed as a contact for that purpose.

In addition to the specific requirements regarding the elements of consent that require the investigator and institution to be listed in the consent form, the investigator has regulatory responsibilities related to the conduct of research that also lead to the necessity of their inclusion in the consent form.  Because the investigator is tasked with personally conducting or supervising the research, as well as obtaining informed consent, the investigator should be denoted in the consent denoting their role as the investigator overseeing the study, and as a contact for the research as well as for questions related to the consent form or consent process.

 

About the Author

Lindsay Abraham, JD, CIP

Ms. Abraham joined Western IRB (WIRB) in 2010 and is currently the Regulatory Lead for the IRB Chairs at WIRB. Ms. Abraham has co-authored several White Papers on topics related to IRB work, and both chairs Board meetings and provides guidance to the Board and clients regarding the interpretation of federal and state laws pertaining to IRB operations and functions. Ms. Abraham also presents education and training courses for Board members and staff. Prior to joining WIRB, Ms. Abraham practiced in the field of family law, and holds a Juris Doctorate from Seattle University School of Law.

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