This new column is devoted both to sharing new information and reminding investigators of regulatory requirements and best practices in research.
This month’s subject—Consent in Human Subjects Research
Did you know?
Consent must be obtained prior to any screening testing or procedures that are performed solely for the purpose of determining eligibility for research—this includes “wash-out” procedures.
Consent must be obtained by a member of the research team who is delegated by the Principal Investigator and is recognized by the IRB as authorized to obtain consent for that study. Consent must be obtained by an individual sufficiently knowledgeable about the study to answer questions that may arise.
It is an FDA regulation that consent documents are personally signed and dated by the research subject or their legally authorized representative. The FDA will issue a citation if a member of the research team fills in the date for the subject or their representative.
There is no allowance for verbal consent in research of FDA-regulated products. Faxed consent may be acceptable if obtained prior to any research activity and conducted in accordance with FDA guidance.
Per the Massachusetts Health Care Proxy statue and Baystate policy (CO 9.100, CO 9.107), a physician must determine, in writing, that a person lacks the ability to make health care decisions prior to consent being obtained from a Health Care Proxy. Additional restrictions apply for clients of the Department of Mental Retardation or the Department of Mental Health.
If a legally authorized representative signs consent on behalf of a subject with temporary incapacity, consent for continued participation in the research must be obtained when subject regains capacity.
For Further Information
Please contact the Human Research Protection Program (HRPP) or the Institutional Review Boards (IRB) at 794-4356 for further information, or with questions on this or any other topic related to the conduct of human subjects research.
FDA Guidance documents