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Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

Who May Consent for Participation in Research Studies (Michigan)

IRBMED

| Approval Date:

April 18, 2012 2:30 pm

	Participant = Minor	Participant = Incapacitated / Incompetent Adult
Outpatient Psychotherapy	Minor age 14 or over if seeking limited confidential outpatient psychotherapy services under M.C.L. §330.1707 Parent(s)* with legal custody or guardian†	See “other clinical research” below.
Substance Abuse	Minor if seeking confidential substance abuse treatment under M.C.L. §333.6121 Parent(s)* with legal custody or guardian†
STDs and HIV/AIDS	Minor if seeking confidential substance abuse treatment under M.C.L. §333.5127 Parent(s)* with legal custody or guardian†
Prenatal / Maternity Care	Minor if seeking confidential prenatal / maternity care under M.C.L. §333.9132 Parent(s)* with legal custody or guardian†
Research Involving Recipient of Mental Health Services	Generally: see “other clinical research” below.For surgical procedures: Parent(s)* with legal custody Guardian† (the guardian must be specifically legally empowered to execute a surgical consent) For ECT: Parent(s)* with legal custody or guardian†(additional restrictions apply) Note: guardians who consent for experimental treatment on recipients of mental health services are not immunized from liability under the mental health code. See M.C.L. §330.1629(3).	Generally: see “other clinical research” below. For surgical procedures: The patient if he or she does not have a guardian for medical purposes The guardian† of the patient if legally empowered to execute a consent to surgery The representative (patient advocate) authorized to consent under a durable power of attorney or other advance directive For ECT: The patient, unless the patient has a guardian A guardian† if legally empowered to execute an ECT consent (additional restrictions apply) Note: guardians who consent for experimental treatment on recipients of mental health services are not immunized from liability under the mental health code. See M.C.L. §330.1629(3).
Terminal Illness	Parent(s)* with legal custody or guardian†	Member of the immediate family Next of kin Guardian
Alzheimer’s	N/A	In order of preference: Guardian Spouse Adult child or children Parent Other adult family members
Transplants (Receipt of Human Blood, Tissue, Organs, or Other Human Specimens)	In order of preference: Parent(s) with legal custody* Guardian† at the time the transplantation,transfusion, introduction, or injection is to be performed	In order of preference: Spouse Adult son or daughter Either parent Adult brother or sister A guardian† at the time the transplantation, transfusion, introduction, or injection is to be performed.
Other Clinical Research	Parent(s)* with legal custody or guardian	Guardian† Patient advocate (named in a durable power of attorney for health care, or DPOA, if the DPOA is sufficient to allow the advocate to consent to research); note that an incompetent patient may not grant a DPOA –this must be done before the patient becomes incompetent Spouse Adult child Parent Adult sibling Other close adult relative
Other Social/ Behavioral Research	Parent(s)* with legal custody or guardian† Note: guardians who consent for experimental treatment on recipients of mental health services are not immunized from liability under the mental health code. See M.C.L. §330.1629(3).	Guardian† Note: guardians who consent for experimental treatment on recipients of mental health services are not immunized from liability under the mental health code. See M.C.L. §330.1629(3).

* Special requirements apply for wards. Foster parents generally do not have authority as parents to give permission for their wards to participate in research. Contact the IRB office when enrolling a ward on a study. Dual signatures may be required for studies involving more than minimal risk. Detailed guidance on who is considered a “child” or “guardian” is provided in the OperationsManual, Part 7: https://research-compliance.umich.edu/sites/default/files/resource-downl….

† A “guardian” is a person with specific legal authority (e.g., through a court order or temporary delegation) to make decisions on behalf of his or her ward. Guardians and patient advocates may consent for research or experimental procedures only to the extent they are specifically legally empowered to do so (i.e., in the durable power of attorney or the court documents granting guardianship). Detailed guidance on who is considered a “child” or “guardian” is provided in the Operations Manual, Part 7: https://research-compliance.umich.edu/sites/default/files/resource-downl….

UNIT: Institutional Review Boards (IRBMED)

TOPICS: Informed Consent & Assent / Investigator & Study Team Responsibilities / Regulations & Policies (Federal, State & Local) / Subject Populations

Questions?

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A list of IRBMED staff is available at our website.

Edited By: [email protected]
Last Updated: December 12, 2024 9:45 PM