Consenting Withdrawn Subjects for Follow-Up Information

Anita Camic

Team Leader

Research Compliance Administration

Tara Bateman

Research Compliance Coordinator

Research Compliance Administration

To Consent or Not to Consent:

That’s the Question!

Issue: Subjects wish to withdraw from a study; however, for purposes of the research study, the subject is requested to undergo follow-up procedures or to have their health followed after they have withdrawn.

What started this discussion?

NCI’s consent template previously included the following statement:

“In the event that you withdraw from the study, we request you allow us to continue to follow your health and continue to collect

clinical data from your medical records.”

What is “Withdrawal?”

“Withdrawal” refers to a subject who signed a consent form, but discontinued participation prior

to his/her completion of the study.

Consent?

If the subject is being asked to complete only end-of-study/final study visit procedures This is normally covered in the main informed consent

document and would not require obtaining an additional consent

If the subject is being asked to complete additional procedures after expressing desire to withdraw from the study This requires obtaining consent, specific for this purpose, at

the time of the subject’s withdrawal

45 CFR 46 Protection of Human Subjects

General Requirements for Informed Consent “A statement that participation is voluntary, refusal to participate will

involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.”

What does this mean?

Subjects must be given the option to agree or not agree to be followed after they have withdrawn from the study; thus, consent must be obtained specifically for this purpose.

The Consent Document

The additional consent should be submitted when a new study is submitted for review and approval by the IRB

The additional consent must include all of the required elements of informed consent, UNLESS, A modification to the required elements for informed consent is

requested via Section XIII of the summary safeguard statement AND is approved by the Board prospectively

References

You can read the guidance from the IRB Executive Committee in the December 2004 edition of the R & SP Communicator,

which can be found at:

http://www.iupui.edu/%7Eresgrad/newsletter.htm

and clicking into the link for “R & SP Communicator archive”

Questions?

Any questions?

Thanks!

Research Compliance Administration

274-8289

www.iupui.edu/~resgrad