Reconsenting Study Subjects

Informed consent is an ongoingprocess requiring you to provide subjects with continual information and clarification, which will enable them to decide whether to continue participating in research studies. Encourage all subjects to ask questions and express concerns. Initial review of an informed consent document is insufficient to ensure that subjects understand important procedures, risks, and other information. Refer to the IRBMED Guidance, Informed Consent Process for more details.

Often, this on-going process involves providing subjects with written documents that contain new information. Although in some instances this information may appear within a memo or letter, most often you must formally amend the consent document, submitting it to the IRB for review. After receiving notification of approval, explain to your subjects all changes in the consent document, asking them once again to sign it if they choose to continue participating. The IRB refers to this process as “reconsenting,” although in effect subjects reconsent throughout their involvement in a study. Confer with the IRB to determine the method appropriate for each situation.

The IRB must approve all documents that you intend to give to your subjects. If you consider a particular document too urgent to await the standard review process, seek guidance from the IRB office immediately.

When you submit a consent amendment or an adverse event report, inform the IRB whether or not you intend to reconsent subjects. If you will reconsent no subjects, or if you will re-consent only certain subjects (such as those still undergoing study intervention or those in the experimental arm), provide your rationale. If the IRB finds your rationale inadequate, they will instruct you how to proceed in order to secure continued project approval. They may also require that you reconsent subjects based on other reports or on continuing review of the study at time of renewal. Sponsors may, as well, require you to abide by reconsenting policies of their own.

Examples of Situations That Usually

Require Reconsent

Examples of Situations That Usually

Do Not Require Reconsent

  • Identification of new “reasonably foreseeable” risks or side effects judged to be “definitely related” to the research.
  • Changes are made to the protocol such as additional tests or research procedures that may affect subjects’ willingness to participate, rights, welfare, or safety.
  • New information becomes available that may affect subjects’ willingness to participate such as previously unknown risks or FDA marketing approval of a previously investigational agent used in the study.
  • A change in principal investigator and contact information.
  • Minor administrative changes, such as study facility or IRB address changes or changes in co-investigatorship.
  • Changes to the protocol are minor, do not increase risks to subjects, and do not impose additional burden to subjects such as additional time needed for study visit(s).
  • A new adverse event that is not deemed “reasonably foreseeable,” such as a single report of a possibly-related adverse event whose cause may be a particular subject’s underlying condition.

 

Original 10/26/09

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