Requirements

• Original copies of all IRB-approved versions (evident by the IRB approval stamp)
• Refer to the QI Program's Informed Consent Compliance Checklist

FAQs

Q: I'm a research/nurse coordinator. Can I obtain informed consent?

Generally, no. For most studies involving more than minimal risk and all studies involving investigational drugs/devices, a licensed physician investigator listed on the protocol must obtain informed consent, although other study staff may participate in the process. The PHRC will allow a licensed nurse or non-licensed physician investigator to obtain informed consent if that nurse or non-licensed physician would be permitted, in a clinical setting, to perform the procedures for which consent is required. In all such cases, the rationale and justification for this approach and the qualifications and training of the relevant study staff must be submitted to the PHRC for review and approval. For more information, consult the PHRC informed consent guidelines (see link below).

Q: What is the best way to ensure I'm not violating the informed consent process?

Review the QI Program's Informed Consent Compliance Checklist (see link below).

Q: I have submitted an amendment to the HRC to make minor changes (correct typos) to the consent form. I plan to use the current version of the consent form until the new one is approved. How do I avoid using an invalid consent form?

As soon as the IRB approves a new version of the consent form, the previous version expires. Call your protocol administrator, or check the Insight database, regarding the approval status of your amendment. If a new consent form has been generated and will not reach you by mail before you consent a subject, ask the protocol administrator to fax a copy to you.

Useful Links

QI Consent Form Compliance Checklist

http://www.partners.org/phsqi/QIWeb/files/ConsentFormComplianceChecklist.pdf

HRC Guidelines:

Informed Consent Guidelines:

http://healthcare.partners.org/phsirb/infcons.htm

Surrogate Consent (not for external use):

http://intranet.massgeneral.org/phrc/surrogate_consent_memo.pdf

Non-English Speaking Subjects:

http://healthcare.partners.org/phsirb/nonengco.htm

Consent Forms (includes instructions, checklist, authorization forms, consent forms, youth assent forms, blood draw consent forms, “short form” consent documents in other languages):

http://healthcare.partners.org/phsirb/consfrm.htm