Office of Research Integrity Staff for Office of Research Integrity research.musc.edu
 

 

Informed Consent

General Information
Standard Consent Guide
 

Standard Paragraphs  - Not FDA Regulated (MUSC)
Standard Paragraphs - FDA Regulated (MUSC)
Standard Paragraphs - Child Not FDA Regulated (MUSC)
Standard Paragraphs - Child FDA Regulated (MUSC)


NEW

INFORMATION REGARDING THE MUSC INFORMED CONSENT – WITNESS SIGNATURE LINE REMOVAL
The IRB no longer requires the signature of a witness on all informed consent documents. The IRB will review the need to have a witness sign the informed consent document on a case by case basis. If the IRB deems the witness signature is necessary, this will be communicated to the Investigator upon review of the protocol.

If the current IRB approved informed consent document(s) being used includes a witness signature, the witness signature is still required.

If an Investigator wishes to remove the witness signature line, an amendment must be submitted to the IRB requesting its removal from the informed consent document(s).

VA PROTOCOLS
If the study is being conducted at the VA hospital using the VA informed consent, the witness signature line may NOT be removed. VA regulations require the signature of a witness.

NEW The wording under the Volunteers Statement of the Standard Paragraphs has been changed. Please make sure to use the revised language when submitting informed consents to the IRB.
Consent for Genetic Research on Biological Samples
  Linked, Potential Recontact
Linked, No Recontact
Unlinked, No Recontact
Consent for Pregnancy Test for Minor
  Pregnancy Test Consent, Parent
Pregnancy Test Assent, Minor
Research Involving DNA
Guidelines and Consent for Tissue Collection
  Autopsy
Excess Surgical / Diagnostic
Veteran's Administration Forms

 

Last Update
8/27/09