Ive heard that consent documents are required to be stamped with approval and expiration dates. Whats that all about?
The Office for Human Research Protections has issued guidance that recommends Institutional Review Boards put approval and expiration dates on all approved consent documents and stipulate that copies of the dated documents be used in obtaining consent. The thought here is that this will help ensure only the current, IRB approved consent documents are presented to prospective subjects. The HSRB has decided to implement this recommendation in order to help researchers in their efforts to use the approved versions of consent documents. Click this link to go to the HSRB’s policy/procedure statement in this regard. [Top] 16. May I use a consent form that provides prospective subjects with the option to actively decline participation (e.g., provide both a “yes, I want to participate” and “no, I don’t want to participate” option and have the prospective subjects choose one or the other)? The federal regulations for the protection of human research subjects do not require documentation that an
Related Questions
- After receiving WIRB approval, how do I apply for changes to the consent documents or procedures, any other modifications and amendments, or continuing review (status reports)?
- Do I have to use copies of the stamped consent documents (e.g., consent forms, assent forms, recruitment ads) to recruit/enroll subjects?
- How does RCS monitor expiration dates on insurance certificates and other documents?
