Informed Consent

Independent IRBs will monitor for language that UW requires to be included in consent documents. Please see the Initial Review page for guidance on how to prepare the informed consent for submission in ARROW and corresponding documents.

Approval Period for an Informed Consent Form Approved by an Independent IRB

Please check with the IRB of Record for approval periods for approved informed consents. For independent IRB contact information, please see the contact information page.

Pregnant Partner Consent Form

To avoid having your research being placed on hold, inquire with your CRO or Sponsor prior to submitting your initial review application to determine if your site will need to submit a pregnant partner informed consent form. If the sponsor has previously had a pregnant partner consent reviewed by the independent IRB, but such a submission is not required by your CRO or sponsor during the initial review submission, please request written documentation supporting this omission and submit the documentation with your initial review application.

For changes of protocol, if the addition of a pregnant partner informed consent is required to your protocol, please obtain the consent template from your CRO, Sponsor or independent IRB. All posted guidance applies.

Language Translation

If the use of a language other than English is required, email to inquire into the latest institutional policy.

Keywords:informed consent, pregnant partner, language translation   Doc ID:22424
Owner:Mike B.Group:Central IRB Gateway
Created:2012-01-26 13:38 CDTUpdated:2018-04-06 09:33 CDT
Sites:Central IRB Gateway
Feedback:  18   16