HS-IRBs News Special Edition - New Informed Consent Tools and Knowledge Base Rollout
Health Sciences and Minimal Risk IRBs, IRB News / Informed Consent Special Edition June 2017
The Health Sciences IRBs Office is excited to announce that newly developed Informed Consent Templates and Additional Model Language are now available on our updated Informed Consent Knowledge Base (KB) page. This newsletter provides an overview of the new materials, including when and how researchers submitting to the HS IRBs can use the documents.
- Informed consent templates to help create consent forms that not only comply with regulatory and institutional requirements, but are briefer and easier to read. Detailed instructions combined with model language and revisable content allow researchers to focus on study-specific content. The new templates and language replace most of the HS IRBs’ previous consent form templates as well as the “Additional Required Language” KB page. The new templates also replace the consent form wizards, which will no longer be available on the HS IRBs KB pages.
- Additional model language that updates and expands on the HS IRBs’ Additional Required Language KB page. The new KB page provides guidance and model language for situations common in studies reviewed by the HS IRBs, such as sharing data, banking samples, Certificates of Confidentiality, and commercial products language. This page will continue to grow, adding model language for more situations as the HS IRBs staff develops it.
- Restructured Informed Consent KB pages that are easier to navigate, consolidate information related to informed consent, and add streamlined description of the many processes for obtaining informed consent available to researchers.
Using the New Templates and Model LanguageThe HS IRBs Office encourages researchers to begin using these templates and model language when creating consent documents for new, investigator-initiated studies that will be reviewed by the Health Sciences or Minimal Risk IRBs. Consent documents that do not use the new templates will still be accepted by the HS IRBs. Effective July 1, however, newly-submitted consent forms will need to incorporate new template language for compensation for injury and contact information. Consent documents currently approved by the HS IRBs do not need to be revised to follow the new templates.
- The HS IRBs Informed Consent Working Group (ICWG) will offer large-group orientation sessions to introduce and answer questions about the new informed consent materials in July. We will announce specific dates and times via the HS IRBs listserv.
- Updated informed consent templates for Humanitarian Use Devices and Emergency/One-time Use will be posted on the HS IRBs KB pages soon.
- ICWG will be updating and creating new guidance related to informed consent processes. If proposed changes to the Federal Common Rule go forward, ICWG will revise the consent templates and guidance as needed to comply with the new regulations.
- ICWG will also continue developing additional model language to use in specific situations.