Toolkit Changes
Documents in the HRPP Toolkit Library are changed periodically in response to feedback from the community, changes in best practices for human research protections, and institutional, local, or federal regulatory changes.
Monthly Toolkit Meetings
Requests from the research community, IRB members, and staff are discussed at monthly Toolkit meetings. Many requests for clarifications, additions, and revisions are incorporated into Toolkit documents. However, some changes, after thoughtful consideration, are not incorporated. To view all requests and decisions, access the Archive of Monthly Toolkit Meeting Summaries.
See below for a list of the most recent changes made to documents in the Toolkit. Access Archive of Toolkit Releases.
April 2019 Toolkit Changes
The HRPP has made changes to the Toolkit to address feedback from the research community and IRB members/staff.
Manuals
Investigator Manual (HRP-103) - Track Changes Copy of HRP-103
- Added guidance about recruitment methods
- Added guidance about research involving students
- Added requirements for research involving non-English speaking research participants that use the short-form method
- Added guidance about the involvement of interpreters
- Added re-consent and significant new findings guidance
- Added instructions for the use of ETHOS for HRPP Scientific Assessment
- Updated information regarding HRPP Scientific Assessment, including the addition of new checklist, HRP-420.
- Updated guidance for research involving fetal tissue, potentially hazardous biological agents, including human gene transfer
- Standard Operating Procedures
Standard Operating Procedures
Informed Consent Process (HRP-090)
- Added requirements for research involving non-English speaking research participants that use the short-form method
- Added re-consent and significant new findings guidance
Written Documentation of Consent (HRP-091)
- Added procedures to capture requirement to add a comment and notify the PI regarding a scheduled convened meeting and reference relevant Toolkit worksheet.
Worksheets
Ancillary Review Matrix (HRP-309)
- Updated ancillary review information for research under the auspices of the Institutional Biosafety Committee (IBC) and the Human Fetal Tissue Research Committee.
- Added examples that may qualify for exempt category 3, prospective collection of biological specimens for research purposes by noninvasive means.
Checklists
- Released new checklist for the conduct of HRPP scientific assessment.
Templates
Protocol Templates
Site Supplement to Sponsor Protocol (HRP-508) (with instructions)
- Revised instructions for Section 4.3, 4.4, and 4.5 regarding biosafety, stem cells, and fetal tissue.
- Revised instructions for Section 20.4 for research involving non-English speaking participants.
Social Behavioral Protocol Template (HRP-580) (with instructions)
- Revised instructions for Section 4.3, 4.4, and 4.5 regarding biosafety, stem cells, and fetal tissue.
- Revised instructions for Section 20.4 for research involving non-English speaking participants
Biomedical Protocol Template (HRP-590) (with instructions)
- Revised instructions for Section 4.3, 4.4, and 4.5 regarding biosafety, stem cells, and fetal tissue.
- Revised instructions for Section 20.4 for research involving non-English speaking participants
Consent Templates
Consent Template for Social Behavioral Research / Medical Research and Assent Template (HRP-582, HRP-592, HRP-583)
- Revised consent language regarding costs of research participation
- Added a Toll Free number and abbreviated webpage URL for research participants that want to communicate questions, complaints, or concerns
- Updated the Witness signature block
Standard Language for Consent Templates (HRP-542a, 542b, 542c)
- Revised language to align with current consent templates
Other Templates or Forms
Business and Industry Funded Study Fee (HRP-537)
- New template to be completed by researchers submitting a Business and Industry sponsored clinical trial for IRB Review.
Scientific Review (HRP-538)
- New template to be completed by researchers that will submit a study for HRPP Facilitated Scientific Review in ETHOS.
Quorum / Advarra Institution Cover Page (HRP-811, HRP-812)
- Revised to align with current toolkit documents