Committee Start-up & Support
HRP Consulting can provide guidance or hands-on assistance with the development, implementation, and ongoing support of research oversight committees, including IRB, IACUC, Conflict of Interest (COI) Review, and others. The successful implementation of such committees is more complex than most appreciate at first glance, HRP can help with the following and more:
- Member composition and documentation
- Federal registrations, when applicable
- Standard Operating Procedures, forms, checklists, and resources
- Electronic system implementation
- Chair, member, staff, and investigator training
- Temporary staff
- Retainers for on-call guidance and support
The Office for Human Research Protections (OHRP) released draft guidance on 1/10/2019 for public comment titled “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l)).” While the guidance is draft, it provides insight into OHRP’s...
NEWS FLASH: OHRP Notice of Availability (NOA) of a Draft Guidance Document Related to the Revised Common Rule Published in the Federal Register
The Office for Human Research Protections (OHRP) has published a draft guidance document to “help entities determine whether a planned activity constitutes a public health surveillance activity deemed not to be research under the 2018 Requirements” (i.e.,...