Human Research Protection Programs (HRPP)
The core concept of a HRPP is to engage all stakeholders in ensuring the protection of human subjects in research. With increasing reliance on external IRBs, a highly functioning HRPP has become even more essential to ensure that organizations fulfill their responsibilities to oversee research, protect local subjects, and support regulatory compliance and best practices.
HRP Consulting can provide expert assistance with practically any aspect of HRPP evaluation, development, or management, including the following:
- Program Evaluation
- Process Assessments
- Establishing or Refining a HRPP
- Accreditation Support
- Policies and Procedures, associated materials
- IRB Evaluation and Support
- IRB or Investigator Audits
- Training and Education
- Interactions with or Responding to Federal Agencies
- Temporary Staff
- Retainers for on-call guidance and support
HRP recently sought clarification from NIH and OHRP regarding the process for organizations to request exceptions from the revised Common Rule requirement for single IRB for cooperative research. While NIH was previously able to grant exceptions from its own single...
On January 2nd, the National Institute of Justice (NIJ) updated their guidance regarding Human Subjects Protections to remind organizations that: “Because the Department of Justice (DOJ) is not a signatory of the Revised Common Rule, the DOJ regulations regarding...