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
On 1/18/19 OHRP issued a FAQ recommending that IRBs continue to conduct continuing review of research that is eligible for expedited review under the current categories 8(b) or 9 of the OHRP Federal Register list even though continuing review is not required for such...
The Office for Human Research Protections (OHRP) released draft guidance on 1/10/2019 for public comment titled “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l)).”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...