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
The Office for Human Research Protections (OHRP) released draft guidance on 1/10/2019 for public comment titled “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l)).”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NEWS FLASH: OHRP Notice of Availability (NOA) of a Draft Guidance Document Related to the Revised Common Rule Published in the Federal Register
The Office for Human Research Protections (OHRP) has published a draft guidance document to “help entities determine whether a planned activity constitutes a public health surveillance activity deemed not to be research under the 2018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.,...