Descriptions of HRPPPs at Various Levels Within the Research Environment
International or National HRPPP: The set of policies and practices dictated by legislation and regulation (e.g., 45 CFR 46, 21 CFR 50 and 56, Guideline for Good Clinical Practice [GCP]) and enforced by governmental authorities (e.g., Office for Human Research Protections [OHRP], the Food and Drug Administration [FDA], the National Institutes of Health [NIH]) or recommended by international bodies (e.g., International Conference on Harmonisation, for drug trials).
Academic HRPPP: The set of policies and practices existing at a particular research institution, consistent with regulations, guidelines, and other applicable standards but enhanced with local laws and/or research-specific considerations and community-specific input.
Industry HRPPP: The set of policies and practices existing at a particular industrial organization, consistent with GCP or other applicable standards but enhanced with local and/or research-specific considerations.
Collaborative HRPPP: The set of policies and practices existing at particular research institutions and industrial firms engaged in collaborative research (e.g., multicenter trials), consistent with GCP or other applicable standards but enhanced with considerations applicable to the collaborative research. In most cases, the sponsor HRPPP would retain ultimate accountability for the conduct and oversight of the study; however, various functions may be contracted out to other appropriate entities (such as contract research organizations or academic institutions) with the necessary assurances.