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.
individual HRPPPs come together to form the system responsible for carrying out all necessary protection functions for a particular protocol. Despite this flexibility, however, it is essential that all basic protection functions be met—although various organizations, depending on their missions and activities, might utilize different individuals, offices, or authorities to exercise each function.
For example, in some research universities a separate office might manage all issues related to financial conflicts of interest, while a smaller research institution might address those issues through the Office of General Counsel (see Chapter 6 for further discussion). In most instances, who ensures that certain functions are being addressed matters less than the fact that responsibility and accountability are clearly defined for each function and that each unit of the protection program understands the system and its role within it. Thus, although systems-based protection programs could take many forms, currently, it is likely that a significant portion of them