the responsibility lies with the president. Authority for implementing the protection program could be delegated to others within the organization or institution, such as a vice president or a dean, but final accountability for the program’s mission, goals, and success (or failure) resides with the CEO or president.

Some elements of the HRPPP may reside within the same research organization or they may be external entities with which the sponsor or the research organization has contracted. Whatever the structure, mechanisms should be in place to assure that appropriate integration of the different elements occurs. For example, financial conflict of interest issues may be subsumed in a more general institutional policy on conflict of interest, but such determinations relevant to research involving humans should be made available to the IRBs reviewing the research in order to be included in the comprehensive ethical review of the study. Lack of coordination and communication within a program leads to duplication of effort that can result in a significant loss of time and resources. Most significantly, lack of communication diminishes a program’s capacity to protect research participants.

When multiple organizations are involved in the research, at least one organization should have primary responsibility for obtaining appropriate and documented assurances from the other participating organizations. In the case of a university and a pharmaceutical firm, for example, the firm would be responsible for meeting FDA sponsor regulations (including safety monitoring) and for choosing qualified investigators and site(s) where an institutional protection program was in place. The university would be responsible for ensuring that the investigators conducting the research at their facilities are appropriately trained in GCP or other relevant standards, that the study is scientifically sound, that the study’s potential benefit outweighs the potential risks, and that the participants are properly informed about these potential risks. The university would also be responsible for complying with all applicable federal, state, or local regulations. In a multisite project, each site could designate its own IRB as the responsible oversight body, or several sites could designate one of the IRBs as the primary IRB (see Chapter 3).

The organization with primary responsibility for obtaining the assurances should also be responsible for acting decisively should violations occur. Such actions could include termination of the study or the site and/or reporting violations and violators to relevant authorities. However, it should not be assumed, for example, that an industry sponsor participating in FDA-regulated trials has sole responsibility for the protection program. Participants are best protected if all organizations and individuals involved share equally in that responsibility, particularly because research organizations and investigators are more directly and closely involved with the research participants than would be a remote sponsor.



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