The protection of research participants is fundamental and should remain paramount to any research endeavor. In today’s complex research environment, appropriate protection can most effectively be provided through a program of systematic and complementary protection functions within which roles and accountability are clearly articulated. HRPPPs, henceforth referred to as “protection programs” or simply “programs,” should be viewed as a system of interdependent elements that involve the research organization, the IRB, the investigators, the sponsors, and most importantly, the volunteer participants. Redundancies in the system that do not add value should be eliminated. To this end, each research entity should develop clear, efficient, and effective processes and procedures. In addition, open and defined communication among those involved in participant protection should be established and maintained.
The diligent application of HRPPP policies and practices will ensure that participants in any research project are protected against undue risk, that informed consent to participate in the research is provided, and that all efforts are made to ensure that participants’ rights, privileges, and privacy are protected throughout the entire research process. Therefore, protection requirements should be extended to include every research project that involves human participants, regardless of funding source or research setting.
The specific structure of a protection program is secondary to its performance of several essential functions. These functions include:
comprehensive review of protocols (including scientific, financial conflict of interest, and ethical reviews),
ethically sound participant-investigator interactions,
ongoing (and risk-appropriate) safety monitoring throughout the conduct of the study, and
quality improvement (QI) and compliance activities.
Recommendation: Adequate protection of participants requires that all human research be subject to a responsible Human Research Participant Protection Program (HRPPP) under federal oversight. Federal law should require every organization sponsoring or conducting research with humans to assure that all of the necessary functions of an HRPPP are carried out and should also require every individual conducting research with humans to be acting under the authority of an established HRPPP. (Recommendation 2.1)