Accountability & News

Human research protection programs primarily focus on ethics and regulatory compliance. However, those are not the only functions of HRPPs; they also serve to preserve public trust in research. We must remember that there is no right to conduct research. Research, especially research involving human subjects, is a privilege granted to the research community by the public. That privilege is granted based on the trust that the research will be conducted according to appropriate ethical principles and regulations. Anything that erodes that trust can result in that privilege being restricted or withdrawn. When the public has serious concerns about research it puts pressure on Congress and federal agencies to further regulate research, which is how we got to the current regulatory situation in this country.

So, how do HRPPs serve to maintain the public trust in human research? Through accountability; that is, being able to demonstrate that organizations and investigators are conducting research according to ethical and regulatory standards. It is not good enough just to do the right thing; we must be able to demonstrate to others that we are doing the right thing!

Accountability begins with investigators and institutions maintaining appropriate documentation. If you examine the federal regulations you will see that, although most of the regulations address the implementation of ethical principles (informed consent, risk/benefit, etc.), the rest is about documentation (consent forms, minutes etc.). This is because the regulations, when they were drafted, were designed to restore public trust in human research.

The next level of accountability involves oversight by government agencies. The federal human subject regulations were first imposed back in the 70s because the public trust in research had eroded. When public trust eroded again in the mid-90s, federal oversight increased. By issuing regulations and overseeing the compliance with those regulations, the government assures the public that human research is being conducted with appropriate safeguards for the rights and welfare of subjects.

Finally, accountability involves accreditation. Organizations must be able to demonstrate that they have an HRPP that meets appropriate standards. An independent accrediting body, currently AAHRPP, develops HRPP standards and assesses organizations as to how well their HRPP meets those standards. Accreditation involves more than just compliance with regulations and appropriate documentation; it also involves the evaluation of the effectiveness of the HRPP through a site visit and interviews. As more organizations become accredited, the public can trust that research at those institutions at least meets AAHRPP standards.

Many people in our field see accountability as just so much bureaucratic nonsense and fail to appreciate the important role it plays in ensuring that important research can continue to be done. Maintaining the public's trust in research is as important as the ethical conduct of research for, without that trust, the conduct of research will be even more difficult.