September 2008 - Response to OHRP

September 29, 2008

Michael A. Carome, MD
Captain, U.S. Public Health Service
1101 Wootton Parkway
Suite 200
Rockville, MD 20852

RE: Human Subjects Protection Training and Education
Submitted electronically to

Dear Dr. Carome,
On behalf of Public Responsibility in Medicine and Research (PRIM&R), we appreciate the opportunity to comment on the recent Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs published in the Federal Register on July 1, 2008. (73 FR 127, 37460-37463.)

PRIM&R is an international, non-profit organization dedicated to advancing the highest ethical standards in the conduct of research. Since 1974, PRIM&R has served the full array of individuals and organizations involved in biomedical, social science, behavioral and educational research. PRIM&R's membership community includes professionals representing human subjects protection, animal care and use, and institutional biosafety programs, as well as researchers, institutional officials, government personnel, subject advocates, ethicists, policy makers, pharmaceutical and biotechnology leaders, and attorneys. Via a wide variety of conferences and courses, PRIM&R provides balanced, well-researched, and accurate information on the range of ethical and regulatory issues affecting research, while also offering access to certification, networking, and professional development resources.

In this RFI, OHRP has requested comments from affected entities and individuals on whether OHRP should issue additional guidance recommending that institutions engaged in human subjects research conducted or supported by HHS implement training and education programs for certain individuals involved in the conduct, review, or oversight of human subjects research, or whether HHS should develop a requirement regarding the implementation of such training and education programs. 

Ethics Education
PRIM&R supports requiring institutions engaged in human subjects research conducted or supported by HHS to implement ethics education programs for their employees and faculty who are directly involved in the conduct, review, or oversight of human subjects research. PRIM&R favors the development of ethics education focused on the application of sound ethical principles, rather than a more specific program of "training" which connotes memorizing and applying by rote rules or techniques.

While many institutions already provide education to their investigators, IRB members and staff, some do not. Requiring education will have the greatest and most needed impact on the latter institutions but, if handled correctly, it can broaden the understanding of ethical requirements at all institutions. Even institutions that have comprehensive training and education programs are vulnerable to gaps in the application of ethical principles and regulatory compliance. (See OHRP Compliance Oversight Determination Letters) Education and training programs can help all research institutions cultivate a climate for the ethical conduct of research.

Education Programs Tailored to the Institution
It is not necessary, and could in fact be counterproductive, for such a requirement to prescribe in detail the process, content or evaluation of such education programs. We are not aware of any consensus as to the precise body of information necessary to "qualify" one to participate in an ethically appropriate manner in the conduct or review of human subjects research. The divergence of opinions arises in large part from the wide ranging needs of research organizations. Different types of research organizations, from large, non-profit academic research institutions to small, for-profit research firms, conducting many different kinds of research, ranging from community based research to biomedical research involving new devices, drugs or surgical techniques demand tailored educational programs to meet their distinct needs. Regulations which attempt to define the precise curriculum and evaluation requirements for so varied an audience will likely result in generic programs that do not address specific circumstances of the individual institution. Programs that are created by and specifically tailored to each institution are more likely to facilitate the application of ethical and regulatory requirements that contribute to an institutional culture of ethical conduct. Furthermore, individuals who participate in such programs will be more receptive to and find more meaning in a program that is specifically relevant to their work.

The qualifications to conduct human subjects research will vary among institutions, disciplines, and types of research. Therefore, professionals in the field, in consultation with individuals knowledgeable about research ethics and compliance , are in the best position to establish education programs with the most relevant content, and the most appropriate standards and procedures for ensuring compliance with the training and education requirements.

Proposed Framework for Education Regulation Based on Institutional Discretion
PRIM&R recognizes that a poorly constructed regulation could create requirements that do not promote the spirit of learning and are perceived as unnecessary bureaucratic requirements that take time and resources with no beneficial impact. This would be worse than no regulation at all and could have a particularly adverse effect on institutions that already have thoughtful and well running educational programs. For this reason we propose the following general recommendations as a framework for a regulation to promote ethical research without creating unnecessary burden.

1. A regulation is promulgated that requires institutions engaged in human subjects research conducted or supported by HHS, to implement ethics education programs for individuals directly and substantially involved in the conduct, review, or oversight of human subjects research;

2. Institutions subject to the requirement should determine who must participate in the education programs, provided that they include IRB members and staff, non-clerical HRPP staff, investigators and other persons with substantial roles in giving research interventions to subjects or collecting research data concerning subjects (recognizing that some clinicians who provide care to subjects and who may incidentally be involved with research interventions or data, do not necessarily have to participate in ethics education if their research-related contacts with subjects occur under the supervision of a research investigator or other person who has completed the requisite ethics education).

3. These institutions should have the discretion to develop their own curricula based on broad topic areas that ensure that individuals involved in the conduct, oversight, administration or review of human subjects research understand and meet their regulatory and ethical responsibilities for protecting human subjects.

The topic areas that should be included in any ethics education program covering human subjects research should cover:

  • The reasons why ethical rules have been founded necessary for governing research
  • The distinction between ethics- and compliance-based approaches
  • The roles and responsibilities of all the parts of the institution's Human Research Protection Program
  • Ethical principles and their application
  • Federal regulations
  • State and local laws
  • The ethical and legal bases for informed consent
  • Research design and related ethical issues

4. To demonstrate compliance with the requirement, these institutions should develop their own standards for measuring the qualifications of the persons who complete the ethics education program.

5. These institutions should be required to affirm that they have provided ethics education to all relevant personnel and have ascertained their qualifications for being directly and substantially involved in the conduct, review, or oversight of human subjects research.

6. The regulation should establish a funding source for the implementation of the education requirement. One such mechanism could be a "set aside" amount designated for the development of an ethics education program that is based on a percentage of each grant or contract involving human subjects research issued by any federal department, office or the agency that is a signatory to the Common Rule.

We trust that the requirements will focus on promoting competence in research ethics and will avoid erecting bureaucratic obstacles. Finally, we hope that, in addition to requiring ethics education, OHRP will develop guidance to help institutions create effective ethics education programs targeted to their particular needs.

Respectfully Submitted,

Leonard Glantz, JD
Chair, Board of Directors
Public Responsibility in Medicine and Research