A Carrot and Sticks Approach

Publicity about abuses involving people who participated knowingly or unwittingly in medical experiments and research studies usually have been followed by the tightening of existing rules and calls for new laws. So it was again at the close of the 20th century.¹ Such a response occurred after the highly publicized death of 18-year-old Jesse Gelsinger, who took part in a gene transfer trial.^2,3

Reviews by two government watchdog agencies of the existing system of research oversight concluded that the system was overburdened, under-resourced, and paper driven and paid little attention to determining whether research institutions were actually fulfilling their responsibilities to protect human subjects.^4,5 At the request of the Secretary of Health and Human Services (HHS), the Institute of Medicine (IOM) of the National Academy of Sciences examined how to improve human research protection programs.⁶

Rewarding good protection

The Health Improvement Institute, a tax-exempt research and educational organization that conducts forums on emerging treatments, gives national awards to organizations and individuals who demonstrate excellence in improving the quality and productivity of America's health care. The Institute believes that incentives to do the right thing (carrots) are needed as much as increased compliance oversight and tighter regulations (sticks).

As a counterpoint to these regulations, the Institute designed the Award for Excellence in Human Research Protection. It launched the Award in 2001 to encourage, recognize, and reward excellence and innovation in human research protection on the part of individual investigators, institutions, and research sponsors. The Award is also intended to facilitate improvements and openness in human research.

"I think that there are lots of institutions doing innovative things in human research protection, and it is important that we share and recognize these efforts," said Susan Kornetsky, director of clinical research at Children's Hospital Boston—a 2006 award winner. The Hospital designed an educational program to increase parental knowledge about the nature of medical research, winning the 2006 Annual Award for Best Practice. This award is given to a research institution, unit or individual with the best way, one of the best ways, or a proven way to achieve or contribute toward achieving the human research protection specified by the practice (see Table 1).

Past Annual Award Winners for Best Practice

Then there is the Award in Innovation (see Table 2), which is given to an individual or team who has introduced an innovation or a novel approach to the protection of human research subjects. The final category is Lifetime Achievement (see Table 3), and this is awarded to an individual who has made significant contributions to the protection of human research subjects over a continuous period of at least 20 years.

Past Annual Award Winners for Excellence in Innovation

Acceptance of applications for an Award begins in February and continues until the last Monday of September. Winners are announced in December on the Web site of the Institute (http://www.hii.org), which also broadcasts the announcement to program participants and health-related associations and issues a media release through a national newswire service.

Winners of the Award for Excellence for Lifetime Achievement

Plaques and honors

Recipients of the Award of Excellence are given a certificate and invited to use the Award logo on their Web site and in print media. Annual Award recipients also receive an engraved brass plaque to proclaim their award. "It's something that's nice internally and externally," said Sarah Fowler-Dixon, education specialist at Washington University's School of Medicine. The merger of the University's multiple IRBs earned a 2006 Award for Excellence, which, according to Fowler-Dixon, validates her work and earns it publicity.

At the end of 2005 and again at the end of 2006, the Institute surveyed former Award of Excellence winners to determine the value of the award. In summary, winners indicated that the Award had brought personal recognition within the institution and community; created personal satisfaction regarding the awardees' contribution to protecting people who participated in clinical research; and imparted recognition to the best practice/innovation within the community. "Not only does it help people know what different IRBs are doing, but it helps publicize what different institutions are doing, and helps validate what they are doing," assessed Fowler-Dixon, "[and] it gives people incentive to continue to do good things."

Blueprint for Excellence

But you don't need to win an award to provide insight. Regardless of the final outcome, the Institute encourages all former participants to provide feedback, and periodically conducts various surveys of all or selected participants to seek suggestions for improving the Awards program.

Early beginnings

The federal Office for Research Protections (OHRP) was the founding sponsor of the Award program. The OHRP is responsible for the oversight of the protection of human research subjects. It established the Division of Assurances and Quality Improvement to assure and improve the performance, quality, and effectiveness of research institutions' human research protection programs, including their IRBs.

The OHRP provided initial financial support to the Institute to launch the award program (because of its regulatory roles and responsibilities, it is not in a position to issue commendations nor to run a program to recognize excellence). And since the beginning, the Institute has received intermittent financial support from the American Diabetes Association, Pfizer, and from a number of other private organizations.

During the first five years of the Award program (2002–2006), 40 individuals and institutions submitted applications. Of the applicants, four won the Annual Award, 17 were granted the Award for Excellence, and 14 received the Certificate of Merit. Of note, Washington University, School of Medicine and Human Studies, has walked away with awards four times, with three awards for best practice.

The program's success to date has depended on the Institute's willingness to continue the Award program, and the volunteers who serve on committees and judge applications. Knowledge about the awards program is spreading slowly by word of mouth. The main incentives for applying for an Award are self satisfaction and peer recognition, as previous winners can attest. Said Kortensky, "We applied for it because I thought we had developed something that was innovative and deserved some type of recognition, and we were very proud of it." She added, "It's nice to be able to attach an award to it [so people] can see that there is recognition behind it."

Positive expectations

In the years ahead, one can expect such factors as internal and external satisfaction to reinforce one another and result in an increase in the number of applications and in the prestige of the Award for Excellence. Inevitably, the process of building awareness and recognition of the value of an award takes time. Further, although the community of researchers is growing in both number and professionalism, the pool of potential applicants for an Award remains relatively small.

Going forward, the Institute expects the Award to both make a lasting contribution to increasing awareness of the importance of subject protection and improving the quality of protection for people who participate in clinical research.

For those interested, the Institute welcomes participation as a sponsor, judge or applicant for an Award. By doing so, you can contribute to the promotion of and receive recognition for excellence in human research protection. For more information about the Award for Excellence in Human Research Protection, visit the institute's Web site or call 301-320-0971.

Acknowledgements

This article was peer-reviewed and accepted with additional editing and content provided by Samantha Etkin, associate editor for Applied Clinical Trials.

Peter Goldschmidt,* MD, DrPH, DMS, is the founder and president of the Health Improvement Institute, 5800 Madaket Road, Suite 200, Bethesda, MD 20816-3201, email: pgg@hii.org Weijie Ma, MBA, is the the Awards coordinator at the Institute.

*To whom all correspondence should be addressed.

References

1. P.G. Goldschmidt and J.M. Cohen, "Accreditation and Certification: Can They Work in Clinical Research?" The Monitor, 20 (2), 35–40 (2006.)

2. S.G. Stolberg, "The Biotech Death of Jesse Gelsinger," New York Times Magazine, November 1999.

3. In 2000, bills were introduced in Congress to further regulate human research subjects and Donna Shalala, Secretary of DDHS, announced several initiatives designed to heighten government oversight of biomedical research and to reemphasize to research institutions their responsibility to oversee their clinical researchers and IRBs. The Office for Protection from Research Risks (OPRR) of the National Institutes of Health became the Office for Human Research Protections (OHRP) in the Office of the Secretary of DHHS.

4. U.S. General Accounting Office, Scientific Research: Continued Vigilance Critical to Protecting Human Subjects, GAO/HEHS-96-72 (Washington, DC, March 1996).

5. Inspector General of the DHHS, Institutional Review Boards: A Time for Reform, OEI-01-97-00193 (DHHS/OIG, Washington, DC, June 1998).

6. Institute of Medicine, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (National Academy Press, Washington, DC, 2001).