NIH’s ethical framework wins award for excellence

Ethical guide applies to international research, also

Guidelines and regulations related to research ethics often are conflicting and difficult to follow, so IRBs are left with a multitude of ways to interpret human subjects research issues that arise during the protocol review process.

The NIH now offers IRBs and researchers some help with this dilemma. NIH has developed a framework that provides a systematic approach to deciding whether a particular research protocol is ethical.

The NIH project, called the Framework and Benchmarks for Evaluation of Research, recently received the 2005 Award for Excellence in Human Research Protection by the Health Improvement Institute of Bethesda, MD.

The first framework was published in the Journal of the American Medicine Association in 2000 and established the seven principles on which the framework is based, says Christine Grady, PhD, RN, head of the section on human subjects research in the department of clinical bioethics at the Clinical Center at NIH.

In 2004, NIH published in the Journal of Infectious Diseases (JID) a second article on the benchmarks, focusing on what makes clinical research in developing countries ethical.1

"This system of seven principles ideally is supposed to be followed sequentially, and they’re meant to be comprehensive, systematic, and universal in terms of different kinds of research," Grady says.

IRBs will find that the guidelines are very familiar and that they synthesize existing guidance, Grady notes.

"We’ve made these in a more systematic fashion, and it’s had a lot of resonance with people who have found the framework helps them think through the ethics of research," Grady says. "It’s worked so well that some IRBs around the world have adopted it as their mode of reviewing research."

In the JID article, which is available in the public domain on-line at the JID website, the focus is on the debate about ethics in developing countries and the three main issues of standard of care, reasonable availability of interventions, and the quality of informed consent.

In the framework Grady and co-authors presented for this issue, the first principle is minimizing exploitation, which is greater in developing nations than it is in resource-wealthy nations. While individuals or communities in developing countries assume the risks of research, most of the benefits may accrue to people in developed countries, the article states.

One way investigators and IRBs can prevent exploitation from taking place is to follow a blueprint to ethical principles and benchmarks, which the authors created and published, as follows:

Collaborative partnership:

— Develop partnerships with researchers, makers of health policies, and the community.

— Involve partners in sharing responsibilities for determining the importance of health problem, assessing the value of research, planning, conducting, and overseeing research, and integrating research into the health care system.

— Respect the community’s values, culture, traditions, and social practices.

— Develop the capacity for researchers, makers of health policies, and the community to become full and equal partners in the research enterprise.

— Ensure that recruited participants and communities receive benefits from the conduct and results of research.

— Share fairly financial and other rewards of the research.

Social value:

— Specify the beneficiaries of the research.

— Assess the importance of the health problems being investigated and the prospective value of the research for each of the beneficiaries.

Enhance the value of the research for each of the beneficiaries through dissemination of knowledge, product development, long-term research collaboration, and/or health system improvements.

— Prevent supplanting the extant health system infrastructure and services.

Scientific validity:

— Ensure the scientific design of the research realizes social value for the primary beneficiaries.

— Ensure that the scientific design realizes the scientific objectives while guaranteeing research participants the health care interventions to which they are entitled.

— Ensure that the research study is feasible within the social, political, and cultural context or with sustainable improvements in the local health care and physical infrastructure.

Fair selection of study population:

— Select the study population to ensure scientific validity of the research.

— Select the study population to minimize the risks of the research and to enhance other principles, especially collaborative partnership and social values.

— Identify and protect vulnerable populations.

Favorable risk-benefit ratio:

— Assess the potential risks and benefits of the research to the study population in the context of its health risks.

— Assess the risk-benefit ratio by comparing the net risks of the research project with the potential benefits derived from collaborative partnership, social value, and respect for study populations.

Independent review:

— Ensure public accountability through reviews mandated by laws and regulations.

— Ensure public accountability through transparency and reviews by other international and nongovernmental bodies, as appropriate.

— Ensure independence and competence of the reviews.

Informed consent:

— Involve the community in establishing recruitment procedures and incentives.

— Disclose information in culturally and linguistically appropriate formats.

— Implement supplementary community and familial consent procedures where culturally appropriate.

— Obtain consent in culturally and linguistically appropriate formats.

— Ensure the freedom to refuse or withdraw.

Respect for recruited participants and study communities:

— Develop and implement procedures to protect the confidentiality of recruited and enrolled participants.

— Ensure that participants know they can withdraw without penalty.

— Provide enrolled participants with information that arises in the course of the research study.

— Monitor and develop interventions for medical conditions, including research-related injuries, for enrolled participants at least as good as existing local norms.

— Inform participants and the study community of the results of the research.

Reference:

  1. Emanuel EJ, Wendler D, Killen J, Grady, C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. JID. 2004;189:930-937.