Human Research Protection Program

HITECH Act

International Research Partners

Yale University researchers partner with a myriad of international collaborators. In protecting persons participating in these international projects, there is an expectation that there will be local Institutional Review Board (IRB) or Ethics Committee (EC) review and ongoing oversight of these projects. Currently, for a research project conducted at an international site, there is dual review by the US IRB and by the local IRB, but often there is little communication and virtually no collaboration regarding concerns, findings and continuing oversight. Language and time barriers interfere, and differences in resources, commitment and processes lead to a lack of coordinated review and incomplete understanding on the part of both IRBs. The U.S. based IRB needs to understand the local culture and context of where the research will be conducted and relies on the international or local IRB review to address contextual issues in a given project.

Human subject protection must involve a well-educated, ‘ethically literate’ research community, especially as the scope and volume of human research initiatives continue to broaden. Competent, informed, conscientious, compassionate and responsible investigators are the best protection possible. Investigators must be trained to incorporate ethical principles when designing protocols, when mentoring students, throughout the conduct of the research, and to ensure ethical conduct of research through well-trained team members.

Institutions must understand these needs and develop ways to meet them. Institutions engaged in human subjects research must develop a programmatic approach to protection of those subjects, which often requires reaching beyond IRB or Ethics Committee review. Establishing materials—an application, template policies and procedures, initial training requirements—for research conduct is only one part of establishing an effective human research protection program. The institution must also develop policies for effectively overseeing and reporting unanticipated problems, ensuring continued training, considering potential conflicts of interest and monitoring of data and safety. Following the creation of policy, the international site must develop procedures and supporting documents for ensuring that the conduct of research is appropriate given their population and culture. Each institution is unique in its structure and in its relationship to the community. Procedures need to promote efficiency while offering appropriate protections to the institution and the human research participants. A plan and materials for education of researchers and the community should be created, so that an understanding of the process, the rights of research volunteers, its goals and requirements are easily available and understood.

All of these elements, once in place, support an international research oversight process that shares responsibility for the ethical conduct of research, and offers maximum protection to research participants.

Template Institutional Policy

The linked policy below can be used by institutions to address oversight and authority of a local human research protection program. The policy recognizes that the protection of human subjects participating in research transcends traditional department jurisdictions and is not the sole responsibility of the IRB. The Institution therefore extends the HRPP to incorporate investigator and Institutional oversight responsibilities to allow for an integrated program for research subject protection initiatives as they relate to the individual and Institution’s core function in supporting the research enterprise. The program ensures (a) the rights and welfare of the research subjects are protected effectively, (2) the risks to subjects are reasonable when considering the potential benefits of the research, (3) the selection of subjects is equitable, and (4) informed consent will be obtained and, when appropriate, documented. Further the program assures compliance with all applicable regulations and with ethical standards for research involving human subjects.

Policy Template

Sample Template in Spanish

Special Topic Policies

In addition to the above, each organization may wish to adopt additional policies or procedures tailored to the unique research environment of that organization. The use of special topic policies should reflect the type of research being conducted currently as well as future anticipated research. Examples of special topic policies include policies for the inclusion of vulnerable populations in research; policies to address certain research practices; or policies for the use of private health information. Yale has created its own institutional policies for many common research situations, and organizations may adopt them in full or modify them as appropriate, with appropriate attribution. Policies are available on this website.

Useful links:

Singapore Statement on Research Integrity

Publication of the Singapore Statement on Research Integrity is intended to challenge governments, organizations and researchers to develop more comprehensive standards, codes and policies to promote research integrity both locally and on a global basis.

The principles and responsibilities summarized in the Statement provide a foundation for more expansive and specific guidance worldwide. Its publication and dissemination are intended to make it easier for others to provide the leadership needed to promote integrity in research on a global basis, with a common approach to the fundamental elements of responsible research practice.

The Statement is applicable to anyone who does research, to any organization that sponsors research and to any country that uses research results in decision-making. Good research practices are expected of all researchers: government, corporate and academic.

Council for International Organizations of Medical Sciences (CIOMS)

The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. In 2009 CIOMS was celebrating the 60th anniversary of its creation. Through its membership, CIOMS is representative of a substantial proportion of the biomedical scientific community. The membership of CIOMS in 2010 includes over 55 international, national and associate member organizations, representing many of the biomedical disciplines, national academies of sciences and medical research councils. The main objectives of CIOMS are:

· To facilitate and promote international activities in the field of biomedical sciences, especially when the participation of several international associations and national institutions is deemed necessary;

· To maintain collaborative relations with the United Nations and its specialized agencies, in particular with WHO and UNESCO;

· To serve the scientific interests of the international biomedical community in general.