Safeguarding the rights and welfare of human subjects involved in biomedical and behavioral research supported by the Foundation is principally the responsibility of the grantee institution, the principal investigator, and the individual researchers. The Foundation’s role is to ensure that a process is in place so that this responsibility is adequately discharged in accordance with applicable law.
It is, therefore, the policy of the Foundation that no research involving human subjects shall be initiated using Foundation funds unless assurances satisfactory to the Foundation's professional staff are obtained that: (a) the rights and welfare of the subjects involved in the research are adequately protected; (b) the methods used to obtain freely given, informed consent of subjects are adequate and appropriate (or if such consent is not to be obtained, justification for waiver of such consent); (c) the balance of risks and potential benefits to the subjects are deemed reasonable and acceptable by the research investigator and by the subjects; and (d) the research will be carried out consistent with applicable laws, regulations and guidelines for the protection of human subjects research in the country in which such research is being conducted.
The Foundation recognizes social, economic and cultural circumstances vary from country to country. In implementing this policy, the Foundation will consider the context in which the research is conducted while seeking to ensure that grantee institutions treat individuals with respect, minimize risk to its research subjects and protect vulnerable populations as institutions conduct research.
Applicability
This policy applies to activities that constitute “research involving human subjects” as defined in the United States Department of Health and Human Services (“DHHS”) regulations for the protection of human subjects (45 Code of Federal Regulations 46, the “Code”). The appendix to this policy provides relevant definitions under the Code.
U.S. Institutions
Grantees located in the United States with an Institutional Review Board (“IRB”) recognized by the DHHS or an equivalent research ethics committee (an “Equivalent IRB”) must certify to the Foundation substantially in the form attached hereto that: (a) there is on file with the DHHS Office for Human Research Protections (“OHRP”) a Federal wide Assurance, satisfactory to the OHRP, under which the research supported by Foundation funds will be conducted; and (b) such research has been reviewed and found acceptable by an IRB or Equivalent IRB. Unless waived by the Foundation, these requirements apply to United States’ grantees conducting research in another country. In such cases, it is also the responsibility of the grantee institution, the principal investigator, and the individual researchers to conduct the research in conformance with the laws, regulations, and guidelines for the protection of human subjects of the country in which the research is conducted. A waiver of requirements must be signed by the program officer at the Foundation responsible for the grant with concurrence by the legal department.
In the absence of an IRB or an Equivalent IRB, a U.S. institution must provide to the Foundation documentation that the research is not subject to the requirements of the Code. This can include a legal opinion, documentation or other analysis satisfactory to the Foundation that the requirements of the Code are not applicable. The institution must represent that the research, will be conducted consistent with the essential protections set forth in the Code (i.e., a set of protocols, informed consent of subjects, protections for vulnerable populations such as minors, privacy of subjects, etc.). Additionally, U.S. institutions that do not have an IRB or an Equivalent IRB will be required to provide documents or other evidence that each of the researchers engaged in the research to be supported by the Foundation have participated or will participate in a training course relating to the conduct of human subjects research. Any waiver of these requirements must be signed by the program officer at the Foundation responsible for the grant with concurrence by the legal department.
If the human subjects research involves biomedical research or vulnerable populations such as children, the Foundation will ordinarily require the institution to seek review for the research by an IRB or an Equivalent IRB.
Research by Organizations Located Outside the United States
Research conducted by organizations located outside the United States must provide to the Foundation documents or other evidence that reasonably assures the Foundation that (a) the rights and welfare of the subjects involved in the research will be adequately protected; (b) participation in the research will be voluntary; (c) participants will be adequately informed about the research procedures, risks and benefits; (d) when appropriate, informed consent will be obtained and, if informed consent is not to be obtained, a justification for waiver of such consent; and (e) identification of the subjects will be confidential and be recorded in such a manner that the subjects cannot be identified. Additionally, grantee institutions located outside the United States must identify applicable laws, regulations and guidelines and certify that the research will be carried out consistent with the applicable laws, regulations and guidelines for the protection of human subjects research in the country in which such research is being conducted.
Depending on the nature of the research, the experience of the researchers, the country in which the research is to be conducted and other relevant factors, the Foundation may require one or more of the following: (i) that the researchers complete a training course relating to the conduct of human subjects research; (ii) the grantee obtain an opinion of local counsel that such research is conducted in compliance with all applicable laws, regulations and guidelines; and (iii) that the grantee provide evidence of the informed consent of the subjects of the research and the methods used to obtain such informed consent.
Questions regarding this Policy should be referred to the Office of the General Counsel.
Effective: June 15, 2012
APPENDIX
The review and conduct of research involving human subjects is regulated under Title 45 Section 46 of the Code of Federal Regulations (45 CFR 46). Although not all human subjects research falls under the purview of 45 CFR 46, these regulations provide a reasonable framework for ensuring oversight and protections of human subjects involved in research. Therefore, for purposes of the Foundation’s Statement of Policy Regarding Biomedical and Behavioral Research Involving Human Subjects, the terms listed below shall have the meanings ascribed to them in 45 CFR 46.
Research. The regulations define “research” as an activity that (a) involves a systematic investigation and (b) is designed to develop or contribute to generalizable knowledge.
Systematic Investigation. A systematic investigation is generally understood to mean a research plan that involves the collection and analysis of data to answer a specific question, test a hypothesis, or develop a theory. Research that contributes to generalizable knowledge includes research conducted with the intent of using its conclusions to develop or contribute to a general body of knowledge.
Contribution to Generalizable Knowledge. Studies that involve interviews, questionnaires, analysis of stored data, trials of experimental drugs or devices, the results of which will be shared broadly will constitute research under the terms of this policy. In contrast, research that is not shared beyond the institution conducting the research would generally not be considered “research” for purposes of this policy.
Human Subjects Research. The research involves human subjects if such research involves a living individual about whom an investigator conducting research obtains (1) information or biospecimens through intervention (by physical procedures or manipulation of the subject’s environment) or interaction with the individual through interpersonal contact or communication (by a survey or interview, for example), or (2) identifiable private information or identifiable biospecimen.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
