§ 26.1603 - EPA review of proposed human research.

§ 26.1603 EPA review of proposed human research.

(a) EPA must review all proposals for new human research submitted under § 26.1125 in a timely manner.

(b) In reviewing proposals for new human research submitted under § 26.1125, the EPA Administrator must consider and make determinations regarding the scientific validity and reliability of the proposed research, including:

(1) Whether the research would be likely to produce data that address an important scientific or policy question that cannot be resolved on the basis of animal data or human observational research.

(2) Whether the proposed research is designed in accordance with current scientific standards and practices to:

(i) Address the research question.

(ii) Include representative study populations for the endpoint in question.

(iii) Have adequate statistical power to detect appropriate effects.

(3) Whether the investigator proposes to conduct the research in accordance with recognized good research practices, including, when appropriate, good clinical practice guidelines and monitoring for the safety of subjects.

(c) In reviewing proposals for new research submitted under § 26.1125, the EPA Administrator must consider and make determinations regarding ethical aspects of the proposed research, including:

(1) Whether adequate information is available from prior animal studies or from other sources to assess the potential risks to subjects in the proposed research.

(2) Whether the research proposal adequately identifies anticipated risks to human subjects and their likelihood of occurrence, minimizes identified risks to human subjects, and identifies likely benefits of the research and their distribution.

(3) Whether the proposed research presents an acceptable balance of risks and benefits. In making this determination for research intended to reduce the interspecies uncertainty factor in a pesticide risk assessment, the EPA Administrator will also consider the process laid out and the attendant discussion for evaluating that type of study as provided in Recommendation 4-1 of the 2004 Report from the National Research Council of the National Academy of Sciences (NAS), entitled “Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues.”

(4) Whether subject selection will be equitable.

(5) Whether subjects' participation would follow free and fully informed consent.

(6) Whether an appropriately constituted IRB or its foreign equivalent has approved the proposed research.

(7) If any person from a vulnerable population may become a subject in the proposed research, whether there is a convincing justification for selection of such a person, and whether measures taken to protect such human subjects are adequate.

(8) If any person with a condition that would put them at increased risk for adverse effects may become a subject in the proposed research, whether there is a convincing justification for selection of such a person, and whether measures taken to protect such human subjects are adequate.

(9) Whether any proposed payments to subjects are consistent with the principles of justice and respect for persons, and whether they are so high as to constitute undue inducement or so low as to be attractive only to individuals who are socioeconomically disadvantaged.

(10) Whether the sponsor or investigator would provide needed medical care for injuries incurred in the proposed research, without cost to the human subjects.

(d) With respect to any research or any class of research subject to this subpart, the EPA Administrator may recommend additional conditions which, in the judgment of the EPA Administrator, are necessary for the protection of human subjects.

(e) In reviewing proposals covered by this subpart, the Administrator may take into account factors such as whether the applicant has been subject to a termination or suspension under § 26.123(a) or § 26.1123 and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the Administrator, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to Federal regulation).

(f) When research covered by subpart K takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in subpart K. (An example is a foreign institution which complies with guidelines consistent with the World Medical Assembly Declaration of Helsinki, issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized.) In these circumstances, if the Administrator determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in subpart K, the Administrator may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in subpart K.

(g) Following initial evaluation of the protocol by Agency staff, EPA shall submit the protocol and all supporting materials, together with the staff evaluation, to the Human Studies Review Board.

(h) EPA must provide the submitter of the proposal copies of the EPA and Human Studies Review Board reviews.

[71 FR 6168, Feb. 6, 2006. Redesignated at 78 FR 10544, Feb. 14, 2013 and amended at 78 FR 10544, Feb. 14, 2013]