Program in Human Research Ethics and Oversight (PHREO) OverviewEPA's Program in Human Research Ethics and Oversight (PHREO) supports the ethical conduct and regulatory compliance of human subjects research conducted or supported by EPA. This support is accomplished through project review, cross-agency partnership, and education and training. Lead by the Human Subjects Research Review Official (HSRRO), the PHREO reviews, supports, and guides the work of EPA conducted or supported researchers involved in human subjects research to ensure that the rights and welfare of human research subjects are protected. The PHREO is in place to ensure that all EPA employees, contractors, grant recipients, and parties to other EPA agreements adhere to the highest standards of ethical conduct and are properly informed of the regulatory aspects of research involving human subjects. All research involving human subjects proposed by EPA staff or EPA supported researchers must be approved by the EPA HSRRO before human subjects work may begin. Show
Human subjects research at EPA allows for the collection of valuable information necessary in our mission to protect human health and the environment. Research involving human subjects informs decision-making and the formulation of regulatory standards at the Agency. HSR is critical for EPA’s program offices to consider when making regulatory decisions under many of the programs it administers, e.g., National Ambient Air Quality Standards, water quality criteria and drinking water standards, pollution mitigation techniques, and pesticide registration. Human subjects research advances scientists’ understanding of the links between human health and the environment so that EPA is better able to carry out its mission.
Davidson College Human Subjects ResearchSources include OHRP Assurance Training and PHRP Online Training DefinitionsResearch: A systematic investigation designed to develop or contribute to generalizable knowledge. Activities that meet this definition include research development, testing, and evaluation. Human Subject: A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information, or (3) identifiable biospecimens. Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life of the general population or during the performance of routine physical or psychological examinations or tests. Privacy: Free from unsanctioned intrusion. Confidentiality: Holding secret all information relating to an individual, unless the individual gives consent permitting disclosure. Equitable: To treat fairly. Equal: To treat in exactly the same way. Debrief: Provide research participants with additional pertinent information after they have participated in a study. Children: Persons who have not attained the legal age of consent to procedures or treatments involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. For purposes of inclusion in NIH-funded research, children are defined as individuals under the age of 18. IntroductionThe relationship between investigators and human subjects should be based on honesty, trust, and respect. All investigators involved in human subjects research should be knowledgeable about basic research ethics and associated federal regulations and policies. This tutorial provides an introduction to the Health and Human Services (HHS) Regulations for the Protection of Human Subjects, 45 CFR Part 46. It is not intended to be exhaustive and investigators are encouraged to click on the links within the tutorial for fuller explanations. HistoryThe Nuremberg Code (PDF) bof 1947, which was a response to Nazi Medical War Crimes (1939-1945) was the first international code of research ethics. The Syphilis Study at Tuskegee, initiated by the U.S. Public Health Service in the 1930s and continued until 1972, is the U.S.’s most notorious example of the violation of the rights and welfare of human subjects, and eventually resulted in the drafting of the Belmont Report by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report of 1979 sets forth the basic ethical principles governing the conduction of human subjects research. In 1991, as an outgrowth of the Belmont Report, the Federal Policy for the Protection of Human Subjects or the “Common Rule” was published. The Office for Human Research Protections (OHRP) was created in June 2000 to lead HHS and other federal agencies’ efforts to protect human subjects in biomedical and behavioral research under the Common Rule. The 2018 Revised Common Rule includes the requirement that subjects be informed about the possibility of future commercial profit from research materials. The Belmont ReportThe Belmont Report sets forth three basic ethical principles for the conduct of human subjects research: Respect for persons
Beneficence
Justice
Application of these ethical principles to the conduct of human subjects research leads to the following requirements: Respect for persons
Beneficence
Justice
IRB Review of ResearchAn IRB (Institutional Review Board) must review all human subjects research activities covered by the HHS regulations. Non-exempt research undergoes either Expedited (subcommittee) review or Full Board review. Protocols cannot be expedited if the research involves more than minimal risk. Investigators should understand that while Expedited review is conducted by fewer individuals, it is no less stringent and not necessarily faster than a Full Board review. Research approved by Full Board review undergoes continuing review by the IRB at least once a year. The following categories of research do not require continuing review:
Exempt ResearchCertain research is exempt from the requirements of the HHS regulations. A determination that research is exempt does not imply that investigators have no ethical responsibilities to subjects in such research; it means only that the regulatory requirements related to IRB review, informed consent, and assurance of compliance do not apply to the research. Exemption categories include:
Respect for PersonsThe Belmont principle of respect for persons is primarily applied by requiring that all human subjects research participants provide voluntary informed consent to participate in research. Informed consent is not a single event or just a form to be signed. Rather, it is an ongoing process that takes place between the investigator and the potential subjects. Informed ConsentThe three fundamental aspects of informed consent are:
Subjects must be informed that participation is voluntary, participation may be discontinued at any time, and there is no penalty or loss of benefits for refusing to participate or discontinuing participation. In order for participation to be voluntary, the potential for coercion and undue influence must be minimized. Compensation should never be presented as a benefit of the research. To avoid undue influence, investigators should carefully consider compensation and other inducements with respect to potential participants’ characteristics such as:
To ensure comprehension, information must be conveyed in language that is understandable to the subject or the subject’s legally authorized representative. The consent process must include full disclosure of the nature of the research and the subject’s participation. The consent form must start with a brief presentation of key information most likely to help prospective subjects understand why someone would or would not want to participate and should consist of a concise explanation covering the following:
HHS regulations require that informed consent be documented using:
BeneficenceThe Belmont principle of beneficence requires that benefits to participants are maximized and risks are minimized. Categories of risks encountered by participants in research include: physical (e.g. fatigue), psychological (e.g. anxiety), social (e.g. stigma), legal (e.g. disclosure of illegal drug use) and economic (e.g. loss of job or advancement). After minimizing risks to the extent possible, HHS regulations require that investigators consider:
Vulnerable populations require additional safeguards:
Protecting Research DataData can be de-identified by coding and anonymizing. Confidentiality can be maintained by:
Certificates of Confidentiality (CoCs) provide additional protection against legal demands for sensitive, identifiable research information. NOTE: Publishing demographic information is only acceptable in situations where the population is large enough, or the condition is common enough, that research participants cannot be identified using the demographic data provided. JusticeThe choice of participants in research needs to be considered carefully to ensure that groups are not selected for inclusion mainly because of easy availability, compromised position, or manipulability. Selection should always depend on reasons directly related to the research questions. The Belmont principle of justice requires that investigators strive for equitable distribution of the risks and potential benefits of the research. NIH inclusion policies require that:
International ResearchWhen HHS-supported research takes place outside of the United States, careful consideration must be given to justice, as well as beneficence, and respect for persons, particularly in resource-poor settings, to avoid exploiting participants. IRB review for research in international settings must be informed by a sufficient knowledge of the local context, which may be provided by:
What steps must a researcher take when dealing with human subjects?Research with Human Subjects
Researchers must get informed consent from their subjects before beginning research. Informed consent means that subjects must know enough about the research to decide whether to participate, and they must agree to participate voluntarily.
What must a researcher obtain before conducting research on humans?When conducting clinical research, the obtaining of informed consent is required. Informed consent is a procedure through which a competent subject, after having received and understood all the research-related information, can voluntarily provide his or her willingness to participate in a clinical trial.
Which set of procedures protects human subjects in research?The Belmont Report, issued by the Commission in 1978, is a statement of basic ethical principles and guidelines designed to help resolve ethical problems that surround the conduct of research with human subjects. The Belmont Report's three key ethical principles were respect for persons, beneficence, and justice.
What are the essential components of human rights in research?Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.
|