High Point University (hereinafter “University”) recognizes the importance of research in the academic environment and to this end established the human participants institutional review board (hereinafter “IRB”) to ensure the ethical treatment of human participants. The IRB shall review all research involving human participants performed under University auspices, for compliance with federal guidelines and with ethical standards as set forth by The Belmont Report and the U.S. Department of Health and Human Services. Research, as stated in The Belmont Report “designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationship). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.” All University faculty, staff, and students whose research involves human participants must be familiar with and conform to this policy for all activities that fall under this definition.
Rights of Human Participants
The University recognizes that the rights of research participants include: the right to be informed regarding the nature of the research, including its methods and procedures and any aspect of the research that could reasonably influence a participant’s willingness to participate, the nature of any expected benefits or foreseeable risks (if any) for the research participant or for society; the right to withdraw from participation in the research without penalty; and the right to have the participant’s confidentiality respected.
Institutional Review Board
Purpose of the IRB
The purpose of the IRB is to set policies and procedures and to provide oversight concerning the protection of human participants involved in research.
Guidelines of the IRB
The primary references used as guidelines for establishing policy and procedures are The Belmont Report and Department of Health and Human Services Federal Regulations (criteria for approval, 45 CFR 46).
All research involving University faculty, staff, or students must be approved by the University’s IRB. The IRB does not have the authority to grant retroactive approval should a research study be initiated without prior IRB review. IRB decisions that involve disapproval, deferral, suspension, or termination of a research study may be appealed through the office of the Provost. An ad-hoc IRB committee may be established to review the previous decision.
Rationale, Regulations, & Ethics for Protection of Human Participants in Research
While scientific research has produced substantial social benefits throughout history, it has also posed troubling ethical questions. Past abuses and violations of the rights and welfare of human participants have resulted in various codes and regulations at the federal level. State and local regulations and institutional policies provide additional protection for research participants.
Regulations are built on three ethical principles described below and govern much of the research conducted in the United States and all research involving human participants at High Point University. As an independent university, the University will voluntarily adhere to the Common Rule of 45 CFR 46, the federal regulation governing research falling under the oversight of the Department of Health and Human Services (DHHS).
DHHS requires research institutions receiving federal funds for research to assure compliance with federal regulations governing research with human participants, with a component of this protection being an IRB with responsibility for reviewing all research activities involving human participants within that institution and for ensuring proper training in research ethics. This assurance, “Federalwide Assurance of Protection for Human Subjects” (FWA), is an enforceable signed agreement held between the IRB and DHHS. The FWA covers, and is required for all federally supported or conducted research. However, the existence of an FWA is sometimes required by funding agencies other than the federal government and can often facilitate approval of research projects by both funding agencies and clinical sites where research may be conducted. High Point University will voluntarily enforce 45 CFR 46 as the minimum standard for all studies across the entire institution, whether or not the study has external funding. The IRB at High Point University is registered with the Office for Human Research Protections (OHRP) and has an FWA on file with DHHS.
45 CFR 46 – 1974 – The National Research Act
The first federal regulations (45 CFR 46) became effective in 1974 and established the IRB system for work with human participants. Federal regulations now required IRB approval for research with human participants, and procedures were established to set up IRBs and to approve of research.
The Belmont Report – 1979
The National Commission on the Protection of Human Subjects, which was appointed in 1974, is well remembered for the publication of The Belmont Report. The Belmont Report is the cornerstone statement of ethical principles for human subjects’ protection. The Three ethical principles of The Belmont Report are: respect for persons, beneficence, and justice.
21 CFR 50 and 21 CFR 56 – 1981
During the same era, the Food and Drug Administration (FDA) requirements were developing. These regulations (21 CFR 50 and 56), first published in 1981, require that researchers seek approval from an IRB for investigational use of drugs, devices, and biologics. The FDA review criteria, consent elements, and IRB membership were similar to those in 45 CFR 46.
The Common Rule – 1991
In 1991, the various rules of seventeen federal agencies were reconciled and published in The Common Rule, which has been integrated into 45 CFR 46. Today, The Common Rule provides the basis for the regulations covering the protection of human participants in research. The concepts from The Common Rule have been adopted by many private foundations, states, and institutions.
The Final Rule – 2017
In 2017, a document was published revising the Common Rule in order to modernize, strengthen, and make more effective the Federal Policy for Protection of Human Subjects. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The general compliance date for the final rule is delayed until January 21, 2019. However, institutions may transition research approved prior to January 21, 2019 to take advantage of the burden-reducing provisions as outlined in the document published June 19, 2018.
Key elements of the ethics of the IRB are found in three principles established in The Belmont Report. The principles are used as the framework for the protection of human participants in biomedical and behavioral research in the United States. These principles are useful for researchers, IRBs, and regulators for both the review of proposals and the evaluation of actions. They are also reflected in the ethical codes established by major professional organizations, such as the American Psychological Association.
- Respect for Persons requires respecting the autonomy of research participants. Vulnerable participants, defined as those with diminished or limited autonomy, are entitled to have additional protections. To allow a participant to express self-determination insists on giving that person sufficient, accurate information to be able to make a choice or ask questions. It means imagining the needs, drives, and fears of a potential participant and framing the process to maximize his or her expression of autonomy. Respect for persons is pragmatically expressed through the informed consent process and through establishing protections of those with diminished autonomy. It also includes the right to confidentiality and the right to withdraw consent without consequence.
- Beneficence is the act of securing the well-being of research participants. The researcher must (1) do no harm, and (2) maximize possible benefits and minimize potential harm. Beneficence is regulated by the IRB review criteria which seek to minimize right to human participants and to ensure that intended benefits exceed potential risks.
- Justice calls for fairness in the distribution of the burdens and benefits of research. Benefits should not be denied without good reason, and burdens should not be unduly imposed. The principle of justice is reflected in the regulations through the IRB review criteria requiring equitable selection of participants.
High Point University’s Assurance of Compliance with the regulations for protection of human participants asserts the following: This institution assures that all of its activities related to human participant research, regardless of funding source, will be guided by the ethical principles set forth in the Belmont Report.
Authority of the IRB
The IRB is an administrative body established to protect the rights and welfare of human research participants conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve and monitor all research activities that fall within its jurisdiction as specified by both the federal regulations and the local institutional policy. In particular, the IRB has the authority to:
- approve, require modification in, or disapprove an application for research;
- monitor the involvement of human participants in a study and require progress reports; and
- suspend, impose restrictions, require modification to a study as a condition for continuation, or terminate a study.
Responsibilities of IRB
The IRB Office is responsible for supporting and facilitating the IRB process. In particular, it is responsible for:
- providing regular training and education for IRB Committee members
- providing regular training and education for investigators and research staff
- maintaining records of compliance, including audits and reviews
- coordinating proposal submissions from investigators and distributing documentation to the IRB Committee members
- coordinating decisions from the IRB Committee to investigators, including amendments, etc.
The IRB is responsible for reviewing all proposed human participant research to determine that:
- Risks to participants are minimized by (1.) using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk, and (2.) using data from procedures already being performed on participants for diagnostic or treatment purposes, when appropriate;
- Risks to participants are reasonable in relation to anticipated benefits, if any, to participants and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that result from the research (as distinguished from risks and benefits of therapies participants would receive if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility;
- Selection of participants is equitable. In making this assessment, the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special considerations of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons;
- Informed consent will be appropriately documented, in accordance with, and to the extent required by federal and state regulations as well as institutional policies and procedures including the IRB;
- When appropriate, the research plan makes adequate provisions for monitoring data collected to assure the safety of participants;
- When appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data;
- There are adequate provisions to protect the rights and welfare of vulnerable populations from coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. The IRB Committee must determine if additional safeguards need to be included in the study to protect the rights and welfare of these participants;
- When appropriate, the need for ancillary care, additional monitoring, counseling, and social support are provided; and
- When appropriate, the informed consent document includes the additional elements of informed consent.
The IRB is also responsible for conducting timely continuing reviews of approved research as set forth by the policy. All research involving University faculty, staff, or students must be reviewed in accordance with the basic ethical principles (respect for persons, beneficence, justice) of The Belmont Report. The IRB is also responsible for completion of annual training.
The IRB must have at least five members, with varying backgrounds and professional competence to promote complete and adequate review of research activities commonly conducted under the auspices of the University. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human participants. The Chairperson and board members shall be appointed in three-year terms by the Provost. The Chairperson may designate another committee member to conduct necessary business in his/her absence. The IRB must include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas; and at least one member who is not otherwise affiliated in any way with the University and who is not part of the immediate family of a person who is affiliated with the University. The IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote. No IRB member may participate in the review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
The principal investigator is the ultimate protector of the research participant’s rights and welfare, and is obligated to be personally certain that each participant is adequately informed and freely consents to participate in the research. The investigator also assumes responsibility for compliance with all Federal, State, and University rules and regulations related to research involving human participants. Investigators may not initiate any research involving human participants without prior IRB review and approval.
The Procedures document will provide each investigator with the information necessary to successfully submit a complete protocol application for review.
Student-directed research must be formally sponsored by a full-time faculty member of the University. Faculty sponsors must provide an assurance to the IRB that student research projects comply with all applicable requirements and ethical guidelines.
Faculty investigators should exercise particular discretion when recruiting students as research participants. Specifically, the investigator should assure that consent for participation is sought only under circumstances that minimize the possibility of coercion or undue influence, and that genuinely equivalent alternatives to participation are available (e.g., alternate research activities, appropriate length term papers).