Institutional Review Board Policy
Click here for a copy of the HPU IRB Policy.
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
The purpose of the IRB is to set policies and procedures and to provide oversight concerning the protection of human participants involved in research.
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).
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.
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 Vice President for Academic Affairs. An ad-hoc IRB committee may be established to review the previous decision.
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 (a) using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk, and (b) 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 principals (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 commonly conducted under the auspices of the University. The IRB must be sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds, including considerations of their racial and cultural heritage and their sensitivity to issues such 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 annually by the Vice President for Academic Affairs. The Chairperson may designate another committee member to conduct necessary business in his/her absence. The IRB must not consist entirely of men or women; at least one member shall be primarily concerned in a scientific area and at least one member shall be primarily concerned in a nonscientific area; and at least one member shall be unaffiliated in any way with the University. The IRB may, in 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 for review an application for approval together with a copy of the complete research protocol.
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).
Federally Funded Research
Investigators seeking federal funding must submit an application for “Approval of Sponsored Research Involving Human Participants.” Written notice of IRB approval must be secured prior to submission of the application for federal funding.
Research Funded by Off-Campus Sources
Investigators seeking research support from non-federal, off-campus sources must submit an application for “Approval of Sponsored Research Involving Human Participants.” Written notice of IRB approval must be secured prior to submission of the application for funding.
High Point University Funded Research
Investigators seeking research support from the University must submit an application for “Approval of Sponsored Research Involving Human Participants.” Written notice of IRB approval must be secured prior to the release of funds.
Investigators must submit an application for “Approval of Research Involving Human Participants” to the IRB. Proposed research projects shall not proceed until written IRB approval has been secured.
Research Exempted from Further Review
Federal guidelines and this policy permit certain types of research to proceed without IRB approval. The determination whether any particular research project qualifies as “exempted” must be made by the Chair of the IRB usually after consultation with at least two members of the IRB. Investigators do not have discretion to make this determination. Investigators who believe their research projects should be classified as “exempted” must secure concurrence from the Chair of the IRB. The following research activities normally fall under the exempt classification:
Research that is conducted in established or commonly accepted educational settings, involving normal educational practices (e.g., curricular changes, teaching styles).
Research that involves the use of educational tests, survey procedures, interview procedures, or observation of public behavior, and the information taken from these sources is recorded in such a manner that the participants cannot be identified either directly or indirectly. (This category does not include personality tests.)
Research that is not exempt under above, but whose human participants are elected or appointed public officials or candidates for public office; or federal statue(s) require (s) without exception that the confidentiality of the personally identifiable information is maintained throughout the research and thereafter.
Research that involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. These are from sources that are publicly available, or the information in them is recorded in such a manner that the participants cannot be identified either directly or indirectly.
Research that is designed to study, evaluate, or otherwise examine a public benefit or service program.
Research that involves taste and food quality evaluations or consumer acceptance studies in which only wholesome foods without additives are consumed; or if a food is consumed that contains an additive food ingredient or an agricultural chemical or environmental contaminant, these are at or below levels considered safe by the Food and Drug Administration, the Environmental Protection Agency, or the U.S. Department of Agriculture.
Research Reviewed Elsewhere
The Chair of the IRB may waive review requirements that ordinarily would apply to a project when the investigator has already secured approval for the particular project from an IRB at another institution that operates according to 45 CFR 46. Investigators seeking a waiver under this provision must submit evidence of prior formal IRB review and approval to the Chair of the IRB.
Expedited review is not normally available. Exceptions will be made for (a) those proposals that clearly fall within an exempted category, or (b) protocol revisions submitted in response to a previous IRB review.
You may direct any questions to the chair of the IRB, Dr. Kimberly Wear (841-9246, firstname.lastname@example.org).