IRB Organization and Procedures
It is the policy of Saint Peter’s University that any research conducted at the University or by any person affiliated with the University which involves, or which may involve human subjects shall be conducted in such a manner that the rights and welfare of such human subjects are adequately protected. It is also recognized that research supported by the United States Government or a department, agency or instrumentality thereof must comply with Part 46 of Title 45 of the Code of Federal Regulations dealing with the protection of human subjects. The establishment of the Institutional Review Board (IRB) is a condition with which the University must comply in order to accept federal funding, including student financial aid, scholarships, and research grants. Saint Peter’s Federal-wide Assurance (on file with HHS) commits the University to abide by all federal regulations governing human subjects research. Moreover, the University has assured the Federal government that it will review all research proposals involving human subjects, regardless of funding source, or whether it is subject to government regulation or not.
The procedures and regulations followed by the IRB are in compliance with the Office of Human Research Protection (OHRP) of the Department of Health and Human Services (DHHS), as well as the ethical principles enunciated in the Belmont Report.
The University has also determined that any and all research involving human subjects which is conducted at the University, or by any person affiliated with the University, must comply with the procedures, principles and policies of the Saint Peter’s University Institutional Review Board (IRB).
The SPU Institutional Review Board has been established to review all proposals for research conducted at the University or by any person affiliated with the University which involves, or which may involve, human subjects. No such research may proceed unless and until approved by the IRB.
The IRB membership consists of seven (7) regular members and at least four (4) alternate members. In order to promote complete and adequate review activities, the members of the IRB have varying backgrounds and expertise, chosen from such disciplines as nursing, education, psychology, sociology, criminal justice, law, biology, chemistry, and philosophy.
Procedures for Review of Research Proposals
Submission of proposals
Any member of the Saint Peter’s academic community wishing to conduct a research project involving human subjects is asked to submit two copies of the completed IRB application and all supporting documents to the Chairperson of the IRB. One copy should be an electronic/digital version sent by email and the second copy should be a printed version, with all required signatures. The IRB Application form, Consent form templates, and other miscellaneous forms currently in use are posted on the IRB web-page.
Upon receipt of both versions of the IRB application and all accompanying documents, the IRB shall conduct a preliminary review of the proposal to determine if:
(1) The protocol can reasonably be included in the categories of research which are exempt from coverage by federal regulations, in which case the IRB will inform the person submitting the proposal is exempt.
(2) While not exempt from coverage by federal regulations, the research involves no more than minimal risk to human subjects and therefore, the IRB may employ an expedited review procedure.
(3) A full review is necessary.
Types of Review Status:
It should be noted that the status of “Exemption” does not mean that a project is exempt from IRB review. Federal regulations stipulate that a researcher or anyone affiliated with the research may not determine exemption status. Therefore, all human subjects research must be submitted to the IRB, without exception. Exempt protocols do not go the full Board for approval, but follow the same review procedures as expedited protocols, and are not subject to continuing review. To qualify as exempt, research activities must (1) present very little, if any, privacy, social , psychological, and/or physical risks to human subjects, and (2) involve only procedures listed on one or more of the six exemption categories designated by 45 CFR 46.101(b). Any research involving prisoners, children, the cognitively impaired, as well as other vulnerable subjects is not exempt.
Under applicable federal regulations, an expedited review procedure may be followed in certain situations. In those categories of research where expedited review procedures may be followed, the review may be carried out by the chairperson of the IRB or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the proposed research, the reviewer(s) may exercise all of the powers of the IRB, except that reviewer(s) may not disapprove the proposed research. Research may be disapproved only after a full (plenary) review.
Full Board Review
In those cases where a full (plenary) review is necessary, the IRB will review the proposal at a convened meeting at which a quorum is present. The review shall be for the purpose of determining that:
(1) Risks to subjects are minimized.
(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result. When assessing risk the IRB shall consider only those risks and benefits that may result from the research itself, as distinguished from the risks and benefits of therapies (if any) subjects would receive even if not participating in the research. The IRB shall not consider the possible long-range effects of applying knowledge gained in the research.
(3) Selections of subjects are equitable, taking into account the purpose of the research.
(4) Informed consent has been obtained from each prospective subject or the subject’s legally authorized representative.
(5) Informed consent has been appropriately documented.
(6) Where appropriate, the research plan makes adequate provision for monitoring the data collected to insure the safety of subjects.
(7) Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(8) Additional safeguards are taken when vulnerable subjects are involved in the research, in order to protect the rights and welfare of these subjects, including, but not limited to, protection against coercion or undue influence.
The IRB has the right to request any additional information the IRB may deem appropriate from any person submitting a research proposal for consideration.
Deliberations and Approval
The IRB considers each research proposal submitted, makes its determination, and communicates that determination in writing to the person submitting the research proposal. The IRB may approve or disapprove the research activities covered by the proposal as submitted or approve the research activities covered by the proposal conditioned on a requirement that modifications be made in the research activities covered by the proposal.
Unanimous approval of proposed research projects is desirable but is not required. In cases where the IRB is not unanimous, the IRB shall discuss what changes, if any will render the proposal unanimously acceptable. If such changes can be agreed upon, they will be communicated to the person submitting the research proposal accordingly and re-submit the proposal to the IRB in its revised form. If the person submitting the research proposal is unwilling to make the changes requested, he or she shall nevertheless be entitled to have the proposal in its original form voted on by the IRB.
Each research project must receive either a majority of the votes of those present at the meeting or at least four (4) affirmative votes, whichever is greater, in order to be approved. In cases where the necessary number of votes are received, but the IRB is not unanimous, and it is not possible to agree on changes which will secure unanimous approval, the project will be submitted to the Vice President for Academic Affairs for a final decision.
Time for Determination
Expedited review of a research proposal should normally be completed and a decision rendered within (15) days.
In the case of a full plenary review, the process should be completed and a decision rendered within thirty (30) days.
The times set forth are, however, not of the essence. The IRB shall be entitled to take whatever reasonable length of time it deems necessary to review a proposal.
Statement of Reasons for Disapproval
In any case in which the IRB disapproves of any research activity it will include in its notification to the person proposing the research activity a statement of the reasons for its decision and shall give the person proposing the research activity an opportunity to respond either in person or in writing.
Oversight of Approved Projects
Each research project approved by the IRB may be reviewed at intervals appropriate to the degree of risk to human subjects involved, but in no case less frequently than annually. The purpose of such review shall include, but shall not be limited to, determining that no material changes have occurred since previous IRB review. The IRB shall also have the right to observe, or to have a third party observe, the consent process or the research.
Suspension or Termination of Approval
The IRB has the authority to terminate or suspend research that is not being conducted in accordance with the IRB’s requirements or that has been associated with serious harm to subjects. Any suspension or termination of approval shall be in writing and shall include a statement of the reasons for the IRB’s action. The person conducting the research shall be promptly furnished with a copy of such written suspension or termination of approval.