All research projects involving the use of human subjects must be reviewed by the IRB. Submission and review procedures are described in this section.
5.1 General Requirements
In order to approve research involving human subjects, the IRB shall determine that all of the following requirements are satisfied:
5.1.1 Risks to subjects are minimized (a) by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and (b) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
5.1.2 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. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
5.1.3 Selection of subjects 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 problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons.
5.1.4 Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with the procedures set forth in this document.
5.1.5 Informed consent will be appropriately documented as set forth in this document.
5.1.6 When appropriate, the research plan makes adequate provision for monitoring the data collected to insure the safety of subjects.
5.1.7 When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
5.1.8 When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects. (See Appendix F: Additional Protections for Vulnerable Populations.) (45 CFR 46.111)
5.2 Review Procedures
5.2.1 Assessment of risk
First, the IRB will make a decision based on common sense and sound professional judgment as to whether or not the proposed research places the subject "at risk." A subject is considered to be at risk if s/he may be exposed to the possibility of harm, whether physical, psychological, sociological, or other, as a consequence of any activity that goes beyond the application of those established accepted methods necessary to meet his needs. The IRB will consider the fact that certain subject populations (e.g., minors, pregnant women, prisoners, mentally retarded) may be at greater risk than others.
Whether a research proposal is designated to be exempt from IRB review or will receive an expedited or full review very much depends on the risk assessment.
Certain risks are inherent in life itself, but the IRB is not concerned with the ordinary risks of public or private living. Risk as applicable to DHHS policy is most obvious in medical and behavioral science research projects involving procedures that may induce a potentially harmful altered physical state or psychological condition. The most obvious examples include surgical procedures, the administration of drugs or radiation, the requirement of strenuous physical exertion and an intervention that precipitates an emotional disturbance. There is also a wide range of medical, social and behavioral procedures and projects in which, although there may be no immediate risk, procedures may be introduced that involve discomfort, anxiety, harassment, invasion of privacy, or that constitute a threat to the subject's dignity. There are also medical and biomedical projects concerned solely with organs, tissues, body fluids and other materials obtained in the routine performance of medical services that obviously involve no element of physical risk to the subject, but their use for certain research, training, and service purposes may present psychological, sociological, or legal risks to the subject or authorized representatives. Finally, the risk element will be examined for those studies dependent upon existing information or stored data that have been obtained for quite different purposes but that, when used in a research context, may present risk to the human subject.
5.2.2 Risks in relation to other factors
If it is judged that the proposed research project will expose a subject to risk, then the IRB must assure itself that (a) the rights and welfare of the subject are adequately protected, (b) the methods used to obtain informed consent are adequate and appropriate, (c) the risks to the subject are outweighed by the potential benefit to the subject or by the importance of the knowledge to be gained, and (d) risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk.
5.2.3 Informed consent
The informed consent of the individual is a vital element in the protection of human subjects. Before a subject participates in an investigation involving risk or the likelihood of substantial stress or discomfort, the nature of these hazards and the procedures to be followed must be carefully explained and subject consent obtained. The IRB will review carefully the consent form to determine if it contains all appropriate elements of informed consent. (See Section 7 for more details.)
If a submitted proposal is determined by the Chair of the IRB to qualify for exemption status, per the guidelines in Section 6.1, the investigator will be notified within approximately three working days following receipt of the proposal.
5.2.5 Minimal risk and expedited review
The IRB may review some or all of the research appearing on the list contained in Section 6.2 through an expedited review procedure if the research involves no more than minimal risk. The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized. Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure.
Within approximately ten working days following receipt of the proposal by the Chairperson, the investigator will be notified of the IRB's decision concerning the proposal. Reviewed proposals will be assigned to one of three categories:
Approved: The proposal is approved and released. The investigator may begin the study.
Approved contingent upon specific modifications: The investigator will be notified in writing as to the nature of the required modifications. As soon as the investigator complies with all required modifications, a release will be issued and the investigator may begin the study unless additional approval is required.
Referred for full IRB review: IRB reviewers have a serious concern and they determine that the proposal should be reviewed by the full IRB.
5.2.6 Non-expedited/Full review
All proposals that do not qualify for expedited review will be submitted to the full IRB. Under a non-expedited review procedure, the IRB will review proposed research at convened meetings during which a majority of the members of the IRB are present, including at least one member whose primary concerns are in non-scientific areas. In order for research to be approved, it shall receive the approval of a majority of those present at the meeting. (45 CFR 46.108)
Within approximately five working days after the Institutional Review Board meeting, the investigator will be notified of the IRB's decision concerning the proposal. Reviewed proposals will be assigned to one of four categories:
Approved: The proposal is approved and released. The investigator may begin the study.
Approved contingent upon specific modifications: The investigator will be notified in writing as to the nature of the required modifications. As soon as the investigator complies with all required modifications, a release will be issued and the investigator may begin the study.
Tabled: The Board requires additional information and/or has a serious concern. The Executive Secretary and/or a member of the Board will be assigned to discuss the proposal with the investigator.
Disapproved: If a proposal is disapproved, the investigator has the right of appeal.
5.3 Items to Submit for IRB Review
If an investigator determines that the proposal qualifies for exempt status, an Exemption Information Form (Appendix B) must be submitted. Additional items, such as Informed Consent/Assent Form(s) (See section 7 and Appendix A), Detailed Research Protocol (Appendix D), and Questionnaires/Test Instruments, should be included in order to provide sufficient information for the IRB Chair to designate review status.
For expedited or full review, a Request for Review Form (Appendix C) and Detailed Research Protocol must be submitted, as well as any of the following if utilized in the study: Informed Consent/Assent Form(s), Questionnaires/Test Instruments, and letter requesting approval from any non-Sacred Heart University facility or agency.
Submit all items in electronic format to: firstname.lastname@example.org
Patricia W. Walker, EdD
Dean, College of Health
5.4 Certification of IRB Review
If an investigator intends to submit his/her grant proposal for federal funding, the IRB will forward certification of IRB review and approval to the Office of Foundations & Grants. If a proposal is currently being reviewed by the IRB, the Office of Foundations & Grants may certify that the research proposal is under review by the IRB. A certification of IRB approval must then be forwarded within 60 days to the federal funding agency.
5.5 Reporting Changes in Research Activity or Injuries
Any change in a protocol which affects the human subjects must be reviewed and approved by the IRB prior to implementation except where necessary to eliminate apparent immediate hazards to the subjects. Minor changes during the period for which approval is in force will be reviewed by an expedited review procedure. (45 CFR 46.109)
Investigators must promptly report to the IRB and to the DHHS (if federally funded) of unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB.
If a subject sustains an injury which is related to a research procedure, the investigator must submit to the IRB within five working days the following information in writing: (1) cause of the injury, (2) nature of the injury, (3) treatment of the subject, and (4) changes in the protocol initiated to prevent further subject injury. (45 CFR 46.113)
5.6 Safeguarding Information
Safeguarding information about an individual that has been obtained in the course of investigation is a primary obligation of the investigator. When the investigator is a student, responsibility for the conduct of the research and the supervision of human subjects lies with the faculty sponsor. Such information shall not be communicated to others unless the following conditions are met: Explicit permission for the release of identifying data must be given by the individual. Information about individuals may be discussed only for professional purposes and only with persons clearly concerned with the project. Written and oral reports should present only data germane to the purposes of the project, and every effort should be made to avoid invasion of privacy.
Provisions must also be made for the maintenance of confidentiality in the preservation and ultimate disposition of any data collected. Adequate security measures must be described to the IRB and carried out by the principal investigator until the records are destroyed. Records containing personal information shall be destroyed as soon as possible in keeping with the long-range goals of the project.
Signed copies of informed consent forms must be maintained by the principal investigator and be stored in a secure manner. Unless otherwise specified by Federal and/or state regulations, retention shall be for a period of at least three years beyond the termination of the study. If the investigator resigns from the University before the end of the designated period, the informed consent forms must be submitted to the IRB unless otherwise specified. (45 CFR 46.115)
5.7 Submission of Annual Update
Non-exempt proposals are approved for a maximum period of one year only. For projects which continue beyond one year, it is the responsibility of the principal investigator to submit to the IRB an annual update (Appendix E). The first annual update is due twelve months following the date the proposal was approved and released. Upon receipt of the annual update, the IRB will review and approve continuation of the project for the next twelve-month period. If the IRB determines that a project requires review more often than annually, the investigator will be so notified. When a project is terminated/completed, the investigator must immediately notify the IRB in writing. (45 CFR 46.109)