XI. REVIEW CRITERIA AND RESPONSE
11.1 Review Criteria
Research proposals submitted for initial or continuing review must satisfy the following requirements:
11.1.1 Risks
Minimized Risks to subjects are minimized: 1) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
11.1.2 Risks Balanced with Benefits
Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB will consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receiving even if not participating in research). The IRB will not consider possible long-range effects of applying knowledge gained in research (for example, the potential effects of research on public policy) as among those research risks that fall within the purview of its responsibility.
11.1.3 Fair selection of Subjects
Selection of subjects is equitable. In making this assessment the IRB will take into account the purposes of the research and the setting in which the research will be conducted and will be cognizant of special issues involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
11.1.4 Informed Consent
Informed consent will be sought from each prospective subject or the subject's legally authorized representative and it will be appropriately documented, in accordance with, and to the extent required by law.
11.1.5 Authorization Forms
A signed consent form will be sought from each prospective subject or the subject's legally authorized representative and will be appropriately documented.
11.1.6 Data Monitoring
The research plan must make adequate provision for monitoring the data collected to ensure the safety and confidentiality of patients.
11.1.7 Privacy
The research will protect the privacy of subjects and maintain the confidentiality of data to the greatest extent possible by law.
11.1.8 Vulnerable Population
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 to protect the rights and welfare of these subjects.
11.1.9 SHS Conflict of Interest Forms (SHS-B1-5)
Principal Investigators are expected to comply with SHS' conflict of interest policy and complete required forms.
11.1.10 Financial Conflicts of Interest
The IRB will review the protocol to assure that the researcher does not have a financial interest in the proposed research. Research must be in compliance with SHS' conflict of interest policy and the protocol must not endanger the lives of subjects.
11.2 IRB Response Categories
The IRB may take one of the following actions:
11.2.1 General Approval
The IRB approves the proposed research study.
11.2.2 Conditional Approval
The IRB approves the research proposal subject to minor modification of the "Project Review Form", consent form (s), authorization form (s), and/or research protocol in accordance with the IRB's recommendations. General approval can subsequently be given without resubmitting the entire research study to another full IRB meeting. The completed revisions must be submitted to the IRB Chair prior to initiation of the research protocol and within thirty days of the issuance of instructions for necessary modifications. The due date may be extended for up to thirty days at the discretion of the IRB Chair.
11.2.3 Approval Deferred
The IRB is unable to approve the research in the absence of significant modifications of the "Project Review Form" consent form (s), authorization form (s) and/or research protocol in accordance with their recommendations. In this case, the modifications recommended are of a nature requiring resubmission for the amended "Project Review Form", consent form (s), authorization form (s) and research protocol to a subsequent full IRB meeting. A resubmission date will be set by the IRB Chair in consultation with the Principal Investigator immediately following the meeting at which it was initially considered.
11.2.4 Disapproval
The IRB is unable to approve the proposed research because the IRB determines that the risks to the human subjects outweigh the benefits or knowledge to be gained from the research, or it determines that the study is not adequately designed. Research disapproved by the IRB may be resubmitted to a subsequent IRB meeting if it is determined by the Principal Investigator in consultation with the Chair of the IRB "Project Review Form" consent form (s), authorization form(s) and research protocol can be modified to address the concerns of the IRB.
11.2.5 Approval Term and Monitoring Standard
After approving a research proposal, the IRB will make two determinations:
- It will determine the initial Approval Term during which research may take place. While approval will normally be granted for an Approval Term of one year, the IRB may set the Approval Term for a lesser period of time based upon such factors as the nature of the research, its potential risks and/or based upon the qualifications of the Principal Investigator.
- Second, the IRB shall consider whether the protocol shall be assigned to "Special Oversight" subcommittees based upon such factors as risk, investigator qualifications and the population involved.
11.2.6 Review of Board Recommendations
Favorable recommendations of the IRB are always subject to further review, modification, or rejection by the President/CEO or other SHS designee. Unfavorable rulings by the IRB may not be overruled. (45 CFR 46.112)
11.2.7 Special Committees and Expert Advice
The IRB shall, whenever required by law or whenever desirable, require or recommend within SHS of standing or "special oversight" subcommittees for the protection of special groups of human subjects, such as minors, incompetents, prisoners, pregnant women, and the unborn. The IRB may also appoint, or retain one or more experts in any field to answer questions pertaining to any research protocol pending IRB review.
11.2.8 Commencement of Research
An investigator may not begin enrolling subjects until a letter from the IRB advising them that the Protocol has been approved. In the event that the IRB requires modifications to the submitted application, the approval letter will not be issued until the investigator has submitted all required modifications. These modifications must be reviewed by the IRB or its designee to assure that the investigator has complied with the instructions.
11.2.9 Withdrawal
In the event the Principal Investigator fails to make all of the changes to the "Project Review Form" the consent form(s), authorization form(s), and/or the research protocol recommended by the IRB within the period set, the application will be deemed withdrawn by the Principal Investigator and all files will be closed.
