Institutional Review Board (IRB)
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HUMAN SUBJECTS PROTECTION
SCU IRB Charge
The SCU IRB is responsible for the review, approval, and monitoring of biomedical and behavioral research involving human subjects at SCU to ensure the protection of the rights and welfare of participants in human research. The SCU IRB reviews the risk-benefit of all research projects that involve human subjects performed by SCU faculty, staff or students and ensures that research plans meet the federally mandated criteria for approval and are in compliance with state laws and local policies.
Federal regulations (45 CFR 46) along with oversight from the Human Research Protections (OHRP) within the US Department of Health & Human Services (HHS) empower IRBs to approve, require modifications, or disapprove research prior to the research taking place. Additional requirements for IRBs overseeing research are provided by the Food and Drug Administration (21 CFR 56.111), the Department of Defense, and state/local regulations.
The SCU IRB is guided by the principles set forth in the Belmont Report which identifies the basic ethical principles that underly the conduct of human subject research. The guiding principles of “Respect for Persons”, “Beneficence”, and “Justice”, underpin all decisions made by the SCU IRB.
IRB Authority
Under the Common Rule (§46.109), the IRB has the authority to:
- Review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under §46.104 for which limited IRB review is a condition of exemption (under §46.104(d)(2)(iii), (d)(3)(i)(C), (d)(7), and (d)(8)).
- Require that information given to subjects (or legally authorized representatives, when appropriate) as part of informed consent is in accordance with §46.116. The IRB may require that information, in addition to that specifically mentioned in §46.116, be given to the subjects when in the IRB’s judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
- Require documentation of informed consent or may waive documentation in accordance with §46.117.
- Notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
- Conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year, except as described in §46.109(f).
- Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances:
- Research eligible for expedited review in accordance with §46.110;
- Research reviewed by the IRB in accordance with the limited IRB review described in §46.104(d)(2)(iii), (d)(3)(i)(C), (d)(7), or (d)(8);
- Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
- Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
- Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
- Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances:
- Authority to observe or have a third party observe the consent process and the research.
- Authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head. §46.113
- Evaluate financial interests of investigators and research staff and have the final authority to decide whether the financial interest and management plan, if any, allow the human research to be approved.
Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB. §46.112
Regulations Guiding the IRB
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of HHS.
OHRP provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and behavioral research. OHRP also supports the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which advises the HHS Secretary on issues related to protecting human subjects in research.
IRB Responsibilities
In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied (§46.111 Criteria for IRB approval of research):
- Risks to subjects are minimized:
- By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and
- Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- 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 (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 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. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by, §46.116.
- Informed consent will be appropriately documented or appropriately waived in accordance with §46.117.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
SCU Federalwide Assurance (FWA)
FWA #: FWA00011820
Institution: Southern California University of Health Sciences
Address:
Southern California University of Health Sciences
Institutional Review Board
16200 E Amber Valley Drive
Whittier, CA 90604
Phone:
(562)947-8755
Email:
IRB@scuhs.edu