Institutional Review Board

Mission

The Department of Health & Senior Services’ (Department) Institutional Review Board (IRB) is responsible for the initial and continuing review of human subjects research engaged in under the auspices of the Department’s Federalwide Assurance (FWA-4020) with the U.S. Department of Health and Human Services, regardless of funding source.  The Department becomes engaged in human subjects research when:

1. Department employees or agents interact or intervene with research subjects or obtain research subjects' identifiable private information,
2. The Department funds, sponsors or regulates human subjects research, or
3. The Department supports human subjects research through the provision of identifiable private information or the use of Department facilities, premises or property. 

The Department’s IRB will approve human subjects research projects upon determining that the project’s purpose, goals, design, methods, procedures, instruments, planned analysis and reporting adhere to the ethical principles set forth in The Belmont Report (Respect for Persons, Beneficence and Justice) and the Federal regulations for the protection of human subjects, including Title 45, Part 46.

Authority & Responsibilities

The Department’s Federalwide Assurance grants the IRB the authority to approve, require modifications in, or disapprove human subjects research, and is the only institutional body authorized to approve the performance of non-exempt human subjects research.  Institutional officials may disapprove human subjects research that has been approved by the IRB, but may not approve human subjects research that has been disapproved by the IRB.

The IRB is authorized by the Department’s Federalwide Assurance to approve human subjects research only after it has made an independent determination that the following criteria have been satisfied:

1. The proposed research adheres to the ethical principles in the Belmont Report,
   
   
2. The justification, goals, design, procedures, methods and instruments of the proposed research are scientifically sound (i.e., the risks to the research subjects are minimized, the research subjects are not unnecessarily exposed to risk, and procedures already being performed for diagnostic or treatment purposes are used, when applicable),
   
   
3. The risks to research subjects are reasonable in relation to the anticipated benefits that is reasonably expected to result to the research subjects, if applicable,
   
   
4. The risks to research subjects are reasonable in relation to the importance of the knowledge that is reasonably expected to result,
   
   
5. The selection of the research subjects is equitable given the purpose(s) of the research, the setting(s) in which the research will be conducted, the population that will benefit from the research and the rationale for including a vulnerable population (e.g., children, prisoners, pregnant women, mentally disabled persons or those who are disadvantaged economically, educationally or otherwise),
   
   
6. The informed consent or assent of prospective research subjects or permission of their legally authorized representative will be sought, or waived in accordance with Federal regulations at Title 45, Part 46.116(d).
   
   
7. The informed consent or assent of prospective research subjects or permission of their legally authorized representative will be documented, or will be waived in accordance with Federal regulations at Title 45, Part 46.117(c).
   
   
8. The research data will be monitored to ensure the research subjects' safety, if applicable,
   
   
9. The proposed research appropriately provides for the protection of research subjects' privacy,
   
   
10. The proposed research appropriately ensures investigators and research personnel will fulfill their obligation of confidentiality,
    
11. The proposed research includes additional safeguards for protecting the rights and welfare of research subjects who may be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, mentally disabled persons or those who are disadvantaged economically, educationally or otherwise), if applicable,
    
    
12. The proposed research includes detailed procedures for how the principal investigator will monitor all investigators and research personnel to ensure only Board-approved research activities are conducted, research activities are conducted in accordance with the approved protocol, research activities are only conducted by individuals who have been approved by the Board to conduct the specific activity, investgiators and research personnel comply with the scope and stipulations specified in the Board Approval letter and modifcations are only implemented after obtaining the Board's prior written approval (unless the modification is necessary to eliminate an apparent immediate hazard to the research subjects),
    
    
13. he description of the proposed research as described in the application is consistent with the description in the corresponding funding document (e.g., grant application, memorandum of agreement, contract), if applicable,
    
    
14. The recruitment of pregnant women and fetuses as research subjects satisfies the additional criteria set forth in the Federal regulations at Title 45, Part 46, Subpart B.
    
    
15. The recruitment of prisoners as research subjects satisfies the additional criteria set forth in the Federal regulations at Title 45, Part 46, Subpart C.
    
    
16. The recruitment of children as research subjects satisfies the additional criteria set forth in the Federal regulations at Title 45, Part 46, Subpart D.