IRB Review of Research
The IRB reviews proposed research to assure that human subjects are adequately protected from risk of harm and that the rights of human subjects are protected. In doing so, the IRB seeks to balance the risks to the subjects against the scientific knowledge to be gained and the potential benefits to society.

2.1 - Scope of IRB Review
2.2 - Activities that must be Reviewed by the IRB
2.3 - Human Subject Research Defined
2.4 - Research Risks
2.5 - Research Conducted by Clinical/Adjunct Faculty
2.6 - Research Conducted by Unaffiliated Researchers
2.7 - Research Conducted by Students
2.8 - Research Conducted in Courses
2.9 - Research Conducted in Collaboration with Another Institution
2.10 - Research Conducted in a Foreign Country
2.11 - Pilot Research
2.12 - Research Using "Secondary Data"

2.1 Scope of IRB Review

1. The IRB reviews research to ensure that the rights and welfare of human subjects are protected. It does this by carefully assessing the following criteria:

   • Does the study reasonably balance the benefits of the research against the risks to the subjects?
   • Is the design of the study likely to produce valuable data?
   • Is the design of the study consistent with sound ethical guidelines and legal requirements?
   • Are risks to subjects minimized by using procedures that are consistent with the study design and that do not unnecessarily expose subjects to risk?
   • Is subject selection equitable?
   • Are the informed consent procedures appropriate for all study populations and is the consent form intelligible to all subjects?
   • Are additional safeguards provided if potentially vulnerable subjects are to be studied (e.g., children, prisoners, financially or educationally disadvantaged people, etc.)?
     
     

2. The Role of the IRB in Review of the Design of a Study or Other Aspects of a Study that May Affect the Scientific Quality of a Study.

   • The Basis for the IRB's Obligation of Scientific Review

     The following sections from the internationally recognized ethical guides state that ethical research requires that:
       1) the study is designed to minimize the risks to subjects and
       2) the potential risks of the research are justified by the potential benefits.

     The Ethical Codes:

     • Nuremberg Code (1949)
       Several sections including the following address the question.
       

       Point 3. "The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment."

     • Declaration of Helsinki (2000)
       Several sections including the following address the question.

       Section 11. "Medical Research involving human subjects must conform to generally accepted scientific principles and be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and when appropriate, animal experimentation."

       Section 18. "Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject. This is especially important when the human subjects are healthy volunteers."

       Section 29. "The benefits, risks, burdens, and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic or therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists."

     • Federal Research Regulations
       DHHS and corresponding FDA Sections.

       45 CFR 46.111 Criteria for IRB approval of research.

       1. In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

          (1) Risks to subjects are minimized: (i) 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.

          (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.

       Robert J. Amdur in Ch. 5-2 "Evaluating Study Design and Quality" in IRB Management and Function by Elizabeth A. Bankert and Robert J. Amdur outlines the above references and offers the following guidelines to IRBs when evaluating a study's scientific design and benefit from the perspective of risk to participants.

   • Guidelines:

     1. The IRB should use independent judgment and common sense. For example if the design of a student research project for a course is flawed but creates no effective risk to subjects, there is no ethical basis for the IRB to require revisions for approval. There are only educational reasons to suggest changes.
     2. The IRB should not approve a study without requiring revisions if:
        1. revising the design will decrease the risks to participants in a meaningful way without a major compromise to the persuasiveness of the study results OR
        2. the study design is "so flawed that the value of the study results will be almost zero." In this case, even though the risks may be low if the potential benefit is zero, the overall risk/benefit ratio would be unacceptable OR
        3. the study involves a meaningful risk and asks a question that was already answered in earlier research or "not important" to the field of scientific inquiry.

2.2 Activities that must be Reviewed by the IRB

IRB approval is required for all research involving human subjects. The IRB has oversight of all research involving human subjects conducted at the UConn Storrs campus, the 5 regional campuses (Avery Point, Hartford, Stamford, Torrington, and Waterbury), as well as the Law School and School of Social Work. This oversight applies regardless of the funding source or where the research takes place. In accordance with federal regulations, all research involving human subjects must be reviewed (or determined exempt) by the IRB. The regulatory requirements are applicable to all University authorized activities that in whole or in part involve research with human subjects, including:

• Research supported by the University;
• Research conducted by or under the direction of any employee or agent of the University in connection with his or her institutional responsibilities;
• Research conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution;
• Research involving the use of the University's non-public information (i.e., alumni, students, staff, etc.) to identify or contact human research subjects or prospective subjects.

The requirement for IRB review applies to all human subjects research, regardless of the funding source.

2.3 Human Subject Research Defined

Federal regulations dictate what research must be reviewed by the IRB. The regulatory definition of "human subject research" requires investigators to be familiar with the individual definitions of both "Research" and "Human Subject".

Research:
"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities."
(45 CFR 46.102(d))

Human Subject:
"A human subject is a living individual about whom an investigator (professional or student) conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information."
(45 CFR 46.102(f))

The following activities are included in the scope of the above definitions:

• Physical procedures (like blood drawing);
• Manipulation of the subject's environment;
• Interviews, surveys, and other forms of communication;
• Gathering information about individuals that was collected for purposes other than this specific research (e.g. medical, school or correction records);
• Obtaining bodily materials such as cells, blood or urine, tissue, organs, hair, and nail clippings even if the investigator did not collect these materials; and,
• Access to medical records and data through the medical information systems.

2.4 Research Risks

Human research involves risks that may be social, psychological, financial, physical or legal. See the Definitions of "risk" and "minimal risk" in the References section of the IRB website. Individuals other than the research subject may also be at risk, including people discussed in the study (see also Secondary Subjects), the investigator, society at large and the University. The IRB does not expect research to be free from risk, but does expect the investigator to be aware of the risks, to minimize risk when possible and inform the subject about risks accurately and honestly. Before a study is approved, the IRB will weigh the research risks in relations to:

• The anticipated benefits to the subjects and others,
• The importance of the knowledge that may reasonably be expected to result, and
• The informed consent process to be employed.

See also: 3.1 Assessment of Risk and 3.3 Expedited Review.

2.5 Research Conducted by Clinical/Adjunct Faculty

Research conducted by clinical and adjunct faculty must be reviewed by the IRB, regardless of where the research is taking place. Researchers who are also affiliated with another institution must obtain IRB approval from that institution in addition to the UConn IRB (if such institution has an IRB).

2.6 Research Conducted by Unaffiliated Researchers

If you are an investigator who is not affiliated with the University of Connecticut (UConn), but would like to conduct human subject research (this includes recruitment of study participants only) at the Storrs campus or any of the regional campuses, you must obtain permission from the UConn Institutional Review Board (IRB) on the main campus at Storrs before initiating any study procedures. Please follow these guidelines.

1. UConn IRB, Storrs, CT
2. Recruit Participants
3. Recruitment and Research Procedures
4. Collaborations
5. Additional Information

1. UConn IRB, Storrs, CT:

   The UConn IRB on the main campus at Storrs, CT is responsible for reviewing human subjects research performed at the Storrs campus and at the School of Law and the School of Social Work, the campuses of Greater Hartford, Torrington and Waterbury, and the Stamford and Avery Point Campuses.

   Two additional Institutional Review Boards review human subject research conducted at the University of Connecticut Health Center in Farmington where the Medical and Dental Schools and the John Dempsey Hospital are located. For more information, see the Human Subjects Protection Office (HSPO) website or contact them at (860)-679-3054.

2. Recruit Participants:

   • Submissions:

     Prior to recruitment of participants at any UConn campus you must first submit:

     1. A brief cover letter explaining the research, where on campus you wish to recruit subjects and why you wish to conduct the study at the University of Connecticut.
     2. A copy of the protocol application you filed with the IRB that reviewed the protocol.
     3. The IRB-approved Consent Form(s)
     4. Any surveys, questionnaires, tests or measures, etc. to be used in the research.
     5. Any recruitment materials you wish to use to recruit UConn students, employees (flyers, ads, etc.). Note whether they have been approved by an IRB.
     6. Approval letters from any IRB that has reviewed your protocol.

     These items should be submitted to:
     Office of Research Compliance,Unit 1246
     University of Connecticut
     Whetten Graduate Center, Rm 214
     438 Whitney Rd. Ext.
     Storrs, CT 06269-1246

   • IRB Review:

     The UConn IRB Chair or her designee will review the materials submitted and will determine if permission to recruit may be granted. The IRB Chair reserves the right to require further review by the IRB.

3. Recruitment and Research Procedures:

   • Submissions:

     If you wish to recruit participants and conduct research procedures in a UConn building or with the use of UConn owned equipment at any UConn campus, you must first submit all of the items (1-6) listed above. Depending on the nature of the research, the IRB Chair may also require you to:

     1. Submit additional information or submit the UConn IRB-1 Application Form (if sufficient information is not contained in the submissions),
     2. Sign an Individual Investigator Agreement,
     3. Arrange to have a UConn Faculty Member agree to participate in the study as an "Investigator or a Principal Investigator."

   • IRB Review:

     The UConn IRB Chair or her designee will review the materials submitted and will determine if IRB approval of the research procedures may be granted. The IRB Chair reserves the right to require further review by the IRB.

4. Collaborations:

   If you are collaborating with a University of Connecticut affiliated Investigator (faculty or staff member), see Collaborations.

5. Additional Information:

   If you still have questions after reading these guidelines, you may consult the IRB website or call the Office of Research Compliance at (860) 486-8802 or (860) 486-4164.

2.7 Research Conducted by Students

Students may only conduct research under the supervision of a faculty advisor, who will be the named Principal Investigator and be held ultimately responsible for the conduct of the research and actions of the student. Student research is given the same level of IRB review as faculty-initiated research and must be approved by the IRB before being initiated.

Faculty advisors should mentor the student investigator through the research process. This responsibility includes teaching ethical conduct of research and appropriate scientific design. It is critical for all faculty research advisors to bear in mind that, as a teaching institution, we have an obligation to prepare our students for research opportunities here as well as in their future endeavors.

2.8 Research Conducted in Courses

Certain undergraduate and graduate courses require students to conduct individual research projects as a way of teaching research methods and the development of researching skills in a structured setting. Projects that satisfy the regulatory definition of human subject research must be reviewed and approved by the IRB before being initiated.

However, in cases where the student projects present minimal risk to the subjects and fall into one of the categories for Exempt research or into category 7 for Expedited research, it may be possible for the IRB to approve a single protocol for the research conducted within the RMC.

A RMC protocol (formerly called a "blanket" protocol) will grant approval to the scope of, minimal risk research conducted in the course where the research itself is secondary to the course's primary educational purpose. In this way, student projects that technically meet the regulatory definition of human subject research will not need to be reviewed individually by the IRB and will allow the course instructor to review the individual research projects and determine if they appropriately address all human protection concerns. Further, the IRB need not review consent forms/information sheets as long as the course instructor judges the consent process to have integrity and the written consent documents follow the basic template approved by the IRB. . Instructors are encouraged to involve departmental research review committees in review process when appropriate. In some cases it may be advisable to create small (2-3 person) committees to facilitate the review process.

Any student project that goes beyond the scope of the approved RMC protocol must be submitted to the IRB for independent review. Research involving children (except for projects with children that are only observational in nature) or any other vulnerable population will not be eligible for inclusion in a RMC protocol - such research must be independently reviewed and approved by the IRB.

A RMC protocol must be submitted by the Course Instructor and signed by the Department Head and must contain the following:

• A description of the course's educational purpose;
• A statement of the Exempt research categories or the Expedited category that the student projects satisfy; and,
• A sample or template consent form/information sheet

Course Instructors need to submit a IRB-7 Protocol Application for the Involvement of Human Participants in RMC.

A Student Research Review Template is available to help Course Instructors assess whether a student study falls within the approved RMC protocol.

2.9 Research Conducted in Collaboration with Another Institution

Collaborative research must receive IRB approval from all collaborating institutions. Investigators should identify all collaborating sites in the protocol and indicate which aspects of the research will take place at each site. The overall research will not be approved until each individual IRB has granted full approval. However, research to take place at a specific site that has been approved by that IRB may be initiated even if the other sites have not yet been approved.

It may be possible, in certain circumstances, to designate one IRB as the Primary IRB with responsibility for reviewing the entire study. Investigators who are interested in designating one IRB as the Primary IRB must contact the Office of Research Compliance and ask that the University enter into a Cooperative Agreement with another institution(s).

2.10 Research Conducted in a Foreign Country

When research takes place outside of the United States additional IRB approval is required.

If the study is supported by federal funds (i.e., NIH, DHHS, etc.) the investigator must obtain IRB approval from an institution that holds an assurance with the U.S. Government in the country where the research is taking place. This process is facilitated through the collaborating institution and the federal Office of Human Research Protections (OHRP). However, the UConn Office of Research Compliance (ORC) is available to assist the investigator and collaborating institution. Investigators should note that federal granting agencies will not release funds to a grantee institution unless an appropriate assurance is in place.

If the study is supported by non-federal funds (i.e., private foundations, state funding, industry, etc.) approval from a local IRB or ethical review board in the country where the research is taking place will suffice. Usually any collaborating institution may be able to provide this service. Research in remote locations or research that is not conducted in affiliation with a large institution may present the investigator with unique challenges in identifying a local review board. In such cases the investigator should try to identify a local institution or governing body that can review the research and assess it in light of the local culture and customs, (i.e., hospital, municipal governmental agency, school, tribal committee, etc.).

The investigator must submit evidence of local IRB review and approval once it is obtained.

2.11 Pilot Research

Research at the pilot or testing phase is subject to the same level of IRB review as any other research protocol, regardless of the number of subjects enrolled or the duration of the study. At the end of the pilot/testing phase, the investigator may either 1) close the pilot study and initiate a new protocol for the second phase of the study or 2) amend the approved protocol to expand its scope and duration.

2.12 Research Using "Secondary Data"

Research using secondary data involves materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). Such data must be in existence before the study is initiated. Research using secondary data is subject to the same level of review as any other research protocol. Some research using secondary data may be exempt from continuing review.