Research Labs

***FOR APPLICATION REQUIREMENTS, PLEASE SEE BELOW***

IRB

Institutional Review Board

 

What is the Institutional Review Board?

The Institutional Review Board, or IRB, is a committee that is required by federal law to protect the rights and welfare of human subjects participating in research activities. The committee meets this mandate by reviewing proposed and ongoing research activities, ensuring they meet specific criteria for approval.

The IRB’s function, make-up, and authority are governed by federal law, but meeting the regulations is done on an institution-specific level.  The IRB ensures that valid studies meet the ethical mandates of the Belmont Report, and the legal mandates of federal law.

Federal Regulations

The federal law, commonly referred to as 45 CFR 46, formally, the Code of Federal Regulations at Title 45-Public Welfare, Department of Health and Human Services, Part 46-Protection of Human Subjects, is specific to research conducted or supported by a federal department or agency. However, many institutions voluntarily apply some or all subparts of 45 CFR 46 (also referred to as the “Common Rule”) to all research conducted by their investigators, regardless of status or source of funding.

 

Types of Review

(Exempt, Expedited, Full Committee Review)


There are three types of review that are performed on research that involves human subjects, depending on the level of risk, and whether or nor the study fits into certain categories of activities. If a study is deemed minimal risk, it means that "the probability and magnitude of harm or discomfort anticipated in the research are no greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." This definition should be kept in mind when assessing a study's risk level.

Exempt studies are research activities involving human subjects that are exempt from the federal regulations governing human subject protections. The exemption review process may only be used for research determined to fit within one of the exemption categories defined in 45 CFR 46.101. A designated individual (the IRB Chair) will conduct the review of such studies. To avoid any bias, the investigator is not permitted to review his or her own study for exemption.  

Expedited review may be used for research that involves no more than minimal risk. When a study is reviewed via the expedited review process, it means that only the Chair of the IRB need to review the study without it being brought before the convened meeting. When conducting an expedited review, the reviewer must remember that the research in question is subject to 45 CFR 46, and all federally mandated criteria for approval must be met.

Full Board review is required for any research involving human subjects that does not quality for exempt or expedited review, for example, those involving greater than minimal risk to the subject. Expedited and full review studies may be granted approval for a maximum of one year. The IRB will determine the approval period for each study. Note that amendments or revisions that are approved during a study's approval period do not impact its expiration date. 


Requirements for Applications

Initial Submission and Requirements

Whether exempt, expedited, or full board review is required, there is information that must be provided to the IRB in order for the committee to make important determinations regarding approval.

The IRB Initial Application Requirements are:
·         Application for IRB Review 
·         The protocol, which should include general information, including study title, investigator names,contact information and positions at the institution, funding sources, types of populations to be studied (for example, men, women, minors, adults, etc.), the scientific significance and goal of the study, the number of subjects that would be required to meet the study goals, the inclusion/exclusion criteria for subject entry or for use of data/tissues, the recruitment and consenting processes, the potential risks and direct/indirect benefits to subjects, as well as procedures for minimizing the risks, the procedures to maintain confidentiality and privacy, the vulnerable groups that may be encountered in the subject population, how the capacity to consent will be assessed for all subjects.  A data analysis plan, power analysis, and thorough bibliography should also be included.
·         The consent forms for adult subjects, permission forms for parents of minor subjects, and assent forms for minor subjects (in most states, less than 18 years old). 
·         Copies of all interviews,surveys, questionnaires, and other research instruments if applicable.  
·         All recruitment materials to be used, in any media (for example, letters, printed ads, TV or radio commercials, and email solicitations) if applicable.
·        Proof of current CITI training certification
·         Scientific Validity Assessment Form (can be found in Forms section, not needed for exempt studies)
·         IRB Protocol Screening Form for OSR & EHS (can be found in Forms section)
·         If submitting a Full Board Review, include 12 copies with the original (total of 13) upon submission.

Continuing Review and Modification Submission and Requirements

As stated earlier, federal regulations require human subjects research protocols to be reviewed at least once per year (21 CFR 56.109 and 45 CFR 46.109). The review must be substantive, ensuring that all the criteria for approval are still adequately met.

The IRB Continuing Review Application and Modification Application Requirements are:
·        Application for Continuing Review/Application for Modification 
·        A general progress report on the study's activities over the past approval period, including: the number of subjects enrolled, withdrawn, and removed; a summary of any changes requested and/or approved; any interim findings, and a report of any deviations or unanticipated problems that were reported to the IRB.  
·         If applicable, a description of what research-related activities will continue to occur from this point forward.  
·         If applicable, a description of what research-related modification will be made to current study protocol.
·        The protocol, which should include general information, including study title, investigator names, contact information and positions at the institution, funding sources, types of populations to be studied (for example,men, women, minors, adults, etc.), the scientific significance and goal of the study, the number of subjects that would be required to meet the study goals,the inclusion/exclusion criteria for subject entry or for use of data/tissues,the recruitment and consenting processes, the potential risks and direct/indirect benefits to subjects, as well as procedures for minimizing the risks, the procedures to maintain confidentiality and privacy, the vulnerable groups that may be encountered in the subject population, how the capacity to consent will be assessed for all subjects.  A data analysis plan, power analysis, and thorough bibliography should also be included.
·        The consent forms for adult subjects, permission forms for parents of minor subjects, and assent forms for minor subjects (in most states, less than 18 years old). 
·         Copies of all interviews,surveys, questionnaires, and other research instruments if applicable.  
·         All recruitment materials to be used, in any media (for example, letters, printed ads, TV or radio commercials, and email solicitations) if applicable.
·        Proof of current CITI training certification
·         Scientific Validity Assessment Form (can be found in Forms section, not needed for exempt studies)
·         IRB Protocol Screening Form for OSR & EHS (can be found in Forms section)
·         If submitting a Full Board Review, include 12 copies with the original (total of 13) upon submission.

 

***RECENT CHANGES TO IRB POLICY REGARDING EXEMPT STUDIES***

The procedure for protocols that have received an initial determination of EXEMPT STATUS no longer need to submit an application for continuing review on an annual basis.  In accordance with RFU Institutional Review Board Policy (section VIII of the Manual), changes regarding Exempt Studies areas follows:

If there is a determination of “exempt status,” then the IRB Chair will, on behalf of the IRB, issue a letter to the PI indicating its determination along with any requirements and constraints imposed:

           a.       A determination of “exempt status” does not expire,
           
            b.  For every human research project that has a determination of“exempt status”, the IRB shall require the PI, at a minimum, to notify the IRB on an annual basis of the current status of the research and whether there has been compliance with the PI responsibilities described in Section III of this Manual. This notification shall be through the use of a notification form developed by the IRB and approved by the Vice President for Research. Failure to submit an annual notification to the IRB will be handled by the IRB as a matter of noncompliance with policies or IRB requirements, in accordance with section XV of this Manual.

Please use the new short form entitled “ANNUAL NOTIFICATION TO IRB FOR EXEMPT STUDIES”to inform the IRB on an annual basis of the current status of your exempt research. 

Please note that in accordance with RFU Institutional Review Board Policy (section XI of the Manual),the PI must still apply in a timely manner to voluntarily close the research project such that the application is delivered to the IRB administration office prior to expiration of the existing IRB approval.  If the PI fails to apply before the period of lapse of approval commences, then such failure is to be handled by the IRB as a matter of noncompliance with policies or IRB requirements, in accordance with section XV of the Manual

 

Investigator Non-Compliance

Non-compliance (for example, not following the study protocol, not consenting subjects appropriately, etc.) may be addressed at convened meetings, where determinations are made regarding the seriousness, or "continuing" nature of the non-compliance. Actions concerning suspending or terminating research may be taken as well, and subsequent reports to federal oversight agencies and sponsor may result. The initial determination of whether there is non-compliance can be made by a designated person other than the IRB. However, the IRB must have the final say in whether or not the non-compliance was serious or continuing and determine the required actions.   The Vice President for Research is the University official responsible for implementation and oversight of the Human Research Protection Program. If you are an investigator and want to contact Dr. Ronald S. Kaplan, Vice-President for Research, regarding questions, concerns, and/or suggestions, please call (847) 578-3251.

All University employees and agents (which includes all faculty, staff, students, contractors, and volunteers), are required to comply with this Manual; violations of which could result in sanctions, including termination. 

IRB Staff:

Adam Fleischer, DPM, MPH – IRB Chair
Judy Gathman, Research Coordinator    

If you are a research participant or potential participant and have questions, please contact  the IRB Office, (847) 578-8713.


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