Function and Responsibility of the Local Review Board (LRB).

The LRB is to assist the University Institutional Review Board (IRB) in their review of the methodological and ethical aspects of research involving human participants. The LRB provides a peer-review service for the researcher and the IRB and provides local oversight of the conduct of the research.

Location of Local Review Board:

Title of Protocol:

Principle Investigator:

Type of Protocol (Check one):

Federally funded research ___

Externally funded research ___

Internally funded research (e.g., URC) ___

Non-funded faculty/staff research ___

Doctoral dissertation research ___

Master’s thesis research ___

Classroom projects ___

Other (describe): ___.
 
 

LRB Recommendation (Check one): Exempt ___ Expedited___  Full Review___

Please address the following issues when reviewing a protocol. Check all that apply.

        ___ The research has a clear purpose or research question.

        ___ The research question is clearly stated.

        ___ There is a scholarly base of information that supports the research question.
 
        ___ The proposed research design is methodologically sound.

        ___ The methodology is appropriate for evaluating the research question.

        ___ The research will not unnecessarily expose participants to risk.

        ___ Risks to participants are reasonable in relation to anticipated benefits

                a. ___ The research involves the prospect of direct benefit to participants, or

                b.___ The research is likely to contribute to knowledge.

        ___ The research involves no more than minimal risk to participants.

        ___ The research involves more than minimal risk to participants.

                a. ___ The risk(s) represent a minor increase over minimal risk, or

                b.___ The risk(s) represent more than a minor increase over minimal risk.

        ___ Participant selection is appropriate for the research question.

        ___ Participant’s safety is maximized.

        ___ Participant’s privacy is maximized.

        ___ Participant’s confidentiality is maximized.

        ___ The informed consent includes all necessary elements.

        ___ The consent form is readily understandable (back translations have assured compatability with English versions).

        ___ The process assuring that participants are fully understand the study is appropriate.
 
        ___ The IRB is requested to waive or alter any informed consent requirement.

        ___ A child’s assent is required.

            a. ___ The assent form includes all of the necessary elements.

            b. ___ The form is readily understandable.

        ___ Consent and assent will be obtained by the appropriate people.
 

For Protocols Recommended as Exempt

For research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens follow these steps to determine exemption:

        1. Will this research use solely existing (collected prior to the research for purposes other than the proposed research) data or specimens?

                    Yes__ (go to step 2) No ___ (Not Exempt)

        2.  Are those data or specimens publicly available?

                    Yes ___ (Exempt) No ___ (go to step 3)

        3.  Will information be recorded by the investigator in such a way that it can be linked to the participant?

                    Yes ___ (Not Exempt) No ___ (Exempt)

I have reviewed this project and I am convinced that, if it is carried out as indicated, it meets at least one of the six categories of research that warrant exemption (see the IRB Policies and Procedures Handbook for description of these categories). Accordingly, I agree, as a member of the Local Review Board, to assist the Institutional Review Board in monitoring the project and ascertaining that the procedures carried out as indicated by the investigator continue to meet the criteria for exemption.

Describe Criterion for exemption:
 
 
 
 
 
 
 
 
 

Name (Print, Sign, & Date):__________________________
(Member, LRB) Telephone:

Name (Print, Sign, & Date):__________________________
(Member, LRB) Telephone:

Name (Print, Sign, & Date):__________________________
(Member, LRB) Telephone:
 

For Protocols Recommended as Expedited Approval

I have reviewed this project and I am convinced that, if it is carried out as indicated, the procedures do not generate unwarranted risks to the participant, and they provide for satisfactory safeguards of the rights of participants (see the IRB Policies and Procedures Handbook for description of categories appropriate for expedited review). Accordingly, I agree, as a member of the Local Review Board, to assist the Institutional Review Board in monitoring the project and ascertaining that the procedures and safeguards are being carried out as indicated by the investigator.

Describe Reasons for Recommending Expedited Review and Attach Informed Consent Form:
 
 
 
 
 
 
 
 
 
 
 

Name (Print, Sign, & Date):_____________________________
(Member, LRB)  Telephone:

Name (Print, Sign, & Date):_____________________________
(Member, LRB) Telephone:

Name (Print, Sign, & Date):_____________________________
(Member, LRB)  Telephone:
 
 

For Protocols Recommended with Waived or Altered Informed Consent

When recommending waiver or alteration elements of Informed Consent under Section 46.116(d) of Title 45 CRF Part 46, follow these steps:

        1.  Will the research in its entirety involve greater than "minimal risk" (Section 46.102(i))?

                Yes ___ (No Waiver or Alteration) No ___ (go to step 2)

        2.  Is it practical to conduct the research without the waiver/alteration?

                Yes ___ (No Waiver or Alteration) No ___ (go to step 3)

        3.  Will waiving/altering informed consent adversely affect participants’ rights or welfare?

                Yes ___ (No Waiver or Alteration) No ___ (go to step 4)

        4.  Will pertinent information be provided to participants later, if appropriate?

                Yes ___ (Waiver/alteration is possible if IRB documents these 4 steps and approves waiver or alteration)

                No ___ (No waiver or alteration)

I have reviewed this project and I am convinced that, if it is carried out as indicated, the procedures warrant a waiver or alteration of Informed Consent. Accordingly, I agree, as a member of the Local Review Board, to assist the Institutional Review Board in monitoring the project and ascertaining that the waiver or alteration of Informed Consent does not violate the participants rights or welfare.

Describe the reasons for waiver or alteration of Informed Consent:
 
 
 
 
 
 
 
 
 

Name (Print, Sign, & Date):_____________________________
(Member, LRB)  Telephone:

Name (Print, Sign, & Date):_____________________________
(Member, LRB) Telephone:

Name (Print, Sign, & Date):____________________________
(Member, LRB)Telephone: