Procedures to Establish Local Review Boards (LRB)

 

Although the University Institutional Review Board (IRB) is ultimately responsible for the review of the methodological and ethical aspects of all research involving DePaul University members, the LRB provides essential assistance for the IRB. The LRB conducts the initial review of the project and provides expert peer-review service for both the researcher and the IRB.  The LRB provides assurance that the quality of the research is sufficient to justify any potential risk to the subjects.  Also, the LRB is in closer proximity to the research and can monitor compliance with those research procedures approved by the review board. The LRB provides initial determination of whether or not a research project conducted by anyone within the domain of that LRB is exempt from IRB review.  To establish an LRB in a department/college/unit for reviewing the use of human subjects in research, please follow the procedures listed below:

 

1.      Membership

a)      The LRB should include at least three members from that unit and each member needs to review each protocol.

 

b)      The LRB should reflect the demographic diversity of the unit's membership, if possible.

 

c)      The LRB should reflect the diversity of research methodologies characteristic of that unit.

 

2.      Responsibilities

 

a)      For IRB records, the LRB must provide the IRB Coordinator (x2593) with the names of the members of the LRB, name of the chair of the LRB, contact information for the chair, and copies of the certificates of training (http://ohsr.od.nih.gov/irb_cbt) for each member.

 

b)      The LRB members are responsible for familiarizing themselves with pertinent information about the protection of human subjects who are participating in research projects conducted by that unit.

 

At minimum, the LRB must be familiar with the DePaul University IRB Handbook, the videotape (contact the IRB Coordinator) and web page provided by the federal Office for Human Research Protections, the DePaul University's IRB web page and current federal regulations regarding the protection of human subjects in research.  The IRB will provide these and other materials to LRB members, as well as ongoing consultation and support.

 

c)      In compliance with DePaul University policies and procedures, the LRB is responsible for oversight and review of all research activity in that unit involving human subjects.  These activities include, but are not limited to, the following:

 

·        Class-related projects that require review whether or not information is collected from persons inside or outside the university (see policy on class-related projects review);

 

·        Student theses, major projects, independent study projects and dissertations;

 

·        Faculty/staff research

 

d)      The LRB is responsible for the initial determination of whether or not a research project, conducted by anyone within the domain of that LRB, is exempt from IRB review (see LRB Review Template on IRB web page).  In the event of an LRB decision of “exemption”, then the LRB must provide to the IRB a copy of the researcher’s “claim of exemption” (see “Claim of Exemption” on the web page) and a written account of the reasons and justification for the LRB decision of exemption. “It meets the requirements for exemption” is not a sufficient justification.

 

e)      The LRB also may recommend (with written justification) to the IRB whether a particular protocol is appropriate for “expedited review” (see LRB Review Template on IRB web page).  Again, “It meets the requirements for expedited review” is not a sufficient justification.

 

f)        The LRB is responsible for maintaining records of all projects reviewed, the status of review, and for providing quarterly reports to the IRB of that unit's activity, using a standardized format provided by the IRB.

 

g)      The LRB is responsible for providing education, materials (e.g., application forms), consultation and support to members of that unit.  Thus, the LRB provides education and guidance to researchers concerning the procedures for protecting the rights of human subjects.

 

h)      At least one representative of the LRB is responsible for attending an annual get-together with the IRB to discuss new procedures and policies and other important IRB-LRB issues.  That meeting will be held late in the Spring Quarter.

 

i)        LRB members should not review and make recommendations on their own research projects. At least three members will still need to review the project at the LRB level. In case this situation arises, an alternate member should be available to review a project.

 

3.      Protocols

 

Each protocol that the LRB evaluates and submits to the IRB must include the following:

a.       The researcher’s completed protocol application

b.      Researcher’s grant application, if appropriate

c.       The LRB’s review decision template with signatures of reviewing members

d.      Copies of Informed Consent and Assent forms (in English, translation into other languages if appropriate, and the back translations into English)

e.       Copies of recruitment advertisements, etc.

f.        Copies of debriefing procedures

g.       Copies of letters of collaboration, if appropriate

h.       Copies of data collection instruments such as surveys, questionnaires, interview questions

i.         Course syllabus, if appropriate

 

Failure to provide these documents will result in delay of the review process.  The IRB Coordinator must request the missing documentation before review can continue.

 

Completed applications requiring full IRB board review must be submitted in both hard copy and electronically to the IRB Coordinator by the 15th of the month if the application is to be reviewed that month.  Completed applications received after the 15th of the month will be reviewed in the subsequent month.

 

4.      Review Procedures

 

Local Review Boards should take the initiative to establish their own procedures for reviewing protocol applications. The IRB has some recommendations that may facilitate the process:

 

a)      LRB members should meet as often as necessary to review the incoming protocol applications from that department or school.

 

b)      When determining a meeting time, it may be helpful to consider the IRB deadline for submission of completed application (the 15th of the month).

 

c)      LRBs may want to designate specific members as primary and secondary reviewers for projects. All members should review a protocol, but one or two individuals can present the project and discuss their concerns and questions to the other members. The other members may provide feedback during the meeting.  It may even be helpful if the principal researcher presents his/her project.  However, principal researchers should never be present during deliberations or voting.

 

d)      All documents that can be electronically reproduced should be submitted as such.  This will ensure that the applications are distributed to LRB members efficiently. Submission of electronic documents to the IRB Coordinator also will speed IRB processing.

 

 

For further information please contact:

Sara Gulbrandsen, IRB/IACUC Coordinator, x2593, sgulbran@wppost.depaul.edu

George F. Michel, Chair IRB, x4246, gmichel@wppost.depaul.edu

www.depaul.edu/~gmichel/extra/home.html