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Procedures

Research Proposal Review Procedures

1. Principal Investigator (PI) reviews Policies and Definitions.

The PI reviews Policies and Definitions. Reviewing this form provides a definition of research and of minimal risk according to federal regulations and a description of proposals that qualify as non-research, exempt research, and research that can be reviewed in an expedited manner. The PI must also be familiar with the ethical principles put forth in the Belmont Report.

Actions by the Principal Investigator

2. PI prepares materials for research proposal review. The PI prepares materials for Ethical Research Committee (ERC) review of the proposed research. This preparation includes

a.) Completing Introduction/Cover Sheet
b.) Writing a description of the proposed research according to guidelines in Description of Proposed Research
c.) Writing an informed consent form appropriate for the proposed research using one of the informed consent form templates as a guide
d.) Possibly completing other form(s) as indicated in Introduction/Cover Sheet
e.) Completing on-line course on ethics/protection of human research participants and including certificate of completion in materials for review


The PI should also include a copy of the Methods Section/Chapter of the proposed research and all research instruments (including demographic background questionnaires) in materials for review.

The UCLA on-line course on ethics and protection of human research participants can be taken on any computer workstation in the Library or at home.

After the PI has prepared all of the materials, then

a) If the PI is a faculty member or counseling center administrator/clinician, the materials should be submitted together to the ERC for review. The PI should take the application to the librarian or a member of her staff. The student will fill out a Research Proposal Submission Cover Sheet, and fill out the Library Log of Research Proposal Receipts. The application will be forwarded to ERC. mailbox at the Tarzana campus. Or
b) If the PI is a student, the materials should be submitted together to the faculty advisor/mentor/instructor overseeing the proposed research. The faculty
advisor/mentor/instructor reviews the materials and, when satisfied the PI has prepared them adequately, signs Introduction/Cover Sheet. The PI should then submit the application to the librarian as describe above at the Encino campus or in the ERC mailbox (or ERC mailbox at the Tarzana campus.

Actions by the ERC

3. ERC Chairperson reviews Introduction/Cover Sheet
The ERC Chairperson reviews Introduction/Cover Sheet for
a) Necessary signature(s) and email address used in online ethics training.
b) Involvement of "vulnerable participant group" in the proposed research, as indicated on form
c) Check mark indicating that certificate of completion of on-line course on ethics and protection of human research participants is included in materials for review (actual presence of certificate will also be determined)
d) Check mark indicating request for full either expedited review or exemption from review if so desired.

If necessary signature(s), certificate of completion and appropriate email address are absent, then the materials are returned to the PI.

The ERC chairperson performs an initial review to determine if the proposal qualifies for exempt research status, expedited review, or informed consent waiver and decides on approval/disapproval of the request(s). If no requests are made, the proposal will automatically be referred to full committee. Given that the initial review could take up to one week, the proposal will be processed most expeditiously if requests are only made when appropriate.

If the request for exempt research status a) is approved, then the Review Outcomeis completed and signed by the ERC chairperson and returned to the P.I. If request for exempt research status is disapproved, then the ERC chairperson determines whether the proposed research qualifies for expedited review or requires review by the full ERC.

If the request for expedited review b) is approved, then the ERC chairperson assigns an ERC member as the reviewer. This review is concerned with determining whether the proposed research meets federal regulations for protection of human participants. The ERC member completes and signs Review Outcome and then returns the materials to the ERC Chairperson. The ERC Chairperson completes and signs Review Outcome and then directs a copy to the PI (if the PI is a student, then a copy of Review Outcome is also sent to the faculty advisor/mentor/instructor overseeing the proposed research).

If the PI requests an informed consent waiver, the ERC member follows guidelines in Request for Informed Consent Waiver for approving/disapproving this request. (see research advisor)

c) If the ERC chairperson decides that the proposal is to be considered for full committee review, then the chairperson will schedule a review at an upcoming ERC meeting. Proposals will be assigned for full committee review if a vulnerable participant group is involved in the proposed research, or the chairperson determines that the proposal involves more than minimal risk to the participants. In this instance, the committee as a whole is concerned with determining whether the proposed research meets federal regulations for protection of human participants. Consistent with the committee determination, the ERC Chairperson completes and signs Review Outcome and then directs a copy to the PI (if the PI is a student, then a copy of Review Outcome is also sent to the faculty advisor/mentor/instructor overseeing the proposed research).

Review Outcomes and Response by P.I.

If the proposed research has been determined to have exempt status, then the ERC Chairperson signs and directs copy of Review Outcome to the PI (if the PI is a student, then a copy of Review Outcome is also sent to the faculty advisor/mentor/instructor overseeing the proposed research).

If the proposed research is approved unconditionally, then the ERC Chairperson signs and directs copy of Review Outcome to the PI (if the PI is a student, then a copy of Review Outcome is also sent to the faculty advisor/mentor/instructor overseeing the proposed research).

No further response is required by the P.I. and data collection may begin.

If the proposed research is approved conditionally pending minor revisions, the ERC Chairperson (for full committee review) and the ERC member (for expedited review) directs a copy of Review Outcome to the PI (if the PI is a student, then a copy of Review Outcome is also sent to the faculty advisor/mentor/instructor overseeing the proposed research.

The response of the P.I. will usually include a cover letter addressing these changes made in response to the request for revisions along with the changes made in the proposal. These materials are to be submitted to ERC in the manner used in the initial application.

The decision of the proposed research may be deferred, which occurs when major changes are needed to the proposal before it can be approved. The ERC Chairperson (for full committee review) or ERC member (for expedited review) directs copy of Review Outcome to the PI (if the PI is a student, then a copy of Review Outcome is also sent to the faculty advisor/mentor/instructor overseeing the proposed research).

The response of the P.I. most likely will involve rewriting those parts of the proposal in which major changes need to be made. This should be submitted with a cover describing these changes. In the case that the P.I. does not understand what is being requested, a meeting may be set up with the ERC chairperson or a designated member to go over this material.

The proposed research may be disapproved. This decision is made when no changes can be made to remove the ethical problems of the study. This decision can only be made by the full committee. The ERC Chairperson then signs and directs copy of Review Outcome to the PI (if the PI is a student, then a copy of Review Outcome is also sent to the faculty advisor/mentor/instructor overseeing the proposed research). If the proposed research is undergoing an expedited review and no remediation can be envisioned or there are other serious ethical problems, the ERC member must refer to proposal to the ERC chairperson so that the proposal will be considered for full committee review.

Aside from accepting the decision, the response of the P.I. may be to request permission to orally present the study to the full ERC committee for reconsideration. This will only occur if misunderstandings between the P.I. and the full committee are evident, and the decision is made by the ERC chairperson.

Process Summary & Timeline

Materials for review submitted to ERC Chairperson

1. ERC Chairperson reviews Completing Introduction/Cover Sheet (1 week)

2a. ERC member reviews the materials (up to 3 weeks)

2b. Full ERC reviews the materials (up to 4 weeks)

3. ERC Chairperson processes and mails Review Outcome (1- 3 days)

4. Principal Investigator receives letter with outcome of review

In sum, from the time the materials are submitted to the ERC Chairperson, the expedited review process takes approximately one month to complete. If a research proposal needs to be reviewed by the full ERC, then the time to completion is approximately four to five weeks. The Principal Investigator will receive a letter with the outcome of the review.

If a research proposal has previously been through the review process and has been approved conditionally, then from the time the materials are received by the ERC Chairperson, the expedited review process takes approximately one week to complete. If a research proposal has previously been through the review process and received a referral, then from the time the materials are received by the ERC Chairperson, the review process takes approximately two weeks to one month to complete depending on whether the proposal was previously given expedited or full committee review. If the research proposal needs to be reviewed by the full ERC, then the time to completion is approximately four to five weeks if the proposal is submitted in time for the next meeting. For a proposal to be considered for the next full committee meeting, the proposal must be submitted three weeks prior to the meeting date. The Principal Investigator will receive a letter with the outcome of the review.

All times are approximate, and special circumstances may lengthen the timeline.
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