MEMBER TRAINING PLAN. Shadowing a review

Transcription

1 New IRB members, including alternate members, will meet with the IRB Administrator and/or Chair. The orientation session will include: a. Discussion of workload, expectations, and meeting preparation b. Discussion of competency rubric c. Tour of the IRB website, which includes links to: i. Belmont Report and Nuremberg Code ii. OSU Policies and Procedures for the Protection of Human Subjects iii. Federal regulations relevant to the IRB iv. Guidance documents relevant to the IRB v. Reviewer worksheets and related instructions d. Review member s CV for areas of expertise and existing conflicts of interest e. Provide IRB Member Handbook f. If Community Member, provide Univ. Southern California Community Member Booklet Before assuming the role of a Primary Reviewer, new members will: a. Complete the relevant modules in the CITI Course b. Attend at least two meetings before voting c. Participate in mock review and reviewer worksheet completion with IRB staff d. Shadow the reviews of at least three board members. Whenever possible, the first review will be completed in person with IRB staff and primary reviewer; the second and third will be conducted in person or via based on the preference and needs of the new member Shadowing a review This process is intended to be an opportunity to observe and ask questions. These are not actual assignments for the new member. a. The IRB Office will send the member an notifying them of the assignment and the date of the meeting to discuss the review. The documents will be saved to the restricted share drive in the member s folder within the drive. If the member does not have access to the restricted share drive, the documents will be attached to the notification. b. The new member reads through all study documents and completes the reviewer worksheets but does not return them to the office. The reviewer binder, board member handbook, and the IRB website have guidance documents to assist with the review. c. Once the primary reviewer has completed their review, they will copy the new member on their response. d. The new member compares their reviewer worksheet to the primary reviewer s completed worksheet. e. The new member will meet with the primary reviewer and the IRB staff to discuss the first shadow assignment. At the discretion of the new member, subsequent reviews of these training assignments can be held in person or via .

2 Continuing Education To ensure that oversight of human research is ethically grounded and the decisions made by the IRB are consistent with current regulatory and policy requirements, training is continuous for IRB members throughout their service on the IRB. Educational activities may include, but are not limited to: In-service training at IRB meetings which may include new information that might impact the IRB, including laws, regulations, policies, procedures, and emerging ethical and scientific issues Quarterly Executive Committee meetings Annual retreats, which may include speakers and mock reviews Copies of relevant publications Unlimited access to the IRB office resource library Placemats displaying regulatory information are provided for each member to use during meetings Other training opportunities will be considered by the IO on an annual basis, including attendance at the annual PRIM&R conference or regional conferences on human research protections What follows are step-by-step instructions for the various processes involved in reviewing IRB submissions. This document is meant for reference only; each reviewer is encouraged to develop a method the best suits their style. The IRB Administrator and staff are available to assist members throughout the review.

3 STEP ONE Access IRB shared drive and open the folder with your name 1. Go to is.oregonstate.edu/c lientservices/cn/mycnremote-access 2. Click on Access my home directory

4 3. Enter CN user name and password. If you are not a CNsupported client, use IRB Community login 4. Click Ok 5. Click on Restricted Share 6. Click on IRB

5 7. Click on the folder for the board on which you are a member 8. Click on your name STEP TWO Open the folder with the relevant study number (e.g. 6847) 1. Click on the folder

6 2. Click on each document and select Download from the toolbar 3. Choose Open With and once a program appears to the right, click Ok STEP THREE Read all documents submitted by the researcher (e.g., application, protocol, consent form, recruitment materials, test instruments, funding documents)

7 STEP FOUR Download the worksheets completed by the IRB Coordinator for the submission using the same process as downloading the submitted documents(labeled Study#_PIName_Review erwkstapprovalcriteria _Date.docx) STEP FIVE Read the Coordinator s pre-review comments, suggested stipulations and consultative notes in Section II.

8 STEP SIX Copy the Coordinator s suggested stipulations and consultative notes from Section II into Section I and then edit and/or delete items at your discretion using the reviewer binder, board member handbook, and the IRB website guidance documents to assist with the review process. Respond to any comments or questions from the pre-review section.

9 STEP SEVEN Add stipulations, consultative notes, and comments to Section I

10 STEP EIGHT Indicate on the worksheet whether or not each of the criteria for approval under 45 CFR 46 or 21 CFR and OSU IRB Policies have been met

11 STEP NINE Complete as much of the full-page blue box (page 2) as possible if recommending approval, all sections must be complete. If you are deferring for minor revisions and wish staff to verify, stipulations must require simple concurrence and cannot impact risk to subjects STEP TEN Save the worksheet with new file name that includes your initials and the date of review to your computer

12 STEP ELEVEN Upload the completed worksheet to shared drive 1. Click upload on the top toolbar then click Browse when the window opens 2. Find the file that was saved onto your computer and click Open 3. Click Upload

13 STEP TWELVE Alert the IRB Office that the file has been uploaded by sending an to