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Office of Research Compliance
In order to streamline procedures and prepare the College for significant changes to the regulations in Research Involving Human Subjects expected in 2016, the Teachers College IRB Office announces the following procedural and staffing changes effective immediately:
Exempt protocols should be approved within 2-3 days. Unless we need additional information to verify your exemption, we will NOT request revisions to an exempt protocol. Also, we will no longer require modification to exempt protocols for the following routine changes:
- Changes in project personnel/CITI certificates
- Additional/changes in research sites
- Minor time involvement changes
- Recruitment changes
- Minor changes in compensation to participants
The IRB will only be requiring modifications to exempt protocols IF the proposed change will entail a higher review level. The primary reasons this might occur during ongoing research at TC are:
- Proposed changes now include minors, prisoners or another potentially vulnerable population
- A change to data collection to include identifiers and/or sensitive data.
In these latter two cases, or any other instance where you feel the changes you would like to make might change the review level, check with the IRB office before submitting them.
Informed consent forms have NEVER been required for exempt research. Oral consent, a consent screen on an online survey, the tacit consent given by completely a survey, etc., have all always been acceptable without special IRB permission for EXEMPT research. PIs may include written informed consent if it’s convenient AND doesn’t add to participant risk by associating participant’s names with the study.
The IRB will no longer be stamping EXEMPT consent forms, and as such, changes to EXEMPT consent forms do not need to be submitted to the IRB.
Many studies out of Biobehavioral Studies and occasionally other departments that make use of medical testing/diagnostics, involve more than moderate exercise, etc. have required full committee review at TC in spite of the fact that they fall under an expedited category in the regulations and/or collaborating institutions have reviewed it under expedited procedures. TC will now use expedited review procedures for these protocols, with provisions for individual reviewers to call on the expertise of IRB members or outside experts during review.
After Winter Break 16, we expect the time from submission (or acceptance by advisor) until approval/requests for revisions to take 3-5 business days rather than the 3-4 weeks we have traditionally needed.
FULL COMMITTEE REVIEWS:
Beginning February, 2016, all protocols requiring full committee review will undergo pre-review by the IRB Chair and Staff. We will now request revisions PRIOR to review by the full committee, with the goal of having most protocols ready or almost ready for approval by the time the full committee convenes. The IRB office will adjust deadlines for submission to accommodate this new procedure.
INFORMED CONSENT TEMPLATES:
New Informed Consent Templates have been uploaded to Mentor. We hope they will be easier for PIs to use and participants to understand. Ongoing studies using the older template may continue to do for the duration of the research.
If you are conducting research at a site or with another institution that requires use of a different template, that template may be used in place of the TC template provided you indicate that under the “Informed Consent” section of the protocol form.
BIOBEHAVIORAL STUDIES AND/OR OTHER STUDIES INVOLVING STANDARD MEDICAL PROCEDURES/DIAGNOSTICS:
If a protocol has already been reviewed and approved by a medical school or hospital, the TC IRB will accept that approval (and the approved consent form) without further review at the college. The approved protocol and consent form will still need to be uploaded into Mentor. and investigators. Investigators MUST AWAIT TC ACKNOWLEDGEMENT/APPROVAL before recruitment or data collection on campus.
Myra Luna-Lucero and Eva Hachikian will continue to staff what we are now calling the IRB HELP DESK. Their positions are dedicated 100% to PI inquiries, protocol development assistance and training. Since they’ll both be covering the phones and email when they’re here but their individual hours may change week by week, reaching them through firstname.lastname@example.org is best. The phone number remains 212/678-4105.
The IRB duties that used to be performed by the Research Compliance Manager will now be performed by Axiom Education, providers of the Mentor IRB software. Requests for additional documentation, clarifications and some revisions will be going out directly to PIs from either Joelle Willis or Curt Naser, whose names should be familiar to anyone who has applied to the IRB since October.
The new proposed regulations I alluded to at the beginning of this memo have the promise to streamline and simplify IRB review at TC even further. I will be keeping the community apprised of new developments and announcing training in the new regulations when they become available.
NOTE FOR DISSERTATION STUDIES: Please note that the IRB will only review dissertation studies after the proposal hearing has been passed, and note that regardless of the type of study, no study can begin (including recruitment of subjects) without first having received IRB approval.
MODIFICATIONS: To change a study that has been approved by the IRB, you will need to request a modification. To do so, scroll to the bottom of the page of your study, and find the "Modifications" tab. From there, click on the "Upload New Modification" button. You will need to upload a Memo describing what you are changing and why, along with the revised application to reflect your revised study and any other documents (such as recruitment materials, Consent forms, etc.) that need to change as a result of your modification. If you have multiple additional documents that you need to upload, then after you submit your modification, you should click on the page icon (with the maroon lines) next to your modification entry and select "Upload Additional Docs." NOTE THAT YOU CANNOT BEGIN IMPLEMENTATION OF A MODIFICATION UNTIL AFTER IT HAS BEEN APPROVED BY THE IRB.