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Office of Research Compliance
On January 20, 2017, six years after they were first proposed the Office of Human Research Protections (OHRP) passed a new set of human research protections regulations. This is the first major overhaul of the HS regs since 1991. The new regulations tend to reduce oversight of social and behavioral research and to move much of the administrative burden of the IRB away from PIs and committee members and into administrative offices.
The new regulations go into effect January 19, 2018. This is the first of several notices we’ll be sending to remind you of the changes. The text of the new regs leaves much open for interpretation and awaits clarification from OHRP, which we will pass on to you as it becomes available. For now, here are the broad outlines of the new regulations as they impact TC and social/behavioral research more generally:
1) Continuing review: Continuing review is no longer required for expedited protocols. At TC, this means that there will be no paperwork required for about 90% of the protocols submitted after initial approval. Each institution may decide whether to require continuing review for expedited protocols approved prior to January 20, 2018, and TC’s IRB may want to ask PIs periodically to confirm research is still ongoing. We will have a policy announcement after the November IRB meeting. The new regulations clarify that a study is closed if no more data collection is taking place, even if data analysis or routine clinical care are ongoing.
2) Survey and interview research: under current regulations, surveys and interviews can be either exempt or expedited depending on the sensitivity of the data collected and if the data are collected anonymously or not. Under the new regulations, all survey and interview research may be considered exempt provided data is stored securely and the only risk to participants is a breach of confidentiality. The IRB is going to develop a list of standards, practices and resources that we have certified can collect, store and transmit data securely to aid investigators. In practice, when a protocol uses a resource from the list, we’ll approve it as exempt. Unfamiliar resources and/or protocols with risks in addition to a breach of confidentiality will be reviewed under expedited procedures.
3) Benign behavioral interventions: The new regulations create a new category of exemption for research involving “benign behavioral interventions.” Unfortunately, the regs don’t define the category. so right now institutions are left to interpret it on their own. Upon initial review of recent protocols we believe that research utilizing the following methodologies will most likely be exempt:
- Game playing, role playing and computer games for adult subjects
- Minor diet/nutrition/exercise interventions for healthy or moderately overweight adults
- Meditation/mindfulness interventions with healthy adults
The above list is not exhaustive and will be evolving as OHRP issues guidance and other institutions begin to share their standards.
4) Training: There will now be a training recertification requirement that requires PIs, advisors and project staff to update their CITI training once every 3 years. Fortunately, CITI has a “refresher module” they estimate takes just 25% of the time it takes to do the full training that will work for all researcher, advisors and staff who have already taken the CITI training at any point. We’ll send a separate email concerning CITI recertification at a later date.
5) Single IRB Review and Reliance Agreements: Previously, each institution participating in a research project needed to review and approve an identical IRB protocol. The entire federal government will move to a “one grant, one IRB of record” model in January 2020. NIH grants award in January 2018 will be subject to a more limited version of this requirement. Check with your SPA if the requirement effect your grant. “Reliance agreements” are the mechanism institutions use to rely on the other’s IRB. Further information on creating and reviewing these agreements is on the IRB webpage.
The regulations concerning research with children, pregnant women and fetus and prisoners remain the same, as does research involving deception. If your research has routinely required full committee review in the past, it will still do so under the new regs.
OHRP estimates that in the past 50% of research in the social and behavioral sciences was exempt; under the new regulations they estimate a full 80% of SBE research will be exempt, which translates into even less paperwork and better turnaround times for the vast majority of protocols. Looking ahead to 2020, OHRP will no longer be requiring research conducted collaboratively to be reviewed at each participating institution. We will update the community on that aspect of the new regs as guidance becomes available and we get closer to the date.
Inquiries about the new regulations may be sent to firstname.lastname@example.org.
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 email@example.com 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.