1. What kinds of projects need to have CHS approval?
The CHS must review and approve (or grant an exemption to) all “research involving human subjects,” which is defined by an activity that meets definition of “research” and involves “human subjects” under the DHHS or FDA regulations.
2. How long does it take to get CHS approval?
Reviews are a collaborative process between the IRB office and the Investigator. In general, we have found that the following timelines apply from submission to approval:
Research and Human subjects determinations, 2-4 weeks
Exemption determinations, 2-4 weeks
Expedited reviews, 4-6 weeks
Full Committee reviews, 6-8 weeks
For quickest results, submit all required materials at one time and communicate diligently with the IRB staff assigned to review your study.
3. How can I get a speedy IRB Review?
You can help!
- Be sure to complete ALL of the questions on the application and submit ALL of the required materials (outlined in the application and the application instructions). If we review your application two weeks after it is submitted and we have to request completion of questions or submission of materials, it will take longer to get your approval.
- Respond as quickly as you can to inquiries and requests of office staff. Office staff members see many applications and work very closely with Committee Members, so they have a very good idea of what will qualify for approval, and what will require revisions (which will delay your approval).
- Be sure to add a cover letter and indicate any time-sensitive review requests.
4. What materials do I need to submit in order to get CHS approval?
For initial approval:
- Initial IRB Application Materials and appropriate supplemental forms
- CVs/Biosketches for the Investigator and research personnel with human studies responsibilities (including members of the team who interact with participants or handle data/specimens containing participant identifiers);
- HETHR or equivalent human subjects protection certification (such as CITI or NIH) for all research personnel with human studies responsibilities (including members of the team who interact with participants or handle data/specimens containing participant identifiers);
- The appropriate Disclosure Statement Form (Sponsored Research or Protocol) for all research personnel;
- IRB approvals from appropriate institutions, or letter of support if the institution does not require IRB review, as applicable;
- All funding application/s (including grants, subcontracts and clinical trial agreements) supporting the research;
- The full protocol (when one exists);
- The sponsor protocol (when one exists);
- The complete DHHS-approved protocol (when one exists);
- Recruitment materials (cover letters, fliers, brochures, email notices);
- Study materials (telephone scripts, question guides, written questionnaires and surveys);
- Educational materials (information sheets, study guides);
- Consent materials, including any requests for waivers;
- HIPAA materials (including any waiver requests and proposed authorizations);
- Investigators Brochure (or package insert or pages from the Physicians Desk Reference, if a marketed drug).
- Continuation application and appropriate supplemental materials
- Data Safety Monitoring Board (DSMB) reports, or adverse/unanticipated event reports with resolution from the institution where the research is taking place.
- Competing/non-competing grant submissions/annual/progress reports to funders.
- Copies of publications or abstracts resulting from the research.
- IRB approvals from any other reviewing IRB.
- Consent form(s) currently being used to enroll participants. Any revisions to the existing consent form or significant new findings that may relate to the participant's willingness to continue participation should be included in a new/revised consent form for CHS approval. If consent forms have been translated into languages other than English, a current copy of the translated version, as well the Translation Attestation Form also must be submitted for CHS review.
- Requests for amendments of any modifications sought to the research project (such as the addition or removal of research personnel, changes in study design or study population, addition or subtraction of the number of participants to be enrolled in the study, additions or changes to recruitment or other research materials) and any supporting materials (such as revised protocols and/or revised CHS applications).
For continuing approval:
5. What if I have changes to my study/study materials after I get approval?
An Amendment Request Form, as well as any revised study materials, must be submitted to the CHS for approval, prior to implementation.
6. Who can I talk to in the CHS Office?
There are 5 people in the CHS office, and anyone in the office can help you with basic inquiries. Once a CHS application is submitted, a CHS Research Officer will be assigned to work with you and will contact you directly.
Updated: 03-Mar-2010