Frequently Asked Questions

1. What kinds of projects need to have CHS approval?
2. How long does it take to get CHS approval?
3. How can I get a speedy IRB Review?
4. What materials do I need to submit for CHS approval?
5. What if I have changes to my study after I get approval?
6. Who can I talk to in the CHS Office?

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.

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2. How long does it take to get CHS approval?

A new CHS protocol generally takes 6-8 weeks from submission to approval, depending on the completeness of the application and submission of all required materials. For quickest results, submit all required materials at one time and communicate diligently with the CHS Coordinator assigned to review your study.

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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.

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4. What materials do I need to submit in order to get CHS approval?

• CHS Application
• Grant application or funding application/contract
• The full protocol
• The sponsor protocol (if applicable)
• The complete DHHS-approved protocol (when one exists)
• The DHHS-approved sample consent document (when one exists)
• The Investigator’s brochure (or package insert or pages from the Physician’s Desk Reference, if a marketed drug)
• IRB approvals from other institutions (and applications, when appropriate)
• Waiver requests
• HIPAA authorizations
• Consent forms
• Recruitment materials
• Study materials (including educational materials and any surveys, questionnaires or assessments)

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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.

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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 Coordinator will be assigned to work with you and will contact you directly.

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Updated: 04-Sep-2007

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