Faculty of Medicine CHS

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Forms and Instructions Forms Submission Guidelines Amendments Continuing Review Adverse or Unanticipated Events Ceded Review Study Closure Deadlines and Timelines Committee Meeting Dates Consent Requirements Information About Consent Required Consent Elements Conditions for a Waiver of Consent Study Management Tools Responsibilities of the Investigator Active-Study Record Management Post-Study Record Retention Policy and Procedures IRB Policy and Procedures HMS and Harvard University HIPAA at HMS Required Training CITI Human Subjects Training HETHR and Other Trainings Training Requirements Information for Students Student Information Student FAQ Student IRB Submission Information Special Requirements for Students Frequently Asked Questions FAQ What the IRB Reviews Who Needs to Submit an Application Why the IRB Conducts a Review Reference Federal and State Guidelines Countway Library Records Review Harvard University Links Definitions Presentation Library Faculty Information Research with Student Participants Information for Multi-Site Studies Information for International Studies Non-Full Time Faculty Information Information for IRB Members Reviewer Sheets Educational Materials Electronic Training Book Information for Participants Information about Research Your Rights as a Research Participant Sus Derechos como Participante de un Estudio de Investigación Who to Contact with Complaints or Comments Quality Assurance P-StAMP Program Information P-StAMP Policies and Procedures Contact Information	Student Frequently Asked Questions What kinds of projects need to have CHS approval? How long does it take to get CHS approval? How can I get a speedy IRB Review? What materials do I need to submit in order to get CHS approval? I am going to develop my study materials on-site – how can I get IRB approval for my project or these materials once I am on-site? What if I have changes to my study materials after I get to my site? How do I know if the site where I am performing my research has an IRB? Can I get CHS approval without an HMS or on-site mentor? How do I contact 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. Under these definitions the following activities may also be human studies research: program evaluations, curriculum studies, surveys, questionnaires, specimens and data analysis. [back to top] 2. How long does it take to get CHS approval? Student applications generally take eight 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 Research Officer assigned to review your study. Summer research proposals are due by April 1st of every year. [back to top] 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). 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. [back to top] 4. What materials do I need to submit in order to get CHS approval? Cover letter; human studies application signed by student and mentor (with supplemental forms, as appropriate); copy of the grant, contract, and/or Scholars in Medicine Office (SMO) application; informed consent forms or request for waiver (also HIPAA authorization or request for waiver of same); research materials: recruitment fliers, survey instruments, questionnaires, telephone scripts, focus group questions, etc.; Human Subjects Protection Training certificate; IRB approvals from other institutions/sites; Mentor letters (HMS/HSDM faculty and on-site supervisor). [back to top] 5. I am going to develop my study materials on-site – how can I get CHS approval for my project or these materials once I am on-site? The CHS and CHS staff may review materials submitted via email or fax. All materials to be used with study participants must receive CHS approval, prior to implementation. [back to top] 6. What if I have changes to my study materials after I get to my site? Students should submit an Amendment Request Form, as well as any revised study materials, to the CHS via email or fax for approval, prior to implementation. [back to top] 7. How do I know if the site where I am performing my research has an IRB? The DHHS Office for Human Research Protections (OHRP) has put together a document entitled “The International Compilation of Human Subject Research Protections” which contains the regulations and organizations that review research in many countries around the world. Most sites (domestic and international) have IRBs, ethics committees, councils of elders, or some entity that reviews the activities of the community where students may be performing research. [back to top] 8. Can I get CHS approval without an HMS or on-site mentor? No – an HMS/HSDM mentor, as well as an on-site mentor is required for all students performing research studies. [back to top] 9. How do I contact the CHS Office? Once a CHS application is submitted, a CHS Research Officer will be assigned to work with you and that person will contact you directly. Otherwise, please contact the office at 617 432 3071 or orsp@hms.harvard.edu. [back to top] Updated: 11-Aug-2006
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