Application Deadline (Wed)	Meeting (Thurs)
3 September	18 September
1 October	16 October
29 October	13 November
3 December	18 December
5 January (Monday)	15 January
4 February	19 February
4 March	19 March
1 April	16 April
6 May	21 May
3 June	18 June

2. Where do I get an application and instructions?

Applications and The Intelligent Scholar's Guide to the Use of Humans Subjects in Research are available on the web.

3. What happens after I submit my application?

You will receive an email message from the Committee Office telling you the name of and contact information for the reviewing Research Officer, and the application/protocol number that has been assigned to your project. You can then communicate directly with the staff person responsible for seeing you and your project through the review and approval process.

4. What if I don't get an email message telling me who the Research Officer is?

If you have not received an email within a week, contact the Committee Office at (617) 496-CUHS or cuhs@fas.harvard.edu.

5. Do students' academic research projects require IRB approval?

Yes, if human subjects are involved. Student researchers must have a faculty sponsor for each research project. For more information, consult the Intelligent Scholar's Guide , available on the web or contact the Committee Office at (617) 496-CUHS or cuhs@fas.harvard.edu.

6. Can I collect personal data from other students?

With adequate informed consent, protection of confidentiality, and committee approval if necessary, yes. However, instructors or teaching fellows are discouraged from collecting personal data from students in their own courses or sections because of the potential for coercion, and problems inherent in student revelation/sharing of private infomation.

7. Do course projects involving human subjects require IRB approval?

Yes. In many cases, the instructor can complete a human subjects application for the "generic" project, detailing the kinds of procedures, recruitment, subjects, risks, benefits, etc. The Committee then reviews and approves this application and delegates responsibility to the instructor to act as a proxy reviewer. Students in turn complete the application, or otherwise present sufficient information to the instructor so that s/he can make a judgment: does this project fall within the boundaries of what was approved, generically, by the IRB? If so, the project may proceed. If not, the student is referred to the Research Officer to decide whether a separate application is needed.

8. Is informed consent required even if the data will be collected from my friends and colleagues?

Yes. All research involving interaction with human subjects requires informed consent regardless of who the subjects are. There are exceptions to this rule: in some studies, subjects are not given complete information about all procedures or hypotheses because full prior knowledge would affect their responses. Deception of subjects must be justified in each case, and subjects should be provided with a full explanation or debriefing as soon as practicable. The Committee does not routinely approve such projects (in particular we do not believe it is an appropriate exercise for undergraduate researchers), and prior explanation of risks must never be withheld.

When the risk to subjects is minimal and a signed consent would be the only link between a subject and his or her data, oral consent is preferable. For additional information on consent forms, see Appendix A of the Intelligent Scholar's Guide.

9. If I'm just counting pedestrians on Mass. Ave., do I need to submit an application?

If research involves observation of public behavior where information is recorded in such a manner that the subjects cannot be identified (directly or through identifiers linked to the subject), it does not need to be reviewed.

10. I'm using subjects from a local hospital. Whose IRB should review my project?

Investigators need to have their own institution's review board approval, and hospitals require in addition that their board review projects. Applications can be submitted simultaneously.

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Staying On Track

11. Can I share my IRB protocol approval with colleagues working on similar projects?

No. The IRB approves protocols with the understanding that the work will be conducted only by the investigators named in the application. If your colleagues would like to work on your project, you may modify your existing protocol by contacting the Committee Office (cuhs@fas), phone (617) 496-CUHS, or a Research Officer. Otherwise, they must make their own application.

12. What's the difference between confidentiality and anonymity?

Confidentiality means that information is private, but that it is possible for you, or a determined person familiar with your subjects and/or able to gain access to your data, to figure out a subject's identity. Anonymity means that it is impossible for you--or anyone else--to connect a subject with the data they've provided. Common conditions that make data confidential rather than anonymous include:

the use of audiotapes to record interviews
demographic data such as date of birth; use of small descriptive categories, e.g. black female senior official in a police department, Asian male executive nurse in a healthcare organization
qualitative studies of few subjects with highly individual information, e.g. three school teachers describing what drew them to teaching, or their assessment of their school's principal
the use of ID numbers on subjects' data with a separate name/number list

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Administrative Issues

13. What's an expedited review, and can I get one?: Projects that appear to offer no risk of harm to subjects may be eligible for review and approval outside of the Committee's regular meeting schedule. This is called "expedited review." There are specific rules that the Committee muct follow in determining whether a study may be approved by expedited review or must be reviewed at a Committee meeting. Expedited review is always used when possible. You may consult with a Research Officer.
14. I think my study is eligible for exempt status. How can I tell?: View the flowchart for determining the need for Committee review.; Consult the guidelines for determining the need for Committee review.; Consult with a Research Officer Research Officer (phone (617) 496-CUHS).
15. How long will it take for Committee review?: Studies that can be approved by expedited review are ordinarily approved in one to three weeks, except at peak times (most typically the week preceding the deadline for submission for the monthly meeting).; Projects requiring full committee review are considered at the Committee's monthly meeting. A formal letter of approval is ordinarily emailed in the week after the Committee meeting.
16. How can I find out whether my study has been approved?: For studies that are eligible for expedited review, investigators may contact the responsible Research Officer any time after you receive an email notification from the Committee Office that your project has been assigned to a Resarch Officer.; For studies that require full review at the Committee's monthly meeting, the responsible Research Officer ordinarily contacts investigators by email within a day or two after the meeting if the Committee had further questions, required changes, or stipulated conditions necessary before approval could be granted. A formal letter of approval is ordinarily emailed in the week after the Committee meeting. Investigators may contact the responsible Research Officer on the Friday after the meeting for an immediate response.
17. My project will last longer than a year. Can I get approval for the entire project all at once?: No. Federal regulations require that an IRB conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year.
18. My grant proposal is due at the agency next week but the Committee doesn't meet until next month. What can I do?: Contact the Committee Office, providing your name, the name of your project as it will appear on the grant application, and the name of the funding agency. Commitee staff will issue a certification of "pending review". Then complete the application and submit it for the next regularly scheduled meeting. When a grant is obtained, a human subjects application must be reviewed and approved before funds will be released.
19. I don't see any meetings scheduled in the summer. Can I get a project approved in July?: The Committee Office is open all summer and expedited reviews are conducted just as they are during the academic year. The Committee has no regularly scheduled meetings during the summer but will convene a meeting if there are projects in need of review.

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Ethical Problems

20. Who is responsible for reporting any problems that may occur during the conduct of approved research?: Investigators and laboratory or department heads are responsible for reporting promptly to the Committee any serious or continuing noncompliance with university policies or federal regulations. In addition, every approval of a research project is granted with the stipulation that any unanticipated problems and risks, changes in the research plan, and any injury to subjects be reported to the Committee.
21. What should I do if I know of research that has violated ethics?: You should notify the chair of the department and the Committee Office. You may also talk to any member of the Committee. If you are uncertain what constitutes a violation, please contact a Research Officer.

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Learning More about Ethical Issues in the Use of Human Subjects in Research

22. Is anyone available to speak to classes and/or groups about the protection of human subjects and the IRB process?: Yes, the Research Officers are available to present and to discuss human subjects issues with any group on campus.
23. How can an investigator obtain further information or advice regarding the use of human subjects?: Contact the Committee Office, phone (617) 496-CUHS.

CUHS - Frequently Asked Questions

Getting Started

Staying On Track

Administrative Issues

Ethical Problems

Learning More about Ethical Issues in the Use of Human Subjects in Research

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Getting Started

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Staying On Track

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Administrative Issues

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Ethical Problems

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Learning More about Ethical Issues in the Use of Human Subjects in Research

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[Last modified: 10/23/12 ]