How long are ethics training certificates good for?
How do I print my CITI certificate?
You can download the certificate right in your profile in CITI. Just log in, click on "Course Completion History" and then click on View under Completion Report. The certificate opens in a new window, and from there you can print it.
Isn’t “exempt” and “not human subjects” the same thing?
No. Not human subjects means that the research does not involve a “human subject” as defined by the federal regulations. Exempt research is research with human subjects however the research is “minimal risk” and the only involvement of human subjects fits into one or more federally defined categories.
I think my study is exempt. Do I still need to apply?
Yes. The regulatory category of "exempt" research must be reviewed by CUHS prior to being carried out. Whether your study is exempt is a determination made by the designated CUHS staff person who reviews your application.
Is there a separate form for exempt studies?
No. All applications should be submitted on the CUHS Protocol Template form. However, please refer to specific information about studies that may be determined to be exempt in the CUHS protocol guide.
Can I request an expedited review?
No. Expedited does not mean that your application is reviewed faster; it means that the research activity has been determined to be minimal risk and meets the qualifications of one or more federally defined categories. Expedited studies are not required to be reviewed by the convened IRB and are instead reviewed by a CUHS staff person.
Do I need a faculty sponsor?
Harvard requires that students (graduate and undergraduates) as well as post-doctoral fellows have a PI-eligible faculty member assume overall responsibility for the conduct of their human subject research. Read more about investigator responsibilities.
How long does it take to get approval?
Once your application has been submitted by you and your faculty sponsor, it usually takes around 2 weeks for it to be assigned to a staff member for review. From there, it's impossible to tell how long the review will take; it varies from application to application, depending on the complexity of the study and the completeness of the application when it is submitted. Having said that, for straightforward studies without the need for a lot of going back and forth, the average turnaround time is 4 weeks (so 6 weeks in total). This page provides some helpful tips on what you can do to help speed up the time of the review: http://cuhs.harvard.edu/6-tips-speeding-review-your-application
I missed the application deadline. Can I still submit my application or do I have to wait until next month?
You can submit your application at any time. The deadlines on our website are for the committee meetings, but only a small portion of the applications we receive need to be reviewed by the full committee. The majority are reviewed by our CUHS staff on a daily basis.
Do I need to renew my study?
If you can answer yes to ALL of the following statements:
- The research is permanently closed to enrollment
- All participants have completed all research-related interventions / interactions
- Collection of private identifiable information is complete
- Analysis of private identifiable information is complete
Then the study can be closed. If not, it needs to be renewed. However, only the CUHS may officially close your study.
Can my study be closed?
I’m finished with my study; can I just let it expire?
No. All studies have to be formally closed by creating and filling out a Continuing Review in ESTR. A Summary of Study Progress form should be uploaded under Question 7 on the online “smart form”.
Is the IRB office open in the summer?
Yes, we are here year round (except for during winter recess), and applications are reviewed as usual.
I missed the Drop-In hours this week. Do I have to wait until the next time to ask my questions?
No, you can call our office (617-496-2847) to ask questions or make an appointment with a CUHS staff member at any time.