KSG Research Administration Office - Preliminary Questionnaire on the Use of Human Subjects or Human Subjects Data in Research

In order to help us determine whether the use of human subjects in your proposed research requires further review, please answer the questions listed below as applicable. Certain types of interviews, such as with government officials and other corporate or non-profit organization "elites" about the performance of their official duties, or anonymous surveys of adults on non-sensitive topics, are usually considered exempt from human subjects review. However, we ask that PIs consult with the Research Administration Office (RAO) so that we can confirm that research is exempt from review or facilitate further review as needed. Further review does not necessarily mean that a project will need to go before the University's Human Subjects Committee, or if it does it may very well receive expedited approval. Please be assured that we will not delay sending out your proposal while the human subjects issue is pending. Please send completed questionnaire to RAO [charlene_arzigian@harvard.edu] via email attachment. Thank you.

KSG Research Administration Office Preliminary Questionnaire [download form]

PI Name:                                                            Sponsor Name:                                                

Project Title:                                                                                                                              

Exemption Number(under 45CFR46):                                 (RAO Use Only)

Date of Exemption Determination:                                      (RAO Use Only)

1. Who will be participating as research subjects? (Please list type of institutional affiliation, e.g., employees of a non-profit organization, managers in a corporation, high school students, etc.)
   
2. How are subjects recruited and how is informed consent to participate obtained?
   
3. Briefly, what are subjects asked to do, or what type of information is collected from or about them?
   
4. Will identifiers be collected? If so, how are confidentiality and/or anonymity assured (if applicable)? At what stage are identifiers removed from the data?
   
5. Will subjects be asked about potentially sensitive topics, about their own personal behavior, or be put at risk for any financial, employment, psychological, legal, social, or reputational harm? Could the subject be compromised in some way if information collected leaked outside the research context?
   
6. Are subjects deceived in any way?
   
7. Will research data be destroyed at the end of the study? If not, how and for how long will it be stored? Will data be put to future use and how will subjects' permission for further use of their data be obtained?

Please note: Under federal regulations, the Principal Investigator is not permitted to determine independently whether his/her new research activity is exempt from Human Subjects review. Following consultation with the RAO, if a new or renewal project is determined to be exempt from further Human Subjects review at the proposal stage, it is the PI's responsibility to notify the RAO should any procedures change once an award is made, that might implicate the protection of human subjects. Such notification must be made before any activities involving human subjects can commence.