FREQUENTLY ASKED QUESTIONS
About the Human Subjects Approval Process

1. If I am just talking to people and there are no experiments or clinical trials, do I need human subjects approval?

Yes. Federal regulations define human subjects research to broadly cover interactions as well as interventions with human subjects for research purposes. Surveys, interviews, questionnaires, oral history interviews etc. are all covered by the federal regulations. IRB approval must be obtained prior to commencing the research. Most of this research, however, qualifies as "exempt".

2. If my research qualifies as "exempt" under the federal regulations, must I submit an application for approval?

Yes. The term "exempt" in terms of review process really means "exempt from full committee review". It is CUNY policy to review all research in order to ensure that the research is, in fact, exempt. The only possible exceptions are in-classroom research practica as outlined in the CUNY Policy for Student Research With Human Subjects. The application for exempt research is less extensive, and under most, but not all, circumstances, written, signed informed consent is not required. However, as a general matter, investigators are required to give their subjects a written statement containing information about the study and their part in it.

3. If I am using data compiled by other third parties, e.g. governmental agencies or another researcher, do I need approval?

Yes. Use of existing data is exempt research but still requires prior approval. Even if you have worked with the original investigator in obtaining the data, your independent use of the data requires approval. This issue comes up often with Ph.D. dissertation research. All Ph.D. candidates must get their own human subjects approval for their research even if it involves working with data collected by a collaborator with his or her own human subjects approval.

4. What are some common things that may disqualify research as "exempt" research?

• Use of identifiers
• Use of minors
• The subject of research relates to sensitive information where the names of the subjects may be capable of being identified
• Research requires subjects to do a task, for example, write responses to certain objects shown on a computer screen, or give responses to vignettes shown on a videotape

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

Not usually. Course-related research projects usually are limited in scope, do not lead to generalizable knowledge and are not undertaken with that goal in mind. These projects are considered classroom exercises and are not subject to review by the IRB. (Please refer to http://www.rfcuny.org/ResCompliance/Student_Research.htmlfor more detail.) However, the course instructor must have completed the CUNY Computer-Based Training Program for Human Subjects Protection before he or she can decide whether an assigned classroom exercise qualifies as "research practica".

6. 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. Please refer to the CUNY Policy for Student Research With Human Subjects.

7. What is the difference between student research practica and research projects?

Student research practica are solely designed to provide students with an opportunity to practice research methods such as interview, survey and observation techniques. These practica are considered classroom exercises only and are not intended to lead to generalizable knowledge. Student research practica do not require IRB approval. On the other hand, student projects, directed or independent, that are designed with the intent to contribute to generalizable knowledge, require IRB review. If you are in doubt, please contact your local IRB office or the Office of Research Conduct, telephone (718) 951-5488.

8. If I want to make a minor change in the study - add/remove a question, put an ad in the newspaper to recruit more subjects - do I need to do anything?

Yes. Any change for any reason requires filing an amendment to the study. You are responsible for submitting your proposed amendment(s) to the IRB in writing, including any revisions made to the protocol, informed consent forms or data collection forms. No matter how minor, the change must be approved before it is instituted.

9. 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.

10. How long will it take for IRB review?

Studies that can be approved by expedited review are ordinarily approved in 2-3 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 mailed in the week after the Committee meeting.

11. My grant proposal is due at the agency next week but the IRB committee does not meet until next month. What can I do?

Contact the Research Officer, who will issue a certification of "pending review". Then complete the application and submit it for the next regularly scheduled meeting.

12. What else do I need to submit with my application?

Any test instruments, questionnaires, recruitment flyers, newspaper ads, e-mail ads, phone solicitations, or other communications with the subjects. For individual or group interviews, we must have a list of the types of questions you will ask. We understand that you may not in every instance be able to anticipate the direction that some interviews will take. For our purposes, however, we need to know the range of questions and general areas to be explored.

13. What is a "CITI"? Do I have to take it?

The Collaborative Institutional Training Initiative (CITI) is a required program to be taken by all CUNY key personnel involved in human subjects research, regardless if their research is funded or non-funded. The program presents common concepts, principles and issues related to the protection of human participants in research and will help you understand how to protect the rights and welfare of all human participants involved in research. The certificate of completion must be included in your research proposal to the IRB.

14. Who is included in Key Personnel?

Key Personnel includes all individuals responsible for the design or conduct of the study, and has been defined very broadly by DHHS to include all staff ranging from principal investigators to field interviewers to most support personnel. Examples include individuals contacting potential subjects for recruitment or scheduling purposes, data entry specialists, student assistants who handle or process data for any reason. Key personnel also includes consultants who are identified as key personnel with human subject responsibilities, as well as key personnel with human subject responsibilities under foreign or domestic subcontracts.

15. 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. Please use the Serious Adverse Events Form on the CCNY IRB website.

16. Where can I obtain further information or advice regarding the use of human subjects?

Contact your local IRB office or the Office of Research Conduct, telephone (718) 951-5488.