Getting Started as a Principal Investigator Conducting Research with Human Subjects
If you are doing research that involves human subjects you will need to obtain IRB approval or an IRB determination of exemption prior to beginning the project.
All CUNY research policies can be accessed here: http://www.cuny.edu/research/compliance.html
Is your project research and does it include human subjects?
Research is defined as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (45CFR46.102(d)).
A human subject is defined as a “living individual about whom an investigator (whether professional or student_ conducting research obtains (1) data through intervention or interaction with the individual, or (2) obtains identifiable private information” (45CFR46.102(f)).
For a project to require IRB review and approval, or IRB determination of exemption, the project must qualify as “research” and involve “human subjects” as defined above. For additional information, view the OHRP decision tree, Chart 1 at Http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#
Have you completed the required training?
You and every person listed on your protocol, who will be interacting with research participants or their identifiable data or samples must complete the human subjects’ protection training before IRB approval can be given. HIPAA training may also be required. Human Subject Protection and HIPAA Privacy training are available at the http://www2.cuny.edu/research/research-compliance/training-education/citi-training/ (at the bottom of the page is the link with instructions).
Do you or any members of the research team have any financial or non-financial relationships with the proposed research that may pose a conflict of interest?
External financial or non-financial interests related to the research that are held by Principal Investigators, co-investigators, persons obtaining consent or members of their immediate family have or may have the potential to affect the protection of individuals volunteering for the research. Such interests must be disclosed to the Principal Investigator and the IRB. These interests may need to be managed, minimized or reduced.
Selecting the right application
Is my protocol exempt?
Research may qualify for exemption when the only involvement of human subjects in the research falls into certain categories. See HRPP Policies, Procedures and Guidelines (link above).
What if my study is human research and doesn’t fall into any of these categories?
If your study does not meet the criteria above, it requires that the full IRB application be completed. Here are the steps to follow
- You will need to read the instructions for and complete the IRB Protocol Application form. For electronic submissions see https://ideate.cuny.edu/home/
- Utilize the prompts provided within the application form template to assist in the protocol development.
- Complete the IRB protocol application form, the informed consent or compound authorization form(s) and other related documents needed to support the protocol.
- Ensure that research personnel have completed the required training.
- Determine whether or not research team members have a real or potential protocol-related COI and modify the study design or documents to reduce, eliminate or manage the interest. Ensure that research team members have submitted or updated their COI forms, if applicable.
- After submission, an IRB staff member may contact you to clarify the information in your protocol application.
- Depending on the risks to research participants and the interventions of the study, your protocol will either be scheduled for review at one of the meetings of the fully convened IRBs or reviewed by IRB reviewers designated by the Chair to perform expedited review. Generally protocols that are reviewed by the full committee are scheduled for the next meeting of the IRB, provided that the application is received at least three weeks prior to the meeting date. The IRB meeting schedule is available at: http://www2.cuny.edu/wp-content/uploads/sites/4/page-assets/research/research-compliance/human-research-protection-program-hrpp/CUNY-UI-IRB-Meeting-Spring-2017.pdf
- After review, you’ll be notified of approval or a request for any revisions that are required for approval. You’ll also be notified of the IRB contact person for your protocol.
- Submit the revisions requested by the IRB to the coordinator identified. Revisions should be submitted within 60 days of the IRB request for revisions.
Studies may not start until the approval process (which may include revisions), is complete, so always allow adequate time for review of your protocol
How Long Does This Process Take?
It is difficult to predict a general length of time for protocol development and approval. Protocol development time is unique to each study and varies depending on the complexity of the research. Once a protocol is received by the IRB, you should allow at least three weeks for IRB review (but depending on the load, it may not happen until a later IRB meeting date). If the IRB requests changes or clarification, those will need to be made prior to approval and will need additional time.
How Do I Contact the IRB?
The CUNY Research Compliance Staff Directory is found at: http://www.cuny.edu/research/compliance/StaffDirectory.html
Working with Researchers from Other Universities/Institutions
What if I plan to include colleagues from other universities or institutions in my research?
Approval by the collaborating researcher(s)’ institutional IRB may be required. Generally documentation of IRB approval must be provided when employees or agents of that university or institution, as part of the research, obtain (1) data about the research subjects through intervention or interaction with them or (2) identifiable private information about the subjects. Such documentation must be received by the IRB prior to such colleagues taking part in the research.
What documentation is required?
Researchers from other institutions must submit a copy of their institution’s IRB approval or other determination to the CUNY Graduate School of Public Health and Health Policy principal investigator, who is responsible for ensuring that it is submitted to the CUNY IRB.
What if the institution doesn’t have an IRB?
Other agreements are necessary. Some institutions have filed Assurances with federal authorities permitting them to designate other IRBs as their IRB of record. This means that the CUNY IRB review, conducted on behalf of the CUNY investigator, will also satisfy the IRB approval required of researchers from these external institutions. For more information see http://www.cuny.edu/research/compliance/Research-Agreements/SOP-IRB-Authorization-Agreements.pdf
When CUNY investigators collaborate with colleagues from an external institution without a local IRB or an agreement with CUNY, it may be necessary for that institution/organization to file as Assurance with federal authorities and designate an IRB to review and approve the research. Typically, an institution that is routinely involved in the conduct of human research would be required to do so. Other arrangements may be made if the institution does not plan to regularly take part in human research (see question below) or contact the IRB office for more information. The review of the research by an IRB representing the external institution/organization must take place prior to such representative participating in the research.
What If My Research Takes Place in a Community Agency?
Research conducted within a community agency requires a letter of support from the agency. The letter must indicate that permission is granted to the investigator to conduct the research at the site and/or with their clients. This letter must be submitted to the IRB before the research can begin.
The agency may also require that other conditions be met before the research can begin. These conditions should be considered when planning the research, as time is required to obtain the necessary permissions.
What If I’ll Be Using Community Agency Staff in My Research Project?
If you plan to engage the community agency in your research by having its staff, as part of the research, obtain (1) data about the research participants through intervention or interaction with them or (2) identifiable private information about the research subjects, arrangements must be made in one of the following ways:
- If the community agency has its own IRB, or is affiliated with an IRB, that IRB must review the research for the agency’s participation. A copy of the IRB approval must be provided to the CUNY IRB. Alternatively, the agency’s IRB may request that a CUNY IRB review the research on its behalf.
- If the community agency a) does not plan to regularly take part in other research projects and b) is only interested in taking part in the research being proposed by a CUNY faculty member, the agency staff working on the research can enter into an agreement with CUNY whereby the CUNY IRB review covers their participation. See the link above.
What If I’m Conducting Human Research Abroad?
All human research conducted outside the United States must receive approval from the CUNY Institutional Review Board (IRB) and the IRB used by the international site (or justification for why the international IRB approval cannot be obtained) before researchers initiate work under the protocol. Researchers should anticipate the time that obtaining local review and approval will require. This varies from country to country, and can take several months. To ensure review and approval by CUNY IRBs, protocols should be submitted two months prior to leaving the country. The CUNY IRB is responsible for ensuring that human research conducted outside the United States conforms to the same ethical and regulatory standards to which research conducted in the United States is held. International human research must be conducted in accordance with applicable CUNY policies for the conduct and review of human research, including informed consent and use of vulnerable populations.
Human research conducted outside the United States must comply with the relevant laws of the host country. If an international institution or site is considered engaged in research, and if the research is supported by federal funding, special requirements must be met.
Think about Team Science
Many of today’s most critical public health challenges are increasingly complex. Often more than a single discipline is necessary. Interdisciplinary approaches hold great promise; exciting research findings are emerging at the edges of traditional disciplines. Numerous funding opportunities demand interdisciplinary approaches and team science will make you more productive.