How to Apply to Use Human Subjects for Research
Per the Human Subject Research Policy, The Cooper Union Institutional Review Board (IRB) is charged with the review and oversight of research and classroom projects involving human subjects carried out by members of the Cooper Union community. The IRB safeguards the rights, privacy, and welfare of participants in research activities (human subject research) that originate at The Cooper Union.
Researchers are required to submit a request for review to the IRB if their research involves human participants or their data. Researchers are encouraged to review their research proposals with appropriate parties in their school or faculty, to verify whether human subjects are involved and if they are, review next steps for the IRB research proposal/survey review.
The request must be reviewed by the IRB prior to collecting data or contacting participants.
The IRB's intention is not to hinder research. Its only objective is to ensure that human subjects' rights are protected and that the project complies with federal standards.
Are there forms of research involving human subjects that can be exempt from the IRB oversight?
Yes. For a determination about exempt research (typically student surveys) complete this IRB Exempt Request. For all other research complete the Review Request Form.
How long will it take for notification of receipt?
You will be notified of receipt within 2 business days of submission.
What are the deadlines for submitting a request for review?
Applications are accepted throughout the year. The IRB will determine if the research meets the requirements for oversight in keeping with federal regulations. A research proposal can be exempt; expedited, or require a full IRB committee review. Should a research proposal require a full IRB committee review, the committee will convene at least once each fall and spring term. Researchers are always encouraged to plan in advance!
What do I need to submit to the IRB?
Fill out a Request for Review form. Attach your certification of successful completion of training in the protection of human research subjects (see CITI training, below) along with all other materials relevant to the study. Assemble the following:
- Review Request Form
- Certification of Human Subjects Research Training. (See below for details)
- All relevant materials including research and survey protocols, recruitment materials, and IRBs from research partners. See samples (accessible only to Cooper students, staff and faculty)
How long does the permit last?
The IRB approval is granted for up to one year. The exact period of time will be established in the approval notification.
What happens if my research needs to continue past the permitted time established by the IRB?
If IRB approval of the research proposal expires, all study procedures related to the proposal must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection of private identifiable information. Continuing research procedures is a violation of federal regulations. The researcher will need to advance a request for continuing review/revision and secure continued approval from the IRB in order to continue research.
Can students apply directly to the IRB?
Students conducting human subjects research need a faculty advisor. The advisor should be the one to initiate the IRB review by forwarding the Request for Review Form. By forwarding the form, the advisor indicates that he or she approves of the project as outlined in the research proposal and in the IRB Request for Review Form.
What might cause the IRB to reject a human research proposal?
If human subjects are not protected or survey protocols are not followed. Often a denial will come with recommendations.
Do I need to follow up with the IRB?
There is a post-report form due in the month of May that follows the end of the study
How do I get certification of training in the ethical treatment of human research subjects?
To prepare for research projects involving human participants, you must certify that you have been trained in the ethical treatment of human research subjects. You will be required to provide certification of this training in your IRB submission. The Collaborative Institutional Training Initiative (CITI) training is made available to provide this certification. The NIH used to provide this training, so some faculty may have an NIH certificate.
Do all members of the research team need provide a certificate?
No. In order to submit an IRB proposal, at least one member of the research team needs to have completed training addressing the ethical inclusion of Human Subjects in Research.
What is involved in the CITI training?
In order to engage in studies involving human subjects, researchers must demonstrate that they have been appropriately trained in the practices and approaches that safeguard the rights, privacy, and welfare of participants in research activities (human subject research), and the ethical treatment of human subjects. A certificate of completion or certification in human research subjects training must accompany your IRB proposal.
How do I start the process of CITI training?
Cooper has implemented single-sign-on (SSO) for CITI Training. However, to avoid any delay to your project, you can register an account with Citi using the following steps:
- Navigate to citiprogram.org
- Select "Register "in the top right corner
- Select the blue box on the left, “Select Your Organization Affiliation” and type "Cooper Union for the Advancement of Science and Art" into the organizational affiliates box and select the SSO option that appears
- Check the consent boxes then select the blue box on the left, “Log in with Cooper Union for the Advancement of Science and Art”
- Add your course(s). You can fill out this survey to determine which training courses you will need. (NOTE: Link only works after you have logged in.)
For instance, typical selections to the questionnaire include:
Question 1: Human Subjects Research: Social & Behavioral Research Investigators (Choose this group to satisfy CITI training requirements for Investigators and staff involved primarily in Social and Behavioral research with human subjects)
Question 2: Institutional/Signatory Officials & IRB Chair: [No selections]
Question 3: Public Health Research: Not at this time
Question 4: Information Privacy Security: Family Educational Rights and Privacy Act (FERPA
Question 5: Responsible Conduct of Research: Social and Behavioral Responsible Conduct of Research
This should add the appropriate courses to your personal account. You will be able to begin the courses from that webpage; and complete them as your schedule allows; you do not have to finish them during one session.
Once you successfully complete the required CITI courses, you should receive a completion certificate or acknowledgement screen (a “completion report”). Please make sure to save an electronic copy of this, as you will need to submit it along with your IRB proposal.
I have more questions
Questions regarding research and institutional review of research should be advanced to the irb@cooper.edu