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.
For information on how to apply for research involving human subjects, see the How To Apply page.
These protections are largely informed by Health and Human Services regulations, 45 CFR part 46 subpart A, also known as the Federal Policy or the “Common Rule”. The Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. The Common Rule is a federal policy regarding Human Subjects Protection that applies to 17 Federal agencies and offices. It does not apply to federal agencies that have not signed the agreement (e.g., Department of Labor, etc.) The main elements of the Common Rule include:
- Requirements for assuring compliance by research institutions
- Requirements for researchers' obtaining and documenting informed consent
- Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.
The Common Rule includes additional protections for certain vulnerable research subjects.
- Subpart B provides additional protections for pregnant women, in vitro fertilization, and fetuses
- Subpart C contains additional protections for prisoners
- Subpart D does the same for children.
The compliance date for the revised Common Rule (the New Common Rule) was January 21, 2019. All new proposals submitted after December 21, 2018 and renewals of projects previously approved must comply with the new regulations. The Office for Human Research Protections, under the U.S. Department of Health & Human Services, has additional information and resources regarding the revised Common Rule.
The system of protection for human research subjects is heavily influenced by the Belmont Report. This report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, outlines the basic ethical principles in research involving human subjects and guidelines to assure that research is conducted in accordance with these principals.
The Cooper Union IRB is registered with the Office of Human Research Protections (OHRP). OHRP provides clarification and guidance, offers educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and social-behavioral research.
The Cooper Union has committed to HHS that it will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR part 46 by filing a Federalwide Assurance (FWA) attesting it will comply with the Terms of the FWA. The Federalwide Assurance is the only type of assurance currently accepted and approved by OHRP.
Conduct of Research
Human subjects research constitutes a range of scholarly activities, including activities that produce generalizable knowledge, explore the application of knowledge, or constitute outcomes or program evaluation. If a faculty member, staff member, or student is planning research that includes human subjects, the University requires review by the Institutional Review Board, IRB.
Through the Research Review process the IRB will offer the support, guidance and education to facilitate research that is both ethically and scientifically sound.
The IRB is comprised of at least five members with varying backgrounds to promote a complete and adequate review of research activities commonly conducted by the institution. The experience and expertise of its members (professional competence), and the diversity of its membership including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, are such that they promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. Its membership is such that it will be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB will include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
The IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
Any questions regarding IRB submission or human subjects in research can be directed to email@example.com.
The IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under §46.104 for which limited IRB review is a condition of exemption
The IRB shall require that information given to subjects (or legally authorized representatives, when appropriate) as part of informed consent is in accordance with §46.116.
The IRB shall require documentation of informed consent or may waive documentation in accordance with §46.117.
The IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
CITI Training on Ethical Treatment of Human Subjects . You can fill out the survey at https://www.citiprogram.org/members/index.cfm?pageID=167#view to determine which training courses you will need.
Questions regarding research and institutional review of research should be advanced to the firstname.lastname@example.org