Human Subjects in Research

The Office of Research and Sponsored Programs at York College identifies all scientific research activities that involve human subjects as eligible for review under YC's principles of fairness.

The Office of Research and Sponsored Programs at YC defines a 'Human Subject' as a living person involved in an empirical project or research initiative, where, research personnel acquire experimental data through collaboration and/or communication with the individual, or otherwise by retrieving personally identifiable information said person via public records or private observation.

Human Subject research includes all research activities that involve a living person, this means, data analysis and publication of empirical results, and activities that are qualified for exemption under the Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services (HSS) Federal Guidelines. Additionally, said research is thusly conducted on the YC campus, sponsored by YC (in whole or in part), e.g., under the direction of YC personnel or funded through YC. Moreover, research that utilizes YC-affiliated subjects or information related to YC-affiliated subjects, is subject to evaluation by the ORSP and The Office of Diversity and Compliance before Human Subject research activities can commence. Note: if the primary investigator (PI) is conducting research in cooperation with another academic institution, York College will then require the PI to attain appropriate approval from said institution.
Further information and applications are available from the Office of Diversity and Compliance. For further information please contact the Office of Diversity and Compliance at x2137 or the ORSP at x2061.

ORSP Human Subjects in Research - Guidelines

The IRB Process

All personnel involved in research containing human subjects, in any capacity, are required to take the Online CITI Training Course. Note: For your institutional affiliation, please select "City University of New York".
After you have completed the required CITI Training Course, you must apply for an IRB review. To apply for IRB approval, you will need an account in the IRB Manager Program. For complete instructions on how to use the IRB Manager service, please feel free to access the CUNY IRB Manager Manual.
For information about the CUNY IRB process, as well as suggested language for consent forms, please visit the CUNY Human Research Protection Program Webpage.
It is important when using human subjects to remember that these individuals must be treated ethically. Therefore, under Federal Guidelines, the ORSP allows your research to use human subjects. Please see the HSS Office for Human Research Protections Statutes for more information.
It is our duty at the ORSP to project both the human subject involved in the research and the researchers involved, as such please be sure to review all necessary materials that involve human subjects.
The Office of Research and Sponsored Programs is here to assist faculty, staff, and students with applying relevant federal regulations and CUNY policies to research protocols involving data collected from human subjects.

What Are the Rules and Regulations in Using Human Subjects?

The U.S. Department of Health and Human Services OHRP Regulations to Protect Research Participants guidelines serve to explain the following:

Due to the public outcry from cases of unethical research in the twentieth century, and prior, in 1979, Congress passed a law requiring Federal Rules (45 CFR 46) to protect human subjects who participate in empirical research tasks.
The Common Rule necessitates researchers to obtain informed consent from individuals who intend to participate in research as human subjects. This includes providing these individuals with whatever information is required for them to make informed decisions during their participation, in the language they speak and understand.
And, in cases where research is not required to follow the Common Rule, other regulations may provide human subject protections.

For more information regarding the regulations that protect human subject research volunteers, why these regulations are in place, and who enforces them, please visit the Regulations to Protect Research Participants Webpage.

What Do You Do When an Incident Happens?

As a general caution, it is best to avoid any incidents or accidents when dealing with human subjects. However, at the ORSP, we are aware that incidents may occur. In the event an incident does transpire regarding a human subject, it must be reported immediately.
Please contact either the ORSP at x2061 or speak with us directly in room AC2H05. For more information, please visit the Guidance on Reporting Incidents to OHRPR Webpage.
The ORSP would like to make your research experience as forthright as possible. To ensure this, we would ask that faculty and staff do their part in maintaining human subject rules and regulations - including all training required - and we also ask that you allow the ORSP to do its part in assisting throughout the process.
If you are experiencing any difficulties or are in need of any assistance, please feel free to contact us at x2061 or for more specific assistance please contact the S taff at the HSS OHRP.

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