IRB and Human Participants Information

Institutional Human Participants Policy

SUNY Cortland acknowledges and accepts its responsibilities for protecting the rights and welfare of human participants of research. The institution is guided by the ethical principles regarding all research involving humans as participants as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research. In addition, the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46) will apply to funded research and, for the requirements for reporting information to Health and Human Services (HHS), all other research without regard to source of funding. This section of the Code was most recently revised in November 2001 and is referred to as the Common Rule. It has been adopted by HHS and other federal agencies. Briefly, the HHS requirements state:

1. The involvement of human participants in research will not be permitted until the IRB has reviewed and approved the research protocol and informed consent has been obtained.

2. The IRB will conduct a review of ongoing research at appropriate intervals but not less than once a year.

In addition SUNY Cortland is guided by the New York State Guidelines for Institutions, Institutional Review Boards, and Researchers Regarding Biomedical Research with Normal Health Subjects (March 1999). These guidelines are consistent with both the Federal CFR (noted above) as well as New York Public Health Law 2440-2446.

The institution encourages and promotes constructive communication among the research administrators, department heads, research investigators, IRB, other institutional officials, and human participants as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the participants.

SUNY Cortland research policies and federal regulations require all faculty investigators conducting or supervising research involving human participants to certify their completion in educational programs at regular intervals. For your convenience, the campus now offers this certification online using the Collaborative IRB Training Initiative (CITI) training program, maintained by the University of Miami (please contact Nancy Aumann or Leslie Eaton for more information)

Please note: Faculty investigators serving as student sponsors and/or assigning HRP research projects in classes are responsible for providing the appropriate level of training to students to assure the ethical and safe treatment of human research participants in their student projects.

The required elements of HRP training as set for by the Office for Human Research Protections http://www.hhs.gov/ohrp/.

The required elements of HRP compliance at SUNY Cortland include:

1. CITI Program - https://www.citiprogram.org/
2. Belmont Report –http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
3. Familiarity with 45 CFR 46 - Protection of Human Subjects - http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
4. Familiarity with SUNY Cortland's Protecting Human Subjects: Procedures and Regulations available from the IRB Administrator and/or IRB Chair.

For investigators interested in additional resources and links to other originating ethical codes please see:

*Declaration of Helsinki - http://www.fda.gov/oc/ohrt/IRBs/helsinki89.html
*Nuremburg Code - http://wma.wma.net/e/policy/b3.htm

All protocols for HRP must be accompanied by a special application formand submitted to the IRB Administrator, Leslie Eaton in the Psychology Department. The IRB meets when necessary, and your application for review must be sent to the Academic Affairs Office, Miller Building 404-F with enough lead time for review. If you have any questions as to whether your project requires an IRB review, please contact Leslie Eaton. This is extremely important because agencies will not accept a proposal involving human subjects unless it has undergone proper review.

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

HIPAA regulates organizations, businesses, and health care groups’ use and handling of personal identifiable health information (PIHI). The HIPAA Privacy Rule establishes the conditions that certain entities can use or disclose PIHI –including research purposes. HIPAA preempts State laws related to privacy of health information; that is, states may do more, but not less than the HIPAA requirements.

Health Insurance Portability and Accountability Act (HIPAA) Sponsored Research Policy Statement:

All research studies at SUNY Cortland are reviewed to determine if the researcher functions as a part of a HIPAA defined health care plan, clearinghouse or a health care provider that performs one of the standards electronic transactions. For human research participants protocols, the Institutional Review Board (IRB) or its designee, shall serve as the final determiner for HIPAA com- pliance. For sponsored and non-sponsored research programs, the IRB Administrator shall determine HIPAA compliance. If the researcher performs one of the electronic transactions or serves as a clearinghouse, the researcher shall disclose his or her procedures for adherence to HIPAA legislation and regulators to either the IRB..