The SUNY Cortland IRB is an administrative committee appointed by the Provost to protect the rights and welfare of human research participants in studies conducted at or sponsored by the university, regardless of funding source, pursuant to federal regulations (45 CFR part 46 and 21 CFR part 56). The IRB ensures research is conducted ethically and in compliance with the Belmont Report and applicable federal, state, local, and institutional requirements through prospective and continuing review of protocols, informed consent processes, and subject enrollment procedures.
Research is a systematic investigation designed to develop or contribute to generalizable knowledge. A human participant is a living individual from whom a research investigator obtains data through intervention, interaction, or individually identifiable information. This includes surveys, behavioral observations, experiments involving human responses, interviews, focus groups, and data collection from existing records.
A project requires IRB review if it involves both research and human participants. The SUNY Cortland IRB makes the final determination of whether a study requires review.
“Identifiable data" refers to information that can be used to identify a specific individual, either directly or through a combination of data points. These include both direct identifiers (e.g. names, email, Social Security numbers) and indirect identifiers (e.g. geographic location or occupation).
Yes, studies conducted by SUNY Cortland undergraduate and graduate students need IRB approval if the project fits the definitions of "research" and "human participants" as described above. If the project is to be used in the classroom setting only to teach research methods (i.e., only intended to meet a class requirement), the project may not constitute human participant research. However, this means that at no point during or after the conclusion of the course can the results or data be used for publication, presentation, or other research purposes. So students should discuss these limitations with their instructor or faculty advisor to determine whether IRB review is necessary.
Studies that meet the definition of “exempt” research receive a streamlined review and less ongoing administrative oversight. However, this does not mean such studies can bypass IRB review entirely. To receive an exemption determination, investigators must submit an application to the IRB along with all study-related materials, including consent forms, surveys, questionnaires, and interview scripts or outlines. Only IRB staff can make the official determination of whether a study qualifies for exempt status.
Researchers are required to have current IRB approval for human participants research as whenever they are recruiting participants, conducting interventions, collecting data, or analyzing identifiable data. For some researchers this may mean submitting a continuation request to the original IRB, for others it may mean completing a data transfer agreement so that SUNY Cortland IRB becomes the IRB of record for the study.
All researchers must have a current certification in the CITI Basic Social Behavioral Course modules before their IRB application will be reviewed. CITI certification is valid for three years and can be transferred from other institutions. Faculty members with questions concerning CITI certification or eligibility should contact the IRB. Students who have questions about certification should contact their instructor or thesis advisor.
Investigators are not permitted to implement any protocol changes without prior IRB review and approval. All changes to a research project must be submitted to the IRB as a modification request. Modifications are categorized as either major or minor and are distinguished based on the type of changes proposed. Minor modifications (e.g. addition of another investigator or recruitment site, minor change in recruitment strategy) to exempt or expedited studies can be approved on expedited basis. Major changes to an exempt or expedited study, changes that increase the level of risk for participants, and changes to full board research will require a longer, more thorough review.
Any study personnel other than the principal investigator (PI) can be added or removed from an active protocol by submitting an updated Appendix B. The change will be reviewed on an expedited basis as a minor modification. If the original PI leaves a research project, the IRB must review the application and again and approve it to continue under the new PI.
Research approved by the IRB as exempt does not expire. Expedited research studies are typically approved for a year. Investigators can submit a up to two continuation requests to extend the approval for another year each. These requests are reviewed on a expedited basis. After three years (a first year of initial approval, then two additional years of continuation requests) the investigator must submit a new application. Continuation requests for full board research must approved by the full board of the IRB, unless the study is closed to enrollment, all interventions have been concluded, and the only research activities are the monitoring participants or data analysis. In this case continuation request for the research may be reviewed on an expedited basis.
The Provost appointments faculty to the IRB for three-year terms. Recommendations for new members are solicited from the Dean of each school, ensuring that in addition to meeting the federal requirements for IRB membership, pools of candidates also represent the full scope of academic disciplines and research at SUNY Cortland. Interested faculty are encouraged to self-nominate to their respective Deans.
Any research conducted on the SUNY Cortland campus or with members of our community needs to be reviewed by the SUNY Corland IRB. However, the SUNY Cortland IRB routinely allow outside IRBs to serve as the IRB of record for exempt and expedited research studies conducted at multiple sites, especially when the study originated or is. funded at another institution. Typically, this requires a review of the initial application and approval letter from the other institution, and the creation of a data use agreement.
International research poses ethical risks that necessitate additional safeguards and levels of IRB review. The proposed research must comply with all local laws, regulations, and ethical standards. This determination is made on a case-by-case basis in collaboration with local IRBs, ethics boards, or other experts who are not involved with the research study, and with input from SUNY Legal Counsel. This significantly increases the time required for initial IRB review. It is increasingly the case that legal counsel is determining that SUNY is unable to meet international data privacy laws such as the General Data Protection Regulation (GDPR) in Europe or the Personal Information Protection Law (PIPL) in China. Investigators who plan to conduct research with human participants outside the U.S., or who are citizens of another nation but currently residing in the U.S., are encouraged to reach out the IRB in the early planning stages and to be aware that they may not be allowed to collect personal information or identifiers in their research.
Informed consent in research requires several key elements to ensure participants understand the study and voluntarily agree to participate. These include a plain-language explanation of the study's purpose, duration, and procedures, a description of potential risks and benefits, and information about the voluntary nature of participation and the right to withdraw at any time with out penalty. Consent documents must also provide contact information of the PI and the SUNY Cortland IRB, and the dates for which the study has been approved. The IRB provides and best practices guide and several customizable templates for consent and assent documents.
The IRB will waive the documentation of informed consent for research involving online data collection, provided that participants receive the required information about the research and their rights as participants prior to clicking to engaging with the online data collection tool.
Research that involves the use of crowdsourcing platforms to recruit participants is held to the same standards as research using other methodology. The application must clearly demonstrate that participant recruitment is ethical and equitable, potential participants are fully informed about the research procedures, benefits and risks, and that any compensation for participation is appropriate and not coercive. Any crowdsourcing platforms used in research are also required to have appropriate data security measures in place given the study population.