What is human subjects research?
Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
Human subjects means a living individual about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual, or
- Identifiable private information
(Definitions provided by the Office of Human Research Protections: 45 CFR 46.102)
Is special training required to do human subjects research?
Yes. Federal regulations stipulate that researchers working with human participants must complete specialized training. Brockport requires the CITI training course for human subjects research. CITI certification is valid for three years from date of completion.
What is the submission process?
The proposal and all attachments are submitted electronically. The proposal receives an initial review by the IRB office, who provides feedback directly to the Primary Investigator (PI). If necessary, the revised proposal is then forwarded to one or more reviewers on the Institutional Review Board.
Depending upon the level of your review category and the time of the year, proposals are generally approved within two to four weeks after a complete application is submitted. Timing is dependent upon the proposal and the speed with any revisions are made and submitted to the IRB. Following the required guidelines will expedite the process. Please check your proposal carefully prior to submission.
When do proposals have to be submitted?
Proposals may be submitted at any time during the academic year. Proposals that require full board review must be submitted a week in advance of the meeting where it will be discussed. Meetings occur twice a month as needed. You can view the schedule here.
If you are submitting a grant proposal to an external funding source that involves human participant research, please contact the Grants Development Director at (585) 395-5118.
What are my responsibilities as an investigator?
It is the responsibility of all researchers to comply with the following:
- Complete the required human subjects research training
- Obtain IRB approval prior to collecting any data
- Acknowledge and accept your responsibility to protect the rights and welfare of human research participants and for complying with all applicable regulations.
- Provide a copy of the IRB-approved informed consent document to each participant at the time of consent.
- Promptly report proposed changes/modifications to approved studies to the IRB. You may not initiate changes without IRB review and approval.
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Immediately report any problems to the IRB including, but not limited to:
- Injuries of participants
- Unanticipated problems
- Subject complaints
- Submit a continuation of research form if the study will go beyond your approved period. Continuation of research after expiration is a violation of federal guidelines. There is no grace period.
- Complete a close-out form when research is complete.
What happens if an investigator conducts research without IRB approval?
The researcher will need to meet with the board to decide how to continue. In these cases, the IRB will decide if the investigator:
- Can use the data already collected
- Must provide proof of consent, re-consent participants or retroactively consent
- Can continue the research (if not already completed), and which, if any, modifications need to be made
- Must destroy all data collected to data or
- Must take other actions at the discretion of the IRB
After the IRB meeting, the IRB office will send a letter to the investigator indicating the IRB review and what actions the IRB requires, as well as an opportunity for the investigator to respond.
Can IRB approval be suspended or terminated?
The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants.
Can I collaborate with an outside researcher?
Yes, but you will need to list them on your proposal and provide their CITI certificates.
Can I obtain approval from another institution?
If you are conducting human subjects research with another institution and have gone through that institution’s IRB approval process, SUNY Brockport will usually agree that we may rely on the designated IRB for review and continuing oversight of that research.
To obtain a letter of Outside Determination and an IAA, the researcher must submit both the full approved proposal and the proposal approval letter from the other institution. Once the University has reviewed the document, the office will provide a letter of Outside Determination and an IAA that both institutions should keep on file.
If needed, IAA forms are available on the forms webpage of the our website. Our FWA number is 0001867.
Can non-SUNY Brockport researchers conduct research on campus?
Researchers who have already obtained written approval from their institution’s IRB do not have to apply to the the University’s IRB for approval to conduct research on campus. However, they must provide the IRB Coordinator with a copy of their complete application and approval letter from their institution’s IRB prior to beginning research. The IRB office will then send them an official letter allowing them to do research on Brockport’s campus.
Are there special rules for working with children/minors (persons under 18)?
There are special rules and requirements for working with children/minors. Review our Special Population Requirements webpage for more information.
Can prisoners be research subjects?
There are special rules and requirements for working with prisoners. Review our Special Population Requirements webpage for more information.
Can you appeal a decision made by the IRB?
Yes, if the IRB makes a decision that an investigator believes to be unfair, unsubstantiated, or unduly restrictive on the proposal research. The investigator should first discuss the matter with the IRB chair(s) and be prepared to present reasons that the research is in compliance with the university policy and federal regulations.
If the issue cannot be resolved, the investigator may appeal the decision, in writing, to the IRB. The investigator must appear before the IRB to present their appeal and any supportive material or documentation obtained through consultation. Based upon this appeal, the IRB will issue a final recommendation on the proposed research.
Do class projects need IRB approval?
Class projects do not need IRB approval if:
- The instructor’s intention is to teach professional research methods such as interviewing, surveying, or experimental design
- The data are gathered solely for the purposes of teaching how to analyze specific data
- The results will remain in the classroom
These data can be presented at the end of the semester within the confines of the institution. However, if the results will be published, presented at a larger conference off-campus, or generalized in some other way, it will be necessary to obtain IRB approval.
What is the role of the faculty advisor?
The role of the faculty advisor is to guide students through the IRB process by discussing general principles of research ethics with the class/student prior to the initiation of any project involving human subjects.
Faculty members who supervise student research are responsible for the protection of human subjects and are required to:
- Be familiar with the ethical and regulatory requirements of human subjects research
- Determine whether projects require IRB review and assist students with the process. Faculty are encouraged to contact the IRB office to ensure they have made the correct determination. (If the project involves research in a non-US setting, then considerations of local regulations and customs must be understood and satisfied)
- Discuss research ethics with the students
- Advise students conducting international studies on understanding the local customs and ethics
- Monitor student projects, paying special attention to maintaining confidentiality, privacy, level of risk, voluntary participation and withdrawal, and informed consent
- Assure that any unexpected or adverse events are reported to the IRB
Am I allowed to offer compensation for participating in my study?
Compensation (gift cards, stickers or small toys, money, course credits, etc.) can be made to research participants as an incentive to participate in your study. This should not be considered as a benefit of the study, but rather as compensation for volunteering of time. The remuneration should not be so substantial that a potential participant feels they must participate in the study.
All participants must be provided equal payment and/or equal opportunity for rewards. Recruitment publicity may mention but not emphasize compensation. The IRB must determine whether the nature, amount, and method of compensation are appropriate and do not constitute undue inducement for participation.
How long should I retain the records related to my study?
SUNY recommends that faculty and student researchers should maintain all of their records permanently for any research that is published in books, papers, journal articles, and other materials made available to the public. Records for research that is not published should be kept for at least three years after research has concluded.
Are there opportunities for psychology students?
Yes, but only in special cases. Undergraduate students are permitted to conduct research projects of their own design, with the careful supervision of a faculty member.
In addition, psychology students may also participate in research as part of SONA. For more information please contact Rachael Mulvihill.