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
(1) Data through intervention or interaction with the individual, or
(2) 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. There is a link to the CITI training course for human subjects research on the Training section of the IRB website. CITI certification is valid for three years from date of completion.
Why must my research proposal be reviewed by the IRB?
Federal and state laws require this protection. Therefore, it is College policy to ensure that the rights and welfare of human participants are adequately protected in research studies conducted under its auspices.
Who must submit material for review?
Any faculty, staff, student or external person who wants to conduct human participant research under the auspices of the College or on the grounds of the College must have prior approval of the College's IRB. Most research conducted for course evaluation, program quality, or ongoing college processes does not need to be reviewed. More information is in the Proposal Guidance section of the IRB website.
What is the submission process?
Forms are submitted electronically. More information can be found in the Proposal Guidance section of this website.
When do proposals have to be submitted?
Proposals may be submitted at any time. Proposals that require full board review must be submitted a week in advance of the meeting where it will be discussed.
Depending upon the level of your review category and the time of the year, proposals are generally approved within 2-4 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.
If you are submitting a grant proposal to an external funding source that involves human participant research, please call the Grants Development Director immediately at (585) 395-5118.
Who reviews proposals?
The College has authorized the IRB to review and approve human participant research. The IRB is a campus-wide committee made up of faculty members from a range of academic departments as well as at least one representative from the community. Staff support is provided by the IRB Compliance Officer through the Grants Development Office. Please note that the IRB Compliance Officer must do an initial review of all proposals before they are sent out to IRB members. Attentiveness to accuracy and detail in your proposal will significantly expedite the process.
The review process focuses on the procedures affecting the rights and welfare of human participants, including issues of risks to participants, informed consent, voluntary participation, equitable selection of participants, and maintaining confidentiality. These are based upon federal regulations.
Are there special rules for working with children/minors (persons under 18)?
Yes. Research with minors requires both a consent form (signed by the minor's parent or legal guardian) and a minor assent form. These documents can be found at the Forms link on the IRB website.
Research with minors can be considered exempt if it involves research directly related to the curriculum or observations of behavior with no intervention or participation by the researcher in the activity being observed, as long as the data are recorded without individual identifiers.
In addition, the following links to the OHRP decision flowcharts can help you determine whether your research is considered exempt:
Can prisoners be research subjects?
Federal regulations require additional safeguards for research involving prisoners because of the constraints of incarceration may affect the prisoners' ability to make a truly voluntary and uncoerced decision to participate. All research involving prisoners requires a full board review.
Federal regulations define a "prisoner" as "... any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute. Individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial or sentencing."
For purposes of the IRB this would include, individuals held in a prison, county penitentiary, county or city jail, court, detention facility, hospital prison ward, police lockup, halfway house, juvenile secure and/or non-secure detention facility, and juvenile residential placement facility, as well as those committed to a host of alternative settings, such as day reporting facilities, youth courts and drug courts.
Permitted Research: According to federal regulations, research can be conducted using prisoners, only if the proposed research involves the following:
Review Procedures: Federal regulations require that the IRB consider several additional factors beyond its normal review process when the research involves prisoners as participants. For example, the IRB must be satisfied that:
Issues Related to Consent: In a closed institution such as a prison, there may be extraordinary interpersonal pressures that intrude into the decision regarding whether or not to participate as a subject in research. This may be particularly evident in group situations and classroom environments. Whenever possible, prisoners should be given the opportunity to reflect on the decision to participate in private.
On occasion, research will be situated in a prison classroom setting assuring the structured program segment for the day. A prisoner who elects not to participate in such research should be offered an alternative program for the time in question to minimize coercion.
Some prisoners may feel they will lose privileges or be punished if they choose not to participate in research; others may hope for favorable treatment or early release if they do participate. Prisoners must be assured that they will be neither punished nor rewarded for their participation, and that they can discontinue their participation at any time without an institutional penalty.
Many adult prisoners are deficient readers, many have an incomplete formal education, and many speak English poorly or not at all. Researchers must use necessary measures to assure that these populations clearly understand the nature of the research and its potential risks.
Issues Related to Confidentiality:Special care should be taken to avoid requesting information in a group setting that could jeopardize the safety of individual prisoners. In the collection of research data, special care should be taken to assure that confidential materials do not come into possession of prison administrators, guards and correctional officers or other prisoners.
Prisoners are much more likely than other populations to be associated with sensitive data. This could include for example, involvement in illegal activity, and HIV/AIDS. Appropriate safeguards are necessary regarding the collection, storage and destruction of such information.
Issues Related to Content: Researchers must be aware that research into certain topical areas within the institutional setting can be potentially dangerous for participants. For example, the mere act of interviewing a prisoner about sensitive topics such as gang activity, contraband, and prison prostitution may inadvertently label the participant as an informant. Great care must be taken to balance the research against protection of the prisoner as a participant.
The risk of suicide is an ever-present concern in the penal environment. The researcher must assure that debriefing is available whenever the subject is questioned about sensitive topics that could evoke self-injury once the prisoner has returned to the privacy of his or her cell.
More information can be found in the OHRP Prisoner Research FAQ
What are my responsibilities as an investigator?
It is the responsibility of all researchers to comply with the following:
Please note: The continuation of research after expiration of IRB approval is a violation of federal regulations. There is no grace period beyond the expiration date. If IRB approval has expired, research activities must stop, and no new participants may be enrolled in the study until further IRB review and approval has been obtained.
More information can be found in the OHRP Investigator Responsibility FAQ.
What is the difference between privacy and confidentiality?
What is privacy?
Privacy is the control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. For example, persons may not want to be seen entering a place that might stigmatize them, such as a pregnancy counseling center clearly identified by signs on the front of the building. The evaluation of privacy also involves consideration of how the researcher accesses information from or about potential participants (e.g., recruitment process). IRB members consider strategies to protect privacy interests relating to contact with potential participants, and access to private information.
A sense of being in control of access that others have to ourselves
A right to be protected
Is in the eye of the participant, not the researcher or the IRB
What is confidentiality?
Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.
During the informed consent process, if applicable, subjects must be informed of the precautions that will be taken to protect the confidentiality of the data and be informed of the parties who will or may have access (e.g., research team, FDA, OHRP). This will allow subjects to decide about the adequacy of the protections and the acceptability of the possible release of private information to the interested parties.
Is about identifiable data
Is an extension of privacy
Is an agreement about maintenance and who has access to identifiable data
In regards to HIPAA, protects patients from inappropriate disclosures of "Protected Health Information" (PHI)
For instructors: Do class projects require IRB review?
As long as they fit the description of "human subjects research," the regular IRB review rules apply to classroom projects. The following links to the OHRP decision flowcharts can help you determine whether your students' classroom projects need IRB approval. In addition, please review the Class Projects guidelines.
What happens if an investigator conducts research without IRB approval?
All research on campus involving human participants must be reviewed by the IRB prior to conducting the research. The IRB cannot provide or deny approval of projects conducted prior to review and approval.
If an investigator asks for IRB approval after a study has already begun, the IRB will review the request on a case-by-case basis,(under the full review process) to consider how the project was conducted (e.g., if the investigator willingly conducted the research without approval, or was unaware of the requirement), and if the procedures violated any of the College's standards for ethical conduct in research.
In these cases, the IRB will decide if the investigator:
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. A copy of the letter will be sent to the faculty advisor if the researcher is a student, and sent to the Chair/Dean of their department if the researcher is a faculty member.
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. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported within 2 business days to the investigator, the faculty supervisor if applicable, the department chair, the Dean, the Provost, and any governing institution (such as a funding agency or OHRP). Every investigator will be given the opportunity to respond to the IRB and will be invited to the IRB meeting to discuss the study.
Reports of violations to IRB-approved processes will be brought to the IRB at a convened meeting. The IRB Chair and/or IRB Coordinator and at least one other IRB member will constitute a subcommittee to investigate and report to the full IRB and those listed above.
Can I collaborate with an outside researcher?
If you are working in collaboration with another institution/organization that is "engaged" in your research, the second institution/organization must have an assurance filed with the federal government, and have obtained its own IRB. In some cases, a memorandum of understanding between the two sites can be substituted. "Engaged" means that the collaborating site will be assisting in conducting the research, such as recruiting participants, obtaining consent, conducting interviews, or analyzing identifiable data.
If a researcher is using another site for their research, such as school district or social service agency, this is considered a performance site and not a collaboration site. A performance site does not need an assurance. However, written, signed permission to conduct the research at the site must be obtained and provided to the Brockport IRB. The Brockport IRB office will then provide you with a letter of Outside Determination.
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 SUNY Brockport'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 Coordinator will then send them an official letter allowing them to do research on Brockport's campus.
Does international research need to be reviewed by the IRB?
Research in foreign countries (including class projects) presents special concerns regarding the rights and welfare of human participants. Investigators must understand the context of the country they are conducting research within. The following issues apply:
Does ethnographic research need to be reviewed by the IRB?
The essence of ethnographic research is its "participant observation" methodology. The researcher observes human behavior in natural settings and participates in daily life; human participants can decide whether or not to talk to the researcher and can control the content and amount of information they disclose. This mostly poses minimal risk or no risk. Because it is not in a clear research space such as an interview, but rather about being among people as they are in the world in everyday ways, it is important for the researcher to think about how they will establish informed consent with participants. Informed consent is therefore a dynamic, ongoing, negotiated process. These factors will determine whether oral or written consent or a combination is most appropriate. It is suggested that the researcher visit the website of the American Anthropological Association and especially the AAA Committee on Ethics.
Does oral history research need to be reviewed by the IRB?
Investigators must conduct their research ethically, and in a manner that provides fully informed consent, respects the well being and safety of their participants, and protects participants' rights to privacy. Oral history activities such as open-ended interviews that only document a specific historical event or the experiences of individuals without the intent to draw conclusions or generalize findings would not constitute "research" as defined by HHS regulations. However, systematic investigations involving open-ended interviews that are designed to develop or contribute to generalizable knowledge would constitute "research" as defined by HHS regulations and do require review by the IRB. Click here for more information about oral history and IRB oversight.