Human Subjects Research FAQ

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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. Brockport requires the CITI training course for human subjects research. 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?

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 fowarded 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 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.

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. View schedule.

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.

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--who is also a member of the Board--must complete an initial review of all proposals before they are sent out to other IRB members. Attentiveness to accuracy and detail in your proposal will significantly expedite the process.

What do reviewers comment on?

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.

In order for reviewers to ascertain the risk to participants, it is essential that that the researcher describes every aspect of their research in detail.

These are based upon federal regulations and include the following:

  • Background information
    • Historical background provides a basic framework for understanding research already done in this field.
    • References provided reflect current understanding and practice.
    • Clear rationale is provided for conducting the research.
  • Research design
    • Clear hypothesis and/or study focus
    • Study design is appropriate to prove the hypothesis
    • Research is meant to contribute to general knowledge in the field
    • There is consistency among the purpose of the study, the variables identified, the hypothesis, the purpose stated in informed consent and the instruments selected for data collection
  • Equitable selection of participants and recruitment
    • Recruitment of participants is equitable and free from coercion
    • Recruitment process is clearly described and materials are consistent with description
  • Informed consent process
    • Informed consent will be sought from each prospective participant or the participant's legally authorized representative
    • Consent process is voluntary and free from coercion
    • Consent process is clearly described
  • Risks and Benefits
    • Risks to participants are minimized by using procedures that are consistent with sound research design and which do not unnecessarily expose participants to risk
    • Risks to participants are reasonable in relation to anticipated benefits (if any) to participants, and the importance of knowledge that may reasonably be expected to result from the research
  • Special/Vulnerable populations
    • Additional safeguards are included to protect the rights and welfare of vulnerable populations (children, prisoners, pregnant women, cognitively impaired persons elderly/aged persons, members of racial or ethnic minorities, and others). The vulnerability of the subjects in research studies should be considered as a function of the possibility of coercion or undue influence. This type of vulnerability alone should be the IRB focus of concern in determinations about vulnerable populations.
  • Privacy and confidentiality
    • Adequate provisions will be taken to protect the privacy of participants and confidentiality of participants
    • Adequate provisions will be taken to protect confidentiality of study data

More information on specific vulnerable populations can be found on The College at Brockport IRB website at Research with Special or Vulnerable Populations as well as on the OHRP website in Vulnerable Populations and The IRB Guidebook (Chapter VI).

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 course required by the College prior to conducting your research.
  • Obtain IRB approval prior to initiating any human participants research, including recruitment of participants.
  • 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.
    • All signed consent documents and research records are to be retained in a manner approved by the IRB.
  • Promptly report proposed changes/modifications to approved studies to the IRB.
    • You may not initiate changes without IRB review and approval.
  • Immediately report to the IRB any problems (injuries, unanticipated problems, subject complaints, etc.) involving risks to participants that arise in connection with your use of human participants in this study.
  • Submit a continuation of research form if the study will go beyond 12 months.
  • Complete a close-out form when research is complete.

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.

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.

Chart 1: Is an Activity Research Involving Human Subjects?

Chart 2: Is the Human Subjects Research Eligible for Exemption?

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 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:

  • 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. 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 Compliance Officer 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.

Generally speaking, when an investigator engages in human subject research, IRB approval is required from that investigator’s institution, regardless of where the research takes place. However, if the investigator is collaborating with a colleague from another institution, either IRB may, in certain situations, cede review and approval to the collaborating institution. In this case, an Institutional Authorization Agreement (IAA) may be arranged to establish one IRB as the designated IRB of record. The IRB will also provide the investigator with a letter of Outside Determination.

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.

More information can be found here.

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 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)?

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.

More information can be found on the IRB website at Normal Educational Practices Exempt from Committee Review and at Research with Special or Vulnerable Populations as well on the OHRP website at Research with Children FAQ.

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. Most research involving prisoners requires a full board review at The College at Brockport. See Special Population Requirements for more information.

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.

For more information, see Non-English-Speaking Populations and International Research Projects

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 review the American Anthropological Association Statement on Ethnography and Institutional Review Boards.

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.

Last Updated 3/20/18

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