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Brockport / IRB / Human Subjects Research FAQ

Human Subjects Research FAQ

 

Introduction

The purpose of these guidelines is to assist faculty, student, and staff researchers planning to conduct research involving human participants to submit a proposal for review to the Institutional Review Board (IRB). This is a collaborative process with the goal of arriving at research procedures which accomplish the intended research objectives while protecting the rights and welfare of the study participants. The IRB tries to be as flexible as possible and reviews each proposal as a separate case. The IRB sees its role primarily as one of educating and facilitating and encourages consultation at all stages of the research process. 

Frequently Asked Questions

What is human subjects research?

"Human subjects research" is defined as a systematic investigation designed to develop or contribute to general knowledge, which involves the collection of data from or about living human beings  if the knowledge is to be:

      1. generalizable and extrapolated beyond the specific study
      2. involves a systematic design, then it is research. This includes the use of data by agencies, practitioners, or students to modify existing programs, interventions, educational groups, etc. The results do not have to be published to be generalizable. Student research involving human participants outside their own classroom is included in this category if it meets the above criteria. (Federal regulations definition - 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 IRB website. CITI certification is valid for three years from date of completion.

Why must it 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 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. Research conducted for course evaluation, institutional research, or ongoing college processes does not need to be reviewed. If research results in dissemination of information in external publications or presentations, then the research must receive prior approval. If no dissemination is planned at the time the data is gathered, but the possibility of future dissemination exists, the researcher should submit the project for approval before beginning research.

How are proposals submitted?

The guidelines and forms you need are in this document which covers the range of topics related to submission of research proposals to the IRB. Specifically, there are packets for Category 1, 2, and 3 proposal preparation. Forms are submitted to the IRB Administrator, Academic Affairs, 6th Floor, Allen Administration Building, or electronically.

When do proposals have to be submitted?

Proposals may be submitted at any time. 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. Failure to follow the required guidelines will result in additional delays. 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.

The IRB cannot give its approval or disapproval of human participants research projects already conducted. All research involving human subjects must be reviewed and approved prior to conducting the research. 

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 several different departments, as well as at least one representative from the community. Staff support is provided by the IRB Coordinator through the Grants Development Office. Please note that the IRB Coordinator must review all proposals before they are sent out to IRB members. Attentive to accuracy and detail in your proposal will significantly expedite the process.

What do the reviewers look for?

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.

  • Research design: The IRB must determine that the research is scientifically sound. Is the hypothesis or focus of the study clear? Is the study design appropriate to prove the hypothesis? Will the research contribute to general knowledge? Is there consistency between the purpose of the study, the variables identified, the hypothesis,he  purpose stated in informed consent, and the instruments selected for data collection?
  • Risks and Benefits: To approve research, the IRB will determine that the following requirements are satisfied:
    • 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. The IRB will examine study design or scientific merit of a proposed study only within the context of its risk/benefit analysis. Research participants should expect to participate in studies with sound research design.
  • Equitable selection of participants and recruitment: The IRB ensures that the recruitment of participants is equitable and free from coercion. Selection criteria will consider all populations that might potentially benefit from the research. 
  • Informed consent process: Informed consent must be sought from each prospective participant or the participant's legally authorized representative. Their participation must be voluntary.
  • Privacy and confidentiality: The IRB will determine that adequate provisions have been taken to protect the privacy of participants and for ensuring confidentiality of an individual's participation as well as confidentiality of study data.
  • Special populations: When some or all of the participants are likely to be vulnerable to coercion or undue influence (such as children, prisoners, pregnant women, persons who are physically or mentally disabled, or economically or educationally disadvantaged persons), additional safeguards must be included in the study to protect the rights and welfare of these participants. 

What are my responsibilities as an investigator?

It is the responsibility of all researchers to comply with the following:

  • Obtain IRB approval prior to initiating any human participants research.
  • Acknowledge and accept your responsibility to protect the rights and welfare of human research participants and for complying with all applicable regulations.
  • Complete the required educational training course required by the College prior to conducting your research.
  • 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 and kept for seven years after the completion of the study (for a category 3 proposal only).
  • 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 Coordinator 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.

Be aware that 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.

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.

On a case-by-case basis, the IRB will review the project (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:

  • 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's meeting a letter from the IRB Coordinator on behalf of the IRB will be sent to the investigator, indicating the IRB's review, what actions the IRB requires, and 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 Coordinatoror and at least one other IRB member will constitute a subcommittee to investigate and report to the full IRB and those listed above.

Am I allowed to pay participants in my study?

Payment to research participants may be made as an incentive to participate. Payment 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 s/he 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 the payment. The IRB must determine whether the nature, amount and method of payment are appropriate and do not constitute undue inducement for participation.  If payments exceed $600 per calendar year the IRB requires the Research Foundation of SUNY report these payments annually to the IRS. Identifying information (name, address and social security number) must be reported by law. 

What if I want to 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 or in some cases, a memorandum of understanding between the two sites must be obtained. "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 (example 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 permission to conduct the research at the site must be obtained and provided to the IRB.

Can non-SUNY Brockport researchers conduct research on campus?

Researchers wishing to conduct research at SUNY Brockport who have already obtained written approval from their institution's IRB do not have to apply to the SUNY Brockport's IRB for approval. 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 provide them with an official letter allowing them to do research on Brockport's campus.

What are the parameters of using deception in research?

Sometimes research designs require that information deliberately be withheld from participants or false information be provided to them. There should be scientifically justifiable reasons for doing this. These circumstances involve a breach of the concept of informed consent. Therefore, certain criteria must be met before such research can take place. If your research involves deception, you will need to fill out Form 202, Research Involving Psychological Intervention.

  • All research involving deception must be reviewed as a Category 3 full review.
  • Deception cannot be used in any study where there is risk to participants or where the deception itself would create risk.
  • In general, no information can be withheld from participants that could significantly affect their decision to participate. When the deception involves a falsehood told, no information can be provided to participants that would have a harmful effect on them if the statement were believed. Since there is no informed consent in research involving deception, the terms "Informed Consent" or "Consent Form" should not be used. However, participants still need to be informed about the nature of the research in a way that does not invalidate the data. One possibility is to provide the participants with a "Participant Information Sheet" which contains the necessary information. Participants must be provided with sufficient information for them to decide whether to participate and must be allowed to withdraw at any time without penalty.
  • The investigator should keep deception to a minimum and provide as much information as possible to the participants while still accomplishing the research goals.
  • All participants must be debriefed regarding the true nature of the research after their participation. Care should be taken in the debriefing process to protect the well-being of the participants. A written text of the explanation must be submitted to the IRB, which can then serve as the basis for conducting the debriefing.

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:

  • All human participants research in foreign countries must be reviewed by the full IRB regardless of the nature of the research.
  • All materials including consent forms, must have English language translations included with the protocol.
  • Documentation of permission from local authorities is generally required before approval can be granted. To expedite this process, the investigator is asked to provide the name of someone who has knowledge and/or experience in conducting research in that country.
  • Each foreign site where the research will be conducted must have a federal-wide assurance on file with the Office for Human Research Protections (OHRP) or a Memorandum of Understanding may be used instead of the federal-wide assurance. See OHRP web site: http://ohrp.osophs,dhhs.gov/humansubjects/assurance/ass-intl.htm.

 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 (http://www.aaanet.org) and especially the link to 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. Please contact the IRB coordinator with specific situations if you are unclear.

How can I invite prisoners to 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. (Federal regulation 45 CFR 46 Subpart C). All research involving prisoners requires a Category 3 (full) 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: 

  • "A study of possible causes, effects, and processes of incarceration, and of criminal behavior"
  • "Study of prisons as institutional structures or of prisoners as incarcerated persons"
  • "Research on conditions particularly affecting prisoners as a class (for example vaccine trial and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults)" or
  • "Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject"

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: 

  • "any possible advantages to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunities of earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired"
  • "The risks involved in the research are commensurate with the risks that would be accepted by non-prisoner volunteers"
  • "Procedures for the selection of participants within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or other prisoners"
  • "The information is presented in language which is understandable to the subject population"
  • "Adequate assurances exists that the parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole" and
  • "Adequate provision has been made for any follow-up examination or care of participants, given varying lengths of prisoners' sentences"

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.

 

Questions? Please contact Julie Wilkens at (585) 395-2779 or jwilkens@brockport.edu.
You may also contact Kim Remley at (585) 395-2523 or kremley@brockport.edu.

Last Updated 2/27/15