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IRB Policies

Randolph College IRB Policies

IRB Review Process

Each proposal, with the appropriate supporting documents, will be reviewed by members of the IRB. If any member of the Board has questions or concerns, the investigator will be invited to a convened meeting of the Board. The investigator will be given an opportunity to answer questions at this time. The investigator will then absence him/herself from the meeting, and the Board will vote on the proposal. After the review is complete, a decision will be returned to the investigator. In the case of co-authored projects, the reviewed submission will be returned to the first author. For student projects, materials will be returned to the student, and a copy of the decision and IRB comments will be sent to the faculty sponsor.

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Continuing Review of Research

The IRB will exercise continuing review over human subjects research by requiring annual renewals of all research proposals, including research that has been determined to be exempt. A new proposal with any changes that may have occurred should be submitted 30 days prior to the end of the one-year approval period stated in the most recent approval letter for the research. Research cannot be continued past the one-year period prior to the approval process.

The following materials will be required for IRB review, whether the continuing review is made by expedited review or by review of the convened board. OHRP requires that the IRB receives and reviews a protocol summary and a status report on the progress of the research that includes the materials below. Thus, investigators renewing a project must provide

  1. A brief project summary (this may be an email that communicates the proposal and other material required below to the IRB).
  2. A copy of the research proposal previously approved by the IRB (if there are no changes to the research) or a copy of the revised research proposal with changes highlighted for IRB review.
  3. A report that the research is proceeding in accordance with the IRB-approved protocol.
  4. The number of subjects accrued (total subject enrollment).
  5. The number of subjects who discontinued their participation and a summary of the reasons for the withdrawals, if known.
  6. A summary of any unanticipated problems (in many cases, such a summary could be a simple brief statement that there have been no unanticipated problems).
  7. Available information regarding adverse events, including the expected frequency and level of severity as documented in the research protocol.
  8. A summary of any complaints about the research since the last IRB review.
  9. A summary of any recent literature that may be relevant to the research and any amendments or modifications to the research since the last IRB review.
  10. Any other relevant information, especially information about risks associated with the research.
  11. A copy of the current informed consent document and any newly proposed consent documents.

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Conflict of Interest in Reviewing Proposals

Randolph College IRB members will submit in writing any potential conflicts of interest that result from financial interests, such as outside income from funders of research. IRB members will excuse themselves from voting on proposals in which they have a conflict of interest. A conflict of interest will not be considered to exist when an IRB member teaches or has experience or expertise in a given area, or is a faculty advisor on a student research proposal. A research proposal for which an IRB member is the investigator will be considered a conflict of interest, and the member will not vote on the action and will not count as part of the quorum on the action. Members who excuse themselves from voting on an IRB matter will not be required to absent themselves from the meeting room unless the issue of the members’ presence is raised (either before or during the meeting). For the purposes of service on the IRB, a member desiring clarification of whether or not a conflict of interest exists should disclose and resolve the issue with the chair of the IRB. Such disclosure shall take the form of at least one written query to the IRB Chair.

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Outside Expertise in Review Process

The IRB may, on occasion, invite non-voting individuals with expertise in specific areas to assist in the review process. These areas include, but are not limited to, mental disabilities, pregnancy, prisoners, children, and fetuses.

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Investigator Attendance at IRB Meetings

Investigators or other persons may be invited to attend a meeting of the IRB for the purposes of answering questions or providing information to the IRB. Non-Board members will be asked to absent themselves when the Board discusses and votes on a proposal.

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Class Assignments and IRB Review

Classroom assignments involving human subjects usually fall under IRB jurisdiction. Involvement of human subjects generally means some form of interaction, including the collection of personally identifiable records about a person. At Randolph College, such interaction often involves surveys, interviews, and some experiments involving minimal risk. While some human subject research is exempt from regulation, only the IRB can classify research as “exempt”; therefore all classroom assignments involving human subjects must be submitted to the IRB for its review. The Chair is authorized by the IRB to work with faculty members and investigators on classroom assignments involving minimal risk.

Student projects that are part of an in-class assignment (e.g. class members only interview or survey each other) and do not involve physically or psychologically invasive, intrusive, or stressful procedures or, in the judgment of the instructor, do not have the potential for placing the subjects at more than minimal risk, and results are not reported beyond the classroom, may be classified as exempt by the IRB. According to the Department of Health and Human Services Code of Federal Regulations 45CFR46.102(i), minimal risk is defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
Classroom assignments involving human subjects outside of the traditional classroom and involving minimal risk will be categorized as exempt or expedited depending on the type of research procedure. The IRB Chair will make the category of review determination.

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Monitoring Minimal Risk Research Projects

The research study progress should be monitored by the investigator(s) with special emphasis placed on health, safety, and protection of the participants. Faculty supervisors of student research are expected to maintain a monitoring process to assure the health, safety, and protection of participants.

Serious or continuing non-compliance of institutional or federal regulations regarding research with human participants will be reported to the Vice President for Academic Affairs who subsequently will notify any necessary supporting agency official, as well as notifying proper authorities at OHRP.

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Monitoring Moderate Risk Research Projects

In the event the study involves more than minimal risk, or the inclusion of, but not limited to, the high-risk participant categories of children, pregnant women, fetuses, prisoners, and the mentally or emotionally impaired, the IRB Chair, along with the investigator will follow the progress of the study throughout its process. Faculty supervisors of student research are expected to maintain a monitoring process to assure the health, safety, and protection of participants.

Serious or continuing non-compliance of institutional or federal regulations regarding research with human participants will be reported to the Vice President for Academic Affairs who subsequently will notify any necessary supporting agency official, as well as notifying proper authorities at OHRP.

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Research Involving Children

It will be rare when the Randolph College IRB uses the expedited process for studies involving children. Investigators should expect a full Board review and schedule their research activities accordingly. Minor changes to proposals approved by the convened Board may be reviewed using the expedited process at the discretion of the Chair.

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Definition of a Child

A child is a person under 18 years of age. Federal regulations involving research with children leave the definition of children to the 50 states. In Virginia, a child is legally defined as a person who is under 18 years of age (Section 1-207 of the Code of Virginia). As there are students at Randolph College who are under 18 years of age, investigators cannot assume that all students are of legal age to provide informed consent. Consequently, studies should generally state that the research is limited to persons 18 years of age and older. Consent forms should include a statement whereby participants attest that they are 18 or older. The definition of a child may differ abroad. (In some countries, a child is defined as a person who is under 20 years of age.) It is the responsibility of the researcher to determine the age of consent in the countries where he or she may be doing research.

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Parental/Guardian Consent

Parental/guardian consent and subject assent are required when children are research subjects. When children are used in research projects, the consent of the parent/guardian is required, as well as the assent of the child. According to the Department of Health and Human Services Code of Federal Regulations (45 CFR 46.402(b)), “‘Assent’ means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. This means the child must actively show his or her willingness to participate in the research, rather than just complying with directions to participate and not resisting in any way.” Because children (1) may not be capable of comprehending a study and its risks, and (2) are not legally of age to provide their own consent, federal regulations require that the consent to participate in a research study must be provided by the parents or guardians of the child. Investigators preparing proposals involving children must include consent forms for the parents and assent forms for the child.

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Waive of Informed Consent

All research studies should include an informed consent for participants. Waivers of informed consent will be infrequent for approved proposals. Occasions when informed consent can be waived include if the nature of a study or standard methodology (such as an ethnography involving a personal interview with a single respondent) makes obtaining the written consent of participants inappropriate or potentially compromising. The IRB will consider other methods for obtaining consent on a case-by-case basis. A waiver of some element of informed consent might be given when some measure of deception is used and full informed consent would negate the purpose of the research. In such cases, a debriefing will be made in which the subjects are informed of the nature of the deception and the reasons for it. Rather than requesting a standard written consent from a participant, the investigator may wish to provide each participant with a written statement explaining consent and confidentiality safeguards. Investigators must keep documentation of verbal and/or written statements.

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Suspension or Termination of Research

The IRB has the ability to suspend or terminate approval of research that is not in accordance with OHRP regulations and/or may cause serious harm to participants. The IRB Chair will state in a letter to the investigator, faculty advisor (if applicable), and the Vice President for Academic Affairs, the reasons for the IRB’s action of suspension or termination. The IRB Chair will inform the Vice President for Academic Affairs who subsequently will notify any necessary supporting agency official, as well as notifying proper authorities at OHRP.

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Record Keeping

The IRB Chair will keep a file of all proposals, requested proposal changes by the IRB, approval letters, end of project reports, adverse event report (if necessary), meeting minutes, and emails that are associated with individual projects during each academic year. IRB emails will be stored on the College’s email server with access available by the IRB Chair, Grants Coordinator, and Dean of the College office. All IRB records will be kept on file for three years and stored in the Dean of the College office.

The IRB Chair will maintain a summary document of full, expedited, continued, and exempt reviews by the IRB during the academic year, and report the document to the IRB as needed. The document should include the following information:

  1. The date the proposal was received.
  2. The name of the investigator.
  3. The investigators classification (student, faculty, staff, other).
  4. The faculty advisor, if applicable.
  5. The course for which the research was prepared, if applicable.
  6. The title of the proposal.
  7. A brief summary of the methods used in the proposal (i.e. survey, interviews, experiment, etc.).
  8. Comments on the proposal (e.g. minimal risk survey providing anonymity to subjects).
  9. Date of notice of action to applicant.
  10. Action taken (i.e. approval, exemption, returned for more information).
  11. Verification of training dates.

The IRB meeting minutes will be recorded by an assigned IRB Board member each meeting. The Board member will email a copy of the minutes to the Chair for filing purposes. Minutes will include the following:

  1. Date of convened IRB meeting.
  2. Members present.
  3. Proposal discussed.
  4. Action deliberated.
  5. Total of votes approved, not approved, and abstained.
  6. Any other discussion items not related to proposal approvals.
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