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Policies and Procedures

Policies

In addition to following regulations in 45 CFR 46 and state and local laws in its reviews, the Macalester College IRB upholds the following policies:

  1. Student researchers must work with a Research Advisor. All student investigators will work with a Research Advisor throughout the process of submitting an application, following approved protocols, and bringing research to a close. Faculty and staff advisors of student investigators may consult the guidance page for further information about the role of a research advisor.
  2. Only faculty and staff researchers may serve as a PI for research that involves more than minimal risk for participants or seeks to recruit participation from vulnerable populations. Only members of the College’s faculty and staff may serve as a principal investigator for research that requires a full review. Furthermore, approval is contingent on relevant training and/or certifications for the protection of human research subjects. Students may still participate in such research projects, provided they have appropriate training, but not as the principal investigator.
  3. Dual Use Research of Concern by Macalester personnel is subject to IRB oversight. Macalester’s IRB provides oversight for the college’s Dual Use Research of Concern policy. Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. All life science investigators proposing to conducting research using specific toxins or agents are subject to the College’s DURC policy and must contact the IRB chair in order to ensure compliance.
  4. Research must comply with location-specific standards for ethical research. Investigators seeking to recruit participation from human subjects located outside of the United States or on lands of federally-recognized Indian Tribal Entities of the United States must demonstrate that their proposed project meets local ethical standards for research. A current list of such standards is available from OHRP.
    • In order for an international project to be approved, the investigator must demonstrate that, in addition to following all of the US requirements for ethical research with human subjects, their proposed project also meets location-specific standards for such research. If a project involves collecting data in multiple locations, the application must demonstrate compliance with location-specific standards for each.
    • In situations where a research ethics board operates to permit research by an extra-local investigator (e.g., School Districts, federally-recognized Indian Tribal Entities of the United States), the IRB expects investigators to include a statement of approval from an appropriate research ethics board with their application materials.
    • Otherwise, investigators should engage a local researcher to document that the proposed procedures are consistent with location-specific standards for ethical research. A person serving in this role should be positioned at a local research institution or otherwise have experience and expertise relevant to the proposed research (e.g., for a research project on perceptions of safety in public spaces of Cape Town, a statement from a professor of Sociology at the University of Cape Town would suffice).
    • If, however, a local researcher is not available, a Macalester faculty or staff member who has relevant experience working in that particular country and/or with international standards for research with human subjects may serve in this capacity.
      • In either case, the applicant must include a statement from an appropriate researcher that (a) identifies their qualifications to evaluate compliance with location-specific standards for ethical research in a given context, (b) that they have reviewed/discussed the project proposal, and (c) that the project meets location-specific standards for ethical research.

      Procedures

      In addition to the processes outlined in this resource, the Macalester College IRB will observe the following procedures:

      IRB Review Responsibilities

      • The IRB chair may assign review responsibilities to one or more IRB committee members in cases where submissions qualify for exempt or expedited review.

      Expedited Review

      • When a member of the IRB approves an application under the expedited review category, that decision must be communicated with the IRB chair, who in turn is responsible for informing all members of the IRB committee of the decision and the schedule for continuing review of the proposal.

      Full Review

      • When the IRB convenes for a full review of a proposal, a majority of committee members must be present in order to make a decision about a submission. The IRB may use consultants to supplement IRB review when a specific project requires expertise beyond the scope of IRB membership. Each committee member present is entitled to one vote. When a vote is required, outcomes will be determined by a simple majority of votes. The IRB will record minutes for convened meetings in accordance with guidance provided by HHS.

      Conflicts of Interest

      • IRB members are expected to self-identify conflicting interests and should notify the IRB chair when assigned to review research in which they have a potential conflict of interest (which may require the chair to re-assign review responsibilities to another IRB member). Generally, IRB members should recuse themselves when the IRB reviews research in which they may have a conflict of interest. The IRB will have a discussion once the conflicted member has recused themself. If the conflict of interest status of an IRB member changes during a study, the IRB member is required to disclose this to the IRB chair or Provost.

      Continuing Review

      • The IRB will review on an annual basis all continuing research approved under expedited or full review categories. Depending upon the degree of risk to research participants, the continuing review may take place more frequently. As part of continuing review, the IRB will use materials submitted via the Continuing Review Report to assess whether the risk/benefit ratio is still reasonable, whether changes in the informed consent document or study procedures are needed, or whether re-consent is necessary.

      Record Retention

      • The IRB must keep records of all approved projects for at least three years after the project is completed or its protocols are closed. The records will include the following matters:
      1. A list of all IRB members
      2. Proposals submitted to the IRB
      3. Minutes of the meetings of the IRB
      4. Actions taken by the IRB
      5. Copies of all correspondence between the IRB and researchers
      6. Documents regarding consent
      7. Documents regarding modifications and adverse events
      8. Reports filed by investigators upon completion of their studies

      Reporting Non-compliance

      • Non-compliance is defined as the failure to follow any federal, state, or local regulations governing human subjects research and the College’s policies related to human subjects research. Serious cases of non-compliance include instances that entail the willful violation of such regulations and policies and/or intentional deception on materials submitted to the IRB. Serious cases of non-compliance may create an increase of risk to participants, adversely affect the rights and welfare of participants, and/or adversely affect the scientific integrity of the study. A single instance of noncompliance may be deemed as serious noncompliance upon consideration of the facts by the IRB. Serious cases of non-compliance can also emerge when there is a pattern of noncompliance that, if allowed to continue, may increase the risk to research participants, damage the reputation of the college as a research institution, diminish the rights of subjects, or adversely affect the scientific integrity of the study.
      • Reports of non-compliance are reviewed by the IRB chair in conjunction with one or more members of the IRB committee, and, as necessary, the Provost. IRB members may also be consulted to assist with reviewing allegations of noncompliance. If an instance of non-compliance is verified, corrective action may include, but is not limited to:
        • Notification of research subjects or re-consent of current research participants;
        • Observation and/or monitoring of the research or the consent process;
        • Additional education and training for investigators;
        • Modifications to the protocol and/or informed consent documents;
        • Modifications to the continuing review schedule;
        • Stipulations to achieve compliance or prevent recurrence of noncompliance;
        • Suspension or termination of research (including, but not limited to, data collection, data analysis, and use of data for presentation or publication);
        • Suspension of the privileges of a PI to conduct human subjects research at Macalester College.

      Reporting Suspension or Termination of IRB Approval

      • The IRB chair will report promptly to the Provost and, where appropriate, funding institutions, decisions to suspend or terminate IRB approval.