Policy on Research Involving Human Subjects

Approved: Officers
Date Established: June 2002
Responsible Office: Dean of Faculty
Date Last Revised: September 2020
Responsible Administrator: Dean of Faculty

Statement

The purpose of this policy is to provide a single, comprehensive standard of protection for human subjects of research conducted by students, staff, faculty, or visiting researchers at Mount Holyoke College.

Scope/Responsibilities

The intent of this policy is to assure

  • that investigators do not unduly put at risk or harm humans who are the subjects of research,
  • that the subjects of such research are aware of their rights, as defined by the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule)
  • that all investigators (students, staff, faculty or visiting researchers) comply with the College’s Statement of Principles and Ethics (below).

Policy

Oversight by Mount Holyoke College’s Institutional Review Board (IRB) is required for all research involving human subjects, such as: the collection and analysis of data from questionnaires, interviews, observation, manipulation, sampling, and direct experimentation (not an exhaustive list).

Mount Holyoke’s Institutional Review Board is registered with the U. S. Department of Health & Human Services Office for Human Research Protections (#IRB00001900) as the official institutional body that may rule on issues pertaining to the conduct of human subjects research at the College under IORG0001455 and the Federal Wide Assurance FWA00001676.

Policy Violations (if applicable)

Violations of college policies are adjudicated according to procedures outlined in the Student Handbook and the Staff Handbook, with disciplinary consequences imposed by the adjudicating authority up to and including dismissal. Some offenses are punishable under state and federal laws.

Principles and Ethics

While this Policy covers all research on human subjects and is intended to safeguard those subjects’ rights, researchers themselves also bear responsibility for safeguarding those rights. Thus, they are expected to adhere to the following Statement of Principles and Ethics, and are encouraged to consult additional disciplinary statements such as those referenced below.

Statement of Principles and Ethics
Compliance with Law, Standards, and College Policy
Researchers plan and conduct research with human participants in a manner consistent with federal and state law and regulations, as well as professional disciplinary standards governing the conduct of research. As required by this Policy, researchers must obtain institutional approval from the IRB prior to conducting research.

Informed Consent to Participate
Prior to conducting research, researchers enter into an agreement with participants that clarifies the nature of the research. Participants are informed of all features of the research that might influence their willingness to participate. Further, researchers respect each participant's freedom to decline to participate in research or discontinue participation at any time for any reason and without penalty.

Minimization of Invasiveness and Harm
Researchers protect participants from physical and mental discomfort, harm, and danger. Risks to participants are minimized and explained to the participant before she or he agrees to participate. If the research procedure has undesirable effects on participants, the researcher should remedy these effects.

Deception in Research
Researchers do not conduct an investigation involving deception unless they have determined that the use of deceptive techniques is justified by the prospective scientific or educational value and that equally effective alternative procedures that do not use deception are not feasible.

Confidentiality and Privacy
All personally identifiable information obtained from participants is confidential. When the possibility exists that others may obtain this information, participants are informed of this before they consent to participate. All information and data are handled, stored, and discarded in a manner that insures the confidentiality of each participant.

IRB Members

The IRB at Mount Holyoke College will be chaired by a tenured faculty member from the social or natural sciences who will appoint the remainder of the IRB in compliance with 45 CFR 46. In order to meet the federal guidelines, the membership must include at least five members of varying backgrounds. There must be at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. There must also be at least one external member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

A member will not participate in the Board's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested.

It is expected that all internal members of the IRB be familiar with human subjects research from current or prior personal experience with such research. Thus, appointments are made in consultation with departments whose faculty typically conduct research involving human subjects. All Institutional Review Board members must also complete training in human subjects protection. via the Collaborative Institutional Training Initiative (CITI).

IRB Meetings and Recordkeeping

As an appointed Faculty Committee of the College, the Institutional Review Board maintains records of its meetings and decisions, available on request. It sets its meeting dates for each semester of the academic year at the beginning of that semester.

A PI must submit an IRB proposal document, which includes information concerning the purpose of the study, a description of the participants that will be recruited, a detailed description of the procedure of the study, a description of any risks that exceed minimal risk to the participants, and a copy of the informed consent form. The informed consent has to contain a good description of the procedure and any other relevant information the participant would need to make an informed decision regarding their participation in the study, information concerning the voluntary nature of their participation, information on how their data will remain confidential, and any potential risks that exceed minimal risk. In addition, the PI needs to provide documentation of human subjects training, which can be obtained either through the CITI program or though approved coursework.

IRB members review the documents, and can either approve the protocol or ask for further clarification or modifications to procedures so that the project is aligned with OHRP regulations for conducting research on humans. Exempt and Expedited Reviews happen on-line, while review of Full Reviews will take place at a meeting during which time the members of the IRB will convene.

Records pertaining to human subjects that come under Institutional Board purview will be kept for three years after the completion of an approved project, or declination of a proposal. Records will be kept electronically. Records may include: certification of completion in human subjects protection training, applications for approval by the Board, descriptions of project protocol and sample consent forms, sample questionnaires, copies of grant proposals, minutes of Board discussions of proposals, and related memoranda and correspondence.

Who Must Apply

Any Principal Investigator related to Mount Holyoke College who engages in scholarly research involving human subjects, either on- or off-campus, must apply to the IRB for approval of the research. In addition, researchers not affiliated with Mount Holyoke College who are conducting primary research with human subjects on campus must also apply to the IRB for approval, unless their project is a multi-site project for which they have identified and received approval from a designated IRB. In that case, the designated IRB will enter into an agreement with Mount Holyoke’s IRB. Proper paperwork will be filed that indicates which IRB is responsible for the ethical conduct of the work. Such approval must be obtained before undertaking the research.

For help with determining if IRB approval is required, please use the Pre-Proposal Survey in the Mentor IRB system. To see the survey, follow the directions in Mentor IRB for creating a new proposal.

How Proposals are Reviewed

When a proposal is received, the Chair of the IRB will determine if the proposal is (1) exempt, (2) can be reviewed through an Expedited Review Procedure, or (3) if it will require Full Review with a meeting of the Board. If a proposal can be reviewed through the Expedited Review Procedure, the Board will review the proposal following guidelines in 45 CFR 46.110. If a proposal is not in a category eligible for Expedited Review (/irb/expedited), it will be considered under the Full Review Procedure (/irb/full_review).

In all cases, the Board will issue a notification to the Principal Investigator (Co-PIs, Faculty Advisor, and/or MHC Liaison, as applicable) regarding the decision (/irb/decisions_appeals) on the proposal as soon as possible.

Expedited Review:
A research project will be reviewed using the Expedited Review Procedure if the project (1) presents no more than minimal risk to human subjects and (2) falls into one or more of the following categories.

  • Research that collects data from voice, video, digital, or image recordings, or recordings of reaction time;
  • Research on individual or group characteristics or behavior, such as research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodology;
  • Certain classes of studies involving biological samples
  • Certain classes of clinical studies of drugs or medical devices
  • Research involving materials that have been collected or will be collected solely for non-research purposes (such as medical diagnoses)

Federal guidelines define minimal risk 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.

Full Review:
Any research project that cannot be reviewed using the Expedited Review Procedure will be subject to Full Review by the Board. All members of the Board will discuss the proposal. Full Reviews are required for proposals that involve a federally protected group (children under the age of 18, prisoners, or individuals with impaired decision-making capabilities) and/or a proposal that exceeds minimal risk. The IRB will pay particular attention to the elements of the informed consent that addresses how participants will be able to make decisions to participate without coercion, and if the proposal involves more than minimal risks, those risks must be outlined in the informed consent to the participant. A majority vote of the Board is required for approval of a proposal. Minutes of Full Review discussions will be kept, and a summary of those minutes will be available, on request.

Decisions and Appeals

IRB Decisions
All decisions of the Board will be communicated to the Principal Investigator, Co-PIs, Faculty Advisor, and/or MHC Liaison, as applicable. The Board will either approve a project, request changes to the research protocol so that it can be approved, not approve the project, or delay a decision and inform the Principal Investigator how long it will take to review the proposal. If the project is not approved by the Board, the proposal may be revised and resubmitted, or the decision may be appealed. Board approval of a project is for a specified time period, typically one year. If additional time is needed to complete the project an extension may be requested. If the scope of an approved project changes (for example, if a new experiment is designed and implemented, or if additional human subjects are enrolled in the study), an amendment to the protocol must be submitted for IRB review.

In unusual circumstances the IRB may determine that a project requires review more often than annually and/or it may also determine a project requires verification from other sources other than the investigator that no material changes have occurred since previous IRB review.

After a proposal is underway, it is expected that PIs will promptly report to the Board, and other appropriate institutional officials, any unanticipated problems that pose risks to subjects or others. Further, complaints or questions regarding compliance with this Policy should be directed to the Board. Such reports will lead to an investigation and may be cause for suspension or termination of IRB approval for the project. If a PI needs to make any changes to the research protocol, they should submit an amendment to the IRB outlining the changes. No changes may be initiated until the IRB has approved such changes.

Appeals Process
The decision of the Board may be appealed. The Principal Investigator(s) initiates the appeal in writing to the IRB. The PI may submit information pertinent to the proposal and may request a meeting with the Board. The Board may request additional information relevant to the proposal from either the investigator or others. The appeal will be considered by the Board and the decision will be determined by the majority vote of all members of the Board.

Definitions

These definitions apply to terms as they are used in this policy.

Human Subject:
any specific living person who is the subject of research, or information about such a person

Principal Investigator:
any student, faculty member, staff or visitor conducting research

Research
a systematic investigation designed to develop or contribute to generalizable knowledge.

Related Information

How to Apply for IRB Approval

Forms

Requirements/Guidance for Completion of the IRB Review Form

Other Resources:

Disciplinary Professional Organizations’ Statements of Ethics Resources