Research with Human Subjects Policy

I. Scope

This policy applies to all faculty, staff, students, and affiliated researchers, working within the scope of their roles at William & Mary, who conduct research with human subjects. 

Research projects that meet the definition of “research” and “human subjects” as defined in the Code of Federal Regulations 45 C.F.R. § 46 and section III of this policy, must undergo review and receive approval by the William & Mary Institutional Review Board (IRB).

Some human subjects research projects may be subject to additional rules and regulations based on the sponsor(s), collaborations, associated agreements, and research design.

II. Purpose and Policy Statement

The purpose of this policy is to describe the obligations for William & Mary researchers conducting research involving human subjects. Federal law and Virginia state law require that all research involving human subjects conducted by William & Mary – regardless of funding source – must be reviewed and approved by the William & Mary Institutional Review Board (IRB) pursuant to the requirements governing the use of human subjects in research.

III. Definitions

For purposes of this policy, the terms below have the following meanings:

Adverse Event means any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom, or disease, temporally associated with the subject’s participation in the research, whether or not it is considered related to that participation. Adverse Events encompass both physical and psychological harms.

Clinical Trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Cooperative Research are those projects that involve more than one institution. In the conduct of cooperative research, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.

Exemption Determination means that the IRB has determined that a study qualifies for exemption from the federal regulations governing research with human subjects because the proposed protocol presents no more than minimal risk and falls within one or more specific and predefined categories. An exempt determination reduces regulatory oversight but does not relieve investigators of their obligation to comply with applicable ethical principles and institutional policies and procedures.

Federalwide Assurance (FWA): An FWA is an organization’s assurance to the federal government that federally funded human subjects research conducted at that site complies with federal regulations governing the protection of human subjects (45 .C.F.R. § 46). The FWA designates the IRB responsible for reviewing and overseeing the research, specifies the ethical principles under which the research will be conducted, and identifies the individuals responsible for the proper conduct of the research.

Human Subject means a living individual about whom an investigator (whether professional or student) is conducting research if the investigator:

a.  Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
b.  Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

• “Interaction” includes communication or interpersonal contact between the investigator and subject (e.g., surveys, interviews, focus groups).
• “Intervention” includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes (e.g., an educational experiment).
• “Identifiable biospecimen” means a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
• “Identifiable private information” means private information for which the identity of the subject is or may readily be ascertained by the investigator or otherwise associated with the information. This includes circumstances in which re-identification of the subject is reasonably possible based on access, expertise, use of technology, and consideration of all data and information available.

Institutional Review Board (IRB) means the board that prospectively reviews human subjects research protocols and makes determinations concerning the ethical and regulatory compliance of the proposed research protocol. The IRB is responsible for protecting the rights and welfare of human subjects involved in the research at William & Mary. The IRB functions independently of, but in coordination with, other organizational committees and officials. The IRB makes an independent determination whether to approve or disapprove a research protocol based upon whether human subjects are adequately protected.

Institutional Official (IO) means the person legally authorized to represent the university. The IO is the signatory of the FWA and assumes the obligations of the FWA. At William & Mary, the Vice Provost for Research or their delegate(s) serves as the IO. The IO is responsible for ensuring that the university and its IRB have the resources and support necessary to comply with the laws, regulations, and university policies and procedures that govern human subject research.

IRB Approval for Non-Exempt Research means that the William & Mary IRB has reviewed and approved the research protocol in accordance with the federal regulations governing research with human subjects at 45 C.F.R. § 46 and has determined that the research protocol meets the approval criteria specified in 45 C.F.R. §46.111. Once IRB approval has been granted for non-exempt research, the research activities may be conducted in accordance with the IRB’s policies and procedures and within the constraints set forth in the approved protocol.

IRB Chair means the individual responsible for conducting the IRB Full Board meetings, conducting expedited reviews, and serving as signatory for correspondence generated by the IRB. The IRB Chair is authorized to take immediate action to suspend a research study or studies if information is presented regarding subject safety or for any other reason deemed appropriate. The IRB Chair may designate other experienced IRB members or staff to perform duties such as expedited reviews and other IRB functions.

Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Noncompliance means the failure (regardless of intent) to comply with any federal, state, or local regulation governing human subjects research including university policies and procedures. Noncompliance includes conducting human subjects research without prospective IRB approval, any deviation from an IRB approved protocol, or deviations from stipulations imposed by the IRB as a condition of approval. Noncompliance may be “serious,” “non-serious” (minor), or “continuing.”

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether conducted or supported under a program that is considered research for other purposes (see 45 C.F.R. § 46.102(l)).

Unanticipated Problem means any incident, experience, or outcome that meets all the following criteria (as determined by the IRB):

a. The problem is unexpected (in terms of nature, severity, or frequency) given the research procedures described in the protocol-related documents and the characteristics of the subject population being studied;

b. The problem is related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and

c. The problem suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

IV. General Principles

A. Ethical Standards

1. All William & Mary researchers must adhere to ethical standards governing the use of human subjects in research. These principles and standards exist to protect the rights and welfare of individuals participating in research.
2. The Belmont Report establishes the principles of “beneficence,” “justice,” and “respect for persons” as core values in human subjects research. 
3. The ethical principles found in the Belmont Report are incorporated in the approval criteria set forth in the federal regulations governing human subjects research (45 C.F.R. § 46.111)
4. Any research that departs from the spirit or practice of these principles and standards violates university policy and federal law.

B. IRB Oversight

1. Sponsored Research is subject to the IRB regulations at 45 C.F.R. § 46 and all other applicable laws, regulations, and William & Mary policies and procedures.
2. Cooperative Research is subject to the IRB regulations at 45 C.F.R.§ 46 and all other applicable laws, regulations, William & Mary policies and procedures, and the regulations, policies, and procedures of any cooperating organization.
3. Research Associated with an Agreement or Contract is subject to the IRB regulations at 45 C.F.R. § 46 and all other applicable laws, regulations, William & Mary policies and procedures, and the regulations, policies, and procedures set forth in the associated agreement or contract.
4. Unfunded Research is subject to all applicable laws, regulations, and William & Mary policies and procedures.
5. Student Research Regulated by the IRB:

• When student work (e.g., dissertations, thesis) is submitted for IRB review and approval, a William & Mary faculty or staff member, acting within the scope of their appointment, will serve as the Principal Investigator (PI), and the student will serve as Co-Principal Investigator.
• The faculty or staff member serving as PI is ultimately responsible for the conduct of the research and is expected to provide regular oversight and guidance to the student researcher.
• The student whose research is approved by the IRB must adhere to the approved IRB protocol and all William & Mary IRB unit procedures.
• Should no William & Mary faculty or staff member be willing to serve as the PI for student research, research cannot be approved by the IRB.
• Student research that is funded, cooperative, or associated with a contract or agreement, will be reviewed in accordance with sections B.a., B.b., and B.c. of this policy.
  
   6. Class Projects Not Regulated by the IRB
• Class-assigned projects involving human subjects that are conducted for "purely educational purposes" do not meet the criteria in the federal definition of research and are not regulated by the William & Mary IRB.
• “Purely for educational purposes,” means that the class-assigned activities are conducted solely for pedagogical or evaluative reasons and that information or results derived from the activities are not intended to be used or disseminated outside of the class or beyond a single group or organization (refer to IRB standards and guidance for activities considered regulated).

V. Procedure

A. Research Protocol Submission

Research materials including recruitment materials, informed consent forms, data collection tools, instruments, study protocols, and other relevant participant-facing documents, must be submitted to the IRB with the IRB application for review and approval.

B. IRB Review and Review Level

1. Once the IRB application and required materials have been completed and submitted to the IRB, the IRB will review the application.
2. There are four levels of review for projects submitted to the IRB. The level of review will be determined by the IRB staff (in conjunction with the IRB Chair, as necessary) upon consideration of the submitted application and study materials.
3. The four levels of review are:

• Administrative review leading to an Exemption Determination: this level of review is not subject to the regulations at 45.C.F.R.§ 46, but is subject to William & Mary policy. It requires review by an IRB representative to ensure the research protocol is designed and implemented ethically and in compliance with relevant laws, regulations, and university policy and procedures.
• Administrative review leading to an Exemption with a Limited Review. This level of review is not subject to the entire set of regulations at 45 C.F.R. § 46 but is subject to William & Mary policy. It requires review by an IRB representative to ensure the protocol includes adequate provisions to protect the privacy of subjects and maintain the confidentiality of data.
• Expedited Review. This level of review is subject to the regulations at 45 C.F.R. § 46 and is eligible for review by a qualified IRB Full Board member with appropriate expertise, who may serve as the sole reviewer for the study.
• Full Board Review. This level of review is subject to the regulations at 45.C.F.R. § 46 and requires review and approval by a convened IRB Full Board with appropriate representation and expertise to review the study.

4. Refer to the William & Mary IRB Office for unit-level policies and procedures regarding review levels and protocol approval.

5. Research considered “Not Human Subjects Research” (NHSR) is research that does not meet the definition of “research” or “human subjects” as defined by 45.C.F.R. § 46 (refer to section III.E and III.L of this policy).

C. IRB Approval for Non-Exempt Research

1. Approval Types: Upon review of the application, the IRB may issue the following type of approval:

• Approved – The study protocol is approved, and research with human subjects as described in the approved protocol may commence.
• Conditional Approval – If the study is approved with modifications/conditions, the IRB staff will work with the PI to complete the necessary changes and finalize approval before any research activities commence.
• Deferred – If the convened IRB Full Board is unable to find and document that the criteria for approval provided in 45.C.F.R. § 46.111 have been satisfied without additional information, the IRB may defer the study. If the study is deferred, the IRB staff will work with the PI to prepare the study for subsequent review.
• Not Approved – The study, as submitted to the IRB for review, is not eligible for approval and no research with human subjects may take place.
  • A decision of “Not Approved” may only be made by a fully convened IRB Full Board.
  • A decision of “Not Approved” may only be appealed or overturned by a fully convened IRB Full Board.

2. Approval Period and Continuing Review of Research

• When a research protocol is approved, a research approval period is issued.
  • All protocols approved at a convened meeting of the IRB Full Board will have an approval expiration date.
  • Some protocols approved by the IRB at the expedited level or those for which an “exemption determination” has been made, may have an approval expiration determined by the research design or applicable external requirements.
• Continuing Review is the ongoing review of research previously approved by an IRB where an approval period with an expiration date has been assigned.
  • Throughout the approval period, and in order to renew approval, the IRB must re-review the protocol to assess risks in the current national and international climate.
  • This approval renewal ensures that all regulatory approval criteria are still applicable to the protocol and continue to be satisfied.

c. Amendment Requests

• If any changes must be made to the personnel, procedures, or study documents in IRB-approved research – including protocols undergoing Administrative Review leading to Exemption, Administrative Review leading to Exemption with a Limited Review, Expedited Review, and Full Board Review – an Amendment Request must be submitted to the IRB in accordance with IRB policies and procedures.
• No changes to the approved study protocol may be implemented until the Amendment Request is reviewed and approved.

D. Cooperative Research

Cooperative Research with Other Institutions includes

1. Cooperative human subjects research projects are those that involve William & Mary and at least one other institution or unaffiliated investigator.
2. When conducting cooperative human subject research projects, each institution or unaffiliated investigator is responsible for safeguarding the rights and welfare of human subjects and for complying with 45.C.F.R.§ 46.
3. Any institution or unaffiliated investigator engaged in non-exempt federally funded cooperative research must rely upon approval by a single IRB for the research conducted and must adhere to relevant William & Mary policies and procedures.
4. Regardless of funding, any William & Mary researcher or unaffiliated investigator that is engaged in human subjects research with oversight by the William & Mary IRB must adhere to the William & Mary IRB’s policies and procedures governing Cooperative Research.

E. Document Retention

1. Researchers: Under 45.C.F.R. § 46 and the Code of Virginia, researchers are responsible for retaining copies of all research records relating to the research project (including the original submitted protocol, protocols modifications, signed consent forms, correspondence with the IRB, etc.) for no less than five (5) years after the completion of the research. If study records include data subject to HIPAA, records must be retained for no less than six (6) years. All other applicable laws, regulations, and William & Mary policies and procedures governing data retention and records management apply.
2. IRB Office: Under 45.C.F.R. § 46 and the Code of Virginia, the IRB Office is responsible for retaining copies of all approval documentation and determinations regarding human subjects research, as well as all records of participant complaints, unanticipated problems, adverse events, and non-compliance. This documentation is retained for five (5) years after completion of the research. If project records include oversight related to HIPAA, records must be retained for no less than six (6) years. All other applicable laws, regulations, and William & Mary policies and procedures for data retention and records management apply.

F. Data Management

Data must be managed in accordance with the approved IRB protocol and all applicable federal, state, and local laws, as well as William & Mary policies and data security standards.

G. Mandatory Reporting

1. Unanticipated Problems and Adverse Events: All Unanticipated Problems and Adverse Events must be reported by researchers to the IRB Office as soon as possible, with sufficient information to enable the IRB to make appropriate determinations.
2. Non-compliance: William & Mary researchers conducting human subjects research must comply with the provisions of the IRB-approved study, as well as all applicable federal regulations, university policies, and state and local laws. 
3. The Researcher as a Mandated Reporter: In some cases, researchers may be required to report certain information based on their professional role. Researchers are responsible for understanding their reporting obligations and how those obligations may affect the privacy and confidentiality of participants, including the resulting increased risk to participants. Where applicable, mandated reporting obligations must be detailed in the IRB protocol and in the Informed Consent Form.

H. Suspension or Termination of a Study

1. The William & Mary convened IRB or IRB Chair may suspend or terminate some or all research activities under a protocol if events are identified that constitute serious or continuing noncompliance or unanticipated problems involving risk to subjects or others.
2. The William & Mary convened IRB or IRB Chair may also suspend some or all research conducted by a PI because of serious or continuing noncompliance or unanticipated problems involving risk to subjects or others. 

• This action is most often determined by a convened IRB Full Board. However, the IRB Chair in conjunction with the Institutional Official and IRB staff, has the authority to suspend some or all research activities if exceptional human subject safety concerns are identified.

I. Applicable Policies, Procedures, and Guidance

1. All researchers conducting human subjects research must adhere to all policies established by William & Mary and the IRB.
2. Applicable policies may be found on the William & Mary Human Subjects IRB Website

VI. Approval

This policy was approved by the Provost on August 6, 2026.

VII. Related Documents

●     Federal Regulations Governing Research with Human Subjects 45.C.F.R. 46
●     The Belmont Report
●     Nuremberg Code of 1947
●     Office for Human Research Protections (OHRP)
●     Code of Virginia, Research with Human Subjects
●     William & Mary Policy for Conflicts of Interest
●     William & Mary Policy for Financial Conflicts of Interest
●     William & Mary Research Compliance Website
●     William & Mary Data Classification and Protection Policy
●     FDA Regulations
○     21.C.F.R. 50 Protection of Human Subjects
○     21.C.F.R. 56 Institutional Review Boards
○     21.C.F.R. 312 Investigational New Drug Application
○     21.C.F.R. 812 Investigational Device Exemptions
○     21.C.F.R. 600 Biologics
●     DoD Regulations Governing Research with Human Subjects 32.C.F.R. 219
○     DoD Instructions 3216.02
●     NIH Website for Human Subjects’ Research
●     NSF Website for Human Subjects’ Research