Human Subjects in Research
Policy number: 10.10
Policy section: Research
Revised Date: January 2, 2019
Definitions of capitalized terms are set forth in Appendix A.
2. Policy Statement
It is the policy of the University that the use of Human Subjects in Research activities conducted by faculty, staff, or students of the University, or conducted by Affiliated Personnel using University resources, or in which the University is Engaged (“University Research”) will be in accordance with applicable federal and state laws and regulations, and guided by the principles in the Belmont Report. The University will provide for review of University Research that involves Human Subjects (“University Human Subjects Research”), including thorough review of Research Protocols, modifications, and Research conduct, to minimize the risks to Human Subjects and promote protection of the rights and welfare of Human Subjects.
- The University is committed to the principle that Research, teaching, and public service activities should contribute to the acquisition of knowledge and should benefit humanity. Safeguarding the rights and welfare of Human Subjects in Research is of prime concern to the University and is a responsibility of staff, faculty, students, and Affiliated Personnel. University Human Subjects Research, regardless of the source of Funding, will be guided by the ethical principles in the Belmont Report and is subject to this policy.
- University Investigators who conduct Human Subjects Research must comply with federal, state, and local laws and regulations as well as applicable University Policies. University Investigators who perceive inconsistencies between this policy and, where applicable, the Federal Policy, or other laws or regulations, must consult with the IRB rather than making an independent determination as to how to resolve the apparent inconsistencies.
4. IRB Review, Federal Regulations, and the Protection of Human Subjects
- The University maintains an IRB for the protection of Human Subjects. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of Human Subjects. The IRB is responsible for review of University Human Subjects Research, in accordance with University Policies; federal, state, and local regulations; and the principles of the Belmont Report. The IRB has the authority to:
- determine which projects fall outside the scope of the IRB’s oversight;
- determine when projects are exempt from IRB review;
- approve or disapprove, or require modifications to, Research Protocols;
- conduct continuing review of Research at intervals appropriate to the degree of risk, as directed by current DHHS regulations, and monitor or observe the consent process and/or conduct of the Research to promote protection of the rights and welfare of Human Subjects; and
- suspend or terminate approval of Research that is not conducted in accordance with the IRB’s requirements or is associated with unexpected serious harm to Human Subjects.
- Federal regulations generally require IRB Approval for federally supported Human Subjects Research. Although these regulations are not applicable to non-federally-supported Research, it is the University’s policy to apply the same standards to all Research, regardless of funding source. Thus, the University requires IRB Approval as well as compliance with this policy for all non-exempt University Human Subjects Research, whether privately or publicly funded, or unfunded.
- University Human Subjects Research will be reviewed and approved by the IRB before Human Subjects are involved and will be reviewed at least annually thereafter in accordance with current DHHS regulations. Research covered by this policy that has been approved by the IRB may be subject to further appropriate review and approval with conditions or disapproval by University authorities. Human Subjects Research may not be conducted if it has not been approved by the IRB. All submissions for IRB Approval must be routed through the Director of Research Compliance. Researchers with questions regarding whether their project is subject to IRB oversight must contact the IRB or Director of Research Compliance.
- IRB review will be conducted objectively and in a manner that promotes the exercise of independent judgment of the IRB members. Members will be excluded from review of projects or activities in which they have an active role or other conflict of interest, except such members may provide information requested by the IRB.
- IRB review will address ethical implications and potential risks to Human Subjects and benefits of the Research. The IRB will approve Research Protocols or proposed modifications to existing Protocols only if the IRB determines the requirements set forth in 45 CFR Part 46 are satisfied, including, but not limited to, the following:
- Risks to subjects are minimized: (i) by using procedures which are consistent with sound Research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the Research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the Research). The IRB should not consider possible long-range effects of applying knowledge gained in the Research (for example, the possible effects of the Research on public policy) as among those Research risks that fall within the purview of its responsibility.
- Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the Research and the setting in which the Research will be conducted and should be particularly cognizant of the special problems of Research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with 45 CFR Part 46.
- Informed consent will be appropriately documented, in accordance with 45 CFR Part 46.
- When appropriate, the Research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- In addition to the above criteria, when some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, the IRB will determine prior to approving the Research that additional safeguards have been included in the study to protect the rights and welfare of these subjects.
- In accordance with 45 CFR part 46, the IRB will have authority to suspend or terminate approval of Human Subjects Research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. The IRB will address and may investigate allegations it receives or evidence it identifies of the following:
- unexpected harm to subjects;
- unexpected events that could lead to serious harm to subjects (e.g., loss of sensitive personal data);
- failure to comply with applicable requirements of 45 CFR Part 46 or the ethical principles of the Belmont Report or this policy
- failure to comply with any specific requirements of the IRB or requests that the IRB makes of University Investigators (e.g., in correspondence concerning an IRB application);
- deviation from an IRB-approved Protocol without prior approval from the IRB;
- The IRB will promote continuing constructive communication between Board members and Principal Investigator/Project Director(s) identified in the Protocol as a means of safeguarding the rights and welfare of the Human Subjects.
- The IRB will maintain appropriate, adequate, and informative records of IRB activities, in accordance with the standards set forth in 45 CFR Part 46, including but not limited to copies of all Research Protocols reviewed, minutes of IRB meetings, and records of continuing review activities. These records shall be retained for at least 3 years after the closure of the study, and retention of records related to Sponsored Projects shall be retained in accordance with agency-specific regulations.
- The IRB will at least annually perform an internal review or engage a third party to perform an external review of the practices and procedures designed for the protection of Human Subjects. This review shall gauge whether applicable practices and procedures are consistent with the Federal Policy, other applicable laws and regulations, and the Belmont Report.
- In cooperative Research projects (those projects, normally supported through Grants, Contracts, or similar arrangements, that involve institutions in addition to the University), each institution is responsible for safeguarding the rights and welfare of Human Subjects and may be responsible for compliance with the Federal Policy. University Investigators with questions about whether their Research is a cooperative Research project should contact the IRB or Director of Research Compliance. Pursuant to 45 CFR Part 46, an institution participating in cooperative Research may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort. When a University Investigator conducts Human Subjects Research at or in cooperation with another entity, the University Investigator must obtain from the University’s IRB Approval for the Research or written acknowledgement that the University’s IRB accepts another IRB’s approval for the project. If the cooperating institution does not have an institutional review board established in accord with the Federal Policy, the University Investigator must submit to the University’s IRB a letter signed by the cooperating institution’s CEO or authorized signatory of its Federal Wide Assurance (“FWA”) that indicates acceptance of the University’s IRB review and approval of the Research. Whenever the University relies on another entity’s institutional review board established in accord with the Federal Policy, for review of Research covered by the University’s FWA, it will document the arrangement in a written agreement between the University and the other entity. Such agreement will outline the relationship and include a statement that the other entity’s institutional review board will adhere to the requirements of the University’s FWA, in accordance with 45 CFR Part 46. Such agreement must be kept on file at both institutions/organizations and made available on request to DHHS or other federal agency conducting or supporting Research covered by the FWA.
- The IRB and the University will take action to mitigate or eliminate financial conflicts of interest (see University Policy 10.7, Financial Conflicts of Interest in Externally Sponsored Research) that have the potential to affect the rights and welfare of Human Subjects in Research. If the IRB has a concern about a potential financial conflict of interest regarding a Protocol, the IRB Chair will notify the Director of Research Compliance.
5. Roles and Responsibilities: IRB
The IRB is responsible for reviewing, approving, and providing continuous oversight of University Human Subjects Research. The IRB safeguards the protection of Human Subjects in the design and conduct of Human Subjects Research through dissemination of guidance, training, and monitoring activities. The IRB is also responsible for determining if Human Subjects Research is exempt under 45 CFR Part 46. As part of the protocol and informed consent process, the IRB reviews all aspects of remuneration and reimbursement made to Human Subjects. The IRB reviews all intended distributions to assure the University Investigator has not unduly influenced a Human Subject to participate in the study.
6. Roles and Responsibilities: Principal Investigators/Project Directors
- Principal Investigators/Project Directors who are involved in the design, conduct, or analysis of Human Subjects Research are responsible for ensuring adequate Human Subject protection in the course of their Interactions with Human Subjects and/or identifiable Private Information.
- The Principal Investigator/Project Director or his or her designee is the principal point of contact with the IRB.
- The Principal Investigator /Project Director is responsible for submitting Human Subjects Research Protocols and proposed Protocol modifications to the IRB for approval or a determination that the Human Subjects Research is exempt from the provisions of 45 CFR Part 46.
- Principal Investigators/Project Directors and other personnel may not make their own determination regarding whether the provisions of 45 CFR Part 46 apply to a Protocol or proposed modification. Notwithstanding the foregoing, Principal Investigators/Project Directors are not required to submit to the IRB Research Protocols or proposed Protocol modifications for Research that does not involve Human Subjects.
- The Principal Investigators/Project Directors are also responsible for compliance with IRB requirements to maintain IRB Approval for the life of the project.
7. Roles and Responsibilities: University Investigators and Principal Investigator/Project Director
University Investigators are responsible for complying with IRB requirements. University Investigators and Research staff will adhere to the approved Protocol except when non-adherence is necessary to eliminate apparent immediate hazards to the participants. University Investigators and Research staff are responsible for ensuring that the Principal Investigators/Project Directors is notified of any deviations from the approved Protocol. The Principal Investigators/Project Directors are responsible for timely notification of the IRB of any deviations from the approved Protocol. Performing Human Subjects Research in violation of the approved Protocol or without IRB Approval is a serious breach of conduct and is subject to disciplinary action up to and including termination.
8. Roles and Responsibilities: Deans, Associate Deans, Assistant Deans, and Department Chairs
Deans and Department Chairs are responsible for departmental adherence to University Policies related to Human Subjects Research and adherence to funding agency requirements when applicable.
9. Roles and Responsibilities: Institutional Official
The Institutional Official is responsible for oversight of the protection of Human Subjects and the IRB and serves as the signatory official on the FWA. The Institutional Official appoints IRB members and ensures that the IRB retains autonomy and remains free from undue influence. The Institutional Official is responsible for maintaining regular communication with the IRB, including reports of serious or continuing non-compliance with IRB requirements and any other emergent issues. The Institutional Official will enable provision of adequate resources to the IRB to perform its functions.
10. Roles and Responsibilities: Office of Research and Graduate Studies
The Office of Research and Graduate Studies oversees and disseminates University requirements related to Research compliance. The Assistant Vice President for Research Integrity and Operations in the Office of Research and Graduate Studies is designated as the Institutional Official. The Office of Research and Graduate Studies promotes compliance with federal laws, state and local laws, ethical principles including the Belmont Report, and University Policies through interpretation and advice on such requirements.
11. Roles and Responsibilities: Director of Research Compliance
The Director of Research Compliance reports to the Institutional Official and is responsible for:
- Developing, managing and evaluating policies and procedures that promote compliance with federal, state, and local regulations governing sponsored and University-funded Research and the principles of the Belmont Report. This includes monitoring changes in regulations and policies that relate to Human Subjects protection and overseeing all aspects of Research compliance;
- Advising the Institutional Official on key matters regarding Research at the University;
- Submitting, implementing, and maintaining an approved FWA through the Institutional Official;
- Providing information to the Institutional Official regarding the needs and resources required for the Research compliance operations;
- Assisting University Investigators in their efforts to carry out the University’s Research mission;
- Reviewing initial and revised Protocols and related documents for completeness and accuracy prior to submitting to the IRB;
- Developing a training and education program as required and as appropriate for University Investigators, subcommittee members and Research staff, and ensuring that training is completed in a timely manner; and
- Serving as the primary contact and liaison at the University for communications with federal, state, and local regulatory agencies with respect to Human Subjects Research conducted under the University’s FWA or under the oversight of the University’s IRB (e.g., OHRP and the FDA).
12. Additional Requirements and Related Policies, Procedures, and Forms
University Investigators, and Affiliated Personnel, must take responsibility for the ethical treatment of Human Subjects in Research. University Investigators, faculty, staff, students, and Affiliated Personnel who wish to conduct Human Subjects Research are responsible for completing required training regarding Human Subjects Research. This includes, but is not limited to, education on the protection of Human Subjects that the National Institutes of Health (“NIH”) requires for all investigators submitting NIH applications for Research involving Human Subjects. In addition, University Investigators who intend to apply for external Research funding must first complete the University required training in the responsible conduct of Research as identified in the Research Handbook. University Investigators who conduct Human Subjects Research must also be familiar with this policy and with sources including, but not limited to, the following:
Relevant University Policies, Procedures, and Forms
- The University’s Research Compliance website, which contains information about the IRB and procedures, resources, and periodic updates relating to Human Subjects Research.
- Additional or related requirements specified by University Policies and/or University schools, colleges, departments divisions, centers, or institutes for University Investigators conducting Research. Consult the University Policy Manual and the Office of Research and Graduate Studies for more details.
- University Policy 10.1, Sponsored Research and Activities
- University Policy 10.7, Financial Conflicts of Interest in Externally Sponsored Research
- Research Handbook
Relevant Federal and State Statutes and Regulations
- Department of Health and Human Services (DHHS), 45 CFR Part 46, “Protection of Human Subjects”
- Food and Drug Administration (FDA), 21 CFR Part 50, “Protection of Human Subjects”
- Food and Drug Administration (FDA), 21 CFR Part 56, “Institutional Review Boards”
- Public Health Service (PHS), 42 CFR Part 50, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought”
- Ethical guidelines for Human Subjects Research: The Belmont Report.
- Ethical guidelines for Human Subjects Research endorsed by professional organizations in an investigator’s field or related fields (e.g., the American Psychological Association's Ethical Principles of Psychologists and Code of Conduct)
Appendix A: Definitions
“Affiliated Personnel” means individuals who are not University faculty, employees, or students but have a professional relationship with the University, such as visiting faculty, visiting postdoctoral fellows, volunteers, and other scholars. The University’s IRB will have oversight of Human Subjects Research activities of Affiliated Personnel that use University resources unless the University’s IRB determines that the Research is being appropriately overseen by another IRB.
“Award” means a Grant, subgrant, Contract, subcontract, or Cooperative Agreement that provides for Funding.
“Belmont Report” means the report titled Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research created by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published in the Federal Register April 18, 1979. The Belmont Report summarizes ethical principles and guidelines for Research involving Human Subjects. Three core principles are identified: respect for persons, beneficence, and justice.
"Contract" means a legally enforceable agreement between the University and a Sponsor that provides Funding when a primary purpose is delivery to the Sponsor of property or services for the benefit of the Sponsor, in addition to the Research, educational, or service benefit to the University.
“Clinical Investigation” has the meaning set forth in 21 C.F.R. § 50.3, and means any experiment that involves a test article and one or more individuals who participate, either as a recipient of the test article or as a control; and that either is subject to requirements for prior submission to the FDA under sections 505(i) or 520(g) of the Food, Drug and Cosmetics Act, or is not subject to requirements for prior submission to the FDA under these sections of the Food, Drug and Cosmetics Act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit.
"Cooperative Agreement" means a legally enforceable agreement between the University and a Sponsor that provides Funding when substantial interaction between the Sponsor and the University is anticipated during the performance of the Sponsored Project.
“DHHS” means the United States Department of Health and Human Services.
“Engaged”, in relation to a Human Subjects Research project, has the meaning given to that term in 45 CFR Part 46 as interpreted in DHHS Office for Human Research Protections (OHRP) guidance (the “OHRP Definition”). In addition, the University is Engaged in a non-federally supported Research project if it would be Engaged in a Human Subjects Research project (as interpreted in that OHRP guidance) were the Research federally supported.
“Federalwide Assurance” is an assurance of compliance with the U.S. federal regulations for the protection of Human Subjects in Research that the University provides to DHHS. Among other things, the FWA obligates the University to review and approve Research involving Human Subjects in accordance with the ethical principles outlined in the Belmont Report and regulations at 45 CFR Part 46. An institution must have an FWA in order to receive federal support for Research involving Human Subjects. Each FWA must designate at least one IRB that is registered with OHRP.
“FDA” means the United States Food and Drug Administration.
“Federal Policy” means the Federal Policy for the Protection of Human Subjects, as implemented by the DHHS, 45 CFR Part 46. The Federal Policy is also referred to as the Common Rule.
“Funding” means financial support for a Sponsored Project, including money, property, services, or anything of value in lieu of money.
“FWA” means the University’s Federalwide Assurance.
"Grant" means a legally enforceable agreement between the University and a Sponsor that provides Funding when:
- the Sponsor has no expectation of delivery of a specific product or service other than a final written report;
- no substantial interaction between the Sponsor and the University during performance is anticipated; and
- the agreement contains general terms and conditions that stipulate a period of performance and minimal reporting requirements.
“Human Subject” has the meaning set forth in 45 CFR Part 46, and means a living individual about whom a University Investigator conducting Research obtains (1) data through Intervention or Interaction with the individual or (2) identifiable Private Information.
“Human Subjects Research” is defined as any activity, whether or not it is subject to federal regulation that meets the definition of Research and includes Human Subjects. Clinical Investigations always constitute Human Subjects Research.
“Institutional Official” means the Assistant Vice President for Research Integrity and Operations.
“Interaction” has the meaning provided in 45 CFR Part 46, and includes communication or interpersonal contact between University Investigator and subject.
“Intervention” has the meaning provided in 45 CFR Part 46, and includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for Research purposes
“IRB” means the University’s institutional review board established in accord with the Federal Policy for the Protection of Human Subjects, 45 CFR Part 46.
“IRB Approval” means the determination of the IRB that the Research has been reviewed and may be conducted at the University within the constraints and subject to conditions set forth by the IRB and by other University and applicable legal and regulatory requirements.
“OHRP” means the Office of Human Research Protection and provides leadership in the protection of the rights, welfare, and wellbeing of Human Subjects involved in Research conducted or supported by DHHS.
“Principal Investigator/Project Director” means the individual solely responsible for technical conduct of design, conduct or reporting of the Research or other educational activity, whether or not in connection with a Sponsored Project. "Principal Investigator” (PI) includes an individual designated as "Project Director" (PD), when performing the functions of a Principal Investigator, or other individuals performing the functions of a Principal Investigator. The Principal Investigator/Project Director is the individual who assumes full responsibility for the Research project, and who is ultimately responsible for ensuring the Research stays in compliance with federal regulations and University Policies, including this policy.
“Private Information” has the meaning provided in 45 C.F.R. Part 46, and includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private Information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the University Investigator or associated with the information) in order for obtaining the information to constitute Research involving Human Subjects.
“Proposal” means the document submitted to a Sponsor requesting Funding for a Sponsored Project which includes, without limitation, (i) Financial Obligations, Regulatory Obligations, Reporting Obligations or Accounting Obligations, as described under “Sponsored Projects”, (ii) a Statement of Work and (iii) a budget.
“Protocol” is a document (including subsequent amendments) that describes the Research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data. A Protocol usually also gives the background and rationale for a Research activity involving Human Subjects, but this could be provided in other Protocol reference documents.
“Research” is defined as the systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (see 45 CRF, Part 46); or (2) a Clinical Investigation.
“Research Handbook” is a document maintained by the Office of Research and Graduate Studies specifying current procedures and requirements for the proposal, acceptance, execution, and oversight of Sponsored Projects.
“Signatory Official” means the University employee responsible for oversight of human-subject Research, namely, the Assistant Vice President for Research Integrity and Operations.
"Sponsor” means any external entity that provides Funding to the University. Sponsors may be (i) governmental agencies (for example, federal, state, or local governments or their administrative organizations); (ii) nonprofit organizations (for example, universities, nonprofit corporations, foundations, or associations); (iii) for profit organizations (for example, corporations, partnerships, sole proprietorships, and other business entities); or (iv) individuals.
"Sponsored Projects” means all projects, programs, Research, training, public service and other activities that receive external Funding through Grants to the University or through Contracts or Cooperative Agreements between the University and a Sponsor, where one or more of the following obligations applies:
- Financial Obligation. The University is required to comply with conditions imposed when a Sponsor awards Funding for the performance of services or delivery of products described in a Statement of Work;
- Regulatory Obligation. The University is required to comply with Sponsor regulations.
- Reporting Obligation. The University is required to provide to the Sponsor technical performance reports or regulatory or administrative reports; or
- Accounting Obligation. The University is required to establish a separate accounting record of Sponsored Project expenditures to demonstrate allowability of costs, to maintain financial accountability, to make financial reports to the Sponsor, and to preserve appropriate records for audit.
“Statement of Work” means the component of a Proposal or an Award that describes the specific work to be undertaken and the products that will be produced by the Sponsored Project.
“University Investigator” means a faculty member, Principal Investigator/Project Director, research scientist, research associate, or other researcher responsible for the design, conduct, or reporting of the research or other educational activity proposed for funding by a Sponsor or the University. This includes, but is not limited to, persons classified as SMU faculty, staff, and students.
“University Policies” means, for the purposes of this policy, all University Policies included in the University Policy Manual and all other procedures, guidelines and requirements of the Office of Research and Graduate Studies and the Office of Grant and Contract Accounting included in the Research Handbook, and the procedures, guidelines, and requirements of all University colleges, schools, departments, centers, institutes, and divisions.
Revised: January 2, 2019
Adopted: January 15, 2015