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Human Subjects Federal-wide Assurance

FWA #: 00003095
Expires:   4/30/2018

Definition

The Federal wide Assurance of Compliance (FWA) is the contract which Dartmouth College has signed with the federal government allowing research involving human subjects to take place.

Terms of Assurance

In signing the FWA, Dartmouth College and its components have agreed to the following terms:

  1. All of the institution's human subject activities, and all human subject activities of the Institutional Review Boards (IRBs) designated under the Assurance, regardless of funding source, will be guided by the ethical principles in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
  2. The following terms apply whenever (a) IRBs operated by the institution provide review and oversight of Federally-supported human subject research, regardless of where the research takes place or by whom it is conducted; or (b) the institution becomes engaged Federally-supported human subject research. The institution becomes so engaged whenever (a) the institution's employees or agents intervene or interact with living individuals for purposes of Federally-supported research; (b) the institution's employees or agents obtain, release, or access individually identifiable private information for purposes of Federally-supported research; or (c) the institution receives a direct Federal award to conduct human subject research, even where all activities involving human subjects are carried out by a subcontractor or collaborator.
  3. Federally-supported human subject research for which the IRB provides review and oversight will comply with the Federal Policy* (Common Rule) for the Protection of Human Subjects. All human subject research supported by the Department of Health and Human Services (HHS) will comply with all Subparts of HHS regulations at Title 45 Code of Federal Regulations Part 46 (45 CFR 46). All Federally-supported human subject research will also comply with any additional human subject regulations and policies of the supporting Department or Agency.

    All Federally-supported human subject research will comply with any human subject regulations and policies of any relevant regulatory Department or Agency.
    • * 7 CFR 1c Department of Agriculture
    • 10 CFR 745 Department of Energy
    • 14 CFR 1230 National Aeronautics and Space Administration
    • 15 CFR 27 Department of Commerce
    • 16 CFR 1028 Consumer Product Safety Commission
    • 22 CFR 225 Agency for International Development
    • 24 CFR 60 Department of Housing and Urban Development
    • 28 CFR 46 Department of Justice
    • 32 CFR 219 Department of Defense
    • 34 CFR 97 Department of Education
    • 38 CFR 16 Department of Veterans Affairs
    • 40 CFR 26 Environmental Protection Agency
    • 45 CFR 46 Department of Health and Human Services
    • 45 CFR 690 National Science Foundation
    • 49 CFR 11 Department of Transportation
    • By Executive Order Central Intelligence Agency
    • By Statute Social Security Administration
  4. Except for research exempted or waived under Sections 101(b) or 101(i) of the Federal Policy, all human subject research will be reviewed, prospectively approved, and subject to continuing oversight by the designated IRBs. The IRBs will have authority to approve, require modifications in, or disapprove the covered human subject research.
  5. Except where specifically waived or altered by the IRB under Sections 101(i), 116(c) and (d), or 117(c) of the Federal Policy, all human subject research will require written informed consent, in non exculpatory language understandable to the subject (or the subject's legally authorized representative), including the following basic elements per Section 116(a) and (b) of the Federal Policy:
    1. Identification as research; purposes, duration, and procedures; procedures which are experimental;
    2. Reasonably foreseeable risks or discomforts;
    3. Reasonably expected benefits to the subject or others;
    4. Alternative procedures or treatments, if any, that might be advantageous to the subject;
    5. Extent of confidentiality to be maintained;
    6. Whether compensation or medical treatment are available if injury occurs (if more than minimal risk);
    7. Whom to contact for answers to questions about the research, subjects' rights, and research-related injury;
    8. Participation is voluntary; refusal to participate, or discontinuation of participation, will involve no penalty or loss of benefits to which subject is entitled; and
    9. When appropriate, additional elements per Section 116(b) of the Federal Policy.
  6. The institution and the designated IRBs have established (or will establish within 90 days), and will provide to OHRP upon request, written procedures for (a) verifying whether proposed activities qualify for exemption from, or waiver of, IRB review; (b) conducting IRB initial and continuing review, approving research, and reporting IRB findings to the investigator and the institution; (c) determining which projects require review more often than annually, and which projects need verification from sources other than the investigator that no material changes have occurred; (d) ensuring that changes in approved research are reported promptly and are not initiated without IRB approval, except when necessary to eliminate apparent immediate hazards to the subject; and (e) ensuring prompt reporting to the IRB, institutional officials, the relevant Department or Agency Head, any applicable regulatory body, and OHRP of any significant or material finding or action, which may include the following:
    1. Serious and unanticipated problems involving risks to subjects or others in any covered research;
    2. Serious or continuing noncompliance with Federal, institutional, or IRB requirements; and
    3. Suspension or termination of IRB approval for Federally-supported research.
  7. The Institutional Signatory Official, the Human Protections Administrator (e.g., Human Subjects Administrator or Human Subjects Contact Person), and the IRB Chairperson(s) will personally complete the relevant OHRP basic educational modules, or comparable training approved by OHRP, prior to submitting the Assurance. Members and staff of the IRBs will complete relevant training before reviewing human subject research. Research investigators must complete appropriate institutional training before conducting human subject research.
  8. The institution and the designated IRBs have established (or will establish within 90 days), and will provide to OHRP upon request, education and oversight mechanisms (appropriate to the nature and volume of its research) to verify that research investigators, IRB members and staff, and other relevant personnel maintain continuing knowledge of, and comply with, relevant Federal regulations, State and local law, and institutional policies for the protection of human subjects, as well as being cognizant of OHRP and other applicable guidance.? The institution and the designated IRBs will require documentation of such training from research investigators as a condition for conducting HHS-supported human subject research.
  9. The institution is responsible for verifying that IRBs designated under the Assurance agree to comply with items (1) through (8) above and that the IRBs possess appropriate knowledge of the local context in which research for which they are responsible will be conducted.
  10. This institution is responsible for ensuring that all institutions and investigators collaborating in its Federally-supported human subject research operate under an appropriate Assurance of Protection for Human Subjects. All institutions engaged in such research, including subcontractors and subgrantees, must hold their own Assurance.
  11. The institution will provide IRBs that it operates with resources, professional staff, and support staff sufficient to carry out their responsibilities efficiently and effectively.
  12. The activities of individual research investigators who are not employees or agents of the institution may be covered under the Assurance only in accordance with a formal, written agreement of commitment to relevant human subject protection policies and IRB oversight. (OHRP's sample Unaffiliated Investigator Agreement may be used or adapted for this purpose, or the institution may develop its own such commitment agreement.) Institutions must maintain such commitment agreements on file and provide copies to OHRP upon request.
  13. Information provided under this Assurance should be updated every 36 months, even if no changes have occurred, in order to maintain an active Assurance. Failure to update this information may result in restriction, suspension, or termination of the institution's Federal wide Assurance of Protection for Human Subjects.

Components

Following is the list of components that are covered by this FWA:

  • Dartmouth College, including:
  • College of Arts & Sciences
  • The Geisel School of Medicine
  • Dickey Center
  • Hood Museum
  • Hopkins Center
  • Institute for Security Technology
  • C. Everett Koop Institute
  • Rockefeller Center
  • Thayer School of Engineering
  • Tuck Business School
  • Tucker Foundation
  • Mary Hitchcock Memorial Hospital
  • Dartmouth-Hitchcock Clinic(s)

Services Provided

The office of the Committee for the Protection of Human Subjects provides required review for researchers using human subjects. For complete information about the submission process, please go to the CPHS website at www.dartmouth.edu/~cphs

For information about the fees associated with human subjects research review, please go the following URL: http://www.dartmouth.edu/~cphs/tosubmit/fees.html

Last Updated: 9/30/13