Human Subjects

Effective Dates:

May 1, 2000 – April 30, 2004

Glossary of Terms

Part 1 - Principles, Policies, and Applicability

1. Ethical Principles
2. Institutional Policy
3. Applicability

Part 2 - Responsibilities

1. Institution
2. Office of Sponsored Programs Administration
3. Vice President for Research
4. Institutional Review Boards
5. Research Investigator
6. Affiliated Institutions and Investigators

GLOSSARY OF TERMS

Multiple Project Assurance of Compliance with DHHS Regulations For Protection of Human Research Subjects

The State University of New York at Buffalo and The Research Foundation of State University of New York pursuant to the State University of New York policies, hereinafter known as the "institution", hereby gives assurance, as specified below, that it will comply with the Department of Health and Human Services (DHHS) regulations for the protection of human research subjects, 45 CFR Part 46, as amended to include provisions of the Federal Policy for the Protection of Human Subjects (56FR28003) as Subpart A, and as may be further amended during the approval period for this Assurance.

PART 1 - PRINCIPLES, POLICIES AND APPLICABILITY

A. Ethical Principles

1. This institution is guided by the ethical principles regarding all research involving humans as subjects, as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (entitled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research [the "Belmont Report"]), regardless of whether the research is subject to Federal regulation or with whom conducted or the source of support (i.e., sponsorship).
2. All institutional and non-institutional performance sites for this institution, domestic or foreign, will be obligated by this institution to conform to ethical principles which are at least equivalent to those of this institution, as cited in the previous paragraph, or as may be determined by the DHHS Secretary.

B. Institutional Policy

1. All requirements of Title 45, Part 46, of the Code of Federal Regulations (45 CFR 46) will be met for all applicable DHHS-supported research, and all other human subject research regardless of sponsorship, except as otherwise noted in this Assurance. Federal funds for which this Assurance applies (all departments and agencies bound by the Federal Policy) may not be expended for research involving human subjects unless the requirements of this Assurance have been satisfied.
2. Except for those categories specifically exempted or waived under 45 CFR 46, Section 101(b)(1-6) or 101(i), all research covered by this Assurance will be reviewed and approved by an Institutional Review Board (IRB) which has been established under a Multiple Project Assurance (MPA) with OPRR. The involvement of human subjects in research covered by this Assurance will not be permitted until an appropriate IRB has reviewed and approved the research protocol and informed consent has been obtained from the subject or the subject's legal representative (see 45 CFR 46, Sections 111, 116, and 117).
3. This institution assures that before human subjects are involved in nonexempt research covered by this Assurance, the IRBs will give proper consideration to:
   1. the risks to the subjects,
   2. the anticipated benefits to the subjects and others,
   3. the importance of the knowledge that may reasonably be expected to result, and,
   4. the informed consent process to be employed.
4. Certification of IRB review and approval for all research involving human subjects will be submitted to the Office of Sponsored Program Administration (OSPA) for forwarding to the appropriate Federal department or agency. Compliance will occur within the time and in the manner prescribed for forwarding certifications of IRB review to DHHS or other Federal departments or agencies for which this Assurance applies. As required under 45 CFR 46, Section 119, for involvement of human subjects in Federal research activities for which there was no prior intent for such involvement, the IRB will review and if approval is recommended, will forward the research protocol to the appropriate Federal department or agency. The IRB will not permit such involvement until final approval is received by the appropriate Federal department or agency.
5. Institutions that are not direct signatories to this Assurance are not authorized to cite this Assurance. This institution will ensure that such other institutions and investigators not bound by the provisions of this Assurance for research involving human subjects will satisfactorily assure compliance with 45 CFR 46, as a prior condition for involvement in human subject research which is under the auspices of this institution. Institutions that have entered into an Inter-Institutional Amendment (IIA) to this Assurance must submit a Single Project Assurance (SPA) to the Office for Protection from Research Risks (OPRR) of DHHS for DHHS-sponsored research, on request, when that research is not conducted under the auspices of a signatory institution to this Assurance.
6. This institution will ensure that any of its affiliates materially engaged in the conduct of nonfederally sponsored research involving human subjects will possess mechanisms to protect human research subjects that are at least equivalent to those procedures provided for in the ethical principles to which this institution is committed.
7. This institution will comply with the requirements set forth in 45 CFR 46, Section 114 of the regulations regarding cooperative research projects. When research covered by this Assurance is conducted at or in cooperation with another entity, all provisions of this Assurance remain in effect for that research. This institution may accept, for the purpose of meeting the IRB review requirements, the review of an IRB established under another DHHS MPA. Such acceptance must be (a) in writing, (b) approved and signed by an official of this institution's Office of the Vice President for Research (VPR), and (c) approved and signed by correlative officials of each of the other cooperating institutions. A copy of the signed understanding will serve as an addendum to this Assurance and will be forwarded to the OPRR by the OSPA for approval.
8. This institution will exercise appropriate administrative overview to insure that the institution's policies and procedures designed for protecting the rights and welfare of human subjects are being effectively applied in compliance with this Assurance.

C. Applicability

1. Except for research in which the only involvement of humans is in one or more of the categories exempted or waived under 45 CFR 46, Section 101(b)(1-6) or 101(i), this Assurance applies to all research involving human subjects, and all other activities which even in part involve such research, regardless of sponsorship, if one or more of the following apply:
   1. the research is sponsored by this institution, or
   2. the research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities, or
   3. the research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
   4. the research involves the use of this institution's non-public information to identify or contact human research subjects or prospective subjects.
2. All human subject research which is exempt under 45 CFR 46, Section 101(b)(1-6) or 101(i) will be conducted in accordance with: (1) the Belmont Report, (2) this institution's administrative procedures to ensure valid claims of exemption, and (3) orderly accounting for such activities.
3. Components of this institution are bound by the provisions of this Assurance. Those components which can be expected to participate in human subject research sponsored by DHHS or other Federal departments or agencies for which this Assurance will apply are identified in Appendix A. Appendix A will be revised as changes occur and revisions forwarded to OPRR.
4. This Assurance must be accepted by other Federal departments or agencies that are bound by the Federal Policy for the Protection of Human Subjects when appropriate for the research in question and therefore applies to all human subject research so sponsored. Research that is neither conducted nor supported by a Federal department or agency but is subject to regulation as defined in 45 CFR 46, Section 102(e) must be reviewed and approved, in compliance with 45 CFR 46, Sections 101, 102, and 107 through 117.

PART 2 - RESPONSIBILITIES

A. Responsibilities of the Institution

1. This institution acknowledges that it bears full responsibility for the performance of all research involving human subjects, covered by this Assurance, including complying with Federal, state, or local laws as they may relate to such research.
2. This institution will require appropriate additional safeguards in research that involves: (1) fetuses, pregnant women, or human ova in vitro fertilization (see 45 CFR 46 Subpart B), (2) prisoners (see 45 CFR 46 Subpart C), (3) children (see 45 CFR 46 Subpart D), (4) the cognitively impaired, or (5) other potentially vulnerable groups.
3. This institution, including all its named components (see Appendix A), acknowledges and accepts its responsibilities for protecting the rights and welfare of human subjects of research covered by this Assurance.
4. This institution is responsible for acquiring appropriate Assurances or Amendments and certifications of IRB review and approval for federally sponsored research from all its standing affiliates (see Appendix B) and Assurances or Agreements for all others, domestic or foreign, which may otherwise become affiliated on a limited basis in such research.
5. This institution is responsible for ensuring that no affiliates cooperating in the conduct of federally sponsored research for which this Assurance applies do so without an appropriate assurance of compliance and satisfaction of IRB certification requirements.
6. In accordance with the compositional requirements of 45 CFR 46, Section 107, this institution has established the IRBs listed in the attached rosters (see Appendix C). Certain research supported by the U.S. Department of Education will be reviewed in accordance with the requirements of Title 34 CFR Parts 350 and 356 which require that the IRBs include one person who is primarily concerned with the welfare of handicapped children or mentally disturbed persons.
7. This institution will provide both meeting space and sufficient staff to support the IRB's review and record keeping duties.
8. This institution recognizes that involvement in research activities of any OPRR-recognized Cooperative Protocol Research Programs will involve additional reporting and record keeping requirements related to human subject protections.
9. This institution is responsible for ensuring that it and all its affiliates comply fully with all applicable Federal policies and guidelines, including those concerning notification of seropositivity, counseling, and safeguarding confidentiality where research activities directly or indirectly involve the study of human immunodeficiency virus (HIV).

B. Responsibilities of the Office of Sponsored Programs Administration (OSPA)

1. Institutional determinations concerning exemptions, sponsorship, and certification.
   1. The OSPA shall review all research proposals to external agencies to insure compliance with University policy and procedures. If a research project is approved by the IRB, but not permitted due to lack of compliance with institutional or other obtaining policy (e.g., failure to comply with financial disclosure requests), the OSPA will promptly convey notice to the investigator and the IRB chair. Neither the OSPA nor any other office of the institution may approve a research activity that has been disapproved by the appropriate IRB.
   2. All exempted research protocols and all protocols approved by an IRB which are being submitted for external funding shall be forwarded to the potential sponsor by the OSPA. Each protocol submitted to any potential sponsor by the OSPA in accordance with sponsor requirements and procedures may include:
      1. certification that the research was reviewed and approved by an IRB established under this assurance; or
      2. certification that the research was reviewed and approved by an IRB established under another assurance; (The identification numbers of the approving IRB and the assurance under which it was established along with a copy of the signed agreement must be included with the certification.) or
      3. notification that the research was determined to be exempt from coverage under 45 CFR 46 or that coverage was waived.
2. Compliance with the Investigational New Drug or Device Certification Requirement.
   1. The OSPA shall identify the test article (i.e.; drug, biologic, or device) in the certification to DHHS when the proposal involves a test article and state whether the 30-day interval required for test articles has elapsed or was waived by the FDA.
   2. If the 30-day interval has expired, the OSPA shall state in the certification to HHS whether the FDA has requested that the sponsor continue to withhold or restrict the use of the test article for application in human subjects.
   3. If the 30-day interval has not expired and a waiver has not been issued, the OSPA shall send a statement to DHHS upon expiration of the interval.
3. Certification requirement in cases of supplements to externally funded protocols
   1. The OSPA is responsible to certify IRB approval to sponsoring agencies or submit revised protocols, etc. when:
      1. it is proposed to involve human subjects, and the activity previously had only indefinite plans for the involvement of human subjects; or
      2. it is proposed to involve human subjects, and the activity previously had no plans for the involvement of human subjects; or
      3. it is proposed to change the involvement of human subjects and that involvement is significantly different from that which was initially approved by the IRB.
4. Maintenance of records.
   1. The Office of Grant and Contract Services will retain copies of all proposals and IRB approvals (Form OSPA-HS-1A) and/or "Certification of Exemption" (Form OSPA-HS-1) for projects submitted to and carried out under support of external agencies for at least three years after the completion of the research.

C. Responsibilities of the Vice President for Research (VPR)

1. Oversee establishment of Institutional Review Boards (IRBs)
   1. Membership of IRBs will be nominated by the Deans of the Schools/Faculties which they will serve and appointed by the President upon recommendation of the Vice President for Research.
2. Assure that IRB membership requirements are observed
   1. Each IRB shall be comprised of at least five members from diverse backgrounds to promote complete and adequate review of research activities covered by this assurance, and shall have the professional competency necessary to review the specific research activities which will be assigned to it.
   2. Each IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members' backgrounds, including consideration of the racial and cultural backgrounds of members 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.
   3. When research is reviewed involving a category of vulnerable subjects (e.g., prisoners; children; individuals institutionalized as mentally disabled), each IRB shall include in its reviewing body one or more individuals who have as a primary concern the welfare of the subjects.
   4. Each IRB includes both male and female members.
   5. Each IRB includes members representing a variety of professions.
   6. Each IRB includes at least one member whose primary expertise is in a non-scientific area.
   7. Each IRB includes at least one member who is not otherwise affiliated with the institution and who is not a part of the immediate family of a person affiliated with the institution.
   8. No IRB may have a member participating in its initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
   9. An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
3. Reporting requirements
   1. The Vice President for Research (VPR) shall be solely responsible for promptly reporting information, as appropriate, to the IRB, the OPRR, and research investigators and department heads on a variety of issues. Information may flow from sources such as human subjects, research investigators, IRBs, or other institutional staff. Specifically, the VPR shall:
      1. report promptly to the OPRR any injury to human subjects and any unanticipated problems involving risks to subjects or others;
      2. report to the appropriate IRB information received concerning noncompliance by research investigators, injuries to subjects, unanticipated problems involving risks, changes proposed in research activities, and the progress of research;
      3. maintain information concerning the IRB's reasons for the termination or suspension of IRB approval, and notify the sponsor in accordance with its established requirements and/or procedures;
      4. report promptly any changes in IRB membership to the OPRR.
4. Maintenance of Records
   1. The VPR will designate procedures for the retention of signed consent documents for at least three years past completion of the research activity.
   2. The VPR will maintain and arrange access for inspection of IRB records as provided for in Section 115.
5. Ensuring Effective Communication
   1. The VPR is responsible for ensuring effective communication among the research administrators, department heads, research investigators, clinical care staff, human subjects, and institutional officials as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the subjects.
6. Conformance with Special Reporting Requirements
   1. The VPR will ensure (a) solicitation, receipt, and management of all assurances of compliance (whatever the appropriate format), and certifications of IRB review (where appropriate) for all affiliates to this institution (including those listed in Appendix B), and (b) subsequent submission of these documents to the proper authorities as a condition for involvement in human subject research activities sponsored by DHHS or any other Federal department or agency for which this Assurance applies.
   2. The VPR will ensure that all affiliated performance sites that are not otherwise required to submit assurances of compliance with Federal regulations for the protection of research subjects at least document mechanisms to implement the equivalent of ethical principles to which this institution is committed.
   3. When an IRB of this institution accepts responsibility for review of research which is subject to this Assurance and conducted by any independent investigator who is not otherwise subject to the provisions of this Assurance, the VPR will obtain and retain a Noninstitutional Investigator Agreement (NIA) to document the investigator's commitment to abide: (1) by the same requirements for the protection of human research subjects as does this institution and (2) the determinations of the IRBs.
   4. The VPR will be responsible for ensuring conformance with special reporting requirements for any OPRR-recognized Cooperative Protocol Research Programs in which the signatory institution participates.
   5. The VPR will be responsible for arranging procedural and record keeping audits by the University's Internal Audit Department not less than once every year for the purpose of detecting, correcting, and reporting (as required) administrative and/or material breaches in uniformly protecting the rights and welfare of human subjects as required at least by the regulations and as may otherwise be additionally required by this institution.
   6. The VPR will ensure compliance with the requirements set forth in this Assurance and Section 114 regarding cooperative research projects. In particular, where the IRB of another institution with a DHHS MPA is relied upon, the VPR will ensure documentation of this reliance will be (a) in writing, (b) approved and signed by the VPR or a designee, (c) approved and signed by the correlative officials of each of the other cooperating institutions, and (d) retained by the VPR for at least three years past completion of the related research project. Where an agreement between IRBs under different MPAs is planned, the VPR will forward a copy of the required signed understanding to OPRR for approval and for inclusion in this Assurance as an addendum.

D. Institutional Review Board Responsibilities

1. Provision of Human Subjects Documents to Investigators and Reviewers
   1. The IRBs will arrange for and document in their records that each individual who conducts or reviews human subject research has been provided with a copy of this Assurance, as well as with ready access to copies of 45 CFR 46, regulations of other Federal departments or agencies as may apply, the Belmont Report, and all other pertinent Federal policies and guidelines related to the involvement of human subjects in research.
2. IRB Meetings
   1. Convened meetings of each IRB shall occur:
      1. at regular intervals depending upon the volume of proposals anticipated, and at the call of the chairperson when the chairperson judges the meeting to be necessary or advantageous; and
      2. at the call of the chairperson upon receipt of a joint written request of three or more members.
      3. at the request of any IRB member or institutional official to consider any matter concerned with the rights and welfare of any subject.
   2. Requirements for a valid meeting
      1. a majority of the voting members of the IRB must be present
      2. at least one member whose primary concerns are non-scientific
   3. Representation
      1. The IRB will ensure input from affiliated institutions that are identified as performance sites in a research protocol.
      2. This representation may be through a voting or non-voting member or a consultant or approval of a designated official of the performance site.
3. IRB review and approval of research
   1. The IRBs will review all research (whether exempt or not) and decide whether the institution will permit the research. If approved by the IRB, but not permitted by the OSPA, the OSPA will promptly convey notice to the investigator and the IRB Chair. Neither the Office of the Vice President for Research nor any other office of the institution may approve a research activity that has been disapproved by the appropriate IRB.
   2. The IRBs will receive from investigators all research protocols which involve human subjects, keep investigators informed of decisions and administrative processing, and return all disapproved protocols to them.
   3. The IRBs are responsible for reviewing the preliminary determinations of exemption made by investigators and for making a final determination based on Section 101 of the regulations. Notice of the IRBs determination that research is exempt will be promptly conveyed in writing to the investigator.
   4. The IRBs will make the preliminary determination of eligibility for expedited review procedures (see Section 110). Expedited review of research activities will not be permitted where full board review is required.
   5. The IRBs shall have the responsibility to review and the authority to approve, require modification in, or disapprove all activities or proposed changes in previously approved activities covered by this assurance.
   6. The IRBs shall approve research based on the determinations that the following requirements are satisfied:
      1. Risks to subjects are minimized:
         1. by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and,
         2. whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
      2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB shall 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 shall not consider long-range effects of applying knowledge gained in the research as among those research risks that fall within the purview of its responsibility.
      3. Selection of subjects is equitable. In making this assessment the IRB shall take into account the purposes of the research, and the setting in which the research will be conducted and the population from which subjects will be recruited.
      4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116.
      5. Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117.
      6. Where appropriate, the research plan makes adequate provision for monitoring the data collected to insure the safety of subjects.
      7. Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
      8. Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness, or persons who are economically or educationally disadvantaged, appropriate additional safeguards have been included in the study to protect the rights and welfare of these subjects.
      9. The IRBs will determine, in accordance with the criteria found at 45 CFR 46.111 and Federal policies and guidelines for involvement of human subjects in HIV research, that protections for human research subjects are adequate.
      10. Where appropriate, the IRBs will determine that adequate additional protections are ensured for fetuses, pregnant women, prisoners, and children, as required by Subparts B, C, and D of 45 CFR 46. The IRBs will notify VPR promptly when IRB membership is modified to satisfy requirements of 45 CFR 46.304 and when the IRB fulfills its duties under 45 CFR 46.305(c).
4. Documentation of informed consent
   1. In accord with 45 CFR 46.117, the IRB shall require documentation of informed consent by use of a written consent form approved by the IRB. The consent form will include the dates of IRB approval and of approval expiration. Waiver of the requirement for the research investigator to obtain a signed consent form for some or all subjects may be obtained if the IRB determines that:
      1. the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research and the subject's wishes will govern; or
      2. the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
   2. When the documentation requirement is waived, the IRB may require the research investigator to provide subjects with a written statement regarding the research.
5. Waiver or alteration of informed consent
   1. The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent provided the IRB finds and documents that:
      1. The research is to be conducted by, or subject to, the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
         1. federal, state or local benefit or service programs which are not themselves research programs, or
         2. procedures for obtaining benefits or services under these programs, or
         3. possible changes in or alternatives to these programs, or
         4. possible changes in methods or levels of payment for benefits or services under these programs,
         
         and
         
         
      2. The research could not practicably be carried out without the waiver or alteration.
   2. The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in 45 CFR 46.116(a) & (b), or waive the requirements to obtain informed consent provided the IRB finds and documents that:
      1. the research involves no more than minimal risk to the subjects;
      2. the waiver or alteration will not adversely affect the rights and welfare of the subjects;
      3. the research could not practicably be carried out without the waiver or alteration; and
      4. whenever appropriate the subjects will be provided with additional pertinent information after participation.
6. Observation of the consent process and the research
   1. Each IRB shall have the authority to observe or have a third party observe the consent process and the research
7. Frequency of review
   1. No IRB may approve a protocol for a period in excess of one year. Each IRB shall determine, in its review of research protocols, which projects will require IRB review more often than annually. The IRB will notify the investigator in its letter of approval that research may not continue beyond the period for which the IRB has provided approval without subsequent re-approval by the IRB
8. Continuing review
   1. Each IRB shall conduct continuing review of research and approve its continuation at intervals appropriate to the degree of risk, but not less than once per year. Investigators should be notified by the IRB sufficiently in advance so that a request for continuation can be filed in a timely fashion. This notification should inform the investigator that research may not be continued beyond the period for which the IRB has provided approval
9. Review of Cooperative Protocol Research Programs
   1. The IRBs will act with reasonable dispatch, upon request, to provide full board review of protocols of OPRR-recognized Cooperative Protocol Research Programs (CPRPs). The IRB will not employ expedited review procedures for CPRP protocols when they are to be entered into for the purpose of research. Although emergency medical care based on such protocols is permitted without prior IRB approval, patients receiving emergency care under these conditions will not be counted as research subjects and resultant data will not be used for research purposes
10. Verification of change
    1. Each IRB shall determine which projects need verification from sources other than the research investigators that no material changes have occurred since previous IRB review
11. Authority to suspend or terminate approval of research
    1. Each IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's decision, conditions, and requirements or that has been associated with unexpected serious harm to subjects
12. Information dissemination and reporting requirements
    1. The IRB will forward certification of IRB approval of proposed research to OSPA only after all IRB-required modifications have been incorporated to the satisfaction of the IRB.
    2. The IRBs shall be responsible for promptly reporting information to the VPR on a variety of issues. In conjunction with this requirement, the IRB must be prepared to receive and act on information received from a variety of sources, such as human subjects, research investigators, the VPR or other institutional staff. For reporting purposes, the IRB will follow the procedures described below:
       1. injuries to human subjects -- Information received by the IRB concerning injuries to subjects shall be reported promptly to the VPR;
       2. unanticipated problems -- Information received by the IRB concerning unanticipated problems involving risks to subjects or others shall be reported promptly to the VPR; and
       3. any serious or continuing noncompliance by research investigators with the requirements of the IRB -- This information shall be reported promptly to the VPR;
       4. suspension or termination of IRB approval -- Each IRB suspending or terminating approval of research protocols shall include a statement of the reasons for the IRB's action and shall report the action promptly to the research investigator and the VPR
13. IRB records
    1. Each IRB shall prepare and maintain adequate documentation of IRB activities, including the following:
       1. record of all research proposals to external agencies reviewed; copies of proposed protocols for institutionally supported research; scientific evaluations, if any, that accompany the proposals; approved sample consent documents; progress reports submitted to the IRB by research investigators and reports of injuries to subjects; (Copies of proposals to external agencies are retained with the institutional approvals by the Office of Sponsored Program Services.)
       2. minutes of IRB meetings which shall be in sufficient detail to show the names of attendees at the meetings including those other than regular voting members; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; a written summary of the discussion of controverted issues and their resolution; and dissenting reports and opinions. If a member in attendance has a conflicting interest regarding any project, minutes shall show that this member did not participate in the review, except to provide information requested by the IRB;
       3. records of continuing review activities;
       4. copies of all correspondence between the IRB and the research investigator(s);
       5. a list of IRB members as required by 45 CFR 46.103(b)(3);
       6. written procedures for the IRB as required by 45 CFR 46.103(b)(4);
       7. statements of significant new findings provided to subjects, as required by 45 CFR 46.116(b)(5).
    2. Each IRB shall provide for the maintenance of records relating to a specific research activity for at least three years after termination of the last approval period for the activity.
    3. Records shall be accessible for inspection and copying by authorized representatives of sponsoring agencies at reasonable times and in a reasonable manner or shall be copied and forwarded when requested by authorized representatives.
14. Procedures
    1. IRB receives protocol
       1. The IRB chairperson shall receive all nonexempt research protocols and certified HS-1A, "Investigation Involving Human Subjects--Certification of Exemption," forms from the Project Director/Principal Investigator.
    2. Determination of review procedure.
       1. The chairperson shall determine whether the certificate of exemption, HS-1A, complies with Section 101 of the regulations and notify the investigator of the determination
       2. The chairperson shall determine whether the research protocol meets the criteria necessary for an expedited review process.
       3. The chairperson refers all research protocols to either full committee review or expedited review.
    3. Expedited review
       1. The eligibility of some research for review through the expedited procedure is in no way intended to negate or modify the policies of this institution or the other requirements of 45 CFR 46.
       2. An IRB may use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized.
       3. The only other research for which an IRB may use an expedited review procedure is that which involves no more than minimal risk to the subjects and in which the only involvement of human subjects will be in one or more of the following categories:
          1. collection of hair and nail clippings, in a non-disfiguring manner, deciduous teeth; and permanent teeth if patient care indicates a need for extraction;
          2. collection of excreta and external secretions, including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor;
          3. recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy; It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (e.g., x-rays, microwaves).
          4. collection of blood sample by venipuncture, in amounts not exceeding a total of 450 milliliters in any eight week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant;
          5. collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
          6. voice recordings made for research purposes such as investigations of speech defects;
          7. moderate exercise by healthy volunteers;
          8. the study of existing data, documents, records, pathological specimens, or diagnostic specimens;
          9. research on individual or group behavior or characteristics of individuals, such as studies of perception; cognition; game theory; or test development, where the research investigator does not manipulate subject's behavior and the research will not involve stress to subjects;
          10. research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required;
          11. any other category specifically added to this list by DHHS and published in the Federal Register.
       4. Expedited review shall be conducted by the chairperson or by one or more of the experienced members designated by the chairperson to conduct the review.
       5. The member(s) conducting the expedited review may exercise all of the authorities of the IRB except that the reviewer(s) shall refer to the full committee any research protocol which the reviewer(s) would have disapproved for review, or which the reviewer(s) believes warrants full committee review.
       6. When the expedited review procedure is used, the chairperson or member(s) conducting the review shall inform IRB members of research protocols which have been approved under the procedure at the first subsequent convened meeting. This approval will be made a matter of record in the regular minutes of the IRB meeting.
       7. At a convened IRB meeting, any member may request that an activity which has been approved under the expedited procedure be reviewed by the IRB in accordance with non-expedited procedures. A vote of the members shall be taken concerning the request and the majority shall decide the issue.
15. Full committee review
    1. Research protocols scheduled for review shall be distributed to all members of the IRB prior to the meeting providing adequate time for thorough review.
    2. When it is determined that consultants or experts will be required to advise the IRB in its review of a protocol, the research protocol shall also be distributed to the consultants or experts prior to the meeting.
    3. All IRB initial review and continuing review shall be conducted at convened meetings and at timely intervals.
    4. A majority of the membership of an IRB constitutes a quorum and is required in order to convene a meeting for the review of research protocols.
    5. An IRB member whose concerns are primarily in non-scientific areas must be present at each convened meeting before the IRB can conduct its review of research.
    6. For a research protocol to be approved it must receive the approval of a majority of those members present at the convened meeting.
    7. No IRB may have a member participating in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
    8. In cases where research activities were initially approved under expedited procedures and subsequently reviewed by non-expedited procedures, the decision reached at the convened meeting shall supersede any decisions made through the expedited review.
16. IRB notification to research investigators and the OSPA of decision(s)
    1. The IRBs shall notify the research investigator(s) in writing of any conditions and/or requirements which would require modification of the proposal and/or protocol, and ascertain that such modifications be made prior to forwarding their approval to the OSPA
    2. The IRBs shall provide in writing to the research investigator(s) reasons for their decision to disapprove a research protocol and an opportunity for the research investigator to respond, in person or in writing

E. Responsibilities of the Research Investigator

1. Responsibilities of Investigators
   1. Research investigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of this assurance.
2. Determination of human subject involvement
   1. Research investigators shall make a determination as to whether research will involve human subjects as defined in 45 CFR 46.102.
   2. When it is not clear whether the research involves human subjects as defined in 45 CFR 46.102, research investigators should seek assistance from the cognizant IRB in making this determination.
3. Determination of exemption eligibility.
   1. Research investigators shall make preliminary determination as to whether such research which does involve human subjects is exempt from coverage under one or more of the criteria listed immediately below, and certify thereto, using Form OSPA-HS-1 "Investigation Involving Human Subjects--Certification of Exemption." The IRB Chair will make the final determination of exemption from applicable Federal regulations or provisions of this Assurance.
   2. Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from federal regulations unless the research is covered by subparts B through D of 45 CFR 46:
      1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
         1. research on regular and special education instructional strategies, or
         2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
      2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
         1. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
         2. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
      3. Research involving the uses of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
         1. The human subjects are elected or appointed public officials or candidates for public office; or
         2. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
      4. Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
      5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
         1. Public benefit or service programs;
         2. procedures for obtaining benefits or services under those programs;
         3. possible changes in or alternatives to those programs or procedures; or
         4. possible changes in methods or levels of payment for benefits or services under those programs.
      6. Taste and food quality evaluation and consumer acceptance studies,
         1. if wholesome foods without additives are consumed; or
         2. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Food Safety and Inspection Service or the U.S. Department of Agriculture.
4. Preparation of protocol
   1. Research investigators shall prepare a protocol giving a complete description of the proposed research. In the protocol, research investigators shall make provisions for the adequate protection of the rights and welfare of prospective research subjects and insure that pertinent laws and regulations are observed. This requirement is applicable even in cases where the research is exempt under 45 CFR 46.101.
   2. Research investigators shall include samples of proposed informed consent forms with the protocol.
5. Submission and Approval of the Proposal/Protocol
   1. In accordance with established University procedures, the investigator will process research proposals/protocols through the Department Chairperson, Dean, and the Office of Sponsored Programs Administration (OSPA), for their review and approval. In addition:
   2. The investigator will be responsible to send any protocol which involves use of human subjects, approved in accordance with a. above, to the cognizant Institutional Review Board for review and approval in accordance with regulations cited herein and the following considerations:
      1. Research protocols to be submitted for external support and involving exempt categories under 45 CFR 46.101 will be accompanied by University form OSPA-HS-1, "Investigation Involving Human Subjects--Certification of Exemption," with appropriate certification. The certified HS-1 form will be retained with the Administration copy of the pending proposal application. Appropriate certification will be sent to potential sponsors as applicable under their current procedures. An acknowledgement and approval copy of the certified HS-1 form will be sent to the Project Director and the cognizant IRB by the OSPA.
      2. Research or other protocols involving human subjects not exempted as above, to be submitted to external agencies for support, will be submitted by the Project Director to the cognizant Institutional Review Board with an appropriately certified OSPA-HS-1A, "Investigation Involving Human Subjects" form, for Board approval and certification. A copy of the certified form HS-1A bearing Committee approval of the protocol will be forwarded to the OSPA for institutional records. The OSPA will notify potential sponsors of institutional approval of the protocol in accordance with their current procedures.
6. Submission of a supplement to an original protocol to the IRB
   1. Research investigators shall be responsible for submitting a supplement and the original protocol to the IRB when:
      1. it is proposed to involve human subjects, and the activity previously had only indefinite plans for the involvement of human subjects; or
      2. it is proposed to involve human subjects, and the activity previously had no plans for the involvement of human subjects; or
      3. it is proposed to change the involvement of human subjects and that involvement is significantly different from that which was initially approved by the IRB.
7. Complying with IRB decisions
   1. Research investigators shall be responsible for complying with all IRB decisions, conditions, and requirements.
8. Obtaining informed consent
   1. Research investigators are responsible for obtaining informed consent in accordance with 45 CFR 46.116, and for insuring that no human subject will be involved in the research prior to the obtaining of the consent.
   2. Unless otherwise authorized by the IRB, research investigators are responsible for insuring that legally effective informed consent shall:
      1. be obtained from the subject or the subject's legally authorized representative;
      2. be in language understandable to the subject or the representative;
      3. be obtained under circumstances that offer the subject or the representative sufficient opportunity to consider whether the subject should or should not participate; and
      4. not include exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights or releases, or appears to release the research investigator, the sponsor, the institution, or its agents from liability for negligence.
9. Providing basic elements of informed consent
   1. Unless otherwise authorized by the IRB, research investigators at a minimum shall provide the following information to each subject:
      1. a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
      2. a description of any reasonably foreseeable risks or discomforts to the subject;
      3. a description of any benefits to the subject or to others which may reasonably be expected from the research;
      4. a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
      5. a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
      6. for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
      7. an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and  
      8. a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
10. Providing additional elements of information
    1. When required by the IRB, the research investigator shall provide one or more of the following additional elements of information to each subject:
       1. a statement that the particular treatment of procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
       2. anticipated circumstances under which the subject's participation may be terminated by the research investigator without regard to the subject's consent;
       3. any additional costs to the subject that may result from participation in the research;
       4. the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
       5. a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
       6. the approximate number of subjects involved in the study.
11. Documentation of informed consent
    1. Research investigators shall be responsible for insuring that informed consent is documented by the use of a written consent form approved by the IRB including dates of approval and expiration and signed by the subject or the subject's legally authorized representative, unless this requirement is specifically waived by the IRB.
    2. Research investigators shall insure that each person signing the written consent form is given a copy of that form.
    3. Research investigators may use a consent form which is either:
       1. a written consent document that embodies the elements of informed consent required by 45 CFR 46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the research investigator shall give either the subject or the representative adequate opportunity to read the form before signing it; or
       2. a "short form" written consent document stating that the elements of informed consent required by 45 CFR 46.116 have been presented orally to the subject or the subject's legally authorized representative. When the "short form" is used, research investigators shall insure that:
          1. a witness is present at the oral presentation,
          2. the short form is signed by the subject or the representative,
          3. the witness signs both the short form and a copy of the written summary of the oral presentation,
          4. the person obtaining consent signs a copy of the summary,
          5. a copy of both the short form and summary is given to the subject or the representative, and
          6. the written summary of what is to be said to the subject or the representative receives the prior approval of the IRB.
12. Retention of signed consent documents
    1. Research investigators are responsible for placing the consent documents signed by human research subjects in a repository approved by the OSPA and kept for a period of three years after the final IRB approval period.
13. Submission of progress reports on the research
    1. Research investigators are responsible for reporting the progress of the research to the IRB, as often as and in the manner prescribed by the IRB on the basis of risks to subjects, but no less than once per year.
14. Submission of injury reports and reports of unanticipated problems involving risks
    1. Research investigators are responsible for reporting promptly to the IRB any injuries to human subjects.
    2. Research investigators are responsible for reporting promptly to the IRB any unanticipated problems which involve risks to the human research subjects or others.
15. Requesting Re-Approval
    1. Research investigators are responsible for submitting requests to the IRB for re-approval of their research protocol. Research may not continue beyond the specified approval period if re-approval has not been obtained from the IRB.
16. Reporting changes in the research<
    1. Research investigators are responsible for reporting promptly to the IRB proposed changes in a research activity.
    2. Changes in research during the period for which IRB approval has already been given, shall not be initiated by research investigators without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.
17. Prohibition of Use of Emergency Medical Care for Purposes of Research
    1. research investigator who is obligated by the provisions of this Assurance, any associated Inter-Institutional Amendment, or Noninstitutional Investigator Agreement will use data from patient interventions that constitute the provision of emergency medical care without prior IRB approval. A physician may provide emergency medical care to a patient without prior IRB review and approval, to the extent permitted by law (see Section 116[f]). However, such activities will not be counted as research nor the data used in support of research.
18. Notification of IRB of Intent to Admit
    1. Research investigators will advise the IRB of the intent to admit human subjects who are involved in research protocols for which this Assurance or any related Inter-Institutional Amendment or Noninstitutional Investigator Agreement applies. The IRB will notify VPR who, in turn, will notify appropriate officials of other institutions. When such admission is planned or a frequent occurrence, those institutions must possess an applicable OPRR-approved Assurance prior to involvement of such persons as human subjects in those research protocols.
19. Reporting of noncompliance
    1. Research investigators and department heads are responsible for reporting promptly to the VPR and the IRB any serious or continuing noncompliance with the requirements of this assurance or the determinations of the IRB.
20. Attending IRB meetings.
    1. To facilitate the review of research and the protection of the rights and welfare of human subjects, research investigators and department heads are encouraged to attend IRB meetings when invited by the IRB.
21. Notifying the OSPA concerning investigational new drugs
    1. The research investigators shall be responsible for notifying the Food and Drug Administration (FDA) and the OSPA whenever it is anticipated that an investigational new drug or device exemption will be required.

F. Responsibilities of Affiliated Institutions and Investigators

1. Each affiliate to this institution that is involved in DHHS-sponsored research activities must provide to the Office of the Vice President for Research an appropriate written assurance of compliance with the Belmont Report and 45 CFR 46 (or equivalent protections if a foreign site).
2. Each affiliate institution must enter into an agreement with this institution for an Inter-Institutional Amendment or for a Single Project Assurance (standard or modified), when and as appropriate, whichever is most suited to the circumstances.
3. Each non-institutional affiliate (e.g., a private practice physician not otherwise an employee of this institution or who otherwise would not ordinarily be bound by the provisions of this Assurance) who is involved in human subject research of this institution must enter into a Noninstitutional Investigator Agreement.
4. Performance sites that are legally separable components of this institution (whether an institutional or non-institutional affiliate) are not authorized to cite this Assurance.