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RSP PROJECT: Renewal of Multiple Project Assurance
Submitted by: Eugene Hern
Date: February 10, 1998

Statement of the Problem/Issue

The Wright State University's Multiple Project Human Subject Assurance needs to be renewed in order for research involving human subjects to be allowed. This involves revising the current Assurance in accordance with current OPRR recommendations.


Background

1997 DHHS ASSURANCE DOCUMENT DRAFT (WORKING) COPY

Key to revisions from 1992 Assurance Document:

1.Deletions are indicated by italics (i.e., deletions)

2.Additions are indicated in underline (i.e., additions)

3.Site-specific wording pertaining to Wright State University is indicated in underlined bold (i.e., site-specific insert)


Wright State University
Multiple Project Assurance of Compliance with DHHS Regulations
for Protection of Human Research Subjects

The Wright State University (and its off-campus academic administrative units), hereinafter known as the "institution" (See Appendix A), 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 I - PRINCIPLES, POLICIES, AND APPLICABILITY

1.Ethical Principles

A.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 source of support (i.e., sponsorship).

B.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.

II. Institutional Policy

A. All requirements of Title 45, Part 46, of the Code of Federal Regulations (45 CFR 46) will be met for all applicable DHHS supported federally-sponsored research, and all other human subject research regardless of sponsorship except as otherwise noted in this Assurance. Federal (all departments and agencies bound by the Federal Policy) funds for which this Assurance applies may not be expended for research involving human subjects unless the requirements of this Assurance have been satisfied.

B. Except for those categories specifically exempted or waived under 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 or as may be agreed to by OPRR (see Part 1, II, G). 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 infon-ned consent has been obtained from the subject or the subject's legal representative (see Sections 111, 116, and 117), unless properly waived by the IRB under Section 116(c), (d) or by any applicable waiver under Section 101(i).

C. This institution assures that before human subjects are involved in nonexempt research covered by this Assurance, the IRB(S) 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.

D. Certification of IRB review and approval for all Federally-sponsored research involving human subjects will be submitted to the Office of Research and Sponsored Programs (ORSP) 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 provided for under Section 118, applications and proposals lacking definite plans for involvement of human subjects will not require IRB review and approval prior to award. However except for research exempted or waived under Section 101(b) or (i), no human Subjects may be involved in any project supported by such awards until IRB review and approval has been certifies to the appropriate Federal Department or agency.

As required under Section 119, the IRB will review and recommend approval for proposed involvement of human subjects in Federal research activities for which there was no undertaken without prior intent for such involvement, but will not permit such involvement until certification of the IRB's review and approval is received by the appropriate Federal department or agency.

E. 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 DHHS-sponsored research will satisfactorily assure compliance with 45 CFR 46, as required (see Part 2, 1, D and 11, K), as a prior condition for involvement in DHHS-sponsored human subject research which is under the auspices of this institution (see Part 1, III, A). 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.

F. This institution will ensure that any of its affiliates collaborating entities (i.e., those entities engaged in human subject research by virtue of Subject accrual, transfer of identifiable information, and/or in exchange for something of value, such as material support [e.g., money, drugs, or identifiable specimens], coauthorship, intellectual property, or credits) materially engaged in the conduct of nonfederal sponsored research involving human subjects will possess mechanisms to protect human research subjects that are at least equivalent to those procedures provided for the ethical principles to which this institution is committed (see Part 1, I).

G. This institution will comply with the requirements set forth in 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 Research and Sponsored Programs, and (c) approved and signed by correlative officials of each of the other cooperating institutions (i.e., a Cooperative Amendment to this MPA). A copy The original of the signed understanding will serve as an addendum to this Assurance and will be forwarded to the OPRR of DHHS by the ORSP for OPRR approval.

H. 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.

I. Description of this institution's policy for the protection of human subjects is contained in its internal written procedures which are available to OPRR and other Federal department or agencies, upon request. Appendix D to this Assurance abstracts pertinent organizational, personnel, and reporting procedures sufficient to describe the substance and relative prominence conferred upon the protection of subjects.

III. Applicability

A. Except for research in which the only involvement of humans is in one or more of the categories exempted or waived under 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.

B. All human subject research which is exempt under 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.

C. 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.

D. 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 Section 102(e) must be reviewed and approved, in compliance with Sections 101, 102, and 107 through 117.

PART 2 - RESPONSIBILITIES

1.Institution

A. 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.

B. 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.

C. 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.

D. This institution is responsible for acquiring appropriate Assurances or Amendments, when requested, and affiliates 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.

E. This institution is responsible for ensuring that no affiliates performance site cooperating in the conduct of federally sponsored research for which this Assurance applies do so without Federal department or agency approval of an appropriate assurance of compliance, in whatever appropriate form, and satisfaction of IRB certification requirements.

F. In accordance with the compositional requirements of Section 107, this institution has established the IRB(S) listed in the attached roster(s) (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 IRB(S) include one person who is primarily concerned with the welfare of handicapped children or mentally disturbed disabled persons.

G. This institution will provide both meeting space and sufficient staff to support the IRB's review and record-keeping duties.

H. This institution recognizes that involvement in research activities of any OPRR-recognized Cooperative Protocol Research Programs (CPRPS) will involve additional reporting and record-keeping requirements related to human subject protections.

I. 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).

J. This institution will encourage and promote constructive communication among the research administrators, department heads, research investigators, clinical care staff, IRB, other institutional officials and human subjects as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the subjects.

II Office of Research and Sponsored Programs (ORSP)

A. The ORSP 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.

B. The ORSP is responsible for reviewing the preliminaa determinations of exemption by investigators and the Screening Committee (SC) IRB Coordinator is responsible for making the final determination with the concurrence of the Screening Committee (SC) based on Section 101 of the regulations. Notice of concurrence for all exempt research will be promptly conveyed in writing to the investigator. All nonexempt research will be forwarded to the SC (expedited review) or IRB (full board review).

C. The ORSP will make the preliminary determination of eligibility for expedited review procedures (see Section I 10). Expedited review of research activities will not be permitted where full board review is required (e.g., provision of emergency medical care which also constitutes the conduct of more than minimal risk research). Expedited review will be performed by the SC which is a subcommittee of the IRB designated by the Chairman [45 CFR 46.110(b)] and which submits its recommendations to the full Board for ratification.

D. The ORSP 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 ORSP, the ORSP will promptly convey notice to the investigator and the IRB Chair. Neither the ORSP nor any other office of the institution may approve a research activity that has been disapproved by the appropriate IRB.

E. The ORSP will forward certification of IRB approval of proposed research to the appropriate Federal department or agency only after all IRB-required modifications have been incorporated to the satisfaction of the IRIB and all IRB-required restrictions have been removed to the satisfaction of the IRB.

F. The ORSP shall receive all requested appeals of IRB decisions with attached protocols from the research investigators and initiate the process of appeal. The appeals process allows for the appointment of an ad hoc committee to review the protocol and report an advisory opinion to the IRB which has final jurisdiction over all matters pertaining to human subjects. This ad hoc committee shall consist of three (3) or more faculty and/or consultants, be appointed by the IRB, and be acceptable to both investigator(s) and the IRB.

G. The ORSP will designate procedures for the retention of signed consent documents for at least three (3) years past completion of the research activity.

H. The ORSP will maintain and arrange access for inspection of IRB records as provided for in Section 115.

I. The ORSP is responsible for ensuring constructive 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.

J. The ORSP will arrange for and document in its records that each individual who conducts or reviews human subject research has first 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.

K. The ORSP will report promptly to the IRB, appropriate institutional officials, the Office for Protection from Research Risks (OPRR), and any other sponsoring Federal department agency head:

1.any injuries to human subjects or other unanticipated problems involving risks to subjects or others,

2.any serious or continuing noncompliance with the regulations or requirements of the IRB, and

3.any suspension or termination of IRB approval for research.

L. The ORSP will ensure (a) solicitation (or confirmation where applicable assurances to comply already exist), receipt, and management of all assurances of compliance (whatever the appropriate format), and (b) certifications of IRB review (where appropriate) for all affiliates performance sites to this institution (including those listed in Appendix B), and (b) subsequent submission of these new documents to the proper Federal department or agency authorities (e.g., OPRR for DHHS) as a condition for involvement of each site in human subject research activities sponsored by DHHS or any other Federal department or agency for which this Assurance applies.

M. The ORSP 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 (see Part 1, I).

N. 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 ORSP will either (a) obtain and retain a Noninstitutional Investigator Agreement (NIA) for CPRP activities (with copy to the investigator and the authorizing CPRP) or (b) obtain an Agreement for an Independent Investigator (All) for review and approval by the appropriate Federal department or agency for non-CPRP activities to document the investigator's commitment to abide: (1) by the same requirements for the protection of human research subjects as does this institution(s) and (2) the determinations of the IRB.

O. The ORSP assumes responsibility for ensuring performance with special reporting requirements for any OPRR-recognized Cooperative Protocol Research Programs CPRPs in which the signatory institution(s) participate(s).

P. The ORSP will be responsible for procedural and record-keeping audits 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.

Q. The ORSP 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 ORSP will ensure that documentation of this reliance will be (a) in writing, (b) approved and signed by the ORSP, (c) approved and signed by the correlative officials of each of the other cooperating institutions, and (d) retained by the ORSP for at least three years past completion of the related research Project, if limited in scope t eciric research project or retained as a permanent addendum to the MPA if not restricted to a specific Project. For all Cooperative Amendments (CAs),. Where an agreement between MPA IRBs is planned, the ORSP will forward a copy the original of the required signed understanding to OPRR for approval and inclusion in this Assurance as an addendum.

III. Institutional Review Board (IRB)

A. The IRB will review and have the authority to approve, require modification in, or disapprove all research activities, including proposed changes in previously approved human subject research. For approved research, the IRB will determine which activities require continuing review more frequently than every twelve months or need verification that no changes have occurred if there was a previous IRB review and approval.

B. The SC, a standing subcommittee of the full board, shall review and have the authority to recommend to the IRB: full board approval, full board approval pending recommended changes, or review by the full board or disapproval by the full board of those research activities that are eligible for expedited review as permitted by and defined in 45 CFR 46. Review by the SC shall be subject to the following guidelines:

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. The IRB may use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized.

3. When the expedited review procedure is used, the SC members conducting the review shall inform IRB members of research protocols which have been reviewed under the procedure and the SC's recommendations for further action(s).

4. At a convened IRB meeting, any member may request that an activity which has been reviewed and recommended for approval 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.

C. IRB decisions and requirements for modifications will be promptly conveyed to investigators and the ORSP, in writing. Written notification of decisions to disapprove will be accompanied by reasons for the decision with provision of an opportunity for reply by the investigator, in person or in writing.

D. Initial and continuing convened IRB reviews and approvals will occur in compliance with 45 CFR 46 and provisions of this Assurance for each project unless properly found to be exempt (Section 101 [b] and [i]) by the Office of Research and Sponsored Programs. Continuing reviews will be preceded by IRB receipt of appropriate progress reports from the investigator, including available study-wide findings.

E. The IRB will observe the quorum requirements of Section 108(b). This institution's IRB has effective knowledge of subject populations, institutional constraints, differing legal requirements, and other factors which can foreseeably contribute to a determination of risks and benefits to subjects and subjects' informed consent and can properly judge the adequacy of information to be presented to subjects in accordance with requirements of Sections 103(d), 107(a), 111, and 116.

F. The IRB 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.

G. The IRB will ensure that legally effective informed consent will be obtained and documented in a manner that meets the requirements of Sections 116 and 117. The IRB will have the authority to observe or have a third party observe the consent process.

H. Where appropriate, the IRB 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 IRB will notify OPRR 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).

I. Scheduled meetings of the IRB for review of each research activity will occur not less than every 12 months and may be more frequent, if required by the IRB on the basis of degree of risk to subjects. The IRB may be called into an interim review session by the Chairperson at the request of any IRB member or institutional official to consider any matter concerned with the rights and welfare of any subject.

J. The IRB will prepare and maintain adequate documentation of its activities in accordance with Section 46.115 and in conformance with the Office of Research and Sponsored Programs requirements.

K. The IRB will forward to the Office of Research and Sponsored Programs any significant or material finding or action, at least to include the following:

1. injuries or any other unanticipated problems involving risks to subjects or others,

2.any serious or continuing noncompliance with the regulations or requirements of the IRB, and

3.any suspension or termination of IRB approval.

L. In accordance with Section 109, the IRB will have the authority to suspend or terminate previously approved research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.

M. The IRB for this institution will ensure effective input (consultants or voting or nonvoting members) for all initial and continuing reviews conducted on behalf of performance sites where there will be human research subjects. IRB minutes will document attendance of those other than regular voting members. The IRB list(s) in Appendix C includes those who are identified as knowledgeable about any affiliate institution having entered into an Inter-Institutional Amendment or other institutional performance site for which an Assurance is required when relying on one or more of the IRBs of this institution.

N. The IRB will act with reasonable dispatch, upon request, to provide full board review of protocols of OPRR-recognized Cooperative Protocol Research Programs (CPRP). 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.

O. Certifications of IRB review and approval will be forwarded through the ORSP to the appropriate Federal department or agency for research sponsored by such departments or agencies.

IV. Research Investigator

A. 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.

B. Research investigators who intend to involve human research subjects will not make the final determination of exemption from applicable Federal regulations or provisions of this Assurance. That determination shall be made by the IRB Coordinator and the SC through ORSP.

C. Research investigators shall be responsible for ensuring that all research involving human subjects is submitted to ORSP.

D. Research investigators shall prepare a protocol giving a comp1ete 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. Research investigators shall include proposed informed consent forms with the protocol.

E. Research investigators are responsible for providing a copy of the IRB-approved and signed informed consent document to each subject at the time of the consent, unless the IRB has specifically waived this requirement. All signed consent documents are to be retained in a manner approved by the Office of Research and Sponsored Programs.

F. Research investigators will promptly report proposed changes in previously approved human subject research activities to the IRB. The proposed changes will not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects.

G. Research investigators are responsible for reporting progress of approved research to the Office of Research and Sponsored Programs, as often as and in the manner prescribed by the approving IRB on the basis of risks to subjects, but no less than once per year.

H. Research investigators will promptly report to the IRB any injuries or other unanticipated problems involving risks to subjects and or others.

I. No research investigator who is obligated by the provisions of this Assurance, any associated Inter-Institutional Amendment, or Noninstitutional Investigator Agreement will seek to obtain research credit for, or 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.

J. Research investigators will advise the IRB, Office of Research and Sponsored Programs and the appropriate officials of other institutions 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. 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 these research protocols.

V. Affiliated Institutions and Investigators (i.e. all performance sites, with or without IIAs)

A. Each affiliate performance site to this institution that is involved in DHHS Federally sponsored research activities must provide to the Office of Research and Sponsored Programs an appropriate written assurance of compliance with the Belmont Report and 45 CFR 46 the Federal policy, to include Subparts B, C, and D or 45 CFR where appropriate (or equivalent protections if a foreign site), for review.

B. Each affiliate institution institutional performance site must respond to a request by the Office of Research and Sponsored Programs of this institution for an Inter-Institutional Amendment or for a Single Project Assurance (standard or modified), when and, SPA, or CPA (as appropriate), which ever is most suited to the circumstances.

C. Each non-institutional affiliate performance site (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 or any other applicable institutional Assurance) who is involved in human subject research of this institution must respond to a request by the Office of Research and Sponsored Programs of this institution for either an Agreement for an Independent Investigator or a Noninstitutional Investigator Agreement when required, as appropriate, depending on the nature of the research activity.

D. Performance sites that are not legally inseparable components of from this institution (whether an institutional or non-institutional affiliate performance site) are not authorized to cite this Assurance.


Analysis

January 29, 1998

Memo for the Record:

Re: Institutional reporting requirement clause cited in NIH-OPRR's Agreement for an Independent Investigator (All) and their Interinstitutional Amendment (IIA).

During a review of an All, it was noted that one of the reporting clauses found under the section detailing IRB responsibilities stated that the IRB was responsible for reporting to the OPRR "...any changes in this research activity that are reviewed and approved by the IRB." (Item C. 4.). A review of the recent IIA submission between DA-VAMC and WSU contained similar wording (Part 2, Item 111. C. 3. reads that the cited MPA will report promptly to OPRR "any changes in this research activity that are reviewed and approved by the IRB and this Institution." Further review indicates that this wording is in the current (1997) OPRR IIA model but is NOT in our general assurances recently submitted (10/97).

This clause could be interpreted to mean that OPRR would need to be advised of ANY amendment, including administrative, to an affected protocol under IRB review. This would be an impractical burden on both the IRB and on the review facilities at the OPRR.

In a phone conversation with Dr. Katherine Duncan, Adjunct Medical Officer, NIH-OPRR, on January 28, 1998, it was indicated that OPRR did not mean the reporting of ALL amendments to protocols and Dr. Duncan offered the following interpretations/clarifications:

1 .This item refers only to "major changes" in the research activity [e.g., going from no human subjects to using human subjects, initiating one of the other reporting requirements mentioned in these sections (e.g., injuries to human, unanticipated problems involving risks to subjects or others, leading to suspension or termination of IRB approval)].

2 .It is subjective as to what OPRR intended to be reported but they do not want what WSU calls routine amendments (e.g., minor changes in consent forms, changes in populations, changes in procedures) unless they meet the criteria above.

In the model IIA and in future draft documents, it is OK to insert "major" before "changes" in this reporting clauses. In addition, a statement of understanding/clarification should be provided in cover letters submitted with existing documents that contain this apparently more stringent wording.


Outcome

DEPARTMENT OF HEALTH & HUMAN SERVICES
National Institutes of Health
Office for Protection from Research Risks
6100 Executive Boulevard, MSC 7507
Rockville, Maryland 20892-7507

Phone:301-496-7041
FAX: 301-402-0527

February 10, 1998

Eugene P. Hern, Ph.D.
Associate Director
Research and Sponsored Programs
Room 122, Allyn hall
Wright State University
Dayton, Ohio 45435

Subject: Multiple Project Assurance M-1021

Dear Dr. Hern:

The Department of Health and Human Services (DHHS) has approved the revision of your Multiple Project Assurance dated October 22, 1997 submitted by your institution in compliance with the requirements for the protection of human subjects (45 CFR 46).

Your new Assurance became effective on November 1, 1997, and retains the same identification number of M-1021. It will expire on October 31, 2002, and a new Assurance is to be negotiated with the Office for Protection from Research Risks (OPRR) prior to that date. Please reference your Multiple Project Assurance number with all future correspondence to this office.

Your Institutional Review Board (IRB) has been assigned identification number OINR. This IRB number, along with your Assurance number, will be required in certain forms (e.g., PHS-2590) and other correspondence.

The Assurance defines the relationship of your institution to DHHS since it sets out your responsibilities and the procedures that will be used by your institution to protect human subjects. Among the most important elements of the Assurance are the reporting requirements to this office and your agreement to disseminate the content of this Assurance to those individuals at your institution who are in any way associated with human subject research.

A copy of the approved Assurance is enclosed, as is a blank format sheet to facilitate the future reporting of changes in your IRB membership.

If I can be of further help, please contact me.

Sincerely,

Diane L. Aiken, MA
Assurance Coordinator, Assurance Branch
Division of Human Subject Protections
Office for Protection from Research Risks

Enclosures

cc: Joseph F. Thomas, Ph.D., Associate Provost for Research



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