Assurance of Compliance with HHS Regulations For Protection of Human Research Subjects Policy - Northern Michigan University

Purpose:
The purpose of this policy is to provide assurance that Northern Michigan University has established the Institutional Review Board (IRB) with policies and procedures for the protection of human subjects in research.

Applicability:
All faculty, staff, and students.

Northern Michigan University, hereinafter referred to as "institution", or "NMU" hereby gives assurance that it will comply with the Department of Health and Human Services (HHS) regulations for the Protection of Human Subjects (45 CRF 46, as amended) as specified below:

Statement of Applicability, Principles and General Policies.

1. Applicability:
   1. Except as noted in 2 below, this assurance is applicable to all activities which, in whole or in part, involve research with human subjects if:
      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 nonpublic information to identify or contact human research subjects or prospective subjects or
      5. the research involves subjects who are either employees or students

Proposed research projects involving human subjects at Northern Michigan University fall into one of three categories:

          (1) they may be exempt;

          (2) they may be eligible for expedited review; or

          (3) they may require approval of the full IRB.

These guidelines are listed in 45 CFR 46.101. Policies and procedures for submission of such projects to the Institutional Review Board (IRB) may be found on the web-site: http://www.nmu.edu/research/HumanSubjects.html or in the Office of Graduate Studies & Research.

Ethical Principals

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 also referred to as the Belmont Report.
   1. In addition, the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46) will be met for all applicable HHS-funded research and, except for the requirements for reporting information to HHS, all other research without regard to source of funding.

Institutional Policy

1. This institution acknowledges and accepts its responsibility for protecting the rights and welfare of human subjects of research covered by this assurance.
   1. This institution acknowledges that it bears full responsibility for performance of all research involving human subjects, covered by this assurance.
   2. This institution bears full responsibility for complying with federal, state, or local laws as they relate to research covered by this assurance.
   3. This institution has established and will maintain the IRB in accordance with 45 CFR 46. The IRB has the responsibility and authority to review, approve, disapprove or require changes in appropriate research activities involving human subjects.
   4. It is the policy of this institution, that all research covered by this assurance will be reviewed and approved by a Institutional Review Board (IRB) which has been established under another assurance of compliance negotiated with HHS. The involvement of human subjects in research covered by this policy will not be permitted until the IRB or its agent has reviewed and approved the research protocol and informed consent has been obtained in accord with and to the extent required by 45 CFR 46.116. Certification of the IRB’s review and approval for all HHS-funded research involving human subjects will be submitted to HHS with the application or proposal for funding. Furthermore, the IRB’s review of research on a continuing basis will be conducted at appropriate intervals as indicated the approval form.
   5. It is the policy of this institution that unless informed consent has been specifically waived by the IRB in accordance with 45 CFR 46.116, no research investigator shall involve any human being as a subject in research unless the research investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.
   6. This institution bears the responsibility to make available via the web a full policy manual providing all policies, procedures and regulations related to approval of research by the IRB, appointment of the membership of the IRB, types of approval of protocols, and elements of informed consent required for approval.
   7. This institution will maintain documentation of IRB activities as prescribed by 45 CFR 46.115.
   8. This institution will exercise appropriate administrative overview carried out at least annually to insure that its practices and procedures designed for the protection of human subjects are being effectively applied and are in compliance with the requirements of 45 CFR 46 and this assurance.
   9. This institution will comply with the policies set forth in 45 CFR 46, Subpart B which provides additional protections pertaining to research, development and related activities involving fetuses, pregnant women, and in vitro fertilization of the human ova.
   10. This institution will comply with the policies set forth in 45 CFR 46 Subpart C, which provides additional protections for prisoners involved in research.
   11. This institution, in addition to complying with requirements of 45 CFR 46, will consider additional safeguards in research when that research involves children, individuals institutionalized as mentally disabled and other potentially vulnerable subjects.
   12. This institution will comply with the requirements set forth in 45 CFR 46.114 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 assurance of compliance with HHS. Such acceptance must be in writing approved and signed by this Institution’s Dean of Graduate Studies & Research and approved and signed by correlative officials of each of the other cooperating institutions. A copy of the signed agreement must be forwarded to the Office for Protection from Research Risks (OPRR), HHS.
   13. This institution shall provide all members of the University community access to IRB policies and procedures via a website.

Implementation

1. 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 ensure that pertinent laws and regulations are observed. This requirement is applicable even in cases where the research is exempt under 45 CFR 46.101. NMU Protocol Guidelines may be found at www.nmu.edu/research.
      1. Research investigators shall include samples of proposed informed consent forms with the protocol.

Scientific merit and ethical consideration review

1. Department heads, through appropriate procedures established within their respective departments, are responsible for reviewing research protocols for ethical considerations and scientific merit.

Submission to the IRB.

1. Research investigators and department heads shall be responsible for ensuring that all research involving human subjects is submitted to the IRB.
2. 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.

Complying with IRB decisions.

1. Research investigators shall be responsible for complying with all IRB decisions, conditions, and requirements.

Obtaining informed consent.

1. Research investigators are responsible for obtaining informed consent in accordance with 45 CFR 46.116, and for ensuring that no human subject will be involved in the research prior to the obtaining of the consent.
   1. Unless otherwise authorized by the IRB, research investigators are responsible for ensuring that legally effective informed consent shall:
   2. be obtained from the subject or the subject’s legally authorized representative,
   3. be in language understandable to the subject or the representative,
   4. be obtained under circumstances that offer the subject or the representative sufficient opportunity to consider whether the subject should or should not participate; and
   5. 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.
2. 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 subjects 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 be reasonably 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 the compensation/treatments 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.
3. Providing additional elements of informed consent.
   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 or 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.

Documentation

1. Research investigators shall be responsible for ensuring that informed consent is documented by the use of a written consent form approved by the IRB and attached to the protocol which the IRB evaluates. Subject signature (or that of the subject’s legally authorized representative) is mandatory unless this requirement is specifically waived by the IRB.
2. Research investigators shall ensure that each person signing the written consent form is provided 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 ensure 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 said to the subject or representative receives the prior approval of the IRB.

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 IRB.
2. Submission of progress reports on the research.
3. Research investigators are responsible for reporting the progress of the research to the IRB and the Dean of Graduate Studies & Research, as often as directed by the IRB and in the manner prescribed by the IRB

Unanticipated problems involving risks and appropriate actions

1. The research investigator will cease all activities regarding the research until the Dean of Graduate Studies & Research and the IRB approve continuance of the project.
2. The research investigator holds responsibility for filing injury reports and reports of unanticipated problems involving risks.
3. Submission of injury reports and reports of unanticipated problems involving risks.
   1. Research investigators are responsible for following the guidelines established by the IRB and presented in their policy manual involving emergency measures required when an unanticipated problem occurs, and
   2. are responsible for reporting promptly to the Dean of Graduate Studies & Research, the academic department head, and the IRB of unanticipated problems, measures for treatment or correction and consequences of all actions.

Reporting of noncompliance

1. Research investigators and department heads are responsible for reporting promptly to the Dean of Graduate Studies & Research and the IRB any serious or continuing noncompliance with the requirement of this assurance and the determinations of the IRB.

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.

Notifying the IRB concerning investigational new drugs

1. The research investigators shall be responsible for notifying the Food and Drug Administration (FDA) and the Dean of Graduate Studies & Research whenever it is anticipated that an investigational new drug or devise exemption will be required.

Responsibilities of the Office of Graduate Studies & Research

1. Institutional determinations concerning exemptions, sponsorship, and certification.
2. The Office of Graduate Studies & Research shall receive from the research investigators all research protocols which involve human subjects.
3. The Dean of Graduate Studies & Research and the IRB shall keep research investigators aware of decisions and administrative processing affecting the respective protocols and shall return all disapproved protocols to the research investigators.
   1. certification that the research was reviewed and approved by the IRB, established under this assurance, or
   2. certification that the research was reviewed and approved by the IRB established under another assurance; or
   3. notification that the research was determined to be exempt from coverage under 45 CFR 46 or that coverage was waived.
4. All exempted research protocols which are being submitted for HHS funding shall be forwarded to the HHS by the Dean of Graduate Studies & Research. When the IRB approves a protocol based on the condition that the research investigator make modifications to the protocol, the Dean shall not forward the protocol to HHS until the IRB has determined that such modifications are made. As appropriate, the IRB or the Dean may negotiate protocol modifications with the research investigator. Each protocol submitted to HHS by the Dean must include:
   1. The Dean of Graduate Studies & Research shall review all exempted research as well as nonexempt research which has been reviewed and approved by the IRB to determine whether this institution shall support such research.
   2. The Dean of Graduate Studies & Research forwards all nonexempt research protocols to the IRB for review in the manner prescribed in the IRB policy manual.
      1. The Dean of Graduate Studies & Research may delegate oversight of exempt protocol determination to the chair of the IRB but maintains final authority for the process.
      2. The Dean of Graduate Studies & Research holds oversight responsibility for the review and actions of the IRB. All exemptions from coverage under 45 CFR 46 must be approved by the Dean of Graduate Studies & Research.
5. Receive appeal requests.
   1. The Dean of Graduate Studies & Research shall receive all requested appeals of IRB decisions with attached protocols from the research investigator and forward those protocols to the IRB along with the appeal rationale.
6. Comply with the Investigational New Drug or Device Certification Requirement.
   1. Shall identify the test article (i.e., drug biologic or device) in the certification to HHS when the proposal involves a test article and state whether the 30 day interval required for test article has elapsed or was waived by the FDA.
   2. If the 30-day interval has expired, the Dean 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 Dean shall send a statement to HHS upon expiration of the interval.
7. Certification requirement in cases of supplements to HHS funded protocols.
   1. The Dean of Graduate Studies & Research is responsible for submitting a certification to HHS, and when otherwise required by HHS, a supplement to an original protocol, when:
      1. it is proposed to involve human subjects, and the activity previously had only indefinite plans for the involvement of human subjects, orit is proposed to involve human subjects, and the activity previously had no plans for the involvement of human subjects, or
      2. it is proposed to change the involvement of human subjects and that involvement is significantly different form that which was initially approved by the IRB.
      3. In addition, the Dean shall ensure that no human subjects are involved in research projects for which filing of a supplement is required by HHS, prior to review of the submitted supplement and approval by appropriate HHS officials.
8. Retention of signed consent documents.
   1. The Office of Graduate Studies & Research through the IRB shall designate procedures for the retention of the signed consent documents. These documents shall be retained for at least three years after the termination of the last IRB approval period.
9. Reporting Requirements.
   1. The Office of Graduate Studies & Research shall be 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, IRB, or other institutional staff. Specifically the following will occur:
      1. report promptly to the OPRR any instances of injuries to subjects and unanticipated problems involving risks to subjects or others,
      2. report to the IRB information received concerning noncompliance by research investigators, injuries to subjects, unanticipated problems involving risks, changes proposed in research activities, and the progress of the research.
      3. maintain information concerning the IRB’s reasons for the termination or suspicion of IRB approval, and
      4. report promptly any changes in IRB membership to the OPRR.

IRB: Statement of Policies, Functions, and Procedures.

1. Responsibility and Authority of the Institutional Review Board (IRB) at Northern Michigan University (NMU):
   1. Federal standards and policies require that full authority and responsibility for safeguarding the rights and welfare of human subjects in research are placed with a committee referred to as the Institutional Review Board. At NMU the Institutional Review Board is named the Institutional Review Board (IRB) and is the local administrative unit established to ensure protection of the rights and welfare of human subjects used in research conducted under the auspices of NMU.
   2. The IRB reports directly to the Dean of Graduate Studies & Research who serves as the IRB Administrator appointed by the University to oversee research activities. Under University policy, the IRB has the authority to approve, require modification of, or disapprove any and all research activities that fall within its jurisdiction as specified by federal or local institutional policy.
   3. Research approved by the IRB may be subject to review and disapproval by institutional officials, however, institutional officials may not approve research disapproved by the IRB.
   4. The IRB, in its function as the Institutional Review Board, provides assurances to research subjects that every reasonable attempt has been made to protect their rights and safety as research subjects.
2. Institutional Review Board Membership
   1. The Code of Federal Regulations (21 CFR56 and 45 CFR 46) has established membership criteria for the Institutional Review Board (IRB). In accordance with these regulations:
      1. The IRB shall be composed of at least five (5) members with varying backgrounds to promote complete and adequate review of research activities by the institution.
      2. The IRB shall be sufficiently qualified through the experience and expertise of its members and through the diversity of its members based upon consideration of the racial and cultural backgrounds of members and their sensitivity to issues such as understanding community attitudes and promoting respect for IRB advice and counsel in safeguarding the rights and welfare of human subjects
      3. Committee membership shall:
         1. have the professional competence necessary to review specific research activities and to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.
         2. not consist entirely of one gender or of one profession.
         3. have at least one member whose primary concerns are in the non-scientific areas (e.g. lawyer, ethicist, and clergy)
         4. have one member not affiliated with NMU and who is not an immediate family member of a person affiliated with NMU.
         5. It shall permit no member to participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the committee.
         6. It may invite, at its discretion, non-voting individuals with competence in special areas to assist in the review of complex issues that require expertise beyond or in addition to that which is available to the IRB.
      4. Appointment of Members
         1. The IRB Administrator recommends the members of the IRB to the Provost and Vice President for Academic Affairs and the University President. Official appointment to the committee is made by the University President. In the event that a member resigns, the IRB Administrator shall recommend a replacement.
            1. Appointment to the committee is for a three-year term.
            2. The chair of the IRB shall be elected by its membership for a one-year period. The election shall occur at the first meeting of the fall semester.
      5. Membership Files
         1. A list of IRB members shall be available in the IRB administrator’s office, and on the Web page, and shall consist of:
            1. earned degrees
            2. representative capacity
            3. indications of experience to show anticipated contributions to the IRB’s deliberations
            4. any relationship the committee member has to the institution
   2. IRB Functions and Operations
      1. The IRB shall review all research involving human subjects, including research funded by federal, state, private, or corporate funds for which a representative of Northern Michigan University must sign; unfunded research involving NMU facilities or staff; graduate and undergraduate student research projects reaching beyond the immediate classroom. The IRB will follow the procedures outlined in this manual for carrying out its initial and ongoing review of research as well as for reporting its conclusions and actions to the researcher and the institution. The review of proposed research and the ongoing periodic review of approved research by the committee will include the following activities:
         1. Making a critical review of the procedures used to protect the rights and welfare of human subjects to ensure adequate protection; ensuring that the risks to an individual (including physical, psychological, and social) are outweighed by potential benefits to society; and ensuring that a legally acceptable informed consent will be obtained from the subject or the subject’s legally authorized representative and documented. The critical review will include a review of the research design to ensure that the design is consistent with the protection of human subjects.
         2. Making a determination of which projects have expedited review status.
         3. Providing a mechanism to facilitate prompt reporting by the principal investigator of any changes occurring in the project’s approved activities and a means to review and approve such changes prior to the implementation of changes except where it is necessary to remove immediate hazards to the human subjects.
         4. Providing and maintaining a procedure for the principal investigator to promptly report to the committee unanticipated problems involving risks to the human subjects or others.
         5. Hold periodic meetings for the purpose of reviewing proposed research projects (except for determining expedited review which is done by a subcommittee of the IRB). At least one committee member whose primary concerns are in the non-scientific area as well as the majority of IRB committee members must be present at the meeting for research to be approved.
         6. Making a report in writing to the IRB Administrator of any serious or ongoing noncompliance on the part of the researcher with the requirements and determinations of the IRB, or any noncompliance with withdrawn or suspended committee approval. The IRB Administrator, following confirmation that noncompliance has taken place, will contact the researcher’s immediate supervisor and, where required by codes or regulations, notify any appropriate federal agency in writing.
         7. The IRB shall publish policies and procedures in a timely fashion to allow investigators to make appropriate application.