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HRPP Policies

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... governing human research, and knowledge of IRB policies and procedures. ... Revised Policy. SOP 502G. Emergency Use of FDA Regulated Products ... – PowerPoint PPT presentation

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Title: HRPP Policies


1
HRPP Policies Forms Chapter Two
  • Created/Revised for AAHRPP
  • June 1, 2007

2
  • REVISED POLICIES

3
Revised Policy
  • SOP 202
  • Management of IRB
  • The performance of the IRB Chairs, Vice Chairs,
    and IRB Members shall be evaluated on an annual
    basis.
  • This periodic evaluation is conducted to assess
    performance taking into consideration, completion
    of education requirements, attendance,
    preparedness, knowledge and abilities in applying
    the ethical principles and regulations governing
    human research, and knowledge of IRB policies and
    procedures.

4
Newly Created Forms
  • Chair/Vice Chair Evaluation Form
  • Board Member Evaluation Form

5
Revised Policy
  • SOP 403
  • Initial Review - Criteria for IRB Approval
  • The IRB shall evaluate proposed research for
    scientific or scholarly validity based on the
    following
  • Whether the research uses procedures consistent
    with sound research design, which did not
    unnecessarily expose participants to risk.
  • Whether the research is designed to answer the
    proposed question.
  • The importance of the knowledge reasonably
    expected to result from the research.

6
Revised Policy
  • SOP 404
  • Continuing Review
  • As an outcome of continuing review, the IRB may
    require that the research be suspended or
    terminated as per SOP 411 Suspension or
    Termination of IRB Approval.
  • As an outcome of continuing review, the IRB may
    require that any significant new findings that
    arise from the continuing review process and that
    might relate to participants willingness to
    continue participation will be provided to
    participants.

7
Revised Policy
  • SOP 407
  • Unanticipated Problems Involving Risks to
  • Participants or Others Protocol Deviations
  • When a deviation occurs, the Investigator
    completes the protocol deviation form.
  • The Investigator determines if the protocol
    deviation meets the definition of an
    unanticipated problem according to the criteria
    indicated on the deviation form and submits the
    form to the IRB.

8
SOP 407
  • If the IRB Chair determines that the protocol
    deviation is an unanticipated problem involving
    risks to participants or others or resulted from
    serious or continuing noncompliance, the
    deviation report will be reviewed at an IRB
    meeting.
  • If the IRB Chair determines the protocol
    deviation does not meet the criteria of an
    unanticipated problem, the deviation will be
    reviewed by the expedited procedure.

9
Revised Form
  • Protocol Deviation Report Form

10
Revised Policy
  • SOP 502G
  • Emergency Use of FDA Regulated Products
  • Planned emergency research is defined as planned
    research involving a life-threatening emergency
    where the requirement to obtain prospective
    informed consent has been waived.
  • The research plan must be approved in advance by
    the FDA or DHHS and the IRB, and project, as well
    as its results, are publicly disclosed to the
    community in which the research is conducted.

11
SOP 502G
  • The IRB will not review and waive the
    requirement to obtain consent for planned
    emergency research. Therefore, no planned
    emergency research can be conducted at OU.

12
Revised Policy
  • 601
  • IRB Communication and Notification
  • Notification to Institutional Offices and
    Officials
  • The HSC IRB shall notify the HSC Office of the
    Provost, Senior Vice President and Provost as
    Institutional Official of IRB findings and
    actions. The Institutional Official shall
    receive a copy of the IRB meeting minutes for
    each IRB.

13
SOP 601
  • Questions, Concerns and Suggestions Regarding the
  • Human Research Participant Protection Program
  • Investigators can direct questions, concerns and
    suggestions regarding the Human Research
    Participant Protection Program to the HRPP
    Director.
  • Investigators can direct questions, concerns and
    suggestions regarding the Human Research
    Participant Protection Program that cannot be
    satisfactorily addressed by the HRPP Director to
    the Director of Compliance or the Institutional
    Official.

14
Revised Policy
  • SOP 70l
  • Consent Process Documentation
  • Waiver of Documentation of Informed Consent
  • If documentation of informed consent is waived,
    the Investigator will ask whether the participant
    wants documentation linking the participant with
    the research, and the participants wishes will
    govern.

15
SOP 701
  • If the IRB waives the requirement of
    documentation of informed consent, the IRB may
    require the investigator to provide a written
    statement of the research to the participant.
  • The IRB shall review and approve the written
    statement prior to the investigator providing the
    statement to the participant.
  • The consent form reviewed and approved by the IRB
    may also serve as the written statement.

16
SOP 701
  • Legally Authorized Representative
  • For research conducted outside of Oklahoma,
    individuals who meet the definition of a legally
    authorized representative are those individuals
    as described under the applicable law of the
    jurisdiction in which the research will be
    conducted.
  • If recruiting a participant from a legally
    authorized representative the investigator must
    report this category of participant on the IRB
    application and provide to the IRB the definition
    of legally authorized representative for the
    applicable jurisdiction.
  •  

17
Revised Policy
  • SOP 901
  • Quality Improvement
  • Investigator-initiated studies, where the
    investigator holds an IND/IDE, are the primary
    targets of routine evaluation.
  • When assuming the role of the sponsor, the
    investigator is evaluated to ensure compliance
    with the additional regulatory requirements as
    outline in SOP 802 Sponsor Responsibilities and
    good manufacturing practice.

18
SOP 901
  • The investigator is required to submit an annual
    report to the FDA and is notified by the IRB
    sixty days in advance of its due date.
    Compliance with this requirement is monitored by
    the IRB staff via the continuing review
    application.

19
SOP 901
  • Observation of the Consent Process
  • The IRB has the authority to observe, or have a
    third party observe, the informed consent process
    of research it has approved, and to verify that
    the study is being conducted as required by the
    IRB and within the institutional policies and
    procedures and site-specific procedures, as
    appropriate.
  • Before the IRB or third party observes the
    consent process, verbal consent of the
    participant may be sought.

20
SOP 901
  • The IRB may determine it is necessary to observe
    the
  • informed consent process in order to provide
    additional
  • protections and may conduct informed consent
  • observations in the following situations
  • Non-compliance per SOP 903,
  • Unanticipated problems involving risks to
    participants or others per SOP 407,
  • Protocol deviations as per SOP 407,
  • Participant complaints, or
  • or any other situation the IRB deems appropriate
    where additional protections are necessary.

21
Consent Observation
  • Informed Consent Observation Checklist

22
SOP 901
  • IRB Internal Evaluations/Improvement Plan
  • The HRPP shall measure and improve the programs
    effectiveness, quality, and compliance with
    organizational policies and procedures and
    applicable federal, state, and local laws.

23
SOP 901
  • IRB Internal Evaluations
  • Improvements to the HRPP program shall be
    implemented based upon measures identified
    through routine evaluations of the program.
    These improvements include education programs,
    IRB member and staff training, revising Policies
    and Procedures, and form changes.
  • The improvements shall be monitored and measured
    to determine effectiveness. If necessary,
    additional improvements shall be implemented.

24
  • VA-Specific Revisions

25
VA-Specific Revisions
  • Consent Requirement
  • If someone other than the investigator will be
    conducting the interview and obtaining consent,
    the investigator must formally delegate the
    responsibility to an individual who has received
    appropriate training to perform this activity.

26
VA-Specific Revisions
  • For VA research the legally authorized
    representative is
  • defined as the following persons in the following
    order of
  • priority
  • Health-care agent.
  • Legal guardian or special guardian.
  • A close relative of the patient eighteen years of
    age or older, in the following priority spouse,
    adult child (18 years or older), parent, sibling
    (18 years or older), grandparent, adult
    grandchild (18 years or older), close friend (18
    years or older).

27
VA-Specific Revisions
  • Exempt Research Category 2
  • Research involving the use of educational tests
    (cognitive,
  • diagnostic, aptitude, achievement), survey
    procedures,
  • interview procedures, or observation of public
    behavior,
  • unless
  • Information obtained is recorded in such a manner
    that human participants can be identified,
    directly or through identifiers linked to the
    subjects and

28
VA-Specific Revisions
  • Exempt Research Category 2
  • Any disclosure of the human participants'
    responses outside the research could reasonably
    place the participants at risk of criminal or
    civil liability or be damaging to the
    participants' financial standing, employability,
    or reputation. NOTE The Department of Veterans
    Affairs (VA) also includes loss of insurability
    in this category.

29
VA-Specific Revisions
  • Continuing Review
  • For VA research that expires because continuing
    review is not completed the IRB shall notify the
    sponsoring agency, private sponsor, Office of
    Research and Development, Office of Research
    Oversight, or other Federal agencies, as
    appropriate.

30
VA-Specific Revisions
  • Drug Dispensing Accountability
  • The investigator shall provide the pharmacy with
    a signed copy of the VA Form 10-1086 to document
    each participants consent to participate in the
    study.
  • The Investigator shall inform the Chief, Pharmacy
    Service, and the RD Committee when the research
    has been terminated.

31
Sponsored Research Agreements
  • Contracts shall
  • Identify who is responsible to provide and pay
    for medical care for research-related injuries.
  • Include language stating the sponsor will
    promptly notify the organization of any study
    results or findings that could affect the conduct
    of the study, participant safety, participants
    willingness to continue in the study, or the
    IRBs approval to continue the study.

32
  • REVISED FORMS

33
Revised Forms
  • New Research Project Application
  • Determination of Human Research Worksheet

34
Revised Consent Template
  • Consent Template

35
Revised Reviewer Checklists
  • New Study Reviewer Checklist
  • Full Board Review
  • Expedited Review
  • Exempt
  • Continuing Review Checklist
  • VA Criteria
  • Waiver of Consent

36
Effective Date
  • June 1, 2007
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