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HUMAN SUBJECTS PROTECTION PROGRAM

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Consent form / assent form / addendum to consent form; ... use (including consent/assent forms, addendum to consent form, and disclaimer ... – PowerPoint PPT presentation

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Title: HUMAN SUBJECTS PROTECTION PROGRAM


1
HUMAN SUBJECTS PROTECTION PROGRAM
  • Office Location
  • 1350 N. Vine Ave.
  • (one block west of Cherry Ave.
  • three blocks north of Speedway)
  • PO Box 245137
  • Phone 520 / 626-6721
  • http//vpr2.admin.arizona.edu/human_subjects/

2
Announcements
  • Recruitment of patients
  • Direct contact of patients by study personnel is
    PROHIBITED unless prior permission for such
    contact has bee obtained from the patient by
    his/her primary care physician Without this
    prior permission, the Committee considers this an
    invasion of privacy.

3
Announcements
  • Revised Project Approval Forms
  • Both of the Project Approval Forms have been
    updated to reflect the new address of the
    Committee office. Also, the forms are now
    downloadable in Microsoft Word and WordPerfect
    formats.

4
Reminder to All Investigators
  • All changes or additions to consent forms, no
    matter how minor, are to be approved by the Human
    Subjects Committee (IRB) prior to implementation.
    Use of unapproved consent forms can result in
    disallowance of enrollment.

5
Reminder to All Investigators
  • Consent forms are to be signed and dated by the
    subject (or their legal representative) AND by
    the principal investigator (no other study
    personnel may sign the Investigators Affidavit
    without prior approval of the IRB).

6
Documents to Submit for Review(effective with
September Periodic Reviews)
  • For projects which will use currently approved
    consenting documents during the next review
    period
  • Consent form / assent form / addendum to consent
    form
  • Disclaimer form used for survey participation
  • A clean copy, updated to current institutional
    standards, for approval
  • After IRB approval stamp placed on documents,
    ONLY consent/assent documents with valid IRB
    approval stamp can be used to enroll subjects

7
Documents to Submit for Review(effective with
September periodic reviews)
  • For projects which have completed enrollment and
    will no longer be using ANY consenting
    instruments (closed to new subjects/concluded)
  • Submit a copy of ALL consenting documents used
    during the CURRENT reporting period for review.
    On the front page of the form(s), clearly mark
    the dates that each version was in use.

8
Periodic Review Process
  • Effective July 2000, Periodic Review Forms must
    be accompanied by a clean copy of all
    consenting documents currently in use (including
    consent/assent forms, addendum to consent form,
    and disclaimer form used for survey
    participation).
  • Each document will be marked with an IRB approval
    stamp, showing approval/expiration dates, and
    returned to the PI. Only consent/assent
    documents with valid IRB stamp can be used to
    enroll subjects.

9
Consent Documents
  • All consent/assent documents approved after June
    2000 will be marked with an IRB approval stamp
    showing approval/expiration dates.
  • Provide a minimum one inch margin at the top
    right hand corner of front page for stamp.
  • Documents will need to be re-submitted and
    approved at each periodic review.
  • Only consent/assent documents with a valid IRB
    approval stamp can be used to enroll subjects.

10
Forms on the Human Subjects Website
  • Guidelines for Subjects Consent Form(s)
  • Sample Assent Form for Projects involving Minors
  • Project Approval Form for Ethical Review of
    Activities involving Human Subjects
    (Questionnaires, Interviews, Observations,
    Video/Audio Tapes, etc.)
  • Project Approval Form for Ethical Review of
    Activities involving Human Subjects at Risk
    (Medical, drug testing, etc.)
  • Human Subjects Training Verification Form

11
Documents Requiring Translation
  • Documents requiring translation may be submitted
    in English in the original review package, but
    should include a letter stating who will be
    responsible for the translation as well as noting
    their competency to perform the translating task.
  • Consult with Human Subjects Protection Office if
    any questions.

12
Consent Forms
  • Downloadable format (Word/WordPerfect)
  • Explain thoroughly in simple lay language
  • Title form Subjects Consent Form
  • Legality of the subjects signature is the
    responsibility of the principal investigator

13
Guidelines
  • Label consent form at the top of page
  • Be careful when using 1st and 3rd person (I/you)
    in subject context form
  • Criteria for selection of participants be
    careful to explain why you have chosen that
    target audience, as well as why you have not
    included other populations

14
Guidelines
  • Procedures always tell the subject what will
    happen to them as a result of their participation
  • Sample for projects involving participant
    diaries, subjects must turn in their diary at the
    end of the project.
  • Problem the use of a diary was not mentioned in
    the consent form, but was listed in the design
    protocol

15
Guidelines
  • Procedure tell the subject what theyre going
    to be doing (stating it will take 45 minutes, but
    listing 35 minutes on another document)
  • Benefits compensation is not a benefit, but
    should be listed under the compensation section.
    SPELL OUT THE COMPENSATION (25 cash for each
    survey completed)
  • Risk on the consent form it indicates there is
    no risk to the participant, however, the
    project approval form suggests there is risk

16
Guidelines
  • Confidentiality tell subject how data will be
    used and who has access to the data (must be in
    the consent form). List phone numbers for
    participants to contact the PI and/or Human
    Subjects Offices
  • Projects involving women participants be
    careful in using he/she designations
  • Delineate section headings in the Consent Form so
    reviewers can follow your research plan

17
Documents Required for Submission to Human
Subjects Committee for Review
  • Project Approval Form (bio-med/SBS)
  • Consent Form / Assent Form, if required
  • Translator letter, if required
  • Depending on nature of project, one or more of
    the following may be required
  • Questionnaire sample
  • Potential questions to be asked
  • Observations (process)
  • Medical Records (acquisition handling of)

18
Conclusion
  • If you have not yet taken the Human Subjects
    exam, do so right away!
  • If you want to learn more about designing and
    structuring your specific design protocol
    consent forms, bring them with you to the
    workshops scheduled for October 30 and November
    14, 2001
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