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