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 Investigator’s 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 Subject’s 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: Subject’s Consent Form • Legality of the subject’s 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 they’re 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