1. Slide 1 Standard Operating Procedures

2. Slide 2 Goal To review the standard operating procedures Creating the informed consent document Obtaining informed consent Research involving prisoners and informed consent Research involving children and assent/informed consent Ensuring the use of the most recent informed consent forms Promptly reportable events Maintaining regulatory files

3. Slide 3 All supervisory staff must… Sign each SOP Receive training on each SOP Receive a copy of each SOP

4. Slide 4 During this training please sign… Each (7) SOP signature sheet Sign-in sheet

5. Slide 5 Creating the Informed Consent Document IRB provides templates and guidelines Understandable: reading level & language Submit to IRB with protocol Use most recent version with stamp Sponsor approval

6. Slide 6 Revising Informed Consent Form May be necessary when Protocol modified New risks identified Regulations or policies affecting informed consents change IRB and sponsor approval Re-consent participants using bolded, revised document, and clean copy for new participants

7. Slide 7 Obtaining Informed Consent Training on ethical obligations of informed consent Required of all research personnel involved in the consent process or in documenting informed consent UC’s online testing Non-UC personnel undergo training provided by the Division

8. Slide 8 Procedure for Obtaining Consent 1.All participants must complete the document prior to any study-related activities 2.Study is explained to the potential participants Risks and benefits What is required of participant Provided a copy of the document to study

9. Slide 9 Procedure, continued 3. Participant signs after agreeing to participate and all concerns have been addressed 4. Document is signed and dated by participant and person obtaining consent 5. Original document is kept in participant’s file 6. Participant is given a copy 7. Documentation of consent process kept in regulatory binder

10. Slide 10 Participants Unable to Speak English May not be excluded from the study Qualified translator included in the consent process and sign his or her name to the approved translated consent form Family members may not serve as interpreters

11. Slide 11 Participants Who Cannot Read Document, including all required elements of consent, read to participant before an impartial witness Participants signs his or her mark If PI anticipates illiterate participants, describe during initial review how consent will be handled submit a “short form”

12. Slide 12 Short Form Informed Consent IRB approves the verbal summary & short form Who signs what: Participant = short form Witness = short form and copy of summary Person obtaining consent = summary Participant receives copies of summary & form Document use of the short form

13. Slide 13 Research Involving Children Consent of one or both parents required Include in protocol whether the assent of the child is required and whether verbally or in writing IRB may require additional protections (e.g. advocate) Contact IRB first if child: Does not want to participate but parent consents Is a “mature minor”

14. Slide 14 Documentation & Informed Consent Delegation of Responsibilities Log – role of person administering consent and signature Enrollment log – records participants’ receipt of consent form IRB approval letter and stamped copies of consent form Included on consent form: Name & title of person obtaining consent Date & time Name of participant who signed consent form

15. Slide 15 Prisoners & Informed Consent Advantages of participation Sensitive to the unique environment Do not compromise their ability to weigh risks Risks no greater than for non-prisoner participants Selection of participants is free from arbitrary prison administration influence Participants understand that parole is not affected by involvement in the study

16. Slide 16 Children & Assent/Informed Consent Protocols specify minimum age eligible for participation A written assent provided to child Child reads 1 st paragraph out loud to ensure child can read. If cannot read, person obtaining consent reads document Child decides independently whether to participate and signs to indicate assent

17. Slide 17 Ensuring the Use of the Most Recent Informed Consent Forms Older versions destroyed Project director destroys forms at UC On-site staff destroy forms and confirm via email to project director Compliance officer audits Project director establishes system to easily identify most recent electronic copy

18. Slide 18 Promptly Reportable Events, Unanticipated Problems Present risk of serious harm to subject or others Principle Investigator completes and submits the Unanticipated Problems Report within 10 days of recognizing the problem IRB responses range from requesting additional information to termination of the study

19. Slide 19 Maintaining Regulatory Files All participant records and regulatory files are to be kept confidential and stored in a secure location, limited to those who create, work with, or rely on the files Binder should be labeled with the following information: sponsor, principle investigator, protocol number, protocol title In each section, move from most recent to oldest versions, material, correspondence, etc.

20. Slide 20 Monitoring Log IRB or CJName of Monitor Date

21. Slide 21 SOPs Copies of SOPs Signatures

22. Slide 22 Key Personnel Sections Delegation of Responsibilities Log – Example Required Education – Example CVs/professional licensure

23. Slide 23 Delegation of Responsibilities Log Protocol identifiers Key personnel identifiers: name, title, initials & SIGNATURE Role: principle investigator, project director, researcher Delegated duties: e.g., data collection, administer informed consent, data entry, study oversight, study coordination ( ✓ ) Start date and end date

24. Slide 24 Required Education Include copies of COI forms. NameUC/Non-UC Affiliation CITI/UC Training Date of Training COI Form

25. Slide 25 Screening Log If not applicable, insert a “note to file”. Participant ID Date Screened Met Eligibility Criteria Y/N Reason for Exclusion/ screen failure Date of Consent Enrollment Number

26. Slide 26 Enrollment Log Participant is considered enrolled once the written informed consent form is signed MUST include the following: Participant ID Date of consent Copy of signed consent given to participant (Yes/no/NA, verbal consent) If appropriate, include tracking data: e.g., completed, currently active, found ineligible after enrollment, withdrew, dismissed

27. Slide 27 Additional Sections Consent Completed Informed Consent Forms Protocol Progress Report Modifications Notes to File Protocol Violations/Unanticipated Problems Internal Audit Findings Advertising/Recruitment Materials IRB Correspondence Study Termination Misc.

28. Slide 28