1. Research Compliance Office Consent Form Workshop Kristin B. Frazier HRPP Education Specialist Research Compliance Office January 24, 2008

2. Research Compliance Office 2 Topics Consent Process  Children Waivers and Alterations of Consent  Oral consent, telephone screening, online consent, consent by mail Recruitment Methods Obtaining Consent Consent Form Templates  Managing your consent forms  Short form consent process CIRB Other Issues

3. Research Compliance Office 3 Consent Process Remember, it’s an ongoing process…not a one time event (e.g. sign the consent form) Valued Qualities (know your audience)  Communication – tone, vocabulary and level of discussion during the consent process  Timing – some need time to consult with others and gather their own information  Understanding – one understands when the reasons, motivations and expectations are discussed and grasped

4. Research Compliance Office 4 Consent Process eProtocol Application – section 13 Consent Background  Describe the consent process (e.g. when and where consent will be obtained and by whom)  Address potential issues of coercion and undue influence Give participants time to consider participation (let them take the consent form home, especially if a complex study) Make clear the distinction between research and treatment and that refusal to participant will not effect treatment, especially when the treating MD is the investigator

5. Research Compliance Office 5 Consent Process - Children If your protocol includes children and the children reach adulthood (18 years old) while still participating in the research, you must consent these individuals for their continuing participation in the research or request a waiver of consent from the IRB Assent is required for children between 7 and 17 years of age

6. Research Compliance Office 6 Waivers and Alterations of Informed Consent Waiver of Informed Consent Waiver of Documentation of Informed Consent Alteration of Informed Consent

7. Research Compliance Office 7 Consent – Waiver of Consent Basic Elements of Informed Consent Research statement: purpose, procedures Reasonably foreseeable risks or discomforts Reasonably expected benefits to participants or others Appropriate alternatives Extent of confidentiality or privacy protections Compensation or treatment for research related injury Contact information Voluntary participation statement Most often used for retrospective record reviews and other studies when it is impracticable (not just inconvenient) to obtain consent before conducting research Not allowed on FDA regulated research (drug and device studies)

8. Research Compliance Office 8 Waiver of Documentation of Informed Consent Criteria for IRB Approval Risks minimized, research design sound Risks reasonable with regard to benefits Subject selection equitable Informed consent from subject or LAR Informed consent documented Plan for monitoring data, when appropriate Plan for privacy/confidentiality, when appropriate Telephone screen In response to advertisement All elements of consent in phone screen Full consent process with documentation (signature) required before study procedures begin Also used for survey or questionnaire studies that are low risk (oral consent process) A signature is never obtained

9. Research Compliance Office 9 Alternations of Informed Consent Alteration of Informed Consent Can be used for deception in behavioral studies Used less frequently in medical studies Not allowed in FDA-regulated research (device or drug safety/efficacy trials) except for Emergency Use or Planned Emergency Research Basic Elements of Informed Consent  Research statement: purpose, procedures  Reasonably foreseeable risks or discomforts  Reasonably expected benefits to participants or others  Appropriate alternatives  Extent of confidentiality or privacy protections  Compensation or treatment for research related injury  Contact information  Voluntary participation statement

10. Research Compliance Office 10 Waiver and Alternations of Informed Consent To grant an alteration or waiver of consent, the IRB must find that:  The research in its entirety involves no more than minimal risk  The alternation or waiver of consent will not adversely affect participant rights and welfare  Research could not practicably be carried out without alteration or waiver  Whenever appropriate, participants are provided with additional information after participation

11. Research Compliance Office 11 Waiver of Documentation of Informed Consent To grant a waiver of documentation of consent, the IRB must find:  The research presents no more than minimal risk and involves procedures for which written consent is not normally required outside of research context or  That a signature on the consent would be the only link to participation and the principal risk to the participant would be breach of confidentiality (Not allowed by the FDA)

12. Research Compliance Office 12 Identifying Participants How are you getting participants? Clinic patients, tell then about the study at clinic visit  Can be your patients or referrals to clinic for clinical care  For former patients, you can send them a letter telling them about the study – if interested contact you Referrals for research (not for clinical care)  Tell colleagues or send them letters letting them know about your study  Colleagues can give your contact information to the patients or with the patients permission, give you the patient’s contact information  Colleagues can send their patients a letter about your study, interested participants are instructed to call you (All letters need prior IRB approval) Advertisements No cold calls and no passive consent!!

13. Research Compliance Office 13 Obtaining Consent - Process Face-to-face – obtain signature from participant before beginning any research related activity Over the phone – send (mail or fax) consent to participant, then consent process is conducted over the phone – signature is faxed or mailed back (no research related activities can take place until signature received)  Bifurcate the process – (screening consent and study consent) Screening consent (oral consent/waiver of signature) for telephone screening, then full study consent signed in face-to-face meeting if qualifies for the study Oral consent  In person – man on the street research (hand out information sheet)  Phone survey or questionnaire (waiver of signature) On-line consent  Secure computer system  Completing online survey/questionnaire evidences agreement to participate  Waiver of documentation (no signature)

14. Research Compliance Office 14 Managing Consent Forms – eProtocol Consent Form Changes  Track changes in consent and assent forms Practice Tips:  When protocol is approved, go to the approved eProtocol and down load approved consent form – accept the tracked changes and save on your computer  When submitting a subsequent event, attach the saved consent If new event includes changes to the consent, again track the new changes

15. Research Compliance Office 15 Other Issues CIRB (Central IRB) Start with CIRB approved consent forms, then add Stanford required elements and HIPAA authorization  Cancer research only, Phase I, II, III (children) and Phase III (adults) Short Form Consent Non-English speaking participants It is strongly recommended that the full English consent be translated into the participants’ language

16. Research Compliance Office 16 Short Form Consent General Information A translated consent form will usually be requested if the study targets persons who may not speak English Short form process is available and will be approved by the IRB on a case-by-case basis, depending on the complexity of the research, study duration and whether or not it is a treatment study Short form consents in 7 languages available  Spanish, Russian, Chinese, Japanese, Korean, Farsi and Vietnamese

17. Research Compliance Office 17 Short Form Consent - Process Interpreter/translator should explain the consent process to participant and review the full English consent, section by section, with the participant Witness should witness the entire process (Witness must be bilingual) Give the short form consent to participant Participant and witness sign short form consent Person Obtaining Consent and witness sign English consent

18. Research Compliance Office 18 Tissue Banking Text Stanford consent form templates  Reformatted  Revised tissue banking text For studies where specimens (blood/tissue) will be collected - the consent must include either:  A statement that left-over specimens will be destroyed at the end of the study, or  Tissue banking text regarding any future use of the specimens This applies to optional specimen collections too, whether noted in the main consent or in a separate consent

19. Research Compliance Office 19 AAHRPP Accreditation… There're coming back Stanford HRPP received full accreditation in March 2006 3 year accreditation period Starting on the re-accreditation process  Reviewing policies (HRPP) Expect a site visit in September 2008  Anticipate site visitors will want to interview investigators and research personnel again

20. Research Compliance Office 20 Contact Us Questions, concerns, comments or suggestions Feedback on IRB processes Request IRB education  Individualized  Small or large group presentations  Topic specific Suggest topics for upcoming presentations

21. Research Compliance Office 21 Contact Us Kristin Frazier, HRPP Education Specialist  724-7141, kristin.frazier@stanford.edukristin.frazier@stanford.edu Research Compliance website http://humansubjects.stanford.edu/ http://humansubjects.stanford.edu/  Look for notice of updates on website home page