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

2. Research Compliance Office
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
Research Compliance Office

3. Research Compliance Office
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
Research Compliance Office

4. Research Compliance Office
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
Research Compliance Office

5. Consent Process eProtocol section 13(a)
Research Compliance Office

6. Consent Process eProtocol section 13(a)
Research Compliance Office

7. 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
Research Compliance Office

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

9. 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)
Research Compliance Office

10. Waiver of Documentation of Informed Consent
Telephone screen
In response to advertisement
All elements of consent in
phone screen
Full consent process with documentation (signature) required before study procedures begin
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
Also used for survey or questionnaire studies that are low risk (oral consent process)
A signature is never obtained
Research Compliance Office

11. Alternations of Informed 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
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
Research Compliance Office

12. 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
Research Compliance Office

13. 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)
Research Compliance Office

14. 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!!
Research Compliance Office

15. Identifying Participants eProtocol section 8
Research Compliance Office

16. 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)
Research Compliance Office

17. 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
Research Compliance Office

18. Research Compliance Office
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
Research Compliance Office

19. 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
Research Compliance Office

20. 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
Research Compliance Office

21. Research Compliance Office
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
Research Compliance Office

22. 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
Research Compliance Office

23. Research Compliance Office
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
Research Compliance Office

24. Research Compliance Office
Contact Us
Kristin Frazier, HRPP Education Specialist ,
Research Compliance website
Look for notice of updates on website home page
Research Compliance Office