Research Compliance Office Consent Form Workshop Kristin B. Frazier HRPP Education Specialist...
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Transcript of Research Compliance Office Consent Form Workshop Kristin B. Frazier HRPP Education Specialist...
Research Compliance Office
Consent Form Workshop
Kristin B. FrazierHRPP Education Specialist
Research Compliance OfficeJanuary 24, 2008
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
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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
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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
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Consent Process - ChildrenIf 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
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Waivers and Alterations of Informed Consent Waiver of Informed Consent Waiver of Documentation of Informed Consent Alteration of Informed Consent
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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)
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Waiver of Documentation of Informed ConsentCriteria 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
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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-regulatedresearch (device or drug safety/efficacy trials) except for Emergency Use or Planned Emergency Research
Basic Elements of Informed ConsentResearch statement: purpose, proceduresReasonably foreseeable risks or discomfortsReasonably expected benefits to participants or othersAppropriate alternativesExtent of confidentiality or privacy protectionsCompensation or treatment for research related injuryContact informationVoluntary participation statement
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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
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Waiver of Documentation of Informed ConsentTo 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)
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Identifying ParticipantsHow 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!!
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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)
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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
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Other IssuesCIRB (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
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Short Form ConsentGeneral 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
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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
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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
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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
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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
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Contact Us
Kristin Frazier, HRPP Education Specialist 724-7141, [email protected]
Research Compliance websitehttp://humansubjects.stanford.edu/
Look for notice of updates on website home page