Research Compliance Office

Consent Form Workshop

Kristin B. FrazierHRPP Education Specialist

Research Compliance OfficeJanuary 24, 2008

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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, kristin.frazier@stanford.edu

Research Compliance websitehttp://humansubjects.stanford.edu/

Look for notice of updates on website home page