Informed Consent Process

CHARLENE MALARICK, RN, BSN, CCRC

SENIOR QI/QA SPECIALIST

PARTNERS HUMAN RESEARCH QUALITY IMPROVEMENT PROGRAM

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Objectives • Partners Quality Improvement Program

• Requirements for Informed Consent: Federal Institutional Good Clinical Practice

• Pitfalls

• Common QI Findings

• What if scenarios

• Review tools/resources

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Partners QI Program What is the QI Program?

The QI Program is committed to providing on-going support and education to the research community

What do we do?

Our Staff provide the following to the research community: Assistance with study start-up Educational In-Services Assistance with FDA Applications Assistance with ClinicalTrials.gov Registration Not-for-cause onsite reviews For-cause onsite reviews

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Historical Background Historic unethical research – no consent

National Research Act 1974 (informed consent requirement)

Belmont report 1979 (ethical principles of consent)

Development of Federal Regulations

1984 Code of Federal Regulations (required elements of consent)

1991 Common Rule (informed consent requirement for federally funded studies)

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Belmont Report Informed Consent:

Based on the principles of:

Respect for Persons

Beneficence

Justice

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Informed Consent Process Based on principles of:

Information

Comprehension

Voluntary Agreement

Requirements for Informed Consent Federal Regulations

45 CFR 46, Protection of Human Subjects

Applies to all research involving human subjects that is regulated by a federal agency

FDA, 21 CFR 50, 54, 56, 312, 812

Triggered when doing human research using a drug, biologic, and device

Institutional policies and guidance

Good Clinical Practice

Determinations of the IRB

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Federal Regulations Special considerations for vulnerable populations:

Pregnant Women (45 CFR 46.204)

Children (45 CFR 46.407)

Cognitively Impaired (45 CFR 46.111(b))

Prisoners (45 CFR 46.306)

Why it’s important

There are consequences to noncompliance

IRB

Requirements to report noncompliance to the IRB

Reports to OHRP, FDA

Suspension or restriction of research privileges

Internal effort to investigate, respond and report: IRB, QI Program,

Institutional Official, Office of General Council

FDA enforcement

Inspection

Warning letter, Disqualification, Monetary fines, Civil/Criminal liability

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Federal Requirements for Informed Consent

“The investigator must obtain legally effective informed consent of the subject or the subject's legally authorized representative.” [21 CRF 50.20]

“Informed consent shall be documented by use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent. A copy shall be given to the person signing the form.” [21 CRF 50.27]

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Required Elements of Informed Consent [21 CFR 50:25]

1. Statement that study involves “research”; purpose of study; duration; procedures (including those that are research)

2. Risks and benefits

3. Benefits to subject or others

4. Alternative procedures

5. How confidentiality will be maintained and that FDA can inspect records

6. If more that minimal risk, what, if any compensation/treatment is available if injury occurs

7. Who to contact with questions about the research, subject rights or related injury

8. Statement that participation is voluntary and can withdraw at any time

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Partners Policies

Policy: Informed Consent of Research Subjects

• Surrogate Consent

• Minors

• Non-English Speakers

Informed Consent: Surrogate Consent Policy: Surrogate Consent

Considerations:

• How and by whom is capacity to consent determined?

• There is a hierarchy for surrogates and requirements based on risk/benefit ratio

• Surrogate uses “Substituted Judgement”

• Assent of subject if capable

• If capacity regain, will re-consent be sought

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Informed Consent: Minors Policy: Informed Consent of Research Subjects

Considerations

• Minimal risk, or offers direct benefit: consent of 1 Parent (This is an IRB decision)

• Greater than minimal risk, no direct benefit: consent of both Parents

• Assent of child age 7 or older (IRB can waive in some circumstances)

Child 7-13 sign youth assent form

Child 14-17 sign youth line on adult form

• If active in study when subject turns 18, re-consent on own as adult

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Informed Consent: non English-Speakers Policy: Obtaining and Documenting Informed Consent of non English-Speakers

Partners Policy, OHRP, and FDA require:

Translator fluent in both English and the subject's spoken language AND

Written consent document in a language understandable to them

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Non-English Speaking Subjects Written consent document can be:

• A written translation of the entire English version of the Partners Human Research Committee (PHRC) approved consent document

OR

• The “Short Form."

Non English-speaking subjects Correct order for consent form signatures: everyone signs in the language understandable to them.

• Study staff – English, unless PI bilingual

• Subject – Translated form or short form

• Translator – will sign both English and translated/short form

Documents:

• Subject gets a copy of both forms

• Site keeps original of both forms

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Pitfalls - more common than you think

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Protocol adherence

Inadequate documentation of consent

PI delegation & oversight

Study documentation

Informed Consent Pitfalls Non Adherence to consent process specified in protocol:

• Using tablet or eConsent when not indicated in protocol Systems need to be vetted by IRB/Research Computing

• Obtaining phone or mail consent when protocol indicates in-person consent

Need SOP and phone script for phone consent

• Improper scanning and shredding of consent forms Need SOP for scanning and verifying paper forms

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Legally Effective Informed Consent What is legally effective informed consent?

• IRB approved form (has footer)

• Most recent approved copy

• Signed and dated by subject themselves

• Signed by study staff

• Followed policy for surrogate, minor or non English-speaker

• Followed protocol re: consent process, including any re-consent

•Subject received copy of signed consent form

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Approved Consent Form

Subject Population: Adults under going X procedure

IRB Protocol Number: 2004p-123456 Sponsor Protocol Number: 11223344______

Consent Form Valid Date: December 31, 2012 Amendment Number: _1_____________

IRB Expiration Date: December 01, 2013 Amendment Approval Date: December 31, 2012

Subject Population: Adults under going xxx procedure

IRB Protocol Number: 2012p-123456 Sponsor Protocol Number: 11223344______

Consent Form Valid Date: December 15, 2012 Amendment Number: ______________

IRB Expiration Date: December 01, 2013 Amendment Approval Date:,

An amendment to change the consent form was approved on December 31,

2012

Informed Consent – Insight Updates As of 3/05/2013, any IRB-approved informed consent form is now posted to Insight. Site should download and print consent forms as needed, to ensure that consent form is the most current and has the IRB approval footer at the bottom.

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Consent Process: Common QI Audit Findings

Missing entire consent form or missing pages

Missing IRB approval stamp or not most recent copy

Missing signatures and/or dates by subject and/or study staff

Date discrepancy between subject and staff

Not dated by subject themselves

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Consent Process: Common QI Audit Findings (cont) Subject ID not on all pages

Time of consent not completed (required if study procedures same day)

Options sections not completed

Corrections not initialed and dated; not legible

Stray notes or comments on form

Witness signature where none is needed

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Consent Process: Common QI Audit Findings

Copy not given to subject

English consent form used to consent non-English speaking subject

No documentation of consent process

Consent obtained by non IRB-approved staff

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Informed Consent Informed consent must be obtained before beginning any study related procedures.

The QI Informed Consent Compliance checklist assists in meeting the elements of informed consent.

Informed consent process must be documented. The Documentation of Informed Consent Process template can assist with this requirement.

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Consent Process: Corrective Actions As of 3/05/13, approved consents are now posted in Insight. Download as needed.

For prior consents, check IRB approval stamp for accuracy of dates and protocol number

Be sure the version being signed is most current

Obtain IRB approval for any changes to consent form

Review consent form in real time after subject signs for errors, completeness. Use QI consent checklist

Non English-speakers need consent form in their language (“short” or translated form)

What If….

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What if… You have been notified by Sponsor that there will be an audit in 6 weeks. You have enrolled 30 subjects. In preparation, you review the ICFs, and 1 is missing

2 are unstamped

1 is expired

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What if… You also notice in reviewing ICFs that:

1 staff member forgot to date

1 subject has a different date than the staff

2 staff members forgot to record times (fMRI scan done same day as consent

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What if… Your protocol involves a combined fMRI scan and muscle biopsy. The initial IRB application says consent will be obtained by an licensed physician investigator. But in reality, the research nurse has been obtaining consent.

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What if… Recently, the fMRI scanner has been out of commission, as there is an upgrade being done. Since there are other procedures being done, you continuing enrolling and just cross out the fMRI section of the ICF, making sure subjects know that part is not applicable.

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What if… Your new subject has limited English proficiency, but her daughter, a nurse’s aide, is with her. She volunteers to translate, and signs on the English form under “other individual – non-interpreter.

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Electronic Recordkeeping Include in the regulatory binder, a signed and dated note-to-file

indicating the location of electronic correspondences.

If scanning documents with signatures, have SOP that describes

method and any certification

Ensure that electronic copies are available to study staff and

regulatory authorities

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Record Retention HRC

7 years upon completion of the study

FDA

2 years after the marketing permit application is approved or terminated

At the end of study when the FDA is notified that test articles were disposed or returned and a marketing permit is not sought

Industry standard

15 years

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Tools/Resources From QI website:

• Informed Consent Compliance checklist

• Documentation of Informed Consent

• Protocol Amendment/Version Tracking Log

Partners HRC website:

• Informed Consent of Research Subjects

• Surrogate Consent

• Obtaining and Documenting Informed Consent of non English-Speakers

• FAQ – Non English-Speakers

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Informed Consent

Questions?

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