Part 3 of 3 part series: Informed consent:

Documentation

Wendy LloydBA, LPN, CIP,CCRP

Regulatory Compliance Analyst

Objectives:

Regulations and IRB PoliciesSuggestions of what to include in

the documentationCitations when documentation is

not presentExamples of documentation of the

consent process

If you didn’t document it, you didn’t do it!

Remember when…7/20/11- 915AM Pt Alert and Oriented X 3, skin W and D, VS stable, Resting quietly. Able to assist with bathing minimal amount. SOB during exertion. Incision 1 ½ inches wide and 2 ¾ inches long. Drainage is light green color. Drsg Δ per MD orders. WLloyd LPN118 PM Pt complained of incision pain and given percocet X 2 WLloyd LPN515 PM Patient ambulated ½ length of hall with minimal SOB. No c/o pain offered. WLloyd LPN822 PM Drsg Δ per MD orders. Minimal amount of purulent drainage noted. Pt tolerated drsg change well. Pt afebrile with VSS. Family at bedside. WLloyd LPN1125 PM Patient requested pain medication for migraine headache. Percocet X 2 provided. Patient laying in bed with lights out. Call light within reach. WLloyd LPN120 AM Patient resting quietly in bed with eyes closed.WLloyd LPN

Today…

Check boxes almost replace narrative charting

Regulations 45 CFR 46.117 (a) Except as provided in paragraph (c) of this

section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject’s legally authorized representative.

A copy shall be given to the person signing the form.

(b) Except as provided in paragraph (c) of this section, the consent form may be either of the following:◦ (1) A written consent document that This form may be

read to the subject or the subject’s legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or

◦ (2) A short form written consent document presented orally

IV.b.I.F Procedure for Documentation of Informed Consent for Human Subjects Research

The person obtaining consent should document the consent process in the participant’s medical record or the participant’s research record. This may include: ◦How consent was obtained;◦The participant’s level of comprehension ;◦The participant’s decision-making capacity

at the time of consent;◦The time given for the participant to

consider the research and whether others were involved in the decision-making; and

◦ Identify who was present during the consenting process.

45 CFR 46.117 (c) Waiver of documentation

(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:◦ (1) That the only record linking the subject

and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;

OR◦ (2) That the research presents no more than

minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

Do we still have to document the consent process if waiver granted?

Yes, unless both the process and documentation of the process has been waived

Process

Document

45 CFR 46.116 (d) general requirements of informed consent (d) An IRB may approve a consent procedure

which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

◦The research involves no more than minimal risk to the subjects;

◦The waiver or alteration will not adversely affect the rights and welfare of the subjects;

◦The research could not practicably be carried out without the waiver or alteration; and

◦Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Where documentation of consent may occur:Research ChartProgress NotesMD dictationCRC chart

Assure all documentation is consistent with:Medical history and

hospital recordsMD dictationClinic & office chartsLab resultsCommunications

(telephone and emails)

ChecklistsFlow charts

DiariesResearch chartsDrug dispensing

recordsProcedure reports

(UGI, CT, XRAY, EKG etc.)

What to document

How consent obtainedPrivate exam room

Orally presented consent document information

Consent explained over telephone

The participant’s level of comprehensionDid child appear to want to participateDid the subject appear to understandDid subject ask questions, Was subject able to reiterate

◦the main purpose of the study,◦procedures, ◦risks, ◦frequency of visits◦etc.

The participant’s decision-making capacity at the time of consentAlert and orientedComatoseUnder influence of medicationDecreased level of consciousness

Time given for participant to consider the researchAllowed time to reviewSubject allowed to take the consent

home to reviewMailed consent to subject prior to office

visitConsent read and explained to subjectConsent email/faxed

◦No original signed consent due to subject faxed consent back to office

Identify who was present during the processFamily member presentSubject aloneMother and father presentSurrogateLARTranslator

Special study requirements or circumstances

Double barrier pregnancy methodsPregnancy test resultsWash out periods for previous medicationsDiary reviewed

State that a copy of the consent was given to the person signing consent

What came first, The chicken or the Egg?

Document consent obtained prior to study procedures conducted

Special circumstances require more documentationNew information- new consentLegally authorized RepresentativeHealth Care Decision MakerSubject physically unable to sign consent (i.e.

bandaged hands, loss of limbs, contact isolation etc.) Subject not able to read a consent form (i.e. illiteracy,

vision-impairment)Signature illegibleScreen failureChange in cognitive statusWard of the stateSubject becomes incarceratedBirth control (double barrier)Non English speaking consent process

Re-consenting requires the same documentationDate of consentSubject reviewed consentRevisions verbally explained to the subjectSubjects verbally agrees to continue

participationCopy of revised consent given to subject

The patient becomes competent! Document:Subjects desire to continue,

◦Entire consent process repeated and copy given to subject

Subjects revocation: ◦The health care provider to whom the

patient communicates a revocation is responsible for documenting the revocation in the Patient’s medical record

and ◦for informing the rest of the health care

team about the revocation.

When is it time to document?Every time you have an interaction

with a subjects◦Contact for recruitment purposes◦Emails◦Telephone calls◦Face to face interactions◦Assessment of adverse events each visit◦Assessment of cognitive status each visit◦No family available to consent◦During each visit ask if subject desires to continue in the research

Is it ever ok not to document the process?

Certificate of ConfidentialityWaiver of DOCUMENTATION approval from the IRB

Key Points

Remember, organizing your paperwork can be as important as dispensing the right drug

Researchers protect human subjects by having paperwork in order

Tell a story in chronological order that is accurate and factual

Keep files secured◦Locked cabinet/room◦Password protected access

Examples of documentation

Date of Consent:_________ Name of Study: ____________IRB Study Number:_______________ Patient Name:_____________ Patient MRN:____________ Study ID#:_____________________  The following has been explained to the potential study subject, and the subject has been

offered the opportunity to ask questions regarding the study: TOPIC COMMENTS  Purpose of the study _________________________________ Qualifications to participate _________________________________ Location and participants _________________________________ What will happen during the study_________________________________ Risk and benefits _________________________________ Study related injury or illness _________________________________ Alternative treatments_________________________________ Confidentiality _________________________________ Study costs _________________________________ Compensation _________________________________ Who to contact with questions _________________________________ Voluntary participation _________________________________ Termination of participation _________________________________ Questions or comments: __________________________________________________________________

Does the patient state an understanding of the study and procedures and agree to

participate? ___yes ___no  _____________________________________ __________________________ Person administering consent Date / Time  Signed copy given to patient? ___yes ___no Copy in patients chart? ___yes ___no

Informed Consent Worksheet

Template Screening Visit ExampleDMID Protocol: xx-xxxxSite: Vanderbilt University Medical CenterDate: ____________Subject Initials: ____________Subject ID: ____________

This subject is here for the Screening Visit. The subject was given a copy of the IRB approved consent form dated 13Jun2011. The subject was given ample time to read the consent and ask questions. All questions were answered per the subject’s satisfaction, and the subject denied any further questions or concerns. The consent was signed and dated by the subject and the study staff, and a copy was given to the subject. The consent was signed and dated prior to any study procedures being performed. Eligibility criteria and medical history were reviewed, and a complete physical exam was performed by _____________________ and vital signs were obtained. A blood draw was obtained by ___________________________ per Vanderbilt policy. The subject verbalized understanding that they will be contacted with results of the screening labs, and will then be scheduled for the enrollment visit. The subject was given contact information to contact the study staff with any questions or concerns.  Signature:____________________________________________Date:________

Screening Visit NarrativePatient presents today to Screen for the PANTHER study.  He is well versed in this protocol and self-admittantly has read/reviewed the consent many times.  We met about two weeks ago and had a face-to-face meeting (with his wife present) and discussed the study and I answered all his questions.

Today he is here to screen and states that all his questions have been answered.  He voluntarily signed the consent.  He agrees to participate in all the associated sub-studies except Sub-Study # 4 (HRCT comparison) preferring to not be exposed to more radiation than necessary for diagnostic purposes.  He has a copy of this consent.

Documentation example11/28/2013: 1 PM: Received referral from Lee Smith, M.D. of

subject’s intended participation in clinical research study, M04-691, A double-blinded…..

Subject and significant other seen in GI clinic and verbally reviewed consent form; explained the purpose of the study, benefits to subject and mankind, expected duration of participation, subject risks and inconveniences, subject accountability for clinic visits and recoding of weekly diary, confidentiality and ability to withdraw from study at any time without penalty or loss of treatment or benefits, compensation and coverage for injury while involved in study and emergency contact information. Subject given time to review consent form and ask questions.

Questions regarding prep or flex sigmoidoscopy on Day 1 and how results of the study could be obtained answered.

Subject signed consent form and was given a copy. To begin screening on 12/1/2013.

Example of on study visit documentation

TRAUMA RESEARCH PROGRESS NOTEDate:__________Patient was seen today for Day (ENTER 1-14, 30, End of

Treatment, TOC, LFU, discharge, End of Study) visit. All procedures performed per protocol. Patient is unable to provide consent at this time secondary to medical condition. Family is (available / unavailable) at bedside. We will continue to follow this patient closely.

ENTER FREE TEXT HERE

SIGNATURE

What if I make a mistake?Correct errors based on Institutional policy (corrections and approved abbreviations)Departmental SOP’sSponsor SOP’sICG-GCP (4.9.3)

◦initialed, and explained◦should not obscure the original entry

(i.e., an audit trail should be maintained);◦Cross error out with a single line

6/14/14 WL

◦Pt c/o pain to back shoulders…◦NO backdating

Problems that occur when documentation is non-existent

Audit findings at sites All required signatures and dates not completed at

time of consent or completed with different dates Multiple consent documents for same patients with

no explanation why Signatures of subject and consenting person on

different dates Consent and study procedures on same date Copy of consent provided to subject not documented Check boxes within the consent incomplete Crossed out sections or white out used in the IRB

approved consent Unable to locate consent for subject on study Person consenting the subject did not sign the form

FDA findingsFailure to obtain written informed

consent or back-datingSloppy records (e.g. erase, white-

out)Creating fake records or subjectsAltering subject diaries to reflect a

positive outcomeDestroying study records

or

FDA Inspection

Common Deficiencies◦Inadequate consent 51%◦Protocol Non-adherence 31%◦Records Inadequate/Inaccurate 26%◦Drug Accountability Inadequate 20%◦IRB deficiencies 11%

http://www.irbforum.org/documents/documents/Module4.pdf

FDA Warning letter Dated back to 2008….a number of my signatures and parent

signatures as well as initials on consent forms were forged presumably by my research nurse

Documentation of the consent process missing Corrective Action Plan◦ Research staff educated in various topics including

institutional policies and good clinical practice◦ Documentation template per PI:that XX study was explained, questions were answered (if any), subject agreed to participate and signed the consent form, the date and time of consent/assent (filled in by the consenting individuals), all option sections were completed (if any), and a copy of the signed and dated consent form was given to subject and placed in the medical record

In summary

Good documentation is:

Consistent, Concise,Chronological, Continuing, Complete

Documentation Do’s: Include any and all research encounters Should occur immediately to recall as many details as

possible Should include the nature, discussion and outcome of each

research encounter Should be included in the research and/or medical record

and be kept confidential Should be legible, factual and thorough Include a copy of the consent document given to the subject If applicable, include withdrawal or discontinuation with the

reason(s) Include as many details as possible regarding adverse

events and any events leading up to an adverse event whether it is deemed related or not

Should tell a story from beginning to end

Documentation Don’t’s:

Use white outObscure original entryBack dateFabricate the informationDelay chartingAssume people know your process and what you did

Documentation is up to YOU

Take credit for ALL you do and tell the story

Helpful resources:Documentation of informed consenthttp://

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.27

Office for Human Research Protections (OHRP) informed consent tips

http://www.hhs.gov/ohrp/policy/index.htmlhttp://

answers.hhs.gov/ohrp/search/results?q=informed%20consent

OHRP informed consent FAQhttp://answers.hhs.gov/ohrp/categories/1566Vanderbilt IRB Policy

http://mcapps01.mc.vanderbilt.edu/IRB/policy&procedures.nsf/(WebTableOfContents)/

8AF759048966C29D86257731005ECD1F?OpenDocument

If you have additional comments or questions feel free to contact me

Wendy LloydWendy.lloyd@vanderbilt.edu

615-936-7106