PART 3 OF 3 PART SERIES: INFORMED

CONSENT: DOCUMENTATION

Wendy Lloyd

BA, LPN, CIP,CCRP

Regulatory Affairs and Compliance Specialist

OBJECTIVES: Regulations and IRB Policies Suggestions of what to include in the

documentation Citations when documentation is not

present Examples 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 LPN

118 PM Pt complained of incision pain and given percocet X 2 WLloyd LPN

515 PM Patient ambulated ½ length of hall with minimal SOB. No c/o pain offered. WLloyd LPN

822 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 LPN

1125 PM Patient requested pain medication for migraine headache. Percocet X 2 provided. Patient laying in bed with lights out. Call light within reach. WLloyd LPN

120 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

ProcessDocume

nt

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 Chart Electronic Medical Record (StarPanel) Subject tracker MD dictation CRC chart

ASSURE ALL DOCUMENTATION CONSISTENT WITH:

Medical history and hospital records

MD dictation Clinic & office charts Lab results Communications

(telephone and emails)

Checklists Flow charts

Diaries Research charts Drug dispensing

records Procedure reports

(UGI, CT, XRAY, EKG etc.)

What to document

HOW CONSENT OBTAINED Private exam room

Orally presented consent document information

Consent described over telephone

THE PARTICIPANT’S LEVEL OF COMPREHENSION

Did the subject appear to understand Did subject ask questions, Was subject able to reiterate

the main purpose of the study,procedures, risks, frequency of visitsetc.

THE PARTICIPANT’S DECISION-MAKING CAPACITY AT THE TIME OF CONSENT

Alert and oriented Comatose Under influence of medication Decreased level of consciousness

TIME GIVEN FOR PARTICIPANT TO CONSIDER THE RESEARCH Allowed time to review Subject allowed to take the consent

home to review Mailed consent to subject prior to office

visit Consent read and explained to subject

IDENTIFY WHO WAS PRESENT DURING THE PROCESS Family member present Subject alone Mother and father present Surrogate

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 DOCUMENTATION

New information- new consent Legally authorized Representative Health Care Decision Maker Subject 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 illegible Screen failure Change in cognitive status Ward of the state Subject becomes incarcerated Birth control (double barrier) Non english speaking consent process

RE-CONSENTING REQUIRES SAME DOCUMENTATION Date of re consent Subject reviewed consent Revisions verbally explained to the

subject Subjects verbally agrees to continue

participation Copy of revised consent given to subject

THE PATIENT BECOMES COMPETENT! DOCUMENT:

Subjects desire to continue, Entire consent process and copy given

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.

TIMES TO DOCUMENT Every time you have an interaction with a

subjectsContact for recruitment purposesEmailsTelephone callsFace to face interactionsAssessment of adverse events each visitAssessment of cognitive status each visitNo family available to consent

IS IT EVER OK NOT TO DOCUMENT THE PROCESS?

Certificate of Confidentiality Waiver 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

Informed Consent Worksheet

 

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

TEMPLATE SCREENING VISIT EXAMPLE

DMID 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 EXAMPLE11/28/2010: 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 12/1/2010.

EXAMPLE OF ON STUDY VISIT DOCUMENTATIONTRAUMA 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’s Sponsor SOP’s ICG-GCP (4.9.3)

initialed, and explainedshould not obscure the original entry (i.e.,

an audit trail should be maintained);Cross error out with a single line

ex: 6/14/98 WL

Pt claims pain to back shoulders….

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 FINDINGS Failure to obtain written informed

consent or back-dating Sloppy records (e.g. erase, white-out) Creating fake records or subjects Altering subject diaries to reflect a

positive outcome Destroying study records

or

FDA 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 CAP 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, chronologica

l, 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 Contain white out Obscure original entry Back date Fabricate the information Delay charting Assume people know your process and what you did

DOCUMENTATION IS UP TO YOU

Take credit for ALL you do and tell the story

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

Wendy LloydWendy.lloyd@vanderbilt.edu

615-936-7106

OBSERVE THE CONSENT PROCESS

You know you want to: Volunteer to have your consenting

process observed

Contact Wendy Lloyd by phone (936-7106) or by email (wendy.lloyd@vanderbilt.edu)

in advance or just prior to consenting