Part 3 of 3 part series: Informed - PowerPoint Presentation

Slide1

Part 3 of 3 part series: Informed consent: Documentation

Wendy Lloyd

BA, LPN,

CIP,CCRP

Regulatory

Compliance AnalystSlide2

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

processSlide3

If you didn’t document it, you didn’t do it!Slide4

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.

P

t

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 LPNSlide5

Today…

Check boxes almost replace narrative chartingSlide6

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 Slide7

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;

T

he

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.Slide8

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

.Slide9

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

DocumentSlide10

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.Slide11

Where documentation of consent may occur:

Research Chart

Progress

Notes

MD dictation

CRC chartSlide12

Assure all documentation is 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 d

ispensing records

Procedure reports (UGI, CT, XRAY, EKG etc.)Slide13

What to documentSlide14

How consent obtained

Private exam room

Orally presented consent document information

Consent explained over telephone Slide15

The participant’s level of comprehension

Did child appear to want to participate

Did the subject appear to understand

Did subject

ask questions,

Was subject able

to reiterate

the

main purpose of the

study,

procedures

,

risks

,

f

requency of visits

etc. Slide16

The participant’s decision-making capacity at the time of consent

Alert and oriented

Comatose

Under influence of medication

Decreased level of consciousnessSlide17

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

Consent email/faxed

No original signed consent due to

subject faxed consent back to

officeSlide18

Identify who was present during the process

Family member present

Subject alone

Mother and father present

Surrogate

LAR

TranslatorSlide19

Special study requirements or circumstances

Double barrier pregnancy methods

Pregnancy test results

Wash out periods for previous medications

Diary reviewedSlide20

State

that a

copy of the consent

was given to the person

signing consentSlide21

What came first, The chicken or the Egg?

Document

consent obtained prior to study procedures conductedSlide22

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 processSlide23

Re-consenting requires the same documentation

Date of

consent

Subject reviewed consent

Revisions verbally explained to the subject

Subjects verbally agrees to continue participation

Copy of revised consent given to subjectSlide24

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

. Slide25

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

Slide26

Is it ever ok not to document the process?

Certificate of Confidentiality

Waiver of DOCUMENTATION

approval from the IRBSlide27

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

L

ocked cabinet/room

Password protected accessSlide28

Examples of documentationSlide29

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 WorksheetSlide30

Template Screening Visit Example

DMID Protocol:

xx-

xxxx

Site

:

Vanderbilt

University Medical Center

Date

:

____________

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

:________Slide31

Screening Visit Narrative

Patient

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.Slide32

Documentation example

11/28/2013:

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.Slide33

Example of on study visit documentation

TRAUMA RESEARCH PROGRESS NOTE

Date:__________

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

SIGNATURESlide34

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 explained

should

not obscure the original entry (i.e., an audit trail

should be

maintained);

C

ross error out with a single line

6/14/14

WL

Pt

c/o

pain to

back shoulders…

NO backdatingSlide35

Problems that occur when documentation is non-existent Slide36

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 formSlide37

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

orSlide38

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

Slide39

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 Slide40

In summary

Slide41

Good documentation is:

Consistent

,

Concise,

Chronological

,

Continuing

,

CompleteSlide42

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 Slide43

Documentation Don’t’s:

Use

white out

Obscure original entry

Back date

Fabricate the information

Delay charting

Assume people know

your process and what

you didSlide44

Documentation is up to

YOU

Take credit for ALL you do and tell the storySlide45

Helpful resources:

Documentation

of informed consent

http://

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.html

http://

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

OHRP informed consent FAQ

http://

answers.hhs.gov/ohrp/categories/1566

Vanderbilt IRB Policy

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

8AF759048966C29D86257731005ECD1F?OpenDocumentSlide46

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

Wendy Lloyd

Wendy.lloyd@vanderbilt.edu

615-936-7106