Common Problems in Informed Consent - PowerPoint Presentation

Slide1

Common Problems in Informed Consent

Jeri R.

Barney

, JD,

MS

Michele

Antisdel,

MBA/CCRP

HRPP Compliance Manager IRB Regulatory Analyst

Human Research Protection Program (HRPP)

May 16, 2013Slide2

Discussion

Consent Process

Consent Requirements

Common Problems in Informed Consent

Suggestions for ImprovementSlide3

Consent

ProcessSlide4

What is Informed Consent?

Example of Ethical Principle of Respect for Persons

Not a document, but a process

Starts at initial contact (e.g., recruitment)

Slide5

Informed Consent Process

Continues through study participation

an informed participant is better able to adhere to the protocol and therefore provide evaluable data

research staff members are obligated to share any new information related to subject’s participation (e.g., newly identified side effects, etc)Slide6

Informed Consent Process

Handing a participant the consent document and asking them to read and ask questions is NOT Informed Consent

Slide7

Consent

RequirementsSlide8

8 Basic Elements in an ICF

The following eight basic elements of informed consent are

required

to be provided in the course of the consent process. The investigator must ensure that these elements and any others required by the IRB are presented in such a manner as to facilitate the prospective participant’s ability to understand involvement in the research study.

1. Invitation to Participate

2. Risks

3. Benefits

4. Alternatives to Participation

5. Confidentiality Statement

6. Compensation

for Medical Treatment

7. Who to contact (and when) with problems/how to withdraw

8. Voluntary ParticipationSlide9

Consent Requirements

In addition to the 8 required elements, one or more of the following elements are to be provided to the subject when appropriate to the study

:

Procedures-

in lay terms! Tell which are experimental

Research not medical treatment & purpose of the research

Possibility of unforeseeable risks

The

consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject

.

A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.

How long/duration of participation

Subject responsibilities

The approximate number of subjects involved in the study

.

For FDA regulated studies: clinicaltrials.govSlide10

Regulatory Requirements

45 CFR 46.116 (HHS) and 21 CFR 50.20 (FDA) provide the general requirements for informed consent.

No investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative (e.g., for a minor child this would be the parent or guardian).

An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.

The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.

No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

Slide11

Consent Requirements Continued

Documentation

of informed consent.

Informed consent

will

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

is

given to the person signing the form

.

A consent

form may

be

either of the following

:

A

written consent

document (

consent form

or

compound consent and authorization form

)

that embodies the elements of

informed.

A

short form

written consent document stating that the elements of informed consent have been presented orally to the subject or the subject's legally authorized representative. Slide12

Consent Requirements Continued

Documentation

of informed consent.

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

.

I

f the study is FDA regulated,

FDA regulations allow a waiver of informed consent only under very specific

limited circumstances (21 CFR 50.23 and 21 CFR 50.24).

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research

. The document is called an “

Information Sheet

”.Slide13

Common Problems in Informed

ConsentSlide14

Office for Human Research Protections (HRPP) Compliance Oversight Letters

OHRP reviewed 235 compliance oversight determination letters issued to 146 institutions

51% of the institutions reviewed were cited for noncompliance and deficiencies related to IRB approved informed consent documents/processes (2

nd

highest after deficiencies related to the initial IRB review process (56%))

19 determinations of noncompliance for research conducted w/o legally effective informed consentSlide15

Current FDA Statistics

Office of Scientific Investigations

Center for Drug Evaluation & Research (CDER)

(Updated: January 2013)

Source http

://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM256376.pdfSlide16

Frequency

of Clinical Investigator-Related Deficiencies Based on Post-Inspection Correspondence Issued*

(CDER, FY 2012

)

*

Based on letter issue date; Inspections may have multiple deficiencies, [OSI database as of January 24, 2013]

Note that this does not denote number of inspections completed in FY 2012, but rather number of inspection reports evaluated and closed in FY2012

183 Domestic Inspections,

116 Foreign InspectionsSlide17

Frequency of Clinical Investigator Related Deficiencies Based on Post-Inspectional Correspondence Issued:

Official

Action Indicated (OAI) Final classification*

(

CDER, FY 2012)

*Based on letter issue date; Inspections may have multiple deficiencies, includes OAI untitled letters, [OSI database as of January 24, 2013]

Note

that this does not denote number of inspections completed in FY 2012, but rather number of inspection reports evaluated and closed in FY2012.

9 OAI InspectionsSlide18

Examples of Common Consent Issues

Failure to re-consent when new information becomes available

Use of expired forms or non-validated/unapproved forms

PI or consent personnel did not sign/date the form

Failure to provide copies of the forms to subjects

Providing all but the last page of the consent document to subjects

Keeping only the last page of the consent document in study filesSlide19

More Examples

Failure to obtain written informed consent (neglecting to have subjects sign a consent form)

Missing consent documents

No documentation that consent process took place and no signed consent document on

file

Use of wrong form (e.g., child signing parental permission form, patient signing

“healthy control

” form, or subject signing the wrong version)Slide20

Even More Examples

Parental

permission obtained after child assent (may suggest that study interventions took place prior to securing legally effective consent)

Enrolling non-English speaking subjects

without using a proper interpreter (e.g., using a family member or boyfriend/girlfriend to translate)

Failure

to get HIPAA

research (RAF)

signed

Changes made to the consent documents by hand AND without IRB approval (e.g., crossed out information about procedures, increased amount of payment

)Slide21

Suggestions for

ImprovementSlide22

Suggestions for Improvement

ICF Version Control Tips

Use

of expired forms or unapproved forms

Use of wrong form (child signing parental permission form or subject signing the wrong version

)

Check the Validation Box

on the last page of the consent form BEFORE you consent the subject (for paper forms). For electronic forms check the header/footer for the IRB approval. In addition; check the version date to make sure you’re using the most current copy.

Throw Out Expired or Outdated Versions

of the consent documents IMMEDIATELY. Maintain the original in the regulatory binder for the study records but any copies of expired or outdated documents should be destroyed, and electronic copies should be moved to archive folder on computer.Slide23

Suggestions for ImprovementICF Version Control Tips

Use Consent Form Log

listing the different versions, version dates, expiration dates and a brief description

For example

: Version

1: 5/2/12 Initial approval, Healthy

Control

, Healthy Control with Study Drug;

Version

2:

10/13/12

Amendment, Healthy Control

subject payment

added, Healthy Control with Study Drug

subject

payment added, study drug dosage

reduced.

Discuss New ICF Versions

at regular staff meetings to inform all personnel of changes and to ensure all staff will use the correct version. If you do not have regularly scheduled meetings, be sure to inform study personnel in other ways (e.g., via email notices).

Keep different versions in different folders

. Color code and CLEARLY label on the folder AND in the footer of the form itself.Slide24

Suggestions for Improvement

Providing Copies & Keeping Forms

Failure to provide copies of the forms to subjects

Providing all but the last page of the consent document to subjects

Keeping only the last page of the consent document in PI files

PI or consent personnel did not sign/date the form

Make a checklist

and an enrollment note template

Immediately

after signing make a copy and give the copy to subject or have subject sign duplicate copy.

Create & stick to a process

for where the signed ICF is kept (subject chart/folder, separate consent form binder)

Educate staff

so they know to provide FULL copy to subjects and keep FULL original for records

Review the signed form

for completeness BEFORE subject leaves and again BEFORE filing in your files

DO NOT

have PI pre-sign the formsSlide25

Suggestions for Improvement

Amendments & Consent Addendums

Changes made to the consent documents by hand AND without IRB approval (e.g., crossed out information about procedures, increased amount of payment)

Failure to re-consent when new information was available

Educate staff

: if changes are necessary they MUST be submitted to the IRB as an amendment and approved before implementing

Announce addendum in staff meeting or via email

Reconsent log

Check when subject’s next visit is and put a note in his/her chart and in your calendar, mark visit in red, etc.

Put copy of the addendum in the subject chart or binder prior to next visitSlide26

Suggestions for Improvement

Failure to Obtain Consent

Failure

to obtain written informed consent (forgot to have subjects sign a consent form

) or failure to have HIPAA RAF signed

Missing consent documents

No documentation that consent process took place

& no

signed consent document on

file

• Consent should be the VERY FIRST research activity (even if subjects had a form previously mailed to them) and the VERY LAST thing you do before subject leaves

• Switch

to a compound form (or staple it to the consent). REMEMBER to add the RAF to reapproved consents (RAFs don’t get approved every year)

• Use

an enrollment noteSlide27
Slide28

Suggestions for ImprovementFailure to Obtain Consent

Failure to obtain written informed consent (forgot to have subjects sign a consent form) or failure to have HIPAA RAF signed

Missing consent documents

No documentation that consent process took place & no signed consent document on

file

•

Double check each other; Implement a monitoring process to check for consent forms (and other issues) on a routine

basis

•

Have

process and place for signed forms to be kept

• Ensure all study staff know where to find current forms

• Remember what hat you’re wearing Slide29

What You Can Do

Institute Processes/Form Good Habits

Consent form log

Always check the expiration dates on forms

Double check each other

Monitor your own studies on a regular basis

Talk to the staff about problem trends

Assign Responsibility

PI is ultimately responsible

One staff member responsible for consent

forms

Each staff member responsible for their own

activitiesSlide30

What You Can Do

Education

HRPP education sessions

Website policies, templates, instructions: http://www.yale.edu/hrpp/index.html

Communicate with staff (meetings or emails)

Communicate

with IRB Regularly

Ask for help

If you don’t know the answer, it’s better to ask first

Study start-up consultations

QA/QI Reviews

Call with specific questions

(203) 785-4688Slide31

Questions?

Call 203-785-4688

m

ichele.antisdel@yale.edu

jeri.barney@yale.eduSlide32

References

HRPP website:

http://www.yale.edu/hrpp/

http://www.yale.edu/hrpp/policies/index.html

http://www.yale.edu/hrpp/responsibility/compliance.html

OHRP website:

http://www.hhs.gov/ohrp/

FDA website:

http//www.fda.gov/