INFORMED CONSENT

Parker Nolen, MBA, CCRC, CIPHuman Subjects Office/Institutional Review Board Manager

Research Coordinator TrainingFebruary, 2015

• a document • it is a legal contract• it contains understandable (to the subject!) information and does

not allow the subject to waive any rights

• a tool • it gives you the protocol in a nutshell!

• an interaction/thoughtful dialogue• allows the subject to learn as much as possible about the study

before and during the study.

• a process• begins with the first exchange of information and extends to the end

of the study.

What is Informed Consent?

• To communicate in writing (or orally) information to the subject about all aspects of the study and his/her rights as a participant both initially and as the study progresses.

• To provide a guide for verbal explanation and discussion of the study leading to comprehension.

• To allow the potential subject to voluntarily make the best possible decision for themselves.

PURPOSE of an Informed Consent

• It is part of the way we protect subjects-by helping them understand their role in the research and what will be done during the study.

• It is a regulatory requirement!

Why is Informed Consent Important?

Informed Consent Non-compliance is one of top causes (~34%) of IRB suspensions and FDA complaints against investigators.

What the Feds found:

• Who

• Trained, authorized personnel (names on Delegation Log, IRB Application and 1572)

• How

• Written Document or Verbal Reading

• When

• Before any study procedures!

• What

• The Regulations and IRB SOPs Outline Specifics

Who? How? When? And What?

• General Requirements

• Code of Federal Regulations

• Title 21 Part 50

• Title 45 Part 46 (aka “Common Rule”)

• ICH Good Clinical Practice 4.8

• Standard Operating Procedures/IRB

• FDA, NIH, OHRP websites

Informed Consent Resources

• Seek consent under circumstances that provide sufficient opportunity to consider participation.

• Minimize possibility of coercion or undue influence.

• Do not include any exculpatory language (subject or representative waives or appears to waive legal rights or releases investigator, sponsor or institution from negligence).

Important Considerations

Researcher’s perspective is more to: Subject may perceive that consent is:

• Identify risks • Liability protection for researcher

• Expand knowledge • Disease treatment and may be only hope

• Gain knowledge about new drug/effects of treatment plan

• Subject is “subject” to generate knowledge

• Subject is “patient” under regular physician care

Therapeutic Misconception

Research ≠Treatment

• Why you have been contacted

• What is the study purpose

• Number of people in study

• Procedures• Risks (unforeseeable)• Benefits• Alternatives• Confidentiality• Genetic information

Elements of Informed Consent

• Costs

• Payment/Compensation

• Compensation for injury

• Financial interest disclosure

• Contacts

• Voluntary nature of study

• Withdrawal procedures

• Use of specimens

• Subject’s consent

• Subject Bill of Rights *

Waiver or Exception of Consent

• Waiver is allowed if study is conducted by state or local government for public benefit, minimal risk, does not affect rights and involves no procedures for which consent is normally required outside of research

• Exception in ER setting under certain conditions ** (FDA only)

Both require IRB Approval!

• Non-English-speaking subjects• Translated consent form (or “short form”) prepared

and accurate• Translator may be used to facilitate conversation

• Illiterate English-speaking subjects • “Short form” is written document stating that

elements of IC were presented orally (signed by subject or representative and witness)• Needs a witness to oral presentation• IRB approved written summary (signed by witness and

person obtaining consent)

Unique Populations

• Traditional written document

• Contains Basic and any applicable Additional elements

• “Short Form”

• Elements of the informed consent have been orally presented to the subject

Types of Consent Forms Allowed

• Mail out informed consent prior to first meeting.

• Allow adequate time when subject is receptive and alert and able to ask questions.

• Assess subject’s ability to consent on their own.

• Provide opportunity to consult with family, friends or private medical doctor if desired.

• Present overview of protocol stressing required points-highlight a copy.

• Read or go through document with subject.

• Document the process you used!!

Consent Process

When do you need to “re-consent”?

Amendment adds:

• Additional risk

• Additional activity

• Increase in blood draw

• Different PI, address, or IRB

Who gets re-consented? Subjects who are active or need the information

• Using an “unstamped” version

• Using an older version

• Signatures not timely (PI signs later than Subject)

• Failure to update consent when protocol changes occur

• Initiating changes prior to obtaining subject’s amended consent

Common problems with Informed Consent

• “Tell me what you think will happen to you in this study.”

• “What do you expect to gain?”

• “What risks would you be taking by being in this study?”

• “Who can you call if you have any questions?”

• “How long will you be in this study?”

How do you assess understanding?

Ask questions!

• Use standard language available through the IRB template

• Use visual clues (bold, italics, HEADERS)

• Keep it as simple as possible!

• Estimated 32 million adults in USA (about one in seven) have such low literacy skills that it would be tough for them to read anything more challenging than a children’s picture book much less than to understand medication side effect listed on a pill bottle (2003)

source: http://nces.ed.gov/naal/

How to write an Informed Consent

Write consent in lay language

http://medicine.umich.edu/medschool/research/office-research/institutional-review-boards/guidance/simplification-guide-medical-terms

• Use Flesch-Kincaid Readability Statistics to improve understanding

• Built-in to Word

• “Options” Menu• “Proofing” Selection

• Reports Grade-Level and

• Word count

• Averages

• Readability

Consent/Assent Readability

CHNw Informed Consent Template

Research Participant Bill of Rights

• Written consent signed and dated by the subject or legally authorized representative

• Copy given to subject

• FDA/ICH require that the consent be dated by subject (or LAR) [21 CFR 50.27 (a)/4.8.8]

• Document with progress note in subject's EPIC chart and research file (e.g. worksheet for first visit)

• Scan ICD into EPIC

Evidence of Consent Process

Documentation of Informed Consent Mailing and Phone Conversation

At _______________________ (person identifying subject or response to flyer) request, the potential subject was mailed copies of the Informed Consent, Authorization and Diet Record Forms on __________________ (date).Phone call to potential subject ________________ (date) to discuss The Use of a Plant Based Diet to Treat Patients with CKD-MBD study and the study was explained in detail.

The informed consent document, authorization and diet records were reviewed with subject. The subject verbally acknowledged understanding of the three-day diet record and will include at least one weekend day (Friday, Saturday or Sunday) in those records.

The subject was given opportunity to ask questions and all questions and concerns were addressed.The subject stated that they would sign the consent and authorization and bring all documents along with the three-day diet records to their first visit. I signed a duplicate copy of the consent after speaking with the subject today.

[At the first face to face visit, I will sign the subject’s copy of the informed consent or if they neglect to return their copy, will have them sign the copy that I signed when speaking to them. When both signatures are present, a signed copy of the consent will be given to the subject and a copy filed in the research case history. ]

_______________________________________________________________________Name Date Time

• 21 CFR 50 Subpart B

• 45 CFR 46.116

• ICH GCP 4.8

• FDA Guide to Informed Consent

• Comparison of FDA and DHHS regulations

Thank You to Gail Douglass, RN, CCRC for permission to use this presentation

References

Questions & Discussion