Informed consent

Informed Consentالمستنيرة الموافقة

Outline:

1. What is Informed Consent2. Ethical basis: Why?3.The consent process.4. What is required to obtain a valid Informed

Consent?5. Elements of informed consent.5. Special situations6. Conclusions

Informed consent is

a Document or a Process??

Consent is a continuous process, not a one-time event.

A document. useful information for subjects

names and contact information reminder about study procedures

Facts Researchers need the person to enroll. Research can do harm. Protocols may require specific procedures

that may not be the best alternative. Researchers may be blinded to potential

alternatives. Therapeutic misconception of research

subjects.

• Applies the ethical principle: respect for persons.

• Facilitates trust in the research enterprise.

Informed consent

It is no longer an option.

It is now a must under the current

guidelines & regulations

The Consent process:

Information provided

Information understood

Decision made

Comprehension monitored and

maintained

The Process of Consent:

Choose the right environment and location to obtain consent.

Involve multiple health care personnel as necessary.

Include family members in the process as warranted.

Ensure that the subject or Legally Authorized Representative is competent.

The Process of Consent:

(cont’d)

Ensure the subject or LAR has sufficient understanding.

Continue the process of consent throughout the study.

THE CONSENT PROCESS

PLAN

The Plan

1. Identify obstacles to participation in study and ways to overcome obstacles

2. Identify words subject may not understand3. Compile “Frequently Asked Question” list4. Decide who will do consent discussion5. Decide where consent discussion will be held6. Provide adequate time to explain study to

subject7. Provide adequate time for subject to read and

consider and for questions to be answered

Consent Process Plan

.1Identify the obstacles to subject participation and ways to overcome the

obstacles

TRANSPORTATIONFAMILY

WORK

NUMBER OF BLOOD

DRAWS

NUMBER OF VISITS

Obstacles to Participation

How Obstacles Will Be Resolved

Generic Obstacles

1 1

2 2

3 3

Study Specific Obstacles

1 1

2 2

3 3


2. Identify words subject may not understand in ICF

Placebo“a small animal like an amoeba”

IRB / IEC“a committee that reviews your medical records to

see if you should be institutionalized”

Double blind“Means being blind in both eyes”

“Double Blinded Placebo Controlled study to measure

the efficacy of XXXXXX”

How can you translate it to Arabic?

بالعالج محكمة اإلعماء مزدوجة دراسةعقار فاعلية لدراسة XXXXXالوهمي


3. Compile list of questions the subjects may ask about the study and appropriate responses


4. Decide who will conduct consent discussion

Investigator may obtain consent Investigator may delegate responsibility to a knowledgeable person.

Investigator is ultimately responsible for assuring informed consent has been appropriately obtained


5. Decide where consent discussion will be held

Conduct in a quiet area

Subject should have adequate uninterrupted time

Easy access to a study doctor

Provide space for family members or friends to be present during the consent discussion


6. Provide adequate time to explain the study and study procedures to the subject Create a visual description when possible to foster

understanding Use patient education tools / brochures to assist in

discussion Explain the responsibilities of study participation


7. Provide adequate time for subject to read and consider- No undue influence or coercion- Allow subject to take consent home to discuss with

families or friends

8. Provide time for questions to be answered


-“How frequently will you need to come to the clinic during the study”?

-“When can you decide if you want to discontinue from the study”?

-“What medications must you avoid while in the study”?

9. Use open-ended questions to assess if subject has received adequate information to make an informed

decision


10. Avoid closed-ended questions

“Do you understand?”

“Do you have any questions?”


11. An important step towards successful and ethical clinical research

When should Informed Consent be obtained?

Obtain consent after approval by Sponsor and IRB / EC.

Obtain consent prior to initiation of any clinical procedures that are performed solely for purpose of determining eligibility for research

DateSubject orLegally Acceptable

Representative

Person Conducting Review of Consent

Date

DateWitness

Who can sign the Consent Form?

Impartial Witness

Documentation of Informed Consent Process

Check that contact information is complete on ICFs given to subject

Provide subject with one of the copies of the signed and dated ICF

File the original signed and dated ICF in the subject file

Document study participation in medical records of subject

Construction of a complete and

readable consent form can be a

difficult task even in the 21st century

What is required to obtain a valid informed

consent?

All studies must have informed consent prospectively obtained from each research subject (or LAR).

All types. Level of risk. Unless REC waives.

Approved by the REC. Signed by the subject or LAR. A copy must be given to the person

signing the form.

Informed consent must be documented using a written consent form.

A good consent form: Complete information

Accurate information

In compliance with regulations and guidelines

Short simple sentences

Simple understandable language

Culturally sensitive language

Elements of informed consent

Essential Additional

Voluntary participation

Contact information

Compensation

Confidentiality

Alternatives

Benefits

Risks

Purpose

Essential

Additional elements: Statement that there may be risks which

are unforeseeable Withdrawal criteria Additional costs to subjects Consequences of subject’s withdrawal

from research Statement that will be told of new findings Approximate number of subjects in study

No single model represents a

Blue-Print for all countries

Common Findings: Too long consent form

Too complicated language, Section

describing what procedures

Not all the objectives mentioned in the

protocol are mentioned in the consent

form

Alternative are not mentioned.

Common Findings: Procedures do not accurately

describe all relevant issues – for example:

How many times for blood samples to be withdrawn?

Benefits of the research are over-stated

Risks are not complete.

To be adequate an informed consent requires that:

Subject

Autonomousاإلستقاللية

Decision making capacity

القرار اتخاذ قدرة

Children

Pregnant women

Mentally ill

Prisoners

Minorities…

Vulnerable groups:

Children’s assent

To use children in research,

you must first obtain the

permission of the parent(s)

and then obtain assent

from the child .

Waiver of informed consent

Waiving Documentation of Consent.

Waiving Some elements of Consent.

Waiving All of the elements of Consent.

Waiver of consent

Uncommon and exceptional

All studies Must have a consent form or a waiver

of consent.

More than Minimal Risk?

yes

Will waiving adversely affect subjects` rights?

yes

No

Practical to do research without waiver?

No

Information will be provided later” if appropriate”

yes

No

yesNo

No waiving

No waiving

No waiving

No waivingREC approve Waiver

Proper informed consent:

Disclosure

Understanding

Voluntariness


Disclosure

Understanding

Voluntariness

What to tellHow to tell

Circumstances


Disclosure

Understanding

Voluntariness

Challenges??How to assess

Therapeutic misconception/ randomization


Disclosure

Understanding

Voluntariness

Free choiceNo coercion

No undue inducement

Affected by:

Power relation Restricted choices Illness Incentives

Challenges regarding informed consent

Four main challenges:IlliteracyCulture,traditions and religion

Stored biological samplesChild assent

Informed consent and illiteracy

In one of the clinical trials an old illiterate villager told the researchers: “I understood all what you said

and I agree to participate in

this trial but I used not to

sign any paper” What should the researchers

do??

Culture, traditions and religion

+Stored biological samples

Local Research Ethics regulations and LAW are required

Children Every routine intervention that is

undertaken on the child requires consent from the parents.

If the child is able to understand some aspects of the research study, then his or her “assent” must be obtained in addition to the parents’ permission.

Child Assent What ages?

7 years – 14 years – 16 years – 18 years – 19 years – less than 21 years???

Written vs oral What information should be

given?

Willowbrook Studies From 1966 to 1969, hepatitis studies were

carried out at the Willowbrook State School, a NY institution for mentally defective persons.

These studies were designed to gain an understanding of the natural history of infectious hepatitis and subsequently to test the effects of gamma globulin in preventing or ameliorating the disease.

The subjects, all children, were deliberately infected with the hepatitis virus; early subjects were fed extracts from stools of infected individuals, and later subjects received injections of more purified virus preparations.

Willowbrook Studies

Investigators defended the deliberate injections of these children by pointing out that the vast majority of them acquired the infection anyway while at Willowbrook, and perhaps it would be better for them to get infected under carefully controlled research conditions.

The investigators also defended the study by stating that:

They obtained parental consentThe children would receive a subclinical

infection followed by immunity to the particular hepatitis virus.

The study had extreme value in understanding an important disease that would lead to a vaccine.

Willowbrook Studies

During the course of these studies, Willowbrook closed its doors to new patients, but because the research program had its own space, it was able to admit new patients.

Subsequently, parents were able to gain admission for their children only if they agreed to have their children enrolled in the study.

Consent Letter??? Dear_______________: We are studying the possibility of preventing epidemics

of hepatitis on a new principle. Virus is introduced and gamma globulin given later to some, so that either no attack or only a mild attack of hepatitis is expected to follow. This may give the children immunity against this disease for life. We should like to give your child this new form of prevention with the hope that it will afford protection.

Permission form is enclosed for your consideration. If you wish to have your child given the benefit of this new preventative, will you so signify by signing the form.

Sincerely, H. H. Berman, MD

We should like to give your child this new form of prevention with the hope that it will

afford protection .

If you wish to have your child given the benefit of this new preventative…… ,

Case 1 An investigator interviews a potential research subject, explaining the purpose of the study, the foreseeable risks, etc. The subject smiles at the investigator and says, “I am a simple man and I don’t understand all this medical stuff and I don’t think I ever will. But if you believe I should let you do research on me, I will.” Would it be ethical to enroll that person into the study?

Case 2 A post graduate student was asked by

his professor to participate in the control group of the professor’s clinical trial.

Is It Ethical to recruit the student? What should the student do?

Case # 3 An investigator would like to measure

cytokines levels in bronchoalveolar lavage fluid from patients with suspected lung cancer lesions.

He has a colleague who does bronchoscopies on such patients and he asks this colleague if he could obtain an extra 15 cc of lavage fluid from these patients when they undergo bronchoscopy to diagnose the etiology of their lung masses.

Should informed consent be waived for the obtainment of the additional 15cc of lavage fluid?

Case # 4 An oncologist-investigator is conducting a chemotherapy

clinical trial and is actively enrolling patients. Within his clinical practice, at the request of the families, he does not tell many of his patients their cancer diagnosis. Non-disclosure of diagnosis also occurs even if the patients receive chemotherapy.

Based on this culture related factor, he requests from the REC permission to enroll cancer patients in his chemotherapy trials without telling them their cancer diagnosis. He is concerned that a requirement to reveal such information will hinder enrollment.

Should the REC grant a waiver of consent?

Case # 5

An investigator is recruited to do a Phase 4 study for a drug company that aims to collect data on side effects of a recently approved drug for hypertension.

She will obtain data from the patients she sees in her private clinic.

Case #5 Cont.

The data she sends to the drug company will not contain any identifying information

Could informed consent be waived for this study?

Case # 6 An investigator is recruiting patients for a clinical trial

and he has discovered that his subjects are taking the informed consent document to their private physicians, who are persuading the subjects to withdraw from the clinical trial. The subjects are told that the trial is too risky and unethical.

Hence, the investigator tells the REC that he will no longer give his subjects the consent document. He states that the larger number of dropouts is ruining the statistical power of the clinical trial.

Should the REC agree with the investigator?

Cases on Informed Consent

An investigator wants to do a retrospective medical record review of patients admitted to the hospital during the last five years. All data will be recorded anonymously.

Should a waiver of informed consent be granted?

BOTTOM LINE The ultimate responsibility for

protection of the rights and welfare of research subjects rests with the principal investigator.

Obtainment of valid informed consent is an important part of that protection.

Honesty

builds

Trust

Informed consent

Health & Medicine

Transcript of Informed consent