Informed Consent

Requirements and Process

Fall CRC Training

Module 5

Edmagally Villafane, RN, BSN

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Objectives

➢Provide the definition of informed consent.

➢Describe the purpose and the essential elements of informed consent.

➢Discuss the guidelines and interview in obtaining informed consent.

➢Informed Consent and Vulnerable Populations.

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WHAT DOES “CONSENT” MEAN?

Before people can give meaningful informed consent, they must be

“competent” to do so.

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WHAT DOES “INFORMED” MEAN?

To be informed, someone must not merely be provided information, but the

person must understand the information and its implications.

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Informed Consent
Definition:
• Permission granted in full knowledge of the possible consequences, typically that which is
given by a patient to a doctor for treatment with knowledge of the possible risks and
benefits:

Involves providing a potential subject with:

• adequate information to allow for an informed decision participation in the clinical
investigation
• comprehension of the information
• opportunity to ask questions and to consider whether to participate voluntary.

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4.8 Informed Consent of Trial Subjects
The informed consent discussion and the written informed consent form should include
explanations of the following:

• That the trial involves research.

• The purpose of the trial.
• The trial treatment(s) and the probability for random assignment to each treatment
• The trial procedures to be followed, including all invasive procedures.
• The subject's responsibilities.
• Those aspects of the trial that are experimental.

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4.8 Informed Consent of Trial Subjects

• The reasonably foreseeable risks or inconveniences.

• The reasonably expected benefits.
• The alternative procedure or of treatment and their important potential benefits and risks.
• The compensation and/or treatment available in the event of trial-related injury.
• The anticipated prorated payment.

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4.8 Informed Consent of Trial Subjects

• The anticipated expenses.

• The subject's participation in the trial is voluntary, the subject may refuse to participate
or withdraw from the trial, at any time, without penalty or loss of benefits.
• The monitor, the auditor, the IRB/IEC, and the regulatory authority will be granted direct
access to the subject’s original medical records , without violating the confidentiality.

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4.8 Informed Consent of Trial Subjects

That records identifying the subject will be kept confidential. If the results of the
trial are published, the subject’s identity will remain confidential.

The person to contact for further information regarding the trial and the rights of
trial subjects, and whom to contact in the event of trial-related injury.

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4.8 Informed Consent of Trial Subjects

The foreseeable circumstances and/or reasons under which the subject’s

participation in the trial may be terminated.

The expected duration of the subject's participation in the trial.

The approximate number of subjects involved in the trial.

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4.8 Informed Consent of Trial Subjects
In a non-therapeutic trial may be conducted in subjects with consent of a legally acceptable
representative provided the following conditions are fulfilled:

a) The objectives of the trial can not be met by means of a trial in subjects who can give
informed consent personally.

b) The foreseeable risks to the subjects are low.

c) The negative impact on the subject’s well-being is minimized and low.

d) The approval opinion of the IRB/IEC is expressly sought on the inclusion of such subjects.

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Informed Consent and Obligations
• Investigator and Coordinator

» Do not force or unduly influence a subject to participate or to

continue to participate in a trial.
» Obtain a signed and dated voluntary informed consent from
participants and inform the right to withdraw at any time.
» Keep subjects informed about new findings of the ongoing trial.

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Informed Consent and Obligations
Sponsor

→ Responsible for writing the informed consent.

→ Ensure that the investigator use only IRB approved forms.

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Informed Consent and Obligations
IRB

→ Make sure that the information will be presented to the subjects in language
they can understand.
→ Suggest modifications and approved the final version of the ICF.

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Informed Consent and Obligations

Subjects

→ Should properly understand all relevant aspects before signing the form.
→ Feel free to clarify doubts.
→ Should consent voluntarily.

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Informed Consent and Obligations

• Many IRBs have developed standard language and/or a

standard format to be used in portions of all consent
IRB standard documents.
format

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Informed Consent and obligations

Sample or draft consent documents may be developed by a sponsor or

cooperative study group. However, the IRB of record is the final
authority on the content of the consent documents.

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Informed Consent and obligations

• Study protocols may change during the course of the study.

When these changes require revision of the informed
Revision of
consent document, the IRB identifies the revised consent
Consent
document, in order to preclude continued use of the older
Documents
version. While not required by FDA regulations, some IRBs
during the study
stamp the final copy of the consent document with the
approval date.

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Informed Consent and obligations

Non-English-Speaking Subjects

• To meet the requirements of 21 CFR 50.20, the informed consent document

should be in language understandable to the subject (or authorized
representative). When the consent interview is conducted in English, the
consent document should be in English. When the study subject population
includes non-English speaking people, the IRB should require a translated
consent document to be prepared and assure that the translation is
accurate.

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Informed Consent and obligations
Illiterate English-Speaking Subjects

▪ A person who speaks and understands English, but does not read and write, can be
enrolled in a study by "making their mark" on the consent document.

▪ A person who can understand and comprehend spoken English, but is physically unable
to talk or write, can be entered into a study if they are competent and able to indicate
approval or disapproval by other means. If:

* the person retains the ability to understand the concepts and evaluate the
risk and benefit when it is explained verbally (still competent)
* is able to indicate approval or disapproval.

The consent form should document the method used for communication. An impartial third
party should witness the entire consent process and sign the consent document.
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4.8 Informed Consent of Trial Subjects

If a subject is unable to read or if a legally acceptable representative is unable to

read, an impartial witness should be present during the entire informed
consent discussion.
The subject or the subject’s legally acceptable representative has orally
consented to the subject’s participation and has signed and personally dated
the informed consent form, the witness should sign and personally date the
consent form.
By signing the consent form, the witness attests that the information in the
consent form and any other written information was accurately explained,
understood by, the subject or the subject’s LAR, and that informed consent was
freely given by the subject or the subject’s legally acceptable representative.

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4.8 Informed Consent of Trial Subjects

• Before informed consent may be obtained, the investigator, or a person designated by the
investigator, should provide the subject or the subject's legally acceptable representative
ample time and opportunity to inquire about details of the trial

• ‘ All questions about the trial should be answered.

• The written informed consent form should be and personally dated by the subject or by
the subject's legally acceptable representative, and by the person who conducted the
informed consent discussion.

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Documenting Informed Consent at the site

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Documenting Informed Consent at the site

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Documenting Informed Consent at the site

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SAMPLE INFORMED CONSENT
Informed Consent to Participate in a Research Study

Smithsonian Institution [Insert Unit Name and Address]

Title of Research Project:
Name of Principal Investigator:
Phone Number of Principal Investigator:

A. PURPOSE AND BACKGROUND

[Insert researcher’s name and affiliation] is conducting research on [insert what the research is about in terms
understandable to the potential participant]. The purpose of your participation in this research is to help the researcher
[insert why you are doing this research.] You were selected as a possible participant in this study because [state why the
subject was selected]. NOTE: If Researcher is not the Principal Investigator, add information regarding supervision of
researcher.
B. PROCEDURES
If you agree to participate in this research study, the following will occur: [State your process step by step with detail and
include the approximate amount of time the process will take. You should include information on interview or questionnaire
topics, any personal information requested, data collection methods (audio, video, written) and frequency (if more than one
collection).]

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SAMPLE INFORMED CONSENT
C. RISKS
[If there are risks you must state what they are. NOTE: Being uncomfortable, embarrassed and/or
inconvenienced are risks]
D. CONFIDENTIALITY
The records from this study will be kept as confidential as possible. No individual identities will be used
in any reports or publications resulting from the study. All [insert data collection and retention method
i.e. questionnaires, tapes, transcripts, summaries] will be given codes and stored separately from any
names or other direct identification of participants. Research information will be kept in locked files at
all times. Only research personnel will have access to the files and [insert data collection and retention
method] and only those with an essential need to see names or other identifying information will have
access to that particular file. After the study is completed [state time frame for retaining collect data
and whether it will be destroyed].
NOTE: All informed consent forms must have an explanation of the procedures by which participant
confidentiality will be protected and/or the extent that information will be disclosed and to whom.

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SAMPLE INFORMED CONSENT
E. BENEFITS OF PARTICIPATION
There will be no direct benefit to you from participating in this research study. The anticipated benefit
of your participation in this study is [insert the objective you are trying to achieve with this study].
NOTE: “direct benefit” is something that benefits the individual participant such as free medical care
or compensation. If the participant is being given something for participating, state that here in
substitute for the first sentence.
F. VOLUNTARY PARTICIPATION
Your decision whether or not to participate in this study is voluntary and will not affect your
relationship with the Smithsonian Institution or [insert name of any cooperating organization]. If you
choose to participate in this study, you can withdraw your consent and discontinue participation at
any time without prejudice.
G. QUESTIONS
If you have any questions about the study, please contact [insert name of PI] by calling [insert phone
number with area code]. You can also contact [insert IRB contact information] with any questions
about the rights of research participants or research related concerns.

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SAMPLE INFORMED CONSENT
CONSENT
YOU ARE MAKING A DECISION WHETHER OR NOT TO PARTICIPATE IN A RESEARCH STUDY. YOUR
SIGNATURE BELOW INDICATES THAT YOU HAVE DECIDED TO PARTICIPATE IN THE STUDY AFTER
READING ALL OF THE INFORMATION ABOVE AND YOU UNDERSTAND THE INFORMATION IN
THIS FORM, HAVE HAD ANY QUESTIONS ANSWERED AND HAVE RECEIVED A COPY OF THIS
FORM FOR YOU TO KEEP.
Signature ________________________________ Date ________________
Research Participant
Signature ________________________________ Date ________________
Interviewer

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What do you think about the following cases?

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CASE 1

• A 56-year-old female presents to the emergency department with chest pain and is found to
have acute myocardial infarction. She meets all inclusion criteria for a research study to
evaluate a novel therapeutic modality for treatment of acute myocardial infarction. The
research assistant approaches the patient, who is suffering from ongoing pain and anxiety.
The research assistant presents a six-page informed consent document for signature to the
patient, but the patient cannot read the consent in full, nor can she ask questions related to
consent because of her complicated health situation. She willingly signs the document in
triplicate.

Identifies errors during the informed consent process, if any.

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Case 2
• A 24-year-old male presents with a laceration to the forearm. He meets inclusion criteria
for a research study to evaluate the efficacy of a newly developed suture material. His
primary language is Spanish, although he speaks some limited English. He cannot read in
any language. The research assistant approaches the patient and requests his signature on
an informed consent document to participate in the research protocol. Due to the brevity
of the discussion, the research assistant was unaware of the patient’s illiteracy and the
patient willingly signed the document.

Identifies errors during the informed consent process, if any.

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Case 3
• The Investigator discusses informed consent and answers the questions and doubts of the
subject or the LAR during the process. The subject or the subject's legally authorized
representative signs a form containing all the required elements of consent and any
additional information necessary to provide complete disclosure. The person who signed
the consent form is given a copy as a reference and reminder of the information conveyed.

Identifies errors during the informed consent process, if any.

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Who is considered to be a vulnerable population?

Certain groups of human research participants

considered to be either relatively or absolutely
incapable of protecting their own interests.

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Who is considered to be a vulnerable population?
• According to FDA, ICH-GCP, WHO and ICMR guidelines, vulnerable population includes:
1. poor/low-income people
2. illiterate patients
3. children
4. psychiatric patients
5. prisoners
6. pregnant women
7. individuals with questionable capacity to consent
8. students, or employees of the institution conducting the research
9. subjects with catastrophic health conditions.

In developing countries, subjects usually agree for the study because they find these studies as the only option
to obtain free medical care.

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Who is considered to be a vulnerable population?

According to FDA guidelines, children are considered as a

vulnerable population since the children are in the developmental
stage and they lack the capability of understanding the concepts.
Often parents or local guardians are legally responsible for signing
the informed consent but only children can understand the
difficulties they come across during a study.

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Who is considered to be a vulnerable population?

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Who is considered to be a vulnerable population?

Since psychiatric patients lack the ability to understand and

the ability to make decisions, they are always seen as a
vulnerable population.

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How to Minimize Risk and Ensure Informed Consent in These Populations

• Avoid coercive incentives.

• Ensure study related materials
are presented in a manner which
can be understood by the subject.
Educationally/ • Use alternative means of consent
Economically such as videos.
Disadvantaged: • Use a study quiz to gauge
comprehension.

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How to Minimize Risk and Ensure Informed Consent in These Populations

Have an Have friend or

Impaired Use of Legally family member
unaffiliated
Authorized involved in all
Decision Making: Representative.
witness observe research activities
consent process. as observer.

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How to Minimize Risk and Ensure Informed Consent in These Populations

Low Literacy or in Language Fluency of Study:

• Always use translated documents in language of target subject.

• If not fluent in language, use interpreter to translate Informed Consent.

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Additional Information
• Informed Consent for Clinical Trials | FDA

• A Guide to Informed Consent | FDA

• Si tienen preguntas: [email protected]

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Q&A

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Recuerda siempre…

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