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Informed Consent: Issues and Challenges

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DOI: 10.4103/2231-4040.116779 · Source: PubMed

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Review Article

Informed consent: Issues and challenges

Lokesh P. Nijhawan,
Manthan D. Janodia1, Abstract
B. S. Muddukrishna2,
K. M. Bhat2, K. L. Bairy3, Informed consent is an ethical and legal requirement for research involving human
N. Udupa1, Prashant B. Musmade2 participants. It is the process where a participant is informed about all aspects of the
trial, which are important for the participant to make a decision and after studying all
Department of Advanced
Pharmaceutical Studies, 1Department aspects of the trial the participant voluntarily confirms his or her willingness to participate
of Pharmacy Management, 2Department in a particular clinical trial and significance of the research for advancement of medical
of Pharmaceutical Quality Assurance, knowledge and social welfare. The concept of informed consent is embedded in the
Manipal College of Pharmaceutical
Sciences, 3Kasturba Medical College, principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report.
Manipal University, Manipal, Informed consent is an inevitable requirement prior to every research involving human
Karnataka, India being as subjects for study. Obtaining consent involves informing the subject about
J. Adv. Pharm. Technol. Res. his or her rights, the purpose of the study, procedures to be undertaken, potential risks
and benefits of participation, expected duration of study, extent of confidentiality of
personal identification and demographic data, so that the participation of subjects in
the study is entirely voluntary. This article provides an overview of issues in informed
consent: The obligations of investigator, sponsor and Institutional Review Board to
protect rights and welfare of human research subjects. It discusses about the basic
elements of informed consent and the process to be followed while obtaining informed
consent. Some of the circumstances under which informed consent can be waived and
ethical challenges faced by physicians in obtaining informed consent from subjects are
also highlighted in this article.

Key words: Human subjects, informed consent, institutional review board

INTRODUCTION The informed consent is described in ethical codes and

regulations for human subject’s research. The goal of
For a drug to get approved and enter into the market it has to the informed consent process is to provide sufficient
prove its safety and efficacy in clinical trials. Clinical trial is information to a potential participant, in a language which
a term used to describe all research related activities, which is easily understood by him/her, so that he/she can make
use human being as subjects. As no individual has right to the voluntary decision regarding “to” or “not to” participate
infract fundamental rights of another person for the sake in the research study.
of fulfilling his own purpose, so an important tool called
“informed consent” came into existence. Conventionally informed consent is thought to be in terms
of the documents signed and dated by participants, setting
forth the purpose, benefits, risks and other study information
Address for correspondence:
necessary to allow the participants to make an informed
Dr. Prashant B. Musmade,
Manipal College of Pharmaceutical Sciences, Manipal and voluntary decision to participate in the clinical study. In
University, Manipal ‑ 576 104, Karnataka, India. reality, informed consent is the process that applies to each
E‑mail: prashant.musmade@gmail.com communication to participants, commencing with the subject
recruitment material and the initial telephone screening of
Access this article online potential subjects through the conclusion of the study. It also
Quick Response Code: describes the obligation of the investigator to inform the subject
Website:
about personal benefits and risk, individual faces in study.
www.japtr.org

Informed consent is not only required for clinical trials

DOI: but is an essential prerequisite before enrolling each and
10.4103/2231-4040.116779 every participant in any type of research involving human
subjects including; diagnostic, therapeutic, interventional,

134 Journal of Advanced Pharmaceutical Technology & Research | Jul-Sep 2013 | Vol 4 | Issue 3
 Nijhawan, et al.: Informed Consent

bioequivalence, social and behavioral studies and for all Table 1: Contd....
research conducted domestically or abroad. Obtaining 1982‑CIOMS In 1982, the WHO and CIOMS created
consent involves informing the subject about his or guidelines the International Ethical Guidelines for
her rights, the purpose of the study, the procedures Research involving human subjects. Most
to be undergone, the potential risks and/or benefits of recently amended in 2002, the goal of
participation and alternative treatments available if any. the guidelines is to support and help
implement the ethical principles of the
Subjects in the study must participate willingly only after Helsinki Declaration
consenting based on the information given.[1‑3] “particularly in developing countries,
given their socio‑economic
THE ORIGINS OF INFORMED CONSENT circumstances, laws and regulations
and executive and administrative
arrangements.” The guidelines identify
Informed consent is a central tenet of research ethics
26 separate items of information
involving human beings and has evolved into present shape an investigator must provide to trial
over a period of time. The journey of informed consent is participants prior to obtaining their
briefly described below [Tables 1-3].[4‑7] informed consent
1996‑International Guideline for GCP was developed by
Table 1: Evolution of informed consent Conference on International Conference on
Harmonisation‑GCP Harmonisation to provide a unified
1947‑The Developed in response to the Nuremberg trials
standard for the European Union, Japan
Nuremberg Code of Nazi doctors who performed unethical
and United States of America to protect the
experimentation during World War II, the code
rights and wellbeing of subjects involved
was the first major international document to
in clinical trials and to facilitate mutual
provide guidelines on research ethics. It made
acceptance of clinical data by the
voluntary consent a requirement in clinical
regulatory authorities in these regions
research studies, emphasizing that consent can
in the year 1996
be voluntary only if:
WHO: World health organization, CIOMS: Council for international
Participants are able to consent organizations of medical sciences, GCP: Good clinical practices
They are free from coercion (i.e., outside
pressure)
They comprehend the risks and benefits involved. Table  2: Classification of informed consent
The code also states that researchers should Classification[8,9]
minimize risk and harm, make sure that
Consent An adult subject, capable of giving
risks do not significantly outweigh potential
permission to participate in a research
benefits, use appropriate study designs
study, can provide consent. The subject must
and guarantee participant’s freedom to
be 18 years of age and competent to make
withdraw at any time
the decision to participate
1964‑Declaration World Medical Association in Helsinki, Finland
Parental consent/ When children/minors are included in
of Helsinki adopted 12 principles to guide physicians on
permission research, the parent/guardian must sign a
ethical considerations related to biomedical
parental permission consent document.
research. It emphasizes the distinction
Some situations require permission from
between medical care that directly benefits
at least one parent, while other situations
the patient and research that may or may
require permission from both parents.
not provide direct benefit. These guidelines
In some cases, it may be necessary to
were revised at subsequent meetings in
waive the requirement to obtain parental
1975, 1983, 1989, 2000 and 2008
permission
1979‑The Belmont The report sets forth three principles
Assent Assent is a child’s affirmative agreement
Report underlying the ethical conduct of research
to participate in research. If the subject is
Respect for persons: Recognizing the
7‑17 years of age, assent must be obtained.
autonomy and dignity of individuals and
The assent form must be written at the
the need to protect those with diminished
appropriate reading level of the youngest
autonomy (i.e., impaired decision‑making skills),
subject in the age range and use simple
such as children, the aged and the disabled
terminology
Beneficence: An obligation to protect
Verbal Verbal consent still contains all elements of
persons from harm by maximizing benefits
written consent; however, the participant
and minimizing risks
is verbally read the elements and verbally
Justice: Fair distribution of the benefits
agrees to participate
and burdens of research
Short form A “short form” is generally used when there
The Belmont Report explains how these is a language barrier and an IRB’s approved
apply to research practices; for example, consent is orally translated in the subject’s
it identifies informed consent as a process native language
that is essential to the principle of respect IRB: Institutional review board

Journal of Advanced Pharmaceutical Technology & Research | Jul-Sep 2013 | Vol 4 | Issue 3 135
 Nijhawan, et al.: Informed Consent

Table 3: Informed consent and obligations Table 3: Contd...

Informed consent and obligations[10‑12] Record Maintaining custody of required records and the
retention means by which prompt access can be assured
Investigator Design informed consent form
Retention of records at the study site for 2 years
Ensure that consent form include all elements
following the date on which test article approved
required by regional regulatory body, that is to be
by FDA or date on which clinical trial terminated
informed to enrolled subjects
or discontinued by the sponsor
Submit the designed consent form to IRB for
IRB: Institutional review board, FDA: Food and drug administration
approval
Make changes in the form as required by IRB
Use IRB approved consent form to discuss and
explain trial related risks, benefits and other
BASIC ELEMENTS FOR WRITTEN INFORMED
aspects with the potential participant and if CONSENT DOCUMENTS
required, the participant’s legal representative,
before the trial begins 1. A statement that the study involves research;
Provide the potential participant, 2. An explanation of the purpose of research and the
ample time and opportunity to ask
questions about the trial and discuss
expected duration of the subject’s participation;
it with relatives and family members 3. A description of the procedures to be followed and
Do not force or unduly influence a subject to identification of any procedures that are experimental;
participate or to continue to participate in a trial 4. A description of any foreseeable risks or discomforts
Obtain a signed and dated voluntary informed to the subject, an estimate of their likelihood and a
consent from participants if the potential
description of what steps will be taken to prevent or
participants decide to get involved into the study
Inform the participant of their right to withdraw minimize them;
from the ongoing study at any time without 5. A description of any benefits to the subject or to others
penalty, repercussions or reason that may reasonably be expected from the research.
Keep subject informed about new findings of the Monetary compensation is not a benefit;
ongoing trial, which may affect their decision
6. A disclosure of any appropriate alternative procedures
IRB Identify omissions in the consent documents
or courses of treatment that might be advantageous to
provided by the investigators.
Ensure that information will be presented to the subject;
prospective subjects in language they can understand 7. A statement describing to what extent records will be
Take special care to ensure that both kept confidential, including a description of who may
oral presentations and consent forms are have access to research records;
comprehensible to all subjects 8. For research involving more than minimal risk, an
Suggest modifications to be made in the form if
necessary
explanation and description of any compensation and
Suggest investigator to employ devices any medical treatments that are available if research
such as audiovisual aids, tests of the subjects are injured; where further information may
information presented, or consent advisors, to be obtained and whom to contact in the event of a
enhance participant understanding about the research‑related injury;
study
9. Information on the amount of remuneration/
IRB may waive consent requirement under certain
circumstances compensation, if any, that will be provided to subjects;
Sponsor The sponsor and the local site investigators 10. An explanation of whom to contact for answers to
are jointly responsible for writing a site‑specific pertinent questions about the research and the research
informed consent subject’s rights  (include the clinical center’s patient
Confirming that informed consent is sought representative and telephone number);
properly by investigator prior to research
11. A statement that participation is voluntary and that
Ensure that the investigator use only IRB approved
forms to consent volunteers refusal to participate or discontinuing participation at
Subjects Should properly understand all relevant aspects any time will involve no penalty or loss of benefits to
before signing the form which the subject is otherwise entitled.[13]
Must comprehend the relevant information
Feel free to clarify his/her doubts REQUIREMENTS FOR OBTAINING INFORMED
Should consent voluntarily
Should be aware of his/her rights for participating CONSENT
in the study
Regulatory Audit investigator’s site 1. The investigator or a person designated by investigator
bodies To ensure the quality and integrity of data must obtain informed consent
obtained from clinical trials 2. Informed consent must be obtained before non‑routine
To protect the rights and welfare of trial subjects screening procedures are performed and/or before any

136 Journal of Advanced Pharmaceutical Technology & Research | Jul-Sep 2013 | Vol 4 | Issue 3
 Nijhawan, et al.: Informed Consent

change in the subject’s current medical therapy is made 3. All versions of approved consent forms must be kept in
for the purpose of the clinical trial the site study file; only the current Institutional Review
3. The subject/subject’s legally acceptable representative Board (IRB) approved version may be used to consent
should not be forced to sign on consent or participate/ new patients.[14]
continue to participate in the trial
4. The subject/legally acceptable representative and WAIVERS TO INFORMED CONSENT
individual obtaining consent must personally sign
with date the form. The signature of the prospective A. A waiver of informed consent under 45 Code of Federal
subject/legally acceptable representative on informed Regulations (CFR) 46.116 (d)
consent document indicated that content of informed B. An alteration of consent under 45 CFR 46.116 (d)
consent document has been adequately discussed and An IRB may waive the requirements to obtain
the subject/subject’s legally acceptable representative informed  consent provided the IRB finds and
freely gave the informed consent [Figure 1].[13] documents that:
• The research involves no more than minimal risk to
INFORMED CONSENT PROCESS FLOW the subjects;
• The waiver or alteration will not adversely affect the
Notes to Flowchart rights and welfare of the subjects;
1. Source documents must reflect that consent was • The research could not practicably be carried out
obtained before the start of study treatment and without the waiver or alteration and
procedures • W  henever appropriate, the subjects will be
2. A copy of the signed consent form must be kept at the provided with additional pertinent information after
site participation.

Figure 1: Flow chart regarding various informed consent processes

Journal of Advanced Pharmaceutical Technology & Research | Jul-Sep 2013 | Vol 4 | Issue 3 137
 Nijhawan, et al.: Informed Consent

C. A waiver of parent/guardian permission under 45CFR from a potentially life‑saving or life‑enhancing surgery
46.408 (c) or procedure.[17,18]
D. A waiver of assent under 45 CFR 46.408 because the
minors are not capable of assent Table 4: Barriers to participation in clinical trials
E. A waiver of assent under 45 CFR 46.408 because the Theme[19] Example
research holds out a prospect of direct benefit that is Lack of knowledge Limited information about clinical trials
available only in the context of the research.[15] about clinical trials “I can’t participate because I don’t know
anything”
CHALLENGES IN INFORMED CONSENT Fear (1) of new Uncertainties about side‑effects
treatment Concern over quality‑of‑life in trials
PROCESS Fear of receiving placebo as opposed to
actual treatment
Language Barriers Fear (2) of being Fear of being treated as “guinea pig”
It is assumed that the individual who signs the consent treated as a test
form does so with full understanding of what is stated on subject
the consent form. However, it is very difficult to evaluate Psychological issues Denial or depression
their viewpoint about trial since there is no established Financial burden Concern that insurance will not cover the
method to measure the level of understanding that a treatment
participant has about the information given. Thus, it can
be assumed that there is a degree of misunderstanding that Children
occurs. Misunderstandings can occur because of incorrect Where research involves children  (under the age of 18)
or inadequate language translations. Many individuals sign consent/permission has to be obtained from parents. If
the consent form without being fully aware of what they the child is above 7 years of age then “child assent” is also
are signing, which results in withdrawal of subject at later mandatory. It is arguable that children are capable of being
stages of ongoing clinical studies. Hence, the responsibility partners in research and that they have rights to receive
of researcher enlarges when a study is performed in information, to be listened to, have their wishes and feelings
multilingual subjects [Table 4].[16] taken into account and to give or withhold consent if judged
competent to do so. Difficulty arises when parents give their
Religious Influence consent while child refuses to assent.[20]
The informed consent process is designed to give every
participant the liberty to decide whether to accept or Vulnerable People and Groups
refuse the recommended medical treatment. Sometimes Vulnerable groups include the person who is absolutely
their decision for participating in researcher projects is or relatively incapable of protecting their interests.
influenced by the religious beliefs. It is commonly observed Obtaining informed consent is critical when working
that how the methodology of the experiment come into with them, specifically with some groups like people with
conflict with the rules of behavior set by a participant’s learning disabilities. There may be potential problems
religion.[17,18] of understanding what the research is about, what their
role in the research will be and how the research will
False Expectations be used. Hence, obtaining informed consent can be
Even when there are no language barriers or religious difficult and special care needs to be taken to develop the
impediments to hinder the communication relationship appropriate strategies for communicating the implications
between researcher and participant, misunderstanding of involvement in research.[21,22]
can still occur due to participants false expectations of
the experiment outcome. Some patient fear of being Indian Scenario
treated as mere “experimental model” for the studies In countries like India, the clinical investigations are based
while others refuse to take part because of historical on regional values and practices, the concept of disease
evidences of clinical trial fraud and misconducts known as perceived through social values and power hierarchies
to them.[17,18] in family of villages based on cultural systems. To get a
meaningful and ethical informed consent in these settings
Patient Perceptions become challenging due to differences in cultural values in
Most patients believe that, trials will put extra burden western countries and local customs in developing countries
on them. They assume that the conventional treatment including India. In a study by DeCosta et al.[23] that was carried
is best and they are afraid of the unknown side‑effects out in a village of Haryana state of India, the majority of
of new treatment. Convincing and receiving an informed respondents interviewed by them could decide on clinical
consent from such patient is most difficult. In some trial participation after discussing with community members.
case disclosing too much information of the potential Another important factor emerged from this study, which
side‑effects may unnecessarily scare the patient away showed an implicit trust by respondents in the medical

138 Journal of Advanced Pharmaceutical Technology & Research | Jul-Sep 2013 | Vol 4 | Issue 3
 Nijhawan, et al.: Informed Consent

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