Meeting Reports 

(Ethics)

Scenarios in Medical Ethics‑5: Informed Consent Process

Informed consent process is becoming more challenging these • What is the role of re‑consent from the participant in this
days with researchers involved in collecting data during complex situation?
situations like an emergency or an epidemic. Other concerns • During re‑consent, what if the participant is not happy
are about translating into local language of informed consent with including him/her in the study?
documents prepared in English and consent for reuse of stored
samples to obtain additional information, to name a few. To
Comments of the panelists
• While designing the protocol for studies involving
address some of these issues, a 1‑h panel discussion session on
medical emergencies, all possible situations that may
“Informed consent process” was held during the 2‑day workshop
arise with respect to obtaining informed consent need to
organized for Institutional Ethics Committee (IEC) members on
be anticipated and put forth
September16–17, 2019, at Jawaharlal Institute of Postgraduate
• Whenever possible, consent needs to be taken from the
Medical Education and Research, Puducherry, in association with
participant. When the participant is unconscious or not in
Indian Council of Medical Research Bioethics unit, Bangalore.[1,2]
a position to give the consent, it can be obtained from a
We planned each session to have a lecture followed by case LAR and re‑consent taken once the patient recovers
discussions. Each session included a series of 3–6 scenarios • If there is no one accompanying the patient, then the
followed by 1–3 questions. After presenting each scenario, principal investigator who is the surgeon in this case can
the participants were invited to give their comments. After decide and take the opinion of another surgeon in the same
a thorough discussion, a set of panelists, who were experts hospital not involved in the study to agree to this decision
in biomedical ethics, were invited to discuss the scenario and sign on behalf of the patient who is unconscious
and provide more informed and authoritative opinions. The (this should have been included in the protocol and prior
discussions were quite lively, and we believe that the case approval obtained from the EC)
scenarios should be of wider interest. • In case, the participant does not want to be a part of the
Four similar panel discussion sessions on other topics have study and is informed only after the surgery is completed
already been published in earlier issues of this journal. In as he/she was unconscious when the recruitment was done,
this article, we discuss the session on “Informed consent he can withdraw from the study at any time without his
process.” The answers provided by the participants are listed routine treatment being affected and decide not to include
first followed by the expert opinion by the panelists. his/her data in the study.

Scenario 1 Scenario 2
A study is planned to be conducted on patients admitted to Due to unprecedented heavy rains, the huge water reservoir
emergency services with traumatic injuries due to road traffic in a city broke down flooding the entire city. Many houses
accidents who are planned for fracture repair under general were submerged in floodwater. People in low lying areas were
shifted to a camp. To prevent waterborne illness chlorination of
anesthesia. This randomized controlled study aims to compare
water was planned. Dr. XYZ, a community health researcher,
the efficacy of two different surgical approaches to fix the
wants to conduct a clinical trial with two different chlorine
fractures and facilitate healing of fracture. The decision to
preparations for water sanitation. Considering the emergency
operate needs to be taken immediately after admission.
situation, the researcher applies for exemption from ethical
Questions review and waiver of consent with the justification that both
1. When should the consent be taken and from whom? are chlorine preparations and hence individuals are not exposed
2. What are the other ethical issues in this situation? to additional risk due to participation in the study.
Participants’ answers Questions
• Consent may be taken in the emergency ward once the 1. Should the IEC grant review exemption?
patient is stabilized. If the patient is conscious, consent 2. Should the IEC grant waiver of consent?
may be taken from him/her; if not, it can be taken from
the legally acceptable representative (LAR).
Participants’ answers
• As it is an emergency situation and there will not be
Additional questions enough time to submit protocol to IEC and get the
• If there is no one accompanying the patient, can the approval, an administrative approval from the concerned
surgeon take the decision to include the patient as a authorities may be sufficient and an IEC approval need
participant? not be required

154 © 2021 Journal of Pharmacology and Pharmacotherapeutics | Published by Wolters Kluwer - Medknow
 Mathaiyan, et al.: Informed consent process

• Such studies can be done in nonemergency situations the protocol, it was mentioned that the biological samples
• They are vulnerable population and there must be a review would be discarded at the end of the study. When the researcher
mechanism in place. submitted a manuscript with results of this study to a journal,
the peer‑reviewer commented that the study should have
Comments of the panelists included two more SNPs from the selected genes.
• Since it involves research, an IEC approval is definitely
required. As it is an emergency, an expedited review can The researcher has not taken consent from the patient for storing
be obtained from the IEC within a short period of time.[3] his/her blood samples after the study or for future use of the
The IEC can be asked to grant waiver of consent as it samples for research. Now, the researcher applies for waiver of
involves a large population and it may be difficult to obtain consent to IEC and asks for permission to study two more SNPs.
consent in an emergency situation.
Question
Scenario 3 1. Should the IEC grant waiver in such a scenario?
The title of a study in English read “Comparison of combined Participants’ answers and comments
mechanical and oral antibiotic bowel preparation (MOBP) • A re‑consent needs to be taken
versus mechanical bowel preparation (MBP) alone in reducing • Since it was informed that the sample will be discarded
surgical site infection (SSI) in patients undergoing elective and not used for any future use, additional testing is not
colorectal surgeries: A randomised controlled trial.” This was permissible
translated into Tamil as “த ே ர ்ந ் தெ டு க ்க ப ்ப ட ்ட • The IEC can decide if waiver may be given in this situation
பெ ரு ங் கு ட ல் அ று வ ை ச ி க ி ச ்சைக் கு • A tiered consent should have been taken a priory to avoid
உட்படுத்தப்பட்ட ந�ோயாளிகளுக்கு அறுவை such a situation.
சிகிச்சை தள ந�ோய்த்தொற்றை (எஸ்.எஸ்.ஐ)
Comments of the panelists
குறைப்பதில் இயந்திர குடல் தயாரிப்பு (எம்.
• If the participant refuses to allow storage of sample and
பி.பி) மட்டும் ஒருங்கிணைந்த இயந்திர மற்றும்
its future use, it cannot be used for any further study
வாய்வழி ஆண்டிபயாடிக் குடல் தயாரிப்பின்
• If the sample was not discarded in this study, then it is
ஒப்பீடு: ஒரு சீரற்ற கட்டுப்பாட்டு ச�ோதனை.”
violation of protocol
Questions • If in this study, there was no mention of discarding the sample
1. Is it acceptable to have the exact translation of English and the study period was completed, the researcher can apply
words into the regional language? to IEC for extension of the study period and obtain re‑consent
2. What is the solution when it is not possible to find an from the participants for carrying out further analysis.
appropriate word or phrase for translation?
Participants’ answers Scenario 5
• Back translation could be a solution Vasopressin has been tried for cardiopulmonary resuscitation
• An original title, transliterated and another title in simple in adults with mixed results. A  pediatrician wanted to try
words may be included. vasopressin for children with cardiac arrest. He submitted a
protocol to IEC and sought waiver of consent for this study
Comments of the panelists involving trial of vasopressin in children who develop cardiac
• According to the CONSORT guidelines, two titles, one arrest in the intensive care.
the original and another one in a simple language could
be provided Question
• Forum for Ethics Review Committees in India provides 1. How should the IEC approach this case?
explanation to about 1000 commonly used words in the
Participants’ answers
ICD in two formats – one in simplified English (simplifier)
• Waiver of consent may be given.
and another in the local languages of India (now only three
are available – Hindi, Tamil, and Gujarati, will soon be Additional questions
made available in all local languages of India) • Can consent be obtained from the husband for the wife to
• If a community does not have a written language and there participate in research?
is only a dialect as in tribal population, an interpreter who • Can the consent of tribal head be sufficient for research
can talk to the community can be involved in the consent on tribal population?
process and this needs to be documented.
Comments of the panelists
• Delayed consent can be taken after the child’s emergency
Scenario 4 has been tackled
A researcher was studying the influence of five different • Sometimes consent needs to be obtained from the spouse
single‑nucleotide polymorphisms  (SNPs) in two genes on as well just to ensure that the research does not result in
progression‑free survival in patients with ovarian cancer. In a rift within the family considering our cultural habits

Journal of Pharmacology and Pharmacotherapeutics  ¦  Volume 11  ¦  Issue 4  ¦  October-December 2020 155
 Mathaiyan, et al.: Informed consent process

• Individual consent always needs to be obtained whether it Jayanthi Mathaiyan, Narayanan Parameswaran1, Harivenkatesh Natarajan,
is from the wife or when it involves the tribal population, R. Raveendran
giving adequate time for them to consult their spouse or Departments of Pharmacology and 1Paediatrics and Critical Care, JIPMER,
Puducherry, India
the tribal head as the case may be.
Address for correspondence: Dr. Jayanthi Mathaiyan,
Some Additional Points Department of Pharmacology, 3rd Floor, Institute Block, JIPMER,
Puducherry ‑ 605 006, India.
The panelists clarified some additional facts regarding E‑mail: drjayanthi2008@gmail.com
informed consent process.
• All telephonic consents must be documented in a logbook References
and recorded if possible 1. Indian Council of Medical Research Bioethics Unit. ICMR NCDIR.
• For online questionnaire‑based surveys, consent is usually Available from: http://ethics.ncdirindia.org/Dissemination.aspx#. [Last
accessed on 2020 Mar 18].
“implied.” In these studies, there will be an introduction
2. ICMR Workshop on Ethical Guidance for Biomedical Research.
section incorporating the consent requirements. Only Available from: http://ethics.ncdirindia.org/asset/images/dissemination_
when the participant agrees to consent, the questionnaire images/Puducherry_2019/broucher_JIPMER.pdf.  [Last accessed on
is visible 2020 Mar 18].
3. Indian Council of Medical Research 2017. Available from: https://
• Deception is required in studies involving sensitive issues
www.icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_
such as child abuse and illegal abortions where it may not Guidelines_2017.pdf. [Last accessed on 2020 Mar 18].
be ideal to disclose the title or purpose of the study as it
may alert the participants and they may not come out with
the correct information. This is an open access journal, and articles are distributed under the terms of the Creative
Commons Attribution‑NonCommercial‑ShareAlike 4.0 License, which allows others to
In these situations, after collecting data, a debriefing needs to remix, tweak, and build upon the work non‑commercially, as long as appropriate credit
be done in prior consultation with the ethics committee (EC). is given and the new creations are licensed under the identical terms.

The remaining panel discussion will be discussed in the

forthcoming issue.
Access this article online
Acknowledgment
Quick Response Code:
We are thankful to Dr. Rakesh Aggarwal for the valuable inputs Website:
for both conduct of the workshop as well as preparation of this www.jpharmacol.com
manuscript. We wish to acknowledge the resource persons
Dr. Vasantha Muthusamy and Dr. Nandhini for their valuable DOI:
contributions as panelists for this session. We also wish to 10.4103/jpp.jpp_175_20
express our sincere gratitude to Dr. Roli Mathur and team from
ICMR Bioethics Unit for the constant guidance provided and
ICMR for funding the workshop.
Financial support and sponsorship How to cite this article: Mathaiyan J, Parameswaran N, Natarajan H,
Raveendran R. Scenarios in medical ethics-5: Informed consent process.
Nil.
J Pharmacol Pharmacother 2020;11:154-6.
Conflicts of interest Received: 24-12-2020 Revised: 26-12-2020
There are no conflicts of interest. Accepted: 29-12-2020 Web Publication: 14-05-2021

156 Journal of Pharmacology and Pharmacotherapeutics  ¦  Volume 11  ¦  Issue 4  ¦  October-December 2020