|Ahead of print publication
Completeness of informed consent documents in synopsis of postgraduate medical students of a medical college of western Maharashtra
Laxmikant Choudhary1, Promod Chandra Awasthi2, K Rahul Ray2, Renuka Kunte3, Arun Kumar Yadav4
1 Resident, Dept of Community Medicine, AFMC, Pune, Maharashtra, India
2 Faculty, ACMS, New Delhi, India
3 Prof and HoD, Dept of Community Medicine, AFMC, Pune, Maharashtra, India
4 Associate Professor, Dept of Community Medicine, AFMC, Pune, Maharashtra, India
|Date of Submission||31-Aug-2020|
|Date of Decision||17-Sep-2020|
|Date of Acceptance||17-Sep-2020|
Arun Kumar Yadav,
Department of Community Medicine, Armed Forces Medical College, Pune - 411 040, Maharashtra
Source of Support: None, Conflict of Interest: None
Introduction: Research is a key requirement and is an integral part of postgraduate (PG) studies. In biomedical and health research involving human participants, obtaining voluntary informed consent is a must requirement for researchers' respect for individual autonomy as well as safeguard of participants against abuses and exploitations. The Indian Council of Medical Research (ICMR) has come out with the Revised National Ethical Guidelines for Biomedical and Health Research Involving Human Participants – 2017 giving essential and additional elements of an informed consent document (ICD). Materials and Methods: The study was a descriptive study done over a period of 12 weeks. A sample of 155 PG students were selected, who had submitted their synopsis in medical research unit of a medical college of Western Maharashtra. ICDs were scrutinized and evaluated with a checklist given by the ICMR guidelines 2017 and analyzed using SPSS version 20. Results: Of 155 students, 131 (91.6%) were males as compared to 24 (15.48%) females, and 43 (27.7%) belonged to clinical specialty as compared to 112 (78.3%) from para and nonclinical. Of 155 students, 143 (92.3%) had attached informed consent forms (ICFs) as compared to 12 (7.7%) who had not attached in their synopsis. In ICFs among 143 students, 59 (41.1%) students used English and local language (Marathi) and 84 (58.7%) used only English language. Conclusion: PG students have appropriately prepared ICFs; however, there are some discrepancies in some of the elements. There is a requirement of sensitizing PG students through regular training programs to reduce discrepancies in ICDs.
Keywords: Indian Council of Medical Research ethics guidelines, informed consent, postgraduate students
|How to cite this URL:|
Choudhary L, Awasthi PC, Ray K R, Kunte R, Yadav AK. Completeness of informed consent documents in synopsis of postgraduate medical students of a medical college of western Maharashtra. Med J DY Patil Vidyapeeth [Epub ahead of print] [cited 2021 Apr 12]. Available from: https://www.mjdrdypv.org/preprintarticle.asp?id=310587
| Introduction|| |
Key to good informed consent is the way of relaying information to the participants so that risk, inconveniences, and benefits of the study/intervention may be well explained in the simple and easy language which the participant understands.
For postgraduate (PG) students, evidence-based scientific learning is the best tool for enhancing critical thinking, as well as for problem-solving ideas and methodology. Research integrates a very important part in PG studies to teach students about its basics for their future expertise in this field. The PG students are also required to attend a conference before they appear for their final examination., Recording of informed consent is one of the most important steps in the ethical clinical research. However, participants are totally free in taking decision about their participation at any stage from the beginning and are free to quit anytime at any stage of research process if they want.,
The Indian Council of Medical Research (ICMR) has come up with the new National Ethical Guidelines for Biomedical and Health Research Involving Human Participants in 2017. These guidelines are well recognized in India and a number of other countries also. Informed consent document (ICD) has two parts – patient information sheet and the informed consent form (ICF). The ICDs contain essential elements as well as some additional elements depending on the type of study.
At present, there is a paucity of data about the completeness of ICDs for the researches admitted for ethical clearance. Hence, the study was carried out to assess the completeness of ICDs submitted to the institutional ethics committee by PG students.
| Materials and Methods|| |
This study is record-based, cross-sectional, descriptive study; it was conducted from November 2019 to February 2020, over a period of 12 weeks, in a government medical college located in the western part of Maharashtra. All the 155 1st-year PG students synopsis of the college were included in the study. There is a mandatory requirement of taking ethical clearance from the institutional ethical committee (IEC) before submission of synopsis to university. The ICDs are submitted along with the synopsis for ethical approval of projects.
A data extraction form to extract data from synopsis and ICF was designed based on the list of essential elements and additional elements given in the ICMR ethics guidelines. The essential elements in the ICF include mentioning that it is research, purpose and method of research in simple language, expected duration of the participation and frequency of contact with estimated number of participants to be enrolled, types of data collection and methods, benefits to the participant, community and others, any foreseeable risks, discomfort or inconvenience, extent of the confidentiality of records, payment/reimbursement for participation, free treatment and/or compensation, freedom of individual to participate, identity of the research team and contact persons. Additional information such as type of study and department were also collected. Data extraction form was given to experts for their opinion. The data extraction form was pretested in 15 synopses. The subjects were categorized into clinical and para- or pre-clinical as per the Medical Council of India. ICF translated in Hindi or any vernacular language was considered translated to local language.
The study was approved by IEC Serial Number IEC/2019/249 dated November 25, 2019.
The data were extracted by two investigators independently. The findings of the both the investigators were matched and discrepancy if any was resolved with mutual discussion. The data was entered in MS Excel. After collection and compilation, the data were described in the form of number and percentage for qualitative variable, and contingency tables were made. Data was analyzed using IBM Corp. Released 2013. IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp.A P < 0.05 was taken as significant.
| Results|| |
The data were extracted from 155 submitted synopses. The distribution of characteristics is shown in [Table 1]. Of 12 students who did not attach, 5 (41.7%) belonged to clinical specialty and 7 (58.3%) belonged to non/paraclinical specialty. The same is depicted in [Figure 1].
As per the latest ICMR guidelines, adequate information necessary for informed consent should be communicated in a language and manner easily understood by prospective participants. ICF may be in a local language for better communication and understanding of the participants of that area. The ICMR has also recommended to use only ethics committee approved version of consent form that should be translated in local language also. Only 59 students (38.1%) had ICF in both the languages English and local language; 84 students (54%) used only English language for obtaining of consent and 12 students (8%) were those who either not attached ICF or used language other than English and local like Hindi. The same is shown in [Figure 2].
|Figure 2: Language of informed consent form: Blue Part - ICF attached Red Part - ICF not attached.|
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Performance on essential elements
The performance of essential elements is shown in [Figure 3]. Comparison of performance on essential elements between clinical and non/paraclinical students is shown in [Figure 4].
|Figure 4: Comparison of performance on essential elements between clinical and para/preclinical students|
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Performance on additional elements
Of ten additional elements, three elements were not been included by any of the student; these are stigmatization related to research, insurance coverage, and publication plan. Performance of the students about two elements that are data/sample sharing and alternative procedure or course of treatment was more than 90%. Performance on additional elements is shown in [Figure 5], and comparison of performance on additional elements between clinical and para/preclinical is shown in [Figure 6].
|Figure 6: Comparison of performance on additional elements between clinical and para/preclinical students|
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| Discussion|| |
On analysis of the 12 synopses in which the ICFs were not attached, we found that five were descriptive studies, four were cross-sectional studies, two were in vitro studies, and one was qualitative study. Among these, in vitro studies (2) and qualitative studies (1) were as such not requiring informed consent as these studies were not involving human participants. The five descriptive studies for which ICF was not attached, were institutional based studies and as per ICMR guidelines the ICF was not required. Of these four cross-sectional studies, three were to be done in human participants so requiring ICFs and one was institutional-based study so not required to take informed consent. Finally, we can say that three students had not attached ICFs whom ideally had to attach. According to the current ICMR guidelines in some circumstances, studies do not require to obtain informed consent and researcher can take waiver of consent. These situations are retrospective studies where participants are de-identified or cannot be contacted, research on anonymized biological samples/data, certain types of public health studies/surveillance programs/program evaluator, research on data available in public domain, or research during humanitarian emergencies and disasters.
When ICFs were analyzed for types of consent taken, we found that studies included all variety of consents with different combinations (written informed consent only, written informed consent from parents, written informed consent from legally authorized representative [LAR], assent from children of age group of 7–18 years with written consent from parents + written assent from children, and written consent from parent), the reason behind this was that the studies itself were of different variety including participants of different age groups. Written informed consent from the participants was the highest variety of consent being used by 129 PG students, followed by written informed consent from parents (8 PG students).,, Manti and Licari have mentioned that to enroll a child in a research study, the permission by at least one parent or LAR is mandatory as because of their young age as well as their limited emotional and intellectual abilities children are considered to be legally incompetent to give valid informed consent. Nijhawan et al. have also mentioned role of parents in obtaining consent/permission in case the child under the age of 18 is involved as a participant.
The study showed that high percentage of the PG students are doing well on essential elements. The only two essential elements which were in <50% of synopsis were duration of participation and reimbursement of money. In our study, the performance of clinical subject students was better as compared to non/paraclinical subject students for the inclusion of both category of elements, essential and additional elements. In the same type of study by Hussain et al. in 2018, proportion of participants with good knowledge, attitude, and practices were more among PGs in clinical subjects than those perusing postgraduations in nonclinical subjects.
Obtaining of ICF has two different senses moral responsibility as well as legal responsibility presence of both of this is equally important, but inclusion of moral responsibility must be taken care as it is ethically as well as morally correct.,, In our study, average performance (element included by <90% of students) of the students was found for elements, declaration of risk/ discomfort/inconvenience, free treatment/compensation of participants, identity of research team/sponsor/ contact persons while poor performance on elements was found for payment/reimbursement for participation, duration of participation, and frequency of contact. This shows lack of moral responsibility of the students. This result shows that for some students (risk/discomforts/inconvenience in study included by 74.82%), informed consent process is just a formality only to save them from future legal issues; no moral responsibility is there toward participants. Wagoro et al. in Nairobi, Kenya, have concluded that the consent form was mainly used for the students “legal protection” and not for the patients benefits. Hussain et al. have also mentioned in their study that in forced field analysis morally right to inform that the patient was not the highest, it was the second highest driving force. Mandatory regulation by the Medical Council of India and protected by the Court of Law was the highest driving force.
The study was conducted in a medical college where all students underwent course in basic research methodology still the study finds inaccuracies for essential elements in the informed documents. Hence, there is a need for a centralized and focused training on ICDs,, as the doctrine of informed consent relates to negligence in profession and establishes a breach of the duty of care owed to the patient. It has also significant implications for medical trials of medications, devices, or procedures. A study done in Pakistan by Humayun et al. suggested incorporating formal training of bio-ethics in the undergraduate and PG medical curriculum.
Bhupathi and Ravi in their study have mentioned that, to uplift the ethical and moral values of the profession and to ensure practice of obtaining genuine and voluntary informed consent, a thorough knowledge is required to implement the doctrine of consent process in populations with different ethnic, race, and cultural backgrounds.
In 2019, Mandal et al. have recommended that classes on ethical issues in medical research and informed consent should be incorporated in their PG curriculum so that, along with their dissertation preparation, they have a proper knowledge on the ICMR guidelines to undertake such research.
The study was conducted among PG students of a medical college, and hence, the generalizability may be limited. However, since the college has an ecosystem of the research, we feel that the probability gap may be higher in other medical college. Nevertheless, multicenter study involving college of all regions may be conducted and common training program may be formulated on the basis of findings.
| Conclusion|| |
All the elements should be compulsory written in the ICF, if addition of any element is not required as it is possible in some type of study “NOT APPLICABLE” should be written in front of that element. Synopses that are incomplete due to lack of any element (essential/additional) ethics clearance should not be granted till the time all elements are included in the Informed consent form. A checklist should be developed of all elements of ICF and circulated among PG students before submission of synopsis to IEC.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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