|Year : 2022 | Volume
| Issue : 1 | Page : 19-22
Does the informed consent document in allied health research follow the national guidelines? A retrospective analysis of proposals submitted to an institutional ethics committee of a tertiary care hospital
Shilpshree Prashant Palsule1, Jaimala Vijay Shetye2, Manasi Subhash Lad3
1 Department of Occupational Therapy, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
2 Department of Physiotherapy, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
3 Institutional Ethics Committee, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
|Date of Submission||31-Jan-2021|
|Date of Acceptance||12-Feb-2022|
|Date of Web Publication||25-Mar-2022|
Shilpshree Prashant Palsule
Department of Occupational Therapy, Seth GS Medical College and KEM Hospital, Parel, Mumbai, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: Informed consent process forms an essential component of the research process. It protects participants' autonomy to decide whether or not to participate in the research freely. It is expected that the informed consent document (ICD) should explain the nature and content of the research to a participant in simple terminology and in the language that the participant understands. The researcher's responsibility is to obtain informed consent from every participant before his/her participation in the research. Objectives: The objective is to evaluate whether the informed consent process documents of research studies submitted for initial review by allied health branches of a tertiary care hospital follow the Indian Council of Medical Research (ICMR) guidelines and whether they relate to the protocol submitted for initial review. Study Design: This was a retrospective study. Methods: After institutional ethics committee (IEC) approval, all research studies submitted by allied health branches to the ethics committee of Seth GS Medical College and KEM Hospital, a tertiary care hospital in Mumbai, from November 1, 2018, to October 31, 2019, were reviewed. Thirty-five protocols were found to meet the inclusion criteria. The ICDs of these studies were evaluated for adherence to the ICMR 2017 guidelines. Ethics committee comments related to the ICDs were noted and analyzed. Results: 34 out of 35 research studies submitted had included all the ten mandatory points of the informed consent process, as per the Biomedical Health Research norms of the ICMR 2017. Seven protocols did not complete the review process and did not receive a letter of permission. IEC queries were mostly related to use of technical language, short forms of medical terms, improper mention of risks and discomforts, and sample size. Conclusion: This study concluded that the ICDs reviewed were complete in terms of sections recommended by the ICMR 2017 guidelines. However, there were certain lapses on the part of both the investigators and IEC, wherein the submitted ICDs did not convey the true nature of the study and the IEC did not correctly point out all these lapses at the time of the review.
Keywords: Allied Health, Biomedical Health Research, Ethics, Indian Council of Medical Research Guidelines 2017, Informed Consent Document
|How to cite this article:|
Palsule SP, Shetye JV, Lad MS. Does the informed consent document in allied health research follow the national guidelines? A retrospective analysis of proposals submitted to an institutional ethics committee of a tertiary care hospital. Indian J Occup Ther 2022;54:19-22
|How to cite this URL:|
Palsule SP, Shetye JV, Lad MS. Does the informed consent document in allied health research follow the national guidelines? A retrospective analysis of proposals submitted to an institutional ethics committee of a tertiary care hospital. Indian J Occup Ther [serial online] 2022 [cited 2022 May 29];54:19-22. Available from: http://www.ijotonweb.org/text.asp?2022/54/1/19/340895
| Introduction|| |
Research on human participants aims at developing generalizable knowledge that improves health, increases understanding of disease, and is ethically justified by its social value. Every research has some inherent risks and probabilities of harm or inconvenience to the participants.,, All clinical researches must follow the four basic ethical principles, namely autonomy, beneficence, nonmaleficence, and justice.
The informed consent process in research protects participants' autonomy to decide whether or not to participate in the research freely. Sometimes, researchers may not adhere to the requirements of the informed consent process. In a study carried out by Kundapura et al. (2013), it was noted that 70% of the informed consent forms belonging to trials conducted between 2008 and 2013 at a site in Pune were found to be deviating from the requirements of the law. Language barriers, religious influences, false expectations, patient perceptions, and vulnerable groups may pose challenges to the process.
Informed consent document (ICD) should involve concerns regarding provision of relevant and comprehendible information and should assure voluntary participation.
The researcher's responsibility is to obtain informed consent from every participant before his/her participation in the research. The ICDs must include the following ten essential elements per the Indian Council of Medical Research (ICMR) Guidelines for Biomedical Health Research (BHR) requirement.
Research in allied health sciences has increased in recent times, and the ethics committee receives many proposals (student theses and faculty projects) for review from these fields. These branches in our tertiary care hospital include physiotherapy, occupational therapy, and nursing. As per the 2021 Gazette, for allied and healthcare professionals, physiotherapy and occupational therapy are included as healthcare professionals. Most of the allied health sciences research falls into BHR, and ICMR 2017 guidelines must be followed. Failure to adhere to the ICMR guidelines will violate the participant's rights and dilute the research. We did not find studies evaluating whether the ICD in BHR follows ICMR guidelines. Literature search was conducted on PubMed and Google Scholar. Hence, it was decided to assess whether the informed consent process in proposals submitted for initial review by these departments follow the ICMR 2017 guidelines.
Aims and Objectives
The study aimed to evaluate whether the informed consent process documents of projects submitted for ethics review by allied health branches of our tertiary care hospital follow the ICMR guidelines and whether these documents relate closely to the protocol submitted at the time of initial review.
Inclusion criteria were all protocols submitted by physiotherapy, occupational therapy, and nursing from November 1, 2018, to October 31, 2019. Both observational and interventional studies submitted for expedited and full board review were included. Protocols submitted for exemption from review and retrospective studies with the waiver of the informed consent process were excluded from this study.
| Methods|| |
The retrospective study was conducted in the ethics committee office of a tertiary care hospital. Institutional ethics committee (IEC) approved the protocol through expedited review (Protocol No.: EC/OA-22/2020, Date of approval: February 15, 2020). All proposals submitted by the mentioned departments (occupational therapy, physiotherapy, and nursing) from November 1, 2018, to October 31, 2019, with ICDs, were reviewed. The ICDs of all the studies were evaluated for adherence to the ICMR 2017 guidelines. Further, they were also compared with the protocols submitted. Ethics committee comments related to the ICDs for the said protocols were also noted down. Each protocol and ICD were analyzed for adherence to the standards of ICMR 2017 guidelines for BHR.
| Results|| |
The total number of protocols from allied health sciences for review from November 1, 2018, to October 31, 2019, was 40. One protocol was submitted under the “exempt from review” category. Hence, 39 protocols were considered. Seven protocols out of these did not receive the final letter of permission. Out of 39 protocols, four had not submitted the ICD despite being prospective observational studies. ICDs of 35 protocols were hence reviewed. Two protocols out of 35 were still in the process of obtaining approval at the time of data analysis.
Out of 35 research studies submitted, 34 had included all the ten mandatory points of the informed consent process, as per the BHR norms. Seven protocols did not complete the review process and did not receive a letter of permission. IEC's queries were mostly related to technical language used, short forms of medical terms, risks and discomforts not mentioned clearly, and sample size not mentioned in ICD [Figure 1]a and [Figure 1]b. [Table 1] shows details of the flaws on part of the researcher and IEC as regards the mandatory points of the informed consent process.
|Figure 1: Adherence to Inclusion of Essential Points of Informed Consent Document|
Click here to view
| Discussion|| |
Statement of Research
Only one protocol out of 35 (2.86%) had not included the statement's research point. This could be because the institute had a standard format of ICD which was uploaded on the website. Hence, it must have been a ready reckoner for the investigators.
Purpose and Research Methods
In 10 out of 35 (28.57%), the purpose of the study was explained in technical language, and in 4 ICDs (11.43%), the research methods were technical or improperly explained. IEC, however, did not point out the same (50% of the time for purpose and 50% of the time for methods). This can be because, many times, the researchers feel that laypeople can easily comprehend the language. Hence, they did not make efforts to simplify the language of the ICD.
Expected Duration of Research, Frequency of Contact, and Number of Participants
Study duration was not mentioned in 16 out of 35 (45.71%) protocols; in 8 (50%) out of this, IEC did not point out the mistake. The sample size was not mentioned in 12 protocols out of 35 (34.29%). Again, in 50%, IEC did not point out this mistake.
Benefits to Participant or Community
In the benefits section, in 10 out of 35 (28.57%), direct benefits were mentioned, and in 40% of these, this was not pointed out by the IEC.
Any Foreseeable Risks/Discomforts
Most of the protocols were “minimal or low-risk” protocols. However, in the section on risks and discomfort, “no risk/discomfort for participation” was mentioned in 17 out of 35 (48%) protocols. IEC had not pointed out this mistake in 3 out of the 17 protocols(17.64% ) of the time.
The Extent of Confidentiality of Records
Confidentiality statement was found to be appropriate in all the ICDs; however, in one case (2.86%), a query regarding the same was wrongly sent by the IEC.
Payment/Reimbursement for Participation
In 2 out of 35 (5.71%), the clause for payment for participation was inadequately mentioned, and this was rightly pointed out by the IEC in both the instances(100%).
Free Treatment and Compensation for Research-Related Injury
Regarding the statement for compensation and free treatment for study-related injury, the investigators had not mentioned the same in 5 protocols out of 35 (14.28%). In 60% out of these, IEC failed to correct the investigators.
Freedom of the Individual to Participate or Withdraw from the Research
Freedom to participate was not mentioned clearly in 2 protocols out of 35 (5.71%). Both times, IEC rightly pointed this out. What happens when the research trial stops were not mentioned in 5 protocols out of 35 (14.28%). In 100% of these times, IEC had correctly pointed out the mistake.
The Identity and Contact Numbers of the Research Team and Institutional Ethics Committee
Identity of the research team was incompletely mentioned in 4 out of 35 (11.43%) protocols; in 25% of these times (once), IEC had overlooked this mistake.
Some reasons for the above lapses could be that the researchers, mainly the students, who were conducting research as a part of postgraduate theses, were not well versed with the latest ICMR guidelines. They did not give much importance to the contents of the ICD. However, certain lapses on the IEC part, such as technical language, completeness in terms of sample size, duration of the study, free treatment, and compensation for study-related injury, should have been pointed out to the investigator. Since the tertiary hospital IEC caters to an overall protocol load of approximately 400 each year and each of the members is busy with their commitment beyond the ethics committee duties, probably, these lapses might have occurred. Further, many times, the medical personnel are not very well versed with “nonmedical terms” that may explain the condition. Even they may not perceive that the medical language may be difficult for a common person to understand. The findings of this study further emphasize the importance of the layperson in the ethics team, which is mandatory for the composition of the IEC.
The above study gave an insight into the investigator and the IEC's shortcomings with respect to the informed consent process, which is an essential part of the research process, before participant recruitment for any research study. To the best of our knowledge, no such research in allied health science research has been carried out. The study highlights the need for a more sincere effort on the investigator's part to convey the research's true meaning to the participant and on the part of the IEC to scrutinize the ICD vigilantly. In addition, if the postgraduate students are ignorant, the postgraduate guide should be vigilant so that these lapses do not occur. A thorough review by the guide before submitting it to the IEC would help in the early approval of protocols. Since common names for medical terms are not frequently used in the medical setup, it would also help create a dictionary of commonly used terms in allied health research as a ready reckoner.
Only English language ICDs, not regional language ones, were studied as a part of this study. Layperson could have been a part of the study, to gain their perspective regarding the ICDs. Further, the findings of this study are not generalizable to all ethics committees and investigators. Further research in the form of intervention in the form of dedicated training sessions for investigators and evaluating the efficacy can be carried out.
| Conclusion|| |
The study concluded that lapses may occur on part of both the investigators and ethics committees, while preparing and reviewing the ICD, and that attention to be paid to these lacunae in future submission, review, and approval process.
We thank the Dean, Seth GSMC and KEMH, Head of Department, Occupational therapy and Dr. Yashashri Shetty, Associate Professor, Department of Pharmacology for motivating me to conduct the study.
Financial Support and Sponsorship
Conflicts of Interest
There are no conflicts of interest.
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