|Year : 2022 | Volume
| Issue : 2 | Page : 184-188
Organ donation and the medicolegal aspects: A process analysis study of the Indian States - Observational study
Ishwarya Thyagarajan1, Hemal Kanvinde1, Sunil Shroff2, Muneet Kaur Sahi1
1 MOHAN Foundation, Chennai, Tamil Nadu, India
2 Madras Medical Mission Hospital and MOHAN Foundation, Chennai, Tamil Nadu, India
|Date of Submission||09-Jun-2021|
|Date of Acceptance||14-Dec-2021|
|Date of Web Publication||30-Jun-2022|
Dr. Sunil Shroff
MOHAN Foundation, 3rd Floor, Toshniwal Building, 267, Kilpauk Garden Road, Chennai - 600 010, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Context: In India, the majority of brain-dead organ donors are victims of road traffic accidents, thereby making them entities in medicolegal cases (MLC). This places an additional burden and complicates the organ donation process, as an inquest must be conducted by the police station closest to the accident spot before the possibility of organ donation is considered. Following organ retrieval and donation, a postmortem is required before the body is handed back to the police. These procedures cause delays in the organ donation process and subsequently in families receiving the body of their loved ones. The problem is compounded by the fact that there are variations in the inquest and postmortem procedures in different states. Aim: The study aims to comprehensively enumerate the medicolegal protocols followed by the states having an active deceased organ donation program. Design and Methods: A survey, using a structured questionnaire, was conducted among the senior Transplant Coordinators (key stakeholders in the organ donation process) of eight states. Their experiences handling MLC and the state protocols adhered to were captured. Results: It was found that there were differences in protocols followed by the states with respect to medicolegal organ donation cases. Significant variations were observed in the police inquest and postmortem procedures. A need for training of the police personnel in the medicolegal aspects of the organ donation process is evident from the survey responses. Conclusions: The undue delays lead to difficulties in completing the donation and also cause distress among the family members who have said yes to organ donation despite their grief. The study recommends the need for uniformity in protocols to ease pain points in this program. This is of paramount importance in instances of interstate-organ donation cases.
Keywords: Forensic, Inquest, medicolegal cases, organ donation, police, road traffic accidents, transplant law, transplantation of human organs act
|How to cite this article:|
Thyagarajan I, Kanvinde H, Shroff S, Sahi MK. Organ donation and the medicolegal aspects: A process analysis study of the Indian States - Observational study. Indian J Transplant 2022;16:184-8
|How to cite this URL:|
Thyagarajan I, Kanvinde H, Shroff S, Sahi MK. Organ donation and the medicolegal aspects: A process analysis study of the Indian States - Observational study. Indian J Transplant [serial online] 2022 [cited 2022 Aug 15];16:184-8. Available from: https://www.ijtonline.in/text.asp?2022/16/2/184/349351
| Introduction|| |
In India, the potential organ donor pool is majorly comprised road traffic accident (RTA) victims who have sustained traumatic head injuries and have been declared brain dead. According to the 2018 Global Status Report on Road Safety, it was found that the reported number of road traffic deaths in India in the year 2016 was 150,785 and 22.6 was the estimated road traffic death rate per hundred thousand population. India has been ranked number 1 in the number of road accident deaths across 199 countries reported in the World Road Statistics, 2018. Most recently, 151,417 people succumbed to death on the Indian roads following vehicular accidents in 2018 and most victims sustained head trauma. Fatal, traumatic brain injuries were seen in 68.73% of cases of head injuries sustained, according to a study undertaken by AIIMS, New Delhi. Furthermore, a 5-year study of an Indian state's registry data showed that 79% of cases of organ donation came from victims of head trauma/RTAs who have progressed to brain death.
Victims of these unfortunate events inevitably become casualties in medicolegal cases (MLC). Medical professionals classify a case of injury as medicolegal when they think a law-enforcing agency is required to conduct an investigation to establish the cause of the injury. All vehicular and unnatural accident cases, including poisoning, suicide, and assault are treated as medicolegal. The Transplantation of Human Organs Act (1994) and the Transplantation of Human Organs and Tissues (Amendment) Act 1994 (2011) of India have laid out the protocols for organ or tissue donation in MLCs. The body in an MLC is considered property of the state and foul play has to be ruled out when establishing the cause of death. An inquest by a police officer and clearance from a forensic expert for organ retrieval are certain crucial components in the process.
In India, organ donation and transplantation activities are under the purview of the Ministry of Health and Family Welfare and matters of the police fall under the Ministry of Home Affairs. States such as Tamil Nadu and Karnataka have issued Government Orders (GO) for coordinating the MLC cases to facilitate deceased organ donation. Few states have also highlighted the roles of police and forensic doctors in a successful organ donation.
Despite the substantially large potential organ donor pool available, India is still faced with a severe organ shortage. Among the many reasons for this, delay in processing an MLC, retrieving the organs and handing over the body to the family are significant ones. This discourages families from providing consent for donating the organs of their brain-dead relatives.,
In this context, this study attempts a step-wise analysis of the medicolegal procedures followed to understand the grounds for undue delays in organ donation cases. The police inquest and postmortem protocols of eight Indian states that have an active deceased organ donation program, have been critically examined.
| Subjects and Methods|| |
The study was carried out using a survey administered among nine senior transplant coordinators of eight states - Tamil Nadu, Kerala, Telangana, Maharashtra, Madhya Pradesh, Rajasthan, Chandigarh, and Delhi. The transplant coordinators responded to a questionnaire via E-mail. Transplant coordinators are considered the backbone of the organ donation and transplant program, facing and solving every possible problem on the way to a successful donation. The coordinators who participated in the study had an average of 10 years of work experience in both public and private sector hospitals and had handled numerous MLC.
The questionnaire used in the survey was divided into three sections. The first section was framed following discussions with doctors and transplant coordinators. It was designed to highlight widespread difficulties encountered by the hospitals and coordinators and the disparities in the medicolegal procedures in the eight states. The second section primarily focused on capturing the reasons for delays in handing over the donor's body to the family in MLC. The final section aimed at identifying the areas in the organ donation process where the police personnel lacked knowledge and required training.
Declaration of patient consent
The patient consent has been taken for participation in the study and for publication of clinical details and images. Patients understand that the names and initials would not be published, and all standard protocols will be followed to conceal their identity.
The study has been approved by Institutional Ethics Committee of MOHAN Foundation Ethics Committee (EC/NEW/INST/2020/542 submitted to NECRBHR, DHR). All guidelines according to Declaration of Helsinki were followed. The study was performed according to the guidelines in Declaration of Helsinki.
| Results|| |
The findings from the study highlighted the many differences in the protocols followed by the eight states in the steps involved in processing an MLC [Figure 1].
Conducting the inquest
The family of the victim in an MLC is required to file a First Information Report (FIR) at a police station closest to where the accident took place, based on which the police investigate to determine the cause of death. In Madhya Pradesh, Maharashtra (Mumbai), Telangana, Kerala, Punjab, and Rajasthan, the inquest is conducted by the Investigating Officer (IO) from the local jurisdiction where the FIR was filed. Whereas, in the states of Tamil Nadu, Delhi, and Maharashtra (Pune area), an IO from the nearest police station (police outpost or designated police station of the hospital) could start investigating until the IO from the local jurisdiction arrives, to avoid delays.
Inquest and organ retrieval
While the inquest is carried out only after organ retrieval in Madhya Pradesh, Kerala, and Maharashtra (Pune area), the IO initiates the inquest before organ retrieval and would have to complete it after the retrieval process in the other states.
| Performing the Postmortem|| |
In Telangana, Madhya Pradesh, and Rajasthan, the postmortem examination is performed at the same operation theater where the organ retrieval surgeries take place. In contrast, the body is moved to a mortuary for the postmortem in Punjab, Kerala, Maharashtra, Tamil Nadu, and Delhi.
Examination of the cranial cavity during postmortem
With the exception of Telangana and Rajasthan, the cranial cavity is examined by opening the skull during the postmortem procedure in all the other states.
Issuance of no objection certificate for organ retrieval
A no-objection certificate (NOC) has to be mandatorily obtained from the IO to go ahead with organ retrieval in the states of Madhya Pradesh, Rajasthan, Maharashtra, Punjab, and Delhi. However, in Tamil Nadu and Telangana, the role of the IO is restricted to expediting the inquest and postmortem procedures. The forensic expert responsible for the postmortem authorizes the organ retrieval. In Kerala, approval from neither the police nor the medical practitioner is required in the process.
Around 70% of the transplant coordinators have stated that the lack of awareness of the police about brain death and organ donation is the main reason for causing delays in the process. Considerable time has to be spent in explaining the concepts and their role in facilitating the donation process. Nearly half of the transplant coordinators also mentioned that despite explaining the importance of the situation, IOs do not arrive on time, creating a setback in expediting the inquest and postmortem procedures. However, with the exception of the Mumbai region, the rapport between the coordinators and the police is excellent and the police have no trust issues once the situation is accurately explained to them.
Duration of the retrieval surgeries and brain death confirmatory tests mainly contribute to the delay in processing organ donation cases. The delays caused by the inquest and postmortem procedures are relatively shorter.
| Discussion|| |
Since the THO Act was passed in the parliament in 1994, it has undergone amendments aiming to make the organ donation process seamless, transparent, and expand its scope. With respect to MLC, the Transplantation of Human Organs and Tissues Act (THOTA) Rules 2014 of the Amended Act 2011 clearly defines the roles of all the stakeholders.
MLC are inherently complex with the involvement of multiple players and the extensive documentation that is required. The two important stakeholders in MLC are the police and the team of forensic experts performing the postmortem. While the police are responsible for conducting an inquest to determine the cause of death, the forensic team has to ensure the organ retrieval process does not interfere with establishing the cause of death. The THO Act 1994 in Chapter 2 states: (a) the Medical Superintendent to request police to conduct inquest and (b) the forensic medicine doctor to authorize organ retrieval. The THOTA Rules 2014 amended this further by including: (a) The Resident Medical Officer (RMO) of the hospital would request SHO, SP, DIG to conduct inquest for timely retrieval of organs and send a copy of the request to the forensic doctor who will perform postmortem; (b) organ retrieval in any way should not interfere with the determination of the cause of death and the retrieval doctors should prepare reports about organs/tissues that will be retrieved and copy will be included in the postmortem report; (c) the medical practitioner performing the postmortem has to be present during the retrieval surgery whenever possible; and (d) prioritizing the postmortem of organ donors at all costs to ensure the grieving families receive the body at the earliest.,
However, not all states have adopted the amended act [Table 1].
Certain states have initiated the practice of ensuring that a registered postmortem medical practitioner is present during organ retrieval surgeries as laid out in the THOTA Act 2011. Yet, in states like Tamil Nadu, which follow the 1994 Act, the postmortem is either conducted in a designated autopsy/postmortem room in a private hospital or at the mortuary of a government hospital where the body is reopened after organ retrieval. Postmortem in the state is done only during the day in government hospitals and in private hospitals, it is done after retrieval in a different OT by a government forensic doctor. In Indore, Madhya Pradesh, postmortem is performed in the organ retrieval OT by a forensic doctor from a government hospital. Hospitals in Delhi have set aside certain specific timings only during which postmortems could be carried out.
Path-breaking GO issued by some states have turned the tables. For example, the Tamil Nadu GO No. 86, 2011, was issued specifically for medicolegal organ donation cases, easing many pain points. Three exclusive forms– request for police inquest, list of functional organs that could be retrieved, and a form authorizing organ retrieval have been framed as part of this GO. In addition, the state government also released a circular that permits the local police IO to start the inquest if the FIR police station is too far. Karnataka followed suit with a similar one in 2019.
The objective of the inquest proceedings (Section 174 of the Code of Criminal Procedure [CrPC]) is merely to ascertain whether a death has occurred under unnatural circumstances and if so, establish the cause of death. The purpose of preparing the inquest report is to record the identification marks of the deceased victim. Despite the Code of CrPC and the THO act mentioning that the IO is not required to issue an NOC, hospitals in many states still are taking a statement to this effect. This causes confusion in the minds of the IO and leads to delay in handing over the body to the family.
The legal mandate of a postmortem is to determine the cause and manner of death, in addition to collect, store, and document appropriate evidence to aid the medicolegal investigation of the case. The postmortem medical practitioner, a forensic medicine expert, is responsible to prepare the postmortem report. He is authorized to give permission for the retrieval of organs. An NOC from him is the legal requirement (Sec 6 Chapter 2 of THO Act). In 2008, the Tamil Nadu Government passed an Order (Ms. No. 86 dated 26.02.2011) with directions and letter formats specifically for donation in MLCs.
Medical management of potential organ donors until organ retrieval is very crucial as it determines the success of a transplant to a large extent. It is recommended that the organs are retrieved at the earliest after the consent is obtained from families, owing to the medically instability of brain-dead donors. The average survival period of a potential donor on a ventilator after the brainstem death diagnosis is estimated to be around 13 h. The 6-h interval between the two sets of brain death testing also constricts the time available for counseling families and complete MLC formalities before retrieval.
The police inquest, the first step in processing an MLC, therefore has to begin without any delay. Nearly all transplant coordinators mentioned that the IOs arrived late and were unaware of what had to be done and considerable time is spent explaining that. The coordinators suggested that sensitizing the police officers about brain death, legal aspects, donation process and their role would help smoothen and speed up the process of donation. Some also recommended involving the higher police officials (top-down approach) would help in getting adequate support from all levels.
Streamlining the inquest and postmortem procedures and making them uniform would help overcome existing issues in the MLC and avoid delay in handing over the bodies to families after organ donation. Complications particularly arise in the case of inter-state donations, where the states involved have different protocols for processing MLC cases. A central Coroner's Act for India was on the anvil, however, it has not progressed.
Executing the medicolegal formalities thoroughly and ruling out mal-intent in the cause of death is challenging in circumstances where time is of the essence. While the retrieval and transplant teams would be focusing on retrieving the organs at the earliest to ensure their functionality is uncompromised, the inquest and postmortem procedures have to be performed flawlessly, bearing in mind the time constraint. Striking a balance between the two would assure success. Position papers promoting organ donation, published in the US, have also highlighted the constant friction between the transplant professionals and the forensic doctors in MLC organ donation cases.,
The study was carried out in few states and hence the results cannot be generalized to the rest of the country.
| Conclusions|| |
Disparities in inquest and postmortem procedures followed by different states in MLC donation cases are evident. Medicolegal formalities, completed faultlessly, within the shortest period would ensure the grieving families are not further distressed waiting to receive the body of the loved ones. Streamlining the MLC procedures and making them uniform across the country would aid in achieving a common understanding of guidelines for hospitals, transplant coordinators, and other stakeholders. Standardized, uniform protocols will also make it easier for new the states initiating deceased donation program.
Complexities associated with MLC should not make it a deterrent to organ donation. Police personnel at all levels need to be trained in deceased donation procedures, transplant law as well as local state GOs. Common protocols, particularly for postmortem examinations, would avert undue delays in handing over the body of the deceased and also promote interstate donations.
The authors would like to acknowledge the support of
Dr. Srivari Bhanu Chandra, Dr. Amit Joshi, Ms. Rajinder Kaur, Ms. Sunitha A T, Mr. Aneesh P V, Ms. Jigisha Yadav, Mr. Ramprasad Meena, Lt. Col. Sandhya Nair, and Ms. Surekha Joshi.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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