A Medico-Legal Case (MLC) can be defined as a case of injury or ailment, etc., in which investigations by the law-enforcing agencies are essential to fix the responsibility regarding the causation of the injury or ailment. It may be a legal case requiring medical expertise when brought by the police for examination. In this article we shall discuss medico-legal aspect of sexual assault.

List of Medico-Legal Cases:

• All cases of injuries and burns -the circumstances of which suggest commission of an offense by somebody. (Irrespective of suspicion of foul play)
• All vehicular, factory or other unnatural accident cases specially when there is a likelihood of patient’s death or grievous hurt.
• Cases of suspected or evident sexual assault.
• Cases of suspected or evident criminal abortion.
• Cases of unconsciousness where its cause is not natural or not clear.
• All cases of suspected or evident poisoning or intoxication.
• Cases referred from a court or otherwise for age estimation.
• Cases brought dead with improper history creating suspicion of an offense.
• Cases of suspected self-infliction of injuries or attempted suicide.
• Any other case not falling under the above categories but has legal implications

Medical professionals are often unsure of the course of action in medico-legal cases. Thus, they are rather reluctant to attend to cases of accident for fear of being involved in unnecessary litigation later on. Even in cases of serious accidents, medical professionals hesitate to offer help, sometimes resulting in patient’s death. The first question that arises in such cases is whether any medical man can be forced to accept an accident victim. The answer to this till some time back was very clear. The doctor could choose patients according to his own will.

In Parmananda Katara Vs Union of India, AIR 1989 SC 2039 case, the apex court held that every doctor is bound to provide medical aid to the victims irrespective of the cause of injury; he cannot take any excuse of allowing law to take its course. Hence, if now a doctor refuses treatment, in case of emergency, he/she could be sued under the law. Once the doctor accepts the case and starts treatment, then the doctor-patient relationship is established.

The doctor or hospital is required to examine a victim of rape if she reports to the hospital directly, and voluntarily, without a police requisition.

In State of Karnataka v. Manjanna, 2000 (3) SCR 1007 case, the Supreme Court recognized that the rape victim’s need for a medical examination constituted a “medicolegal emergency”. Second, it was also the right of the victim of rape to approach medical services first before legally registering a complaint in a police station. The hospital was obliged to examine her right away; they could always subsequently initiate a police complaint on the request of the victim. The judgment also recognizes the three ways by which a hospital may receive a victim of rape: voluntary reporting by the victim; reporting on requisition by the police, and reporting on requisition by the Court.

Medico-Legal Aspect of Sexual Assault:

Section 375 of the Indian Penal Code defines the term “Rape” as follows:

A man is said to commit “rape” who, except in the case hereinafter excepted, has sexual intercourse with a woman under circumstances falling under any of the six following descriptions:

(First) — Against her will.

(Secondly) —Without her consent.

(Thirdly) — With her consent, when her consent has been obtained by putting her or any person in whom she is interested in fear of death or of hurt.

(Fourthly) —With her consent, when the man knows that he is not her husband, and that her consent is given because she believes that he is another man to whom she is or believes herself to be law¬fully married.

(Fifthly) — With her consent, when, at the time of giving such consent, by reason of unsoundness of mind or intoxication or the administration by him personally or through another of any stupe¬fying or unwholesome substance, she is unable to understand the nature and consequences of that to which she gives consent.

(Sixthly) — With or without her consent, when she is under sixteen years of age.

Explanation: Penetration is sufficient to constitute the sexual intercourse necessary to the offence of rape.

Exception: Sexual intercourse by a man with his own wife, the wife not being under fifteen years of age, is not rape.

Object of Rape Evaluation Test:

Victims of alleged Sexual offences like rape may be brought for the medical examination by police, or by order of a court, or the victim may come on their own. In the event the victim comes directly, the police will be informed and necessary action will be taken to register a case. The objects of medical examination are as follows:

1. Medical assessment and treatment of injuries and assessment, treatment, and prevention of pregnancy and Sexually transmitted diseases (STDs)
2. Collection of forensic evidence;
3. Psychological evaluation;
4. Psychological support;
5. Prepare reports required under the law.

The principal features of the examination are:

1. Primary data;
2. Physical Examination and mental condition;
3. Signs of struggle on clothes and body;
4. Local examination of the genitals.

Medico Legal Aspect of Sexual Assault with Reference to Victim:

Section 53(5) of the CrPC talks about examination of a female victim, which should be done by or under the supervision of a female doctor.
Section 164(A) CrPC explains the legal requirements for medical examination of a victim of rape. One of the main elements of this is that the consent of the victim is mandatory and should be part of the report.

The Section provides for a medical examination of the victim of rape by a registered medical practitioner. It also provides that when no woman doctor is available, there is no bar against a male doctor carrying out the examination, if the victim consents. Though getting the examination done by a woman doctor is ideal, the law does not mandate it, keeping in mind that a medical examination should not be postponed because of an extreme situation such as the want of a female doctor.

The same section mandates that a medical examination must be carried out within 24 hours of the police receiving information, thus recognizing this as a medico legal emergency and putting a timeframe for the investigating officer.

The report shall state precisely the reasons for each conclusion arrived at. The exact time of commencement and completion of the examination shall also be noted in the report. The registered medical practitioner shall, without delay, forward the report to the investigating officer, who shall forward it to the Magistrate referred to in section 173 of Cr. P. C. as part of the documents referred to in clause (a) of sub-section (5) of that section.

Medico Legal Aspect of Sexual Assault with Reference to Accused:

Section 53A of the CrPC provides for a detailed medical examination of a person accused of an offence of rape or an attempt to commit rape. A detailed medical examination is to be carried out by a registered medical practitioner (only allopathic doctors registered under the MCI) employed in a hospital run by government or local authority – and in the absence of such a practitioner within the radius of 16 km from the place where the offence has been committed, by any registered medical practitioner acting on the request of a police officer not below the rank of a sub inspector.

The medical examination should be carried out without any delay and a “reasoned” report be prepared recording the name and address of the accused, the person by whom he was brought, the age of the accused, marks of injury if any, a description of materials collected from the accused for DNA profiling, other material particulars in reasonable detail, and the exact time of commencement and completion of examination. The report should be forwarded without any delay to the investigating officer who in turn shall forward it to the magistrate concerned.

The report shall state precisely the reasons for each conclusion arrived at. The exact time of commencement and completion of the examination shall also be noted in the report. The registered medical practitioner shall, without delay, forward the report to the investigating officer, who shall forward it to the Magistrate referred to in section 173 of Cr. P. C. as part of the documents referred to in clause (a) of sub-section (5) of that section.

Where the accused in a case of sexual offence in police custody is brought for medical examination, consent is not required. Samples may be collected and handed over to the police for forensic examination.

SAFE Kit:

The kit was developed in Chicago in the mid-1970s by Louis Vittulo, in order to provide a more uniform protocol for evidence collection after sexual assaults. For years, the standardized tool was referred to as a Vitullo kit. Today it is colloquially referred to as a rape test kit or a rape kit, which is used interchangeably to refer to the specific evidence that is obtained through the use of the rape kit. Other terms and abbreviations used are sexual assault kit (SAK), a sexual assault forensic evidence kit (SAFE), sexual assault evidence collection kit (SAECK) and PERK (Physical Examination Recovery Kit).

A SAFE kit consists of small boxes, swabs, microscope slides, sterile containers, and plastic bags for collecting and storing evidence such as clothing fibers, hairs, saliva, blood, semen or body fluid from lips, cheeks, thighs, and vagina.

The kit is useful for investigations conducted after an alleged sexual assault, and can be used in evidence to punish the assailant. It is equally useful to exonerate persons who have been falsely accused of sexual assault.

In Delhi Commission of Women v. Delhi Police, W.P. (CRL) 696/2008 case, the Court mandated certain changes in the police system, health services, child welfare committees, legal services and support services in order to give justice to victims of rape. The court pronounced that a SAFE Kit (Sexual Assault Forensic Evidence collection kit) be used by all medical personnel for gathering and preserving physical evidence following sexual assault. Court issued guidelines to police, medical examiners, courts, and prosecution. Click here for guidelines

Guidelines for attending alleged victim of sexual offence

1. The date and time of arrival of the victim must be mentioned, both in the case sheet and the MLC Register. The duplicate copy of case sheet and Medicolegal Report shall be preserved for future reference.
2. The date and time of examination will be mentioned in the case sheet.
3. Case sheet will be initiated, noting personal particulars of the victim, along with date and the time of reporting.
4. MLC will be initiated after filling the MLC Register available at examination facility.
5. The alleged victim will be admitted if the medical condition is serious.
6. The police will be informed telephonically followed by in writing after filling up the MLC Register.
7. The Senior Registrar / Station HQ will be informed.
8. At least two identification marks of the victim will be mentioned in the case sheet as well as in MLC register.
9. Report to the police will be given by name of the victim or as an unknown case (If name of the victim is not known). Care must be taken to preserve the confidentiality of the victim from others not related with the case.
10. Police will register a case under the relevant section of the IPC.
11. The police may take the victim and the accused for medical examination at a hospital which is authorized to carry out medicolegal work.
12. Neither the victim nor accused in cases of sexual offences should be permitted to wash or take a bath till the medical examination is completed.
13. The proforma for recording medical examination of alleged rape victim and the accused are enclosed as in prescribed format respectively.
14. Consent of the victim must be obtained before starting the examination. The steps of examination and their purpose should be explained to the victim in a language she understands. The examination is to be carried out in the presence of a female attendant.
15. All injuries present on the body will be recorded. Line diagrams depicting the front and back of the body may be used for a better description of location of the injuries.
16. If the clothes are the same as those worn during the occurrence of alleged sexual offence, they should be carefully examined for the presence of blood, seminal stains, mud etc.
17. If there are any marks of suspicious stains, the clothes should be preserved with a view to forwarding them to forensic laboratory in prescribed format.
18. If there are foreign hairs, fibres, debris under the nails etc, they must be carefully preserved and sent to experts of forensic laboratory for comparison with those found on the accused. Specimens should include vaginal swab, preferably from the posterior fornix.
19. Care must be taken to preserve various samples of medicolegal importance for their submission to respective police authority.
20. In case the victim reports herself directly to the hospital after the alleged crime, she should not be sent to the police station for legal formalities; instead the police will be called to the hospital for the necessary requirements.

Other Legal provisions Associated with Sexual Assault:

• U/s 228A of Indian Penal Code, no person can disclose the name of the rape victim and if anybody discloses the name, he shall be punished with either description for a term which may extend to two years and shall also be liable for fine.
• U/s 114-A of Indian Evidence Act, presumption can be made as to the absence of consent in certain prosecutions for rape. Whenever the person of a female victim is to be examined under section 53 [5] of Criminal Procedure Code (Cr. P. C), the examination shall be made only by, or under the supervision of, a female registered medical practitioner.
• U/s 327(2) of Code of Criminal Procedure, there should be in camera trial for all rape victims.

Conclusion:

Medico legal evidence has been considered an important component in the prosecution of crimes, especially those related to sexual violence. The courts heavily rely upon it. However, it is important to understand that forensic science itself is a new and emerging discipline. No forensic method has rigorously been able to demonstrate a definitive connection between a specific individual and a sample or source. So special precaution should be taken and care, emphasis should be laid on section 53 CrPC and 164A CrPC.

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Human experimentation can be broadly defined as anything done to an individual to learn how it will affect him. The main objective of human experimentation with drugs is the acquisition of new scientific knowledge rather than therapy. Human experimentation becomes most critical in the field of medicine, where the relationship between the experimenter and his subject is on a direct individual basis and the experiment may affect the subject’s health or life. Medical experimentation is therefore of vital interest to law and society. The traditional physician regarded his patient primarily as a subject for treatment rather than for experimentation. The traditional doctor-patient relationship gets affected by the pressures of experimentation so that now the physician is also an investigator, and the patient is also a subject.

Clinical Trials:

A clinical trial is a systematic study to generate data for discovering or verifying the clinical and pharmacological profile (including pharmacodynamic and pharmacokinetic) or adverse effects of a new drug on humans. Clinical trial is the only way of establishing the safety and efficacy of any drug before its introduction in the market for human use and is preceded by animal trials where the efficacy and side effects are observed in animals and an estimated drug dose is established.

Requirements of Clinical Trials:

• Fully informed consent of all participants
• Full information to be given about the experiment, including its benefits and risks
• Attentions are to be drawn to possible alternatives
• If clinical trial involves a pregnant woman, extra care and protective measures must be taken

Need of Clinical Trials:

• For finding out bioequivalence data volunteer subjects, generally healthy individuals but occasionally in patients are used.
• For testing a drug usually Serum/plasma samples are obtained at regular intervals and assayed for parent drug concentration.
• But these alone neither feasible nor possible to compare the two products of various means of use for instance if drug is to be consumed by inhaling etc.
• Thus testing will be conducted to clinical trials at several different doses to derive expected results.

Phases of Clinical Trial:

There are 4 phases of biomedical clinical trials:

• Phase I studies usually test new drugs for the first time in a small group of people (20 – 80) to evaluate a safe dosage range and identify side effects.
• Phase II studies test treatments that have been found to be safe in phase I but now need a larger group of human subjects (100 – 300) to monitor for any adverse effects.
• Phase III studies are conducted on larger populations (3000) and in different regions and countries, and are often the step right before a new treatment is approved.
• Phase IV studies take place after country approval and there is a need for further testing in a wide population over a longer timeframe.

Participating in Clinical Trials:

A clinical study is conducted according to a research plan known as the protocol. The protocol is designed to answer specific research questions and safeguard the health of participants. It contains the following information:

• The reason for conducting the study
• Who may participate in the study (the eligibility criteria)
• The number of participants needed
• The schedule of tests, procedures, or drugs and their dosages
• The length of the study
• What information will be gathered about the participants

Concerns with Clinical Trials in India:

• The big problem plaguing clinical research is an over-representation of low-income groups among trial subjects.
• Sometimes Clinical research organizations (CROs) recruit them selectively, exploiting financial need and medical ignorance.
• Because these subjects are well-paid, and get no therapeutic benefit, their only reward from the trial is financial.
• Such deception is a risk not only to volunteer health but also to society, because it can throw off the trial’s results.
• Due to this unethical practices unsafe drugs can make their way into the market and safe drugs can get rejected.
• Selectiveness in recruiting subjects for clinical trials leads to human rights violations and to bad science.

Functions of Ethics Committee in Clinical Trials:

According to the Drugs and Cosmetics rules, 1945. an Ethics Committee is a committee comprising of medical, scientific, non-medical and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial and it shall be responsible for reviewing and approving the protocol, the suitability of the investigators, facilities, methods and adequacy of information to be used for obtaining and documenting informed consent of the study subjects and adequacy of confidentiality safeguards. In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Ethics Committee shall analyze and forward its opinion as per procedure specified under APPENDIX XII of Schedule Y.

If the Ethics Committee fails to comply with any of the conditions of registration, the Licensing Authority may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel the registration of the Ethics Committee for such period as considered necessary.

Nuremberg Code:

A major issue at Nuremberg was defining the criteria for ethical human experimentation. Consequently, the Articles of the Nuremberg Tribunal developed as the first formal attempt to create a legal framework governing human experimentation. The Nuremberg Code aimed to protect human subjects from enduring the kind of cruelty and exploitation the prisoners endured at concentration camps. The 10 Articles provide:

1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on results of animal experimentation and a knowledge of the natural history of the disease or other problems under study that the anticipated results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill, and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Helsinki Declaration:

The concepts of Nuremberg were re-evaluated at the meeting of the World Medical Association in Helsinki in Finland, in June of 1964, and were incorporated into the Code of Ethics on Human Experimentation of the World Medical Association. Helsinki declaration of 1964 serves as Bible for all doctors doing biomedical research involving human participants. It is a set of ethical principles relating to human experimentation developed for the medical community by the World Medical Association in 1964, at Helsinki in Finland. It is very important and  best-known policy statement. The first version was adopted in 1964 and has been amended seven times since, most recently at the General Assembly in October 2013. The current (2013) version is the only official one; all previous versions* have been replaced and should not be used or cited except for historical purposes.

The fundamental principle underlying the declaration is respect for individual, his right to self-determination and his right to make an informed decision as regard s to his participation in research, both initially and during the course of research.

Medical research involving human subjects must conform to generally accepted scientific principles and must be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and animal experimentation. Medical research involving human subjects must be conducted only on individuals with appropriate ethics and scientific education, training and qualifications. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

Based upon those underlying concepts the final Code (64th WMA General Assembly, Fortaleza, Brazil, October 2013) embodied the following basic principles:

Preamble

1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.
2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.

General Principles

• The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”
• It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.
• Medical progress is based on research that ultimately must include studies involving human subjects.
• The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.
• Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.
• While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.
• It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.
• Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.
• Medical research should be conducted in a manner that minimises possible harm to the environment.
• Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.
• Groups that are underrepresented in medical research should be provided appropriate access to participation in research.
• Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.
• Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

Risks, Burdens and Benefits

• In medical practice and in medical research, most interventions involve risks and burdens.
• Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.
• All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation. Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.
• Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed. When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.

Vulnerable Groups and Individuals

• Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection.
• Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

Scientific Requirements and Research Protocols

• Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.
• The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.

Research Ethics Committees

• The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions.

Privacy and Confidentiality

• Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

Informed Consent

• Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.
• In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed. All medical research subjects should be given the option of being informed about the general outcome and results of the study.
• When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.
• For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.
• When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.
• Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research  group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.
• The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never adversely affect the patient-physician relationship.
• For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee.

Use of Placebo

• The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances: Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention. Extreme care must be taken to avoid abuse of this option.

Post-Trial Provisions

• In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.

Research Registration and Publication and Dissemination of Results

• Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.
• Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

Unproven Interventions in Clinical Practice

• In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.

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A Medico-Legal Case (MLC) can be defined as a case of injury or ailment, etc., in which investigations by the law-enforcing agencies are essential to fix the responsibility regarding the causation of the injury or ailment. It may be a legal case requiring medical expertise when brought by the police for examination. In this article we shall discuss medico-legal aspect of road accidents

List of Medico-Legal Cases:

• All cases of injuries and burns -the circumstances of which suggest commission of an offense by somebody. (Irrespective of suspicion of foul play)
• All vehicular, factory or other unnatural accident cases specially when there is a likelihood of patient’s death or grievous hurt.
• Cases of suspected or evident sexual assault.
• Cases of suspected or evident criminal abortion.
• Cases of unconsciousness where its cause is not natural or not clear.
• All cases of suspected or evident poisoning or intoxication.
• Cases referred from a court or otherwise for age estimation.
• Cases brought dead with improper history creating suspicion of an offense.
• Cases of suspected self-infliction of injuries or attempted suicide.
• Any other case not falling under the above categories but has legal implications

Medical professionals are often unsure of the course of action in medico-legal cases. Thus, they are rather reluctant to attend to cases of accident for fear of being involved in unnecessary litigation later on. Even in cases of serious accidents, medical professionals hesitate to offer help, sometimes resulting in patient’s death. The first question that arises in such cases is whether any medical man can be forced to accept an accident victim. The answer to this till some time back was very clear. The doctor could choose patients according to his own will.

In Parmananda Katara Vs Union of India, AIR 1989 SC 2039 case, the apex court held that every doctor is bound to provide medical aid to the victims irrespective of the cause of injury; he cannot take any excuse of allowing law to take its course. Hence, if now a doctor refuses treatment, in case of emergency, he/she could be sued under the law. Once the doctor accepts the case and starts treatment, then the doctor-patient relationship is established.

Medico-Legal Aspect of Road Accidents:

Immediate Treatment:

Some key factors that doctors need to keep in mind while receiving an road accident victim are:

• Inject TT Immediately: The doctor may forget to inject TT, and in such cases, if the patient develops tetanus, the doctors can face trial for negligence.
• Take X-rays: Taking X-rays of all possible parts to exclude fractures is crucial.
• Bleeding Points: Internal or external bleeding points should be examined, and should not be missed.
• Ophthalmoscopic Examination: Ophthalmoscopy is an examination of the back part of the eye (fundus), which includes the retina, optic disc, choroid, and blood vessels.

Procedure For Registering a Medico Legal Case:

1. Treatment: Treatment should start immediately. All legal formalities to be suspended till the patient is resuscitated.
2. Identification: When the patient is resuscitated , the medical practitioner must find whether the said case falls under Medico Legal Case or not.
3. Intimation to Police: if the case does fall in Medico Legal category, then he must register the case as an MLC and/ or intimate the same to the nearest police station, either by telephone or in writing.
4. Acknowledgement Receipt : He shall obtain from the police, the acknowledgement receipt for future reference.

Preparation for Medico Legal Case Report:

• The attending doctor should record all the findings and prepare a proper MLC report.
• He/she must record the preliminary particulars including full name, age, sex, occupation, date, and time, brought by whom and history of dying declaration whether necessary or not.
• Identification marks of the patient (details of minimum 2) should also be recorded.
• Date, time, finding, and description of injury (accurate measurements), whether the simple, grievous, or dangerous need to be recorded.
• The record of investigations performed on the patient like X-ray, USG, CT scan, and MRI must be maintained.
• Details of the injuries should be issued to the police or court on demand in the form of certificates. In the case of grievous injury, the details can be issued to the police even without a demand.
• The medical practitioner should fill a “wound certificate” and obtain a “written consent” from bystanders. The matter should be intimated to the police.
• Each page of the MLC report should bear the signature of the doctor and the patient, or a thumb impression of the latter. 
• The report must be written meticulously, expending thought on language and content. This report should demonstrate competence as MLC reports involve litigation, insurance claims, medical negligence claims, and worker compensation issues.

Investigation of Road Accident as MLC:

The Investigation of the accident must be done as soon as possible after it occurs because it helps in observing the conditions as they were at the time of the accident. Investigation officer may take help from an automobile expert and a medical expert. Establishment of facts includes visiting site of accident, examination of mechanical damages. If the driver of the vehicle is survived, his medical examination is mandatory. It should be ascertained if he was under the influence of alcohol or drugs at the time of accident. Medical examination of the victims must be conducted immediately. Medical examination includes noting of injuries suffered, place, angle, extent, and depth of injury. It also includes noting of blood stains on body, tears, grease marks, mud and soil stains, etc.

Generally, there are multiple causes. The investigation officer must consider all possibilities. He should also consider contributing factors which include environmental factors, design factors, human behaviour (carelessness, rushing, and fatigue, etc.). When determining negligence of one of the drivers, the contributory negligence of the other person has also to be taken into account.

In case of accidental death, an autopsy (post mortem) is often performed to ascertain the cause of death. An autopsy or post-mortem is a surgical procedure involving a thorough examination of the corpse by dissection to determine the cause and manner of death. The procedure is performed by specialist pathologists.

Punishment to Offender:

Where offence is committed, the offender must be punished. Rash and negligent driving, drunken driving, over-speeding, red light jumping, etc. are punishable offences. The punishment has dual purpose. It warns the offender that he should take care in future and it also deters other persons from rash and negligent driving.

Compensation to Victim:

Under the law, compensation is recoverable by the victim of the accident, and if he is dead, by his next-of-kin. It is mandatory for all vehicles to be properly insured at all the times.

According to Section 1A of the Fatal Accident Act, 1855 “Whenever the death of a person shall be caused by wrongful act, neglect or default, and the act, neglect or default is such as would (if death had not ensured) have entitled the party injured to maintain an action and recover damages in respect thereof, the party who would have been liable if death had not ensued shall be liable to an action or suit for damages, notwithstanding the death of the person injured, and although the death shall have been caused under such circumstances as amount in law to felony or other crime. Every such action or suit shall be for the benefit of the wife, husband, parent and child, if any, of the person whose death shall have been so caused, and shall be brought by and in the name of the executor, administrator or representative of the person deceased.

Concept of Golden Hour:

The ‘Golden Hour’ is the first hour after the Trauma. However, Golden hour is not always a predefined time period. Sometimes, according to the severity of the situation the golden hour can range from a few minutes to several hours. It is a concept that emphasises the urgency of care required by major trauma patients to prevent ‘early deaths’ predominantly from haemorrhage.

 R. Adams Cowley, founder of Shock Trauma Institute, Baltimore came up with the term ‘Golden Hour’ in the year 1975. He called this time as the time between life and death. According to him, if a person is critically injured, rather than dying right away, that person might have less than sixty minutes for any chance of survival. The concept of golden hour plays an important role even in the current situation as these spreads the importance of seeking urgent medical treatments in cases of traumas. The validity of this concept remains controversial

If proper and timely first aid is given, road accident victims have a higher chance of survival. Prompt action may also reduce the severity of the injuries. Many deaths and impact of injuries can be prevented with First Aid if causalities are treated immediately. One of the misconceptions about road accidents death is that most of them happen due to sever injury and loss of blood. But reality is that most common cause of death in road accidents due to loss of oxygen supply. Normally it takes less than four minutes for a blocked airway to cause death. It is said that these four minutes are crucial. It is not always possible that proper medical care reaches the victim within an hour. In that case the passer-by, onlookers and other people involved can provide the first aid to serious victims.

Good Samaritan Law:

According to the World Health Organisation (WHO), in the absence of established emergency medical services, bystanders can play a game changing role in saving lives. They can call for help, provide first-aid to the injured and even rush them to the nearest hospital, if an ambulance does not arrive in time.

A good Samaritan is a person who is good in faith, and without any expectation of any reward or payment, voluntarily comes forward to help and give immediate assistance and emergency care to a person injured in the accident or other mishap. Such person contacts the police and other authorities, provide first-aid to the injured person, and sometimes even take the person to a hospital if ambulance does not come in time.

In Save Life Foundation v. Union of India, AIR 2016 SC 1617 case, the Supreme Court gave following guidelines.

• A good Samaritan will not be liable for any civil or criminal action for any injury to the victim, or even his death.
• When such a person informs the police authorities or emergency services, he cannot be compelled to give his personal details.
• Such persons cannot also be forced to make the initial payments for the treatment of injured person.
• A good Samaritan cannot be compelled to appear as a witness in the court. But he may do it voluntarily.

Conclusion:

A Medico-Legal Case (MLC) is a case, in which investigations by the law-enforcing agencies are essential to fix the responsibility regarding the causation of the injury or ailment. It is the legal duty of the treating doctor to report it to the nearest police station immediately after completing primary lifesaving medical care of the victim. Quick action by the police also helps to avoid the destruction of evidence by the treating physician.

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A traffic or road accident is defined as an accident involving at least one vehicle on a road open to public traffic in which at least one person is injured or killed. The main cause of accidents and crashes are due to human errors. Most of the road users are quite well aware of the general rules and safety measures while using roads but it is only the laxity on part of road users, which cause accidents and crashes. In this article, we shall study medico-legal aspect of road accident. In this article we shall discuss impact injuries and secondary injuries caused to pedestrian due to road accident.

The main causes for road accidents are:

1. Over-speeding and lane cutting
2. Distraction during driving
3. Drunken driving
4. Jumping red signal
5. Tailgating
6. Wrong lane driving
7. Potholes and damaged roads
8. Poor maintenance of vehicles
9. Large numbers and unruly pedestrians and animals
10. Poor lightings on roads

The road traffic injuries may be sustained to:

• Pedestrians
• Cyclists/ Motor cyclists
• Occupants of a vehicle

Pattern Injuries to Pedestrians:

In case of pedestrians following injuries are often seen:

Primary Impact Injuries:

These are the injuries caused by vehicle when it first struck and hit the person whether crossing the road from one side to the other side or walking with or against the traffic. The importance of primary impact injury is that the body of victim may bear design / pattern of the part of vehicle in form of imprint abrasion pattern bruised. Bumper, wing, headlights, mirrors, grill, headlights, radiator, door handles may cause primary impact injuries.

Projections of vehicle may cause specific injuries like fracture of tibia & fibula of one or both the legs. In case of children the fracture will be in femur. Height of the victim determines site of injury. The impact depends on the speed and weight of the vehicle.

The body part which bears the injury depends upon the position of the person such as:

1. Was the pedestrian struck by the front of Vehicle?
2. Was the pedestrian struck by the side of Vehicle?
3. Was the pedestrian standing on road?
4. Was the pedestrian walking on road?
5. Was the pedestrian lying on road?

The findings of primary impact injury are important to find out the relative position of pedestrian and vehicle and kind of vehicle involved in the Incident.

Impact Against Bumper (Bumper Injuries):

Injuries at the site of bumper impact, in the form of abrasion, contusion, laceration, internal hemorrhage in the calves etc. Most characteristic fracture due to bumper fractures are fracture of the tibia. The fracture fragments are wedge shaped and is displaced forwards. The base of the wedge indicates the site of the impact, the apex points in the direction in which the vehicle was travelling. Rarely, fibula also may get fractured. In children, bumper fracture is seen in femur.  When brakes are applied, the height of the bumper dips down, thus the height of the bumper fracture is less than the height of the bumper. When accelerator is pressed, the phenomenon is reversed.

The level of bumper injury (i.e, the height of injury from ground level) varies with height of bumper of different vehicle. The vehicle can be identified from the height of the bumper fracture from the ground and matching the same with the offending vehicle’s height of bumper from the ground. Frequently Bumper injuries are at different level of the two legs or absent on one leg, which suggest that the victim was walking or running when struck. If bumper injuries are at the same level on both legs, then it means the person is standing.

Impact against mud guard or head lamp:

At impact against the headlamp or mudguard may result in fracture of the pelvis or fracture dislocation of the sacroiliac joint. Injuries usually depend how the victim was positioned. Frontal impacts may cause head injury, chest injury, fracture of ribs. Side impact causes injuries of arms. Rear impact causes injuries to buttocks and sacroiliac joints. The fractured portion of the vertebral column may move forward and may cause transection of the spinal cord and thoracic aorta.

Impact when struck from front:

Injuries are virtually the same, except that the injuries are more on the frontal aspect. Intra-abdominal injuries are seen, like linear superficial tears of the abdomen and inguinal regions, due to over stretching of the skin. They appear dry, yellow and bloodless. Liver and splenic injuries are common. There may be injuries to chest wall and thoracic contents. Direct impact to thorax may cause rupture of the aorta below the arch at the level of ligamentum arteriosum due to sudden increase in the intravascular pressure. The heart may show bruising, laceration and rupture.

Impact when struck on one side:

The injuries are seen predominantly on one side. The opposite side receives injuries while falling on the road.

Impact when the pedestrian walks into the side of the moving vehicle:

There may be injuries on the side of the front of face, chest and arms in the form of glancing abrasions, patterned abrasions, crush lacerations, tear lacerations, fracture ribs with or without lung involvement, abdominal injuries etc.

Secondary Impact Injuries:

They are caused by the second impact with the vehicle (eg: the body of thrown onto the vehicle). They are caused when after sustaining primary impact of injury, the person may be lifted off the ground and thrown of the vehicle. Here the person strikes to windshield or bonnet or placed on the top of car/ vehicle. Usually, such injuries are on the opposite side of primary impact.

Injuries are variable, depending on the area of the body involved. If the feet slide forward, the whole body falls backwards, with a secondary impact of the head against the windshield. If the victim falls on the hood, tangential force is directed by hood to the buttock and thigh, causing separation of the skin and sub cutaneous tissues from the muscle. This produces a pocket in the upper thigh and buttock, leading to collection of large amounts of blood, which is often not visible, externally. If the feet are not firmly fixed on the ground, the victim may be scooped up and thrown in the air and may land over the roof of the vehicle, head hitting first, or may even land on the road behind the vehicle, where he may be run over by other vehicles. Atlanto-occipital dislocation and partial disruption of intervertebral discs are quite common in this situation.

Secondary and tertiary injuries:

They are caused when the body strikes the ground after the collision or striking another stationary object or another vehicle. When the victim is thrown high up in air and strikes the ground injuries are more severe. All kinds of injuries, including abrasions, contusions, lacerations, fractures etc may be seen.

Sometimes the victim may be run over by the same vehicle and another vehicle. Brain damage is frequent without any associated skull fractures. Fracture of the skull and ribs due direct contact with a surface, and fracture of spine due to hyperflexion or extension may be seen. In pedestrian accidents, the common cause of death is head injuries and fracture dislocation of cervical spine.

Run-Over Injuries:

They are caused when the vehicle runs over some part of the body of the victim. In this case the severity of injury depends on the part oof the body run over and the weight of the vehicle.

Abrasions in the form of grazes, impact or imprint abrasions of the tire marks may be seen. They are spread out a little due to yielding and flattening of body from pressure. Skull may be crushed from side to side or forced open with extrusion of the brain matter. The ribs may be fractured at multiple places. The abdomen may be ruptured with extrusion of the contents. The whole body maybe crushed or hemisected.

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