Narrative: The Fear of Disfigurement in Cancer Patients.

Fear of disfigurement affects patients with cancer, in whom the disease or its treatment leaves them permanently marked. Contrary to our thought, disfigurement is equally distressing to male patients, and it causes severe dislocation in their lives. We describe two cases in which disfigurement caused tremendous change in our patients; these cases underline the need for psychotherapy in patients suffering from cancer.

Profile of Patients Opting for Palliative Care in India.

INTRODUCTION: Understanding the profile of end users is a key input for designing a service. Centers that provide full-scale palliative care are few and far between in our country, and there is a need to open more centers to extend the services to a larger percentage of patients. METHODS: Patient data from the inception of the center till January 2016 have been stored in a database. The data were mined, exported to Excel, and analyzed. RESULTS: The data of 11,258 patients revealed the profile of patients, including their age, gender distribution, marital status, symptomology, and outcome. The present paper describes the profile of patients opting for palliative care in our country. CONCLUSIONS: The profile of patients registered at this center validates certain assumptions while debunking others. It is hoped that this profile gives some guidance to those desirous of setting up palliative care services.

Preference of the place of death among people of pune.

AIM: Provision of end-of-life care requires that we have adequate information about the preferred place of death in the population. Since no such study is reported in India, this study was taken up in and around Pune, a large cosmopolitan city. SETTING AND DESIGN: A questionnaire was designed in three parts and distributed among the people above the age of 18 in and around Pune. MATERIALS AND METHODS: The questionnaire had three parts the first being a consent form, followed by one for collection of personal information and lastly questions specific to the subject matter. Filled forms were screened for inconsistencies, gaps of information and errors. RESULTS: The population survey was mixed, both urban and rural, men and women, educated and uneducated, young and old. Despite this heterogeneity, the results were consistent to the point that most of the people surveyed preferred home as the place of death. This preference cuts across all barriers, the only difference being that women had a stronger preference for home death compared to men. CONCLUSIONS: Helping people to die at their preferred place is a part of end-of-life care. Majority of people surveyed by us, prefer to die at home, where they are relatively more comfortable. Public and governmental policies should be directed toward facilitating home deaths.

Stress among Care Givers: The Impact of Nursing a Relative with Cancer.

AIMS: The aim of the present study is to assess the level and areas of stress among care givers nursing their loved ones suffering from cancer. SETTING AND DESIGN: An assessment of care givers' stress providing care to cancer patients at Cipla Palliative Care Center was conducted. The study involves data collection using a questionnaire and subsequent analysis. MATERIALS AND METHODS: A close-ended questionnaire that had seven sections on different aspects of caregivers' stress was developed and administered to 137 participants and purpose of conducting the survey was explained to their understanding. Caregivers who were willing to participate were asked to read and/or explained the questions and requested to reply as per the scales given. Data was collected in the questionnaires and was quantitatively analyzed. RESULTS: The study results showed that overall stress level among caregivers is 5.18 ± 0.26 (on a scale of 0-10); of the total, nearly 62% of caregivers were ready to ask for professional help from nurses, medical social workers and counselors to cope up with their stress. CONCLUSION: Stress among caregivers ultimately affects quality of care that is being provided to the patient. This is also because they are unprepared to provide care, have inadequate knowledge about care giving along with financial burden, physical and emotional stress. Thus interventions are needed to help caregivers to strengthen their confidence in giving care and come out with better quality of care.

Population based family history analysis of Brahmins in a small town in India for the prevalence of type-2 diabetes mellitus.

OBJECTIVES: The objective of this study is to determine the inheritance pattern of type-2 diabetes and make stratification for the general population risk. MATERIALS AND METHODS: A questionnaire was developed for o btaining the family history. Analysis of the data was carried out by using student and Chi-square tests and for stratification; the guidelines of Scheuner et al. were followed. RESULTS: The pattern of inheritance is the male sex specific (χ² =13.44). The mean age of onset of diabetes in parents was 58.61 ± 2.94 and in offspring 46.75 ± 2.54. In all 47.22 ± 11.53% families were found in high risk and 31.94 ± 10.77% in the moderate risk category. In female diabetics, the onset was in the age range of 41-60 years. CONCLUSION: We found a high-risk of diabetes and familial clustering in successive generations of Brahmins with prominent male sex specificity. In females onset of diabetes was coinciding with the period around menopause.

Need for revision: EC process, members' training, and compensation formula in the New Drugs and Clinical Trials Rules 2019.

The New Drugs and Clinical Trial Rules (NDCTR) came in force in 2019, these brought in some changes, but certain earlier parts, such as Rule 122 DAB, were incorporated unchanged. A few sections of the NDCTR are problematic and need revision for the smooth conduct of clinical trials in India. Training of Ethics Committee (EC) members and other stakeholders is a very important driver for clinical research but has not been defined clearly. In addition, some processes of EC review need a relook. Compensation formulae were finalized in 2013; now, the altered economic situation has eroded the value of money. Hence, for the protection of research participants, an urgent review of the compensation formula is suggested.

The Rights of Patients with Chronic Kidney Disease in the World: Legal Perspectives and Challenges in Brazil, India, Portugal, South Africa, and Nigeria.

Clinical Background: Chronic kidney disease (CKD) is a condition that causes important limitations to patients' lives. The limitations imposed as a result of the disease end up hampering the exercise of citizenship by individuals, including work and daily activities. Epidemiology: The prevalence of CKD in Brazil, India, Nigeria, Portugal, and South Africa is, respectively, 5.8-25.2, 13-17.2, 7.8-23.5, 6.1-20.7, and 6.4-17.3%, and is higher among the most disadvantaged populations. Challenges: The present study intends to make an intersection between health sciences, considering the reality faced by the patient with CKD, and the legal perspectives regarding the protective dimension of the right to healthcare and the access of these individuals to a better quality of life. Despite differences in size, population, and human development, there are some similarities among countries in the normative approach regarding the right to healthcare of patients with CKD. The study was developed based on an analysis carried out by legal scholars and specialists from Brazil, India, Portugal, South Africa, and Nigeria. Not only the texts of constitutions and laws were examined, but also how courts interpret and apply them. It was identified that the impact of kidney disease is also associated with human development issues. Adequate access to renal replacement therapy is not always found in the countries examined as well as to kidney transplants. It was observed that the constitutional protection of the right to healthcare is present in some constitutions such as those of Brazil, Portugal, and South Africa. Specific legislation that regulates access to medicines, dialysis, and kidney transplantation was analyzed. Financial aid and right to social assistance and social insurance benefits guaranteed by law are found only in some countries. However, for legal provisions to become effective, it is still necessary to overcome sociocultural and budgetary issues. Prevention and Treatment: Public policies directed to CKD patients, ensuring access to information, preventive measures, and treatment, should be elaborated to answer the increasing demand for renal replacement therapy, including dialysis and transplant.

Ethics committee meetings - Online or face to face?

Ethics committee meetings are held periodically, with all members being physically present in the meeting room. During the COVID-19 pandemic, and the lockdown, a number of committees have resorted to the use of videoconferencing. Online meetings have significant advantages over physical or face-to-face meetings, though the guidelines and regulations imply that online meetings should not be the norm. Considering the advantages of online meetings in terms of saving time and costs, can the regulations and guidelines be tweaked to allow them even after the lockdown is over?

Should a medical ethics journal discuss the actions of the security forces?

This refers to the comment "Use of pellet guns for crowd control in Kashmir: How lethal is 'non-lethal'?" by Siddarth David in the Indian Journal of Medical Ethics. My objection is not to the ethics of the use of pellet guns, but to the ethics of publishing such an article in a journal devoted to medical ethics.

The Global Ethics Corner: foundations, beliefs, and the teaching of biomedical and scientific ethics around the world.

The profound advances in the biomolecular sciences over the last decades have enabled similar advances in biomedicine. These advances have increasingly challenged our abilities to deploy them in an equitable and ethically acceptable manner. As such, it has become necessary and important to teach biomedical and scientific ethics to our students who will become the researchers, medical professionals, and global citizens of the future. As advances in the biosciences and medicine are made, developed, and used across the globe, our survival on an endangered planet requires global dialog and consensual action. To that end, a group of us from around the world have come together to describe the differing foundations of our ethical beliefs, and how ethical issues in biomedicine and in science are described and confronted in our countries. We hope to show the commonality in our beliefs and practices and to encourage readers from around the world to contribute to a continuing discussion through a new section of the journal, The Global Ethics Corner. © 2017 by The International Union of Biochemistry and Molecular Biology, 45(5):385-395, 2017.

The urgent need for advance directives in India.

Many individuals at the end of life are unable to convey their wishes regarding medical treatments. Advance directives (ADs) or living wills (LWs) allow them to crystallise their wishes in a written form so that these can be carried out if the relevant situation arises. In many countries, ADs are legally valid and enforceable; they reduce the use of life-sustaining treatments, which often merely prolong life without improving or even maintaining the quality of life. Such treatment puts a financial burden on the patient's family, often leading to penury. Resources are limited, the more so in countries like ours, and should be spent only when/where they can make a difference. The general public is not well versed in the advantages and disadvantages of life-sustaining treatments and needs to be educated on how to distinguish between them. A well-designed legislation for legalising ADs would help society at large. In addition to legalising ADs, some countries are contemplating making them compulsory. We could learn from them and empower our citizens by giving them the right to self-determination at the end of life.

Assessment and classification of protocol deviations.

INTRODUCTION: Deviations from the approved trial protocol are common during clinical trials. They have been conventionally classified as deviations or violations, depending on their impact on the trial. METHODS: A new method has been proposed by which deviations are classified in five grades from 1 to 5. A deviation of Grade 1 has no impact on the subjects' well-being or on the quality of data. At the maximum, a deviation Grade 5 leads to the death of the subject. This method of classification was applied to deviations noted in the center over the last 3 years. RESULTS: It was observed that most deviations were of Grades 1 and 2, with fewer falling in Grades 3 and 4. There were no deviations that led to the death of the subject (Grade 5). DISCUSSION: This method of classification would help trial managers decide on the action to be taken on the occurrence of deviations, which would be based on their impact.

Conflict of interest in clinical research.

Increased focus on ethical review of research demands a number of improvements in the existing system. Although these are being implemented, some factors that have received less attention in the past could be examined. One of these is conflict of interest. Such conflicts could exist for investigators, ethics committee (EC) members, and even the regulators. Guidance for identification and management of conflicts has been issued by many countries and Indian rules also speak about these conflicts. Greater clarity would help investigators and ECs manage conflicts more effectively. It is admitted that conflicts cannot be done away with, but their timely identification, disclosure, and management can reduce their impact and bring more transparency and accountability to trials in this country.

Ensuring that informed consent is really an informed consent: Role of videography.

The voluntary consent of a subject participating in research is fundamental to the principle of autonomy. This consent must be free from any coercion, intimidation, falsehood, physical, psychological, or economic pressure. It is in the interest of the subject, the investigator and the sponsor to ensure that informed consent processes conform to the guidelines and regulations, both in the letter and spirit. However, ignorance on the part of investigating team causes deviation from these norms. Videography of the entire process has been suggested as a means to ensure the compliance, and draft rules for the same published. The present article examines how best videography can be introduced in the informed consent procedure without violating other protective mechanisms.

Expert committee to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs-comments.

All is not well with the clinical research industry. Instances of scientific misconduct by investigators, cutting corners by sponsors, irregularities by regulators, have brought a bad name to the industry. These however form a small part of the clinical research done in this country. The US FDA has conducted over 40 audits, and not made any major observations, suggesting that the clinical research in India is by and large above board. Regulators have amended trial rules recently which have cost the industry dear. A committee appointed to formulate the policy and guidelines for approval of new drugs, clinical trials and banning of the drugs has made 25 recommendations of which most are either superfluous or not likely produce the desired effect. Clubbing banning of the drugs with approval of new drugs and clinical trials also does not make sense, since the mechanisms involved are totally different. Barring a few, most recommendations are counterproductive and should be rejected outright. It is time we learnt that appointment of a committee is not the best way to solve a problem.

Institutional review boards: Challenges and opportunities.

Institutional Review Boards (IRBs) are an important link in subject protection program, and their function defines ethical credentials of research. Of late there has been a furore in the country over the number of deaths in clinical research, and allegations of unethical research. Clinical trials have been discussed in medical and lay press and even in the parliament, these discussions called for strengthening the subject protection program. The Central Drug Standards and Control Organization (CDSCO), amended the Schedule Y, by issuing three amendments to introduce new compensation rules and registration of IRBs functioning in the country. IRBs in India face a variety of challenges, and need support from the regulators or independent experts. This is also an opportunity to revamp the subject protection program and strengthen the IRB functioning. An independent advisory body comprising of experts who have hands on experience in administering IRBs, is essential to provide support to IRBs in the country. This body should be independent of regulatory influence and work with IRBs to strengthen them.

Insurance in clinical research.

AIMS AND OBJECTIVES: Sponsors need to pay for management of all serious adverse events suffered by subjects in a clinical trial and to compensate for injuries or deaths related to the trial. This study examines if insurance policies of trials, cover all contingencies that require reimbursement or compensation. MATERIALS AND METHODS: Insurance policies of trials submitted to Sahyadri Hospitals between January 2013 and December 2013 were studied, with respect to the policy period, the limit of liability, deductibles, and preconditions if any. RESULTS: All the policies studied had some deficiencies, in one respect or the other and none had a provision to pay full compensation if required. Some insurers have put in preconditions that could jeopardize the payment of compensation to subjects. CONCLUSIONS: Insurances are complicated documents, and need to be critically examined by the ethics committee before approval of the study documents.