The new 2013 seventh version of the Declaration of Helsinki – more old wine.

The eagerly awaited seventh version of the Declaration of Helsinki (DoH) was released by the World Medical Assembly (WMA) on October 19, 2013 at the 64th General Assembly . It has been 13 years since the most debated version of the DoH, the fifth one, was released in 2000, followed by two related notifications in 2002 and 2004 and the less debated sixth version of 2008. The decade following the fifth version has witnessed many conceptual changes and debates all over the world. Of special note is the fact that most research participants are drawn from the developing countries and are considered to have a higher degree of vulnerability than their counterparts in the developed countries. Since 2000, a landmark year from many perspectives, national and international ethical guidelines have been updated or new ones developed to address the current and emerging issues facing the research community.

Obituary.

I was shocked and saddened to read the news that Dr Edmund Pellegrino, 92, professor emeritus of medicine and medical ethics and senior scholar at Georgetown University’s Kennedy Institute of Ethics, passed away on June 13, just nine days before his 93rd birthday.

Ethical issues in genetic counselling with special reference to haemoglobinopathies.

Genetic counselling is provided in places where genetic tests are carried out. The process involves pre-test counselling as well as post-test counselling to enable the individuals to face the situation and take appropriate decisions with the right frame of mind. Major ethical principles which govern the attitudes and actions of counsellors include: respect for patient autonomy, non-maleficence, beneficence, or taking action to help benefit others and prevent harm, both physical and mental, and justice, which requires that services be distributed fairly to those in need. Other moral issues include veracity, the duty to disclose information or to be truthful, and respect for patient confidentiality. Nondirective counselling, a hallmark of this profession, is in accordance with the principle of individual autonomy. High prevalence of haemoglobinopathies with availability of good and sensitive carrier detection tests and prenatal diagnostic techniques makes these good candidates for population screening of carriers along with genetic counselling for primary prevention of the disease. Screening of the extended family members of the affected child, high risk communities and general population screening including antenatal women are the main target groups for planning a Haemoglobinopathy control programme. A critical mass of trained genetic counsellors who have understanding of the ethical issues and its appropriate handling with the required sensitivity is needed in India.

ICMR-DBT Guidelines for Evaluation of Probiotics in Food.

There has been an increased influx of probiotic products in the Indian market during the last decade. However, there has been no systematic approach for evaluation of probiotics in food to ensure their safety and efficacy. An initiative was, therefore, taken by the Indian Council of Medical Research (ICMR) along with the Department of Biotechnology (DBT) to formulate guidelines for regulation of probiotic products in the country. These guidelines define a set of parameters required for a product/strain to be termed as ‘probiotic’. These include identification of the strain, in vitro screening for probiotic characteristics, animal studies to establish safety and in vivo animal and human studies to establish efficacy. The guidelines also include requirements for labeling of the probiotic products with strain specification, viable numbers at the end of shelf life, storage conditions, etc., which would be helpful to the consumers to safeguard their own interest.

Ethical issues in HIV/AIDS research.

Globally the HIV/AIDS epidemic has presented unique health challenges to populations, including a host of ethical and moral issues related to human life and dignity. The disease has most affected the vulnerable groups of people in the world often leading to stigma and discrimination. Currently the critical areas of concern include access to treatment and developing newer, more effective therapeutic and prevention methods while taking care of ethical values in health care and research. The ethical issues mainly revolve around the standard of care, informed consent across cultures, privacy and confidentiality, stigma and discrimination, protection of vulnerable groups, community consultation, ethical review mechanisms, international collaboration, epidemiological studies, clinical trials and also sociobehavioural studies on HIV/AIDS. In addition major concerns are raised regarding HIV/AIDS vaccine trials, microbicidal trials as well as prevention of parent-to-child transmission (PPTCT) trials especially in resource-poor countries. For international collaborative research appropriate standard of care, community benefits, and host country needs must be kept in mind. Improving our understanding of the various ethical and societal concerns related to HIV/AIDS treatment and research would help in development of appropriate policies for disease control and prevention.