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.

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.

Background/Objectives: Malnutrition in children is a challenge in South Asian countries, and understanding its relation with variety of social and economic conditions is imperative. The present systematic review examined the association between maternal employment and the nutritional status of children up to twelve years old from South Asia. Methods: An electronic search for research articles published in the English language between January 2011 and December 2024 was conducted in PubMed, Science Direct, and Web of Science databases. Results: A total of 10,247 articles from five South Asian countries were screened, resulting in the inclusion of 19 studies in the review based on well-defined inclusion and exclusion criteria. The findings showed that the association between maternal employment and children’s nutritional status was context-dependent, with adverse effects in children (stunting, wasting, and growth failure) when mothers worked in unskilled sectors—in low-paying jobs. Children of urban mothers had poor nutritional status, often exacerbated by the lack of or limited childcare support and financial assistance during their work absences. Additionally, many South Asian countries implemented maternal and paternal leave policies and benefits; however, the implementation challenges reduced maternal access to these benefits and predominantly favored mothers working in formal sectors. Conclusions: This systematic review underscores the necessity to strengthen the employment benefit programs for working women in South Asian countries, especially for mothers working in informal sectors. The provision of childcare assistance and supplementary financial benefits to women employed in informal sectors is essential to improve the child nutritional outcomes.

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.

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.

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?