Declaration of Helsinki, 2008: Implications for stakeholders in research

The Declaration of Helsinki (DoH) was adopted by the World Medical Association (WMA) in 1964, as a statement of ethical principles, to provide guidance to physicians and other participants in medical research involving human subjects. Having undergone several amendments, the most recent version was approved on 18 October 2008, by the WMA General Assembly at Seoul, South Korea, replacing all previous versions. This version highlights issues such as, participant safety, the need to include participants from otherwise underrepresented groups, clinical trial registration, post-study access, usage of data and human tissues, compensating participants with research-related injury, and usage of placebo. In this article, we discuss the major aspects of the 2008 version, including the impact of this version on all stakeholders in research, including, investigators, ethics committee members, sponsors, authors, editors, and reviewers

Declaration of Helsinki, 2008: Implications for stakeholders in research

The Declaration of Helsinki (DoH) was adopted by the World Medical Association (WMA) in 1964, as a statement of ethical principles, to provide guidance to physicians and other participants in medical research involving human subjects. Having undergone several amendments, the most recent version was approved on 18 October 2008, by the WMA General Assembly at Seoul, South Korea, replacing all previous versions. This version highlights issues such as, participant safety, the need to include participants from otherwise underrepresented groups, clinical trial registration, post-study access, usage of data and human tissues, compensating participants with research-related injury, and usage of placebo. In this article, we discuss the major aspects of the 2008 version, including the impact of this version on all stakeholders in research, including, investigators, ethics committee members, sponsors, authors, editors, and reviewers

Patterns of antimicrobial use by surgeons in India

Background: In spite of several available guidelines for the appropriate use of antimicrobials in perioperative patients, the fear of high morbidity and mortality associated with Intra-abdominal infections and Surgical Site Infections has led to misuse of antimicrobials in the perioperative period. Aims: This study was conducted to ascertain the antibiotic prescribing patterns of surgeons for treatment of intraabdominal infections and surgical prophylaxis and specifically assess the prescribing patterns of surgeons at Institutions with a Hospital Infection Control Committee (HICC). Setting and Design: Questionnaire survey at ASICON 2003. Materials and Methods: A survey was conducted among surgeons from all over India attending the conference to ascertain the prevalent prescribing trends for treatment of intraabdominal infections and surgical prophylaxis and the average duration of treatment. Surgeons were also requested to indicate the presence of a HICC. Results: 650 surgeons of the 700 asked, filled in the questionnaire legibly. It was observed that third/fourth generation cephalosporin plus an anti-anaerobic agent were preferred for treating intra-abdominal infections (84%) for an average duration of 6.38 + 2.2 days. For surgical prophylaxis, we found that 55% of the surgeons prescribed a single antibiotic for clean surgeries. A combination of two or three antimicrobial agents was preferred in clean contaminated (42.3%) and dirty (46.9%) surgeries respectively. Third generation cephalosporins were the commonly prescribed antibiotics (80%) for all surgeries. However, antibiotics were prescribed for durations longer than recommended in standard guidelines. Although 260 surgeons stated that their Institution had an HICC, this had no major impact on the prescribing trends. Conclusion: There is an urgent need to promote rational antimicrobial prescribing among surgeons and to formulate National guidelines for appropriate use of antibiotics in surgical practice