Perceptions and experiences of community members serving on institutional review boards: a questionnaire based study.

The community representative plays a very important role in an institutional review board (IRB) but there is sparse data about their understanding of their role in an IRB. This study was conducted to assess perceptions of community members serving on IRBs of one region in India. A validated questionnaire (Cohen's kappa coefficient of 0.84) was administered to community members of IRBs in a prospective cross-sectional study. The questions related to demography, perceptions of their role in the IRB, experiences while serving on the IRBs, difficulties faced by them, and suggestions to improve their contributions. Of the 56 IRBs contacted, all 15 of the public institutions shared details of their community members, while only 26 of the 41 IRBs of private institutions responded. When questioned about why they joined the IRB, one third of the respondents said either that there was "no specific reason" for joining or that they accepted the invitation to serve on the insistence of other members of the IRBs or the head of their institution. All except one felt that community members were needed for optimal functioning. Six participants said that they did not review informed consent documents (ICD), and 10 were unaware that their presence was vital for quorum to be met. Twenty-eight said they participated actively in meetings and did not feel intimidated by the presence of clinicians. Twelve reported difficulties in understanding medical terminologies in ICDs. Although the majority of participants were aware about their role in an IRB, some did not review important documents such as ICDs. Restricted participation by private hospital IRBs was a striking observation in our study. There is a need to define eligibility criteria and develop targeted training modules for community members to ensure their effective contribution to effective oversight of clinical research.

Projects not initiated by investigators: a retrospective analysis of the queries raised by the institutional ethics committees of a teaching hospital.

BACKGROUND: Some investigators on receiving queries from Institutional Ethics Committee (IEC), either leave the queries unanswered or withdraw their studies. The present study was conducted to assess the queries raised by two IECs after reviewing studies that were not initiated and to identify reasons for the same. Clinical Trials Registry-India (CTRI) website was checked to review approval status of these studies at other sites. MATERIALS AND METHODS: A retrospective analysis of studies (submitted between January 2006 and December 2011) not initiated by investigators on receiving queries from IECs were identified. The nature of of these studies: whether sponsored (pharmaceutical industry (pharma)/government/investigator initiated), single-centre/multi-centric, and queries raised were analyzed. Status of multi-centric trials; not initiated at our site was checked at CTRI. Data was analyzed using descriptive statistics. RESULTS: A total of 219/2075 (11%) studies were not initiated. The proportions in pharma sponsored, investigator initiated, and government sponsored were 33%. 7.4%, and 8%, respectively. Out of a total of 1676 queries, the maximum queries were related to ethics (42%) and the least were administrative (7%). The largest proportion of queries in the pharma studies was ethical (47%), whereas majority were scientific queries (45.5%) for the investigator initiated studies. Twenty-one of the 94 multi-centric studies not initiated at our site were found registered at the CTRI and were ongoing or completed at 2-55 sites. CONCLUSION: Inability of investigators to defend studies due to lack of good clinical research practice (GCP) and research methodology training or unwillingness of sponsors to comply with local IEC requirements could be potential reasons for studies remaining uninitiated. Continued GCP training of investigators and IEC members and development of uniform ethical review standards across IECs are strongly recommended.

Is methicillin-resistant Staphylococcus aureus involved in community acquired skin and soft tissue infections? Experience from a tertiary care centre in Mumbai.

BACKGROUND: To improve the empiric antimicrobial therapy of community-acquired (CA) skin and soft tissue infections (SSTIs), it is necessary to generate data on the current spectrum and susceptibility profile of associated bacteria. CA methicillin-resistant Staphylococcus aureus (CA MRSA) is increasingly being reported in SSTIs in India and globally. AIMS: The present study was undertaken to determine the bacterial profile of CA-SSTIs, to know the contribution of MRSA in these infections, to determine inducible clindamycin resistance in S. aureus and to compare the resistance patterns of isolates from hospital-acquired (HA) SSTIs. MATERIALS AND METHODS: Eight hundred and twenty patients with CA SSTIs were prospectively studied. Pus samples were cultured and antimicrobial susceptibility pattern determined. Inducible clindamycin resistance was detected by D-test. Laboratory records were analyzed retrospectively to generate data on HA SSTIs. RESULTS: 619 isolates were recovered in CA-SSTIs, of which S. aureus (73%) and Streptococci (12%) were the most common. Pseudomonas aeruginosa (28%) and Acinetobacter spp (18%) were the predominant HA-SSTI pathogens. Susceptibility of CA S. aureus to antibiotics tested was, penicillin (6%), co-trimoxazole (20%), ciprofloxacin (37%), cefazolin (100%), erythromycin (84%), clindamycin (97%), gentamicin (94%) and fusidic acid (95%). No MRSA was found in CA SSTIs whereas 45% of HA S. aureus strains were methicillin-resistant. HA strains demonstrated significantly higher resistance as compared to their CA counterparts (P<0.001). D test was positive in 22% of CA S. aureus tested. CONCLUSIONS: In CA SSTIs, methicillin-susceptible S. aureus is the predominant pathogen. Penicillinase-resistant penicillins, clindamycin and erythromycin in that order can be used as suitable antimicrobials for empiric therapy. D test should be carried out routinely. No CA MRSA was detected in the present series.