Is Institutional Review Board (IRB) Doing Its Job Right? How To Assess This.

Objective: To audit the performance of the institutional review board at a cancer hospital. METHODS: The retrospective study was conducted at the Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan, in 2021, and comprised all records of the institutional review board from 2005 to 2021. The audit was based on a tool created by the Association for the Accreditation of Human Research Protection Programmes, and elements evaluated included terms of reference, membership lists, review records, meeting minutes, institutional research guidelines as well as other relevant policies. RESULTS: The institutional review board was found to be in 100% compliance with all the elements set forth in the Association for the Accreditation of Human Research Protection Programmes. The institutional review board was found to be an independent body with a diverse membership and the chairman was always an unaffiliated member. It had defined processes in line with relevant laws and guidelines. Review of research studies was devised to promote the ethical conduct of research. Conclusion: Though a self-assessment, the audit objectively showed that the institutional review board was in cent per cent compliance with the evaluation instrument developed and used by the Association for the Accreditation of Human Research Protection Programmes. Nevertheless, it still needs further discussion as to how high levels of efficiency and performance of institutional review boards ultimately provide a higher degree of protection to human research participants.

A Scoping Review Of The Literature Of Research Ethics Committees And Ethics Review Framework In Pakistan: What We Know And What We Still Need To Learn.

OBJECTIVE: To map literature on research ethics committees, institutional review boards and ethics review framework in Pakistan to identify key insights during public health emergencies and normal times. Method: The systematic scoping review was conducted in April 2022, and comprised literature search on PubMed, World Health Organisation Global Index Medicus and Summons databases for articles published between January 2005 and February 2022. Information extracted included authors' names, year of publication, title, study methodology, and key insights under the heads of challenges and solutions. Due to data heterogeneity, key themes were identified and analysed. RESULTS: Of the 2,190 studies initially identified, 21(0.95%) were subjected to full-text review, and, from among them, 9(45%) were analysed in detail. There were 4 key insights identified: research ethics committees and institutional review boards in Pakistan remain unregulated as they are currently not registered or accredited by a competent national-level authority; most members of such committees are not formally trained to implement the mandate; internal and external pressures hinder independent decision-making of such committees; and other issues hindering the functionality and performance of research ethics committees and institutional review boards. CONCLUSIONS: Despite existing publications calling for urgent policy and regulatory reforms, there is a dearth of literature and minimal policy actions underlying the fact that ethics review remains a neglected area in Pakistan.

A clinical study to monitor prescription patterns, clinical outcomes, and adverse drug reactions among patients of various interstitial lung diseases attending respiratory medicine outpatient department at tertiary care hospital in Northern India.

Aim: The aim of this study was to monitor prescription patterns, clinical outcomes, and adverse drug reactions (ADR) among patients of various interstitial lung diseases (ILDs). Materials and Methods: This prospective study was conducted in the Department of Pharmacology and Therapeutics in collaboration with the Department of Respiratory Medicine, King George's Medical University, Lucknow, for a period of 12 months (October 2020-September 2021). A total of 77 patients were enrolled after satisfying the inclusion and exclusion criteria. The prescriptions were collected, and necessary details were noted on the case report form. After completion of the study, the data were analyzed for prescription patterns, clinical outcomes, and quality of life with the help of a validated questionnaire-King's Brief ILD (KBILD) questionnaire. At the same time, ADRs, if any, were assessed using Hartwig's Severity Assessment Scale and Naranjo Causality Assessment Scale. Results: The most common ILD was acute/chronic hypersensitivity pneumonitis (HP). Average number of drugs per encounter was 4.45. Crepitations were the most common clinical signs. Clubbing and rhonchi were reported maximum in idiopathic pulmonary fibrosis. It was found that psychological, breathlessness and activities, chest symptoms, and total KBILD reduced significantly after 3 months as compared to baseline with a statistically significant difference as P < 0.01. ADRs were found in 23.38% (18) of the subjects. Maximum ADR reported was gastritis (9.09%), followed by hepatitis (3.90%). Conclusion: The high proportion of patients clinically diagnosed with HP in our study highlights the importance of a detailed environmental exposure history in the diagnostic evaluation of patients with ILD to avoid inaccurate diagnoses. ADR-related hospital admissions are a significant problem in the health-care system.