Public consultation in the evaluation of animal research protocols

One response to calls for increased openness in animal research is to make protocols publicly accessible, but it is unclear what type of input the public would provide if given this opportunity. In this study we invited public responses to five different research projects, using non-technical summaries intended for lay audiences. Our aim was to assess the potential for this type of public consultation in protocol review, and a secondary aim was to better understand what types of animal research people are willing to accept and why. US participants (n = 1521) were asked (via an online survey) “Do you support the use of these (insert species) for this research”, and responded using a seven-point scale (1 = “No”, 4 = “Neutral”, and 7 = “Yes”). Participants were asked to explain the reasons for their choice; open-ended text responses were subjected to thematic analysis. Most participants (89.7%) provided clear comments, showing the potential of an online forum to elicit feedback. Four themes were prevalent in participant reasoning regarding their support for the proposed research: 1) impact on animals, 2) impact on humans, 3) scientific merit, and 4) availability of alternatives. Participant support for the proposed research varied but on average was close to neutral (mean ± SD: 4.5 ± 2.19) suggesting some ambivalence to this animal use. The protocol describing Parkinson’s research (on monkeys) was least supported (3.9 ± 2.17) and the transplant research (on pigs) was most supported (4.9 ± 2.02). These results indicate that public participants are sensitive to specifics of a protocol. We conclude that an online forum can provide meaningful public input on proposed animal research, offering research institutions the opportunity for improved transparency and the chance to reduce the risk that they engage in studies that are out of step with community values.

TO STUDY THE SOCIO-DEMOGRAPHIC PROFILE PATIENTS UNDERGOING LICHTENSTEIN TENSION FREE INGUINAL HERNIOPLASTY FOR FOR INGUINAL HERNIA

Background: All the hernias, 75% occurs in groin and inguinal hernia is the most common form of all. Acquired hernia can be direct, indirect or combination of both. In adult males 65% of inguinal hernias are indirect and 55% of them are right side. Methods: This prospective study was conducted in the Department of Surgery, Dr. Rajendra Prasad Government Medical College Kangra at Tanda from May 2018 to December 2019after being approved by institutional protocol review committe and ethics committee.50 patients were included in the study. Results: In our study, the patients age ranged from 18 years to 87 years with a mean age of 50.26±15.76 years. 22 (44%) patients had inguinal hernia on right side Conclusion: We concluded that mostly patients were more than 50 yrs age group and right side. Keywords: Age, Site, Hernia

A CTSA One Health Alliance guidance on institutional review of veterinary clinical studies

Harmonized institutional processes and reviewer training are vital to maintain integrity and ethical rigor of the veterinary clinical research pipeline and are a prerequisite to future work that might establish centralized or single-site ethical and regulatory review to ease initiation of multi-center studies. Funded by a CTSA One Health Alliance (COHA) pilot award, a diverse working group of veterinary clinicians and institutional representatives was convened in February 2020 to develop a guidance document detailing broadly agreed upon practices for ethical review and approval of veterinary clinical studies conducted in the United States.The working group defined key areas of need for consensus, developed a set of associated guidelines, and circulated these for review by COHA’s fifteen member institutions. Six focus areas were identified by the working group and included vital items of protocol review, composition of the review committee, post-approval monitoring and adverse event reporting, consideration of special circumstances such as satellite sites and the use of healthy veterinary subjects in research, and the informed consent process.This document outlines a broadly agreed-upon framework through which to approach vital items associated with veterinary clinical study protocol review and approval. These approaches represent current best practice in the review and approval of veterinary clinical studies, and can serve as a guidance for veterinary clinician-scientists and regulatory experts, to ensure robust and ethically conducted studies that can contribute to the advancement of both animal and human health.

Sodium (23Na) MRI of the Kidney: Experimental Protocol

Sodium handling is a key physiological hallmark of renal function. Alterations are generally considered a pathophysiologic event associated with kidney injury, with disturbances in the corticomedullary sodium gradient being indicative of a number of conditions. This experimental protocol review describes the individual steps needed to perform 23Na MRI; allowing accurate monitoring of the renal sodium distribution in a step-by-step experimental protocol for rodents.This chapter is based upon work from the PARENCHIMA COST Action, a community-driven network funded by the European Cooperation in Science and Technology (COST) program of the European Union, which aims to improve the reproducibility and standardization of renal MRI biomarkers. This experimental protocol chapter is complemented by two separate chapters describing the basic concept and data analysis.