EXPERIENCES IN REVIEW OF CLINICAL TRIALS
Journal Title: Int J of Pharm Rev& Res - Year 2014, Vol 4, Issue 2
Abstract
The purpose of an IHEC (Institutional Human Ethics Committee) review is to ensure that appropriate steps are taken to protect the rights and welfare of participants as subjects of research. If the risks to participants are found to be too great, the IHEC will not approve the research, or it will specify changes that must be made before the research can be done. The EC (Ethics committee) review process of a trial protocol includes three different considerations: science, ethics and data quality. Any clinical trial with poor science, poor ethics or poor data quality puts participants at unnecessary risk of harm. This study aims to list out the scientific and ethical issues identified during review of clinical trials at IHEC. On IHEC approval, all the clinical trials approved over the past five years in IHEC, were analyzed using a proforma by the investigators (1-3) who are IHEC members & the anonymized raw data was given to the investigator number 4 who is not an IHEC member. 33 clinical trials were included for the study. Scientific and ethical considerations that were raised by IHEC was noted. The results of the study revealed that the issues were mainly related to the methodology and selection of participants as well as on the risks involved, insurance aspects and post-trial access. Most of the clinical trials were approved after the required modifications and some required major revision. Few unacceptable projects were rejected. The data indicate that the ethical committee reviews both scientific as well as ethical aspects.
Authors and Affiliations
Vijaya D1 , Sudha Ramalingam3 , Bhuvaneshwari S2 , Sowndharya J4
Keywords
Related Articles
- EP ID EP122757
- DOI -
- Views 101
- Downloads 0
HIGH FLUORIDE INCIDENCE IN GROUNDWATER AND ITS POTENTIAL HEALTH EFFECTS IN PARTS OF SARGUJA AREA CHHATTISGARH
Assay of fluoride concentration in ground water samples around Surajpur district in Sarguja revealed that fluoride content in beyond the permissible limit in a some residential areas. The extent of Fluoride present in di...
THE CHEMICAL CONSTITUENTS AND PHARMACOLOGICAL IMPORTANCE OF CHROZOPHORA TINCTORIA
Chemical analysis of Chrozophora tinctoria showed that it contained dye substances, flavonoids, alkaloids, oils, diterpenoids, xanthones, coumarins, chromones, diterpenoids, and phenylpropanoid glycosides. The plant poss...
COMPREHENSIVE REVIEW ON TREATMENT OF CANCER USING RETINOIC ACID RECEPTORS
A tumor or neoplasm occurs when abnormal cells form within the brain. There are two main types of tumors they are malignant or cancerous tumors and benign tumors. Brain cancer can have a wide variety of symptoms includin...
EVALUTION OF ANTIASTHMATIC ACTIVITY OF CALOTROPIS GIGANTEA ROOTS
The present study deals with the effect of ethanolic extract of roots Calotropis gigantea by using various in vivo and in vitro animal models. In vitro model like isolated guinea pig ileum preparation was studies to know...
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AMOXYCILLIN AND SULBACTAM IN BINARY MIXTURE
A simple, precise, rapid and accurate RP- HPLC method was developed for simultaneous estimation of Amoxycillin (AMX) and Sulbactam (SUL) in Pharmaceutical dosage forms using Inertsil ODS 4.6x250mm, with 5 μm particle siz...