Ethics in clinical research

Nisha Rajendran, Dixon Thomas, S. Suresh Madhavan, Ronald A. Herman

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review

Abstract

The generation of scientific knowledge and new treatments for diseases benefit humankind greatly. However, clinical research should not be performed by endangering the lives of study participants. Clinical research must be conducted ethically to protect the rights, safety, and well-being of the study participants. Many unethical studies have been conducted in the past on vulnerable segments of society, including prisoners, slaves, and other subjects, without their consent. In response to these well-publicized tragedies, various regulatory guidelines were enacted to structure the conduct of clinical trials in an ethical manner keeping participant interests paramount. Ethics committees came into existence to review the ethics and scientific rationale of proposed studies to permit and monitor the well-being of study subjects. Conflicts of interests continue to be one of the leading ethical challenges of modern times.

Original languageEnglish
Title of host publicationClinical Pharmacy Education, Practice and Research
Subtitle of host publicationClinical Pharmacy, Drug Information, Pharmacovigilance, Pharmacoeconomics and Clinical Research
PublisherElsevier
Pages345-364
Number of pages20
ISBN (Electronic)9780128142769
ISBN (Print)9780128142776
DOIs
StatePublished - 1 Jan 2018

Keywords

  • Biomedical
  • Clinical research
  • Clinical trials
  • Conflicts of interest
  • Ethics
  • Ethics committee
  • IEC
  • Informed consent process
  • IRB

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