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What specific laws protect clinical research subjects or participants as a result of these violations?

What specific laws protect clinical research subjects or participants as a result of these violations?

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Answer #1

1. Protection of Human Subjects (Informed Consent)

CONSENT-IMPORTANT PRINCILPES

  • It should be taken prior to start research
  • Either witten/oral
  • Consent should be known by Research subjects
  • Validity of consent/Research time period should be mentioned
  • Risks related to Research should be expalined
  • No Coerction method will be used for participation in the study

2. Right to information act-2005

Research subjects have a right to cliam any information regarding the study during its study peroid.

3. Confidentiality of Information:

  • Confidentilality of research subjects will be maintained for partcipating in the study.
  • Results of the study will be kept confidential
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