Tag Archives: informed consent issues

Eliminating Informed Consent on Human Experimentation with Vaccines and Drugs

The 21st Century Cure Act would demand that the Food and Drug Administration (FDA) add an exemption from informed Consent requirements for those clinical trials that pose no more than minimal risks and the appropriate safeguards protecting the right, safety and welfare of subjects.

Informed Consent Waiver

The above can be found in section 3024 – Informed Consent Waiver or Alterations for Clinical Investigations.

So what they are saying now they don’t have to obtain informed consents to test vaccinations or drugs on humans beings if it has been determined that the proposed pose no more than minimal risks.

Let’s review the Exemption  for Devices for Investigational Use

(g)(1) The purpose of this section to encourage to the extent consistent with the protection of public health and safety and ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose.

In other words, you can get an exemption for certain conditions.

Question: if you don’t have informed consent in clinical trials experimentation on people, then how does anyone knows you are not part of an experiment?

If sponsors and clinical researchers not longer has to tell you that you are part of it or get your consent to informed you what they are doing? That may sound a little crazy.

Further source of research:

The 21st Century Cures Act Implications

Say Goodbye to Vaccine Safety Science by Barbara Loe Fisher

-FAIR USE-
“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

Advertisements

BIMO Inspections – GCP Dilema

BIMO stands for Bioresearch Monitoring. The FDA releases each year, a list of findings for FDA-regulated product that may be in violation of the agency’s requirements. These inspections’ findings are listed on an FDA Form 483 by the inspector.

Last year, there were over 600 findings from different FDA’s BIMO program (i.e., clinical investigators, IRBs, sponsors, and good laboratory practices).

For example, Findings related to Clinical investigators were:

  • Protocol deviations
  • Inadequate recordkeeping
  • failure to report AEs and informed consent issues
  • Among others…

Common IRB deficiencies were:

  • Inadequate SOPs
  • Subpart D issues
  • Inadequate communication with Clinical Investigator/institution
  • Among others…

The question we would ask ourselves… what have caused these type of findings? Not enough GCP training? Good clinical practice is mandatory for everyone involved in the conduct of clinical research.

The principles of GCP state that: Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s). (2.8, E6 Guideline for Good Clinical Practice)

Form 483 Inspection findings

Observations Frequency of findings
Safety reports (adverse events reporting) 14
Informed consent – Failure to obtain informed consent in accordance with 21 CFR Part 50 from each subject prior to drug administration 23
Consent form not approved/signed/dated 13
protocol compliance 164

Additional information about findings and metrics can be found on the FDA website.

Need an ICH GCP refresher? Contact us and we can recommend a few e-learning training.

Source: Wikipedia Form 483 & BIMO

anayansi gamboa - GCP