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Workshop 4:  

The concept of informed consent, IRB, EIC and other gatekeepers of ethics.

Informed consent discussion and templates from WHO, http://www.who.int/rpc/research_ethics/informed_consent/en/index.html

Watch video on informed consent and read the documents, http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm

Tuskegee airmen: unethical clinical trials. Read about these brave pilots at http://www.tuskegeeairmen.org/Tuskegee_Airmen_History.html. Read about the syphilis clinical trial at http://www.hsl.virginia.edu/historical/medical_history/bad_blood/

Thalidomide. Read the documents on thalidomide and understand the seismic shock thalidomide was to the pharmaceutical industry. Articles on the thalidomide story,  British apologies for thalidomide, package insert for thalidomide.

Informed consent is written at the same time as the protocol, and has to be approved by the IRB and the FDA. Download the pdf of the FDA page here. Go to the FDA page and read the documents.

Assignment 4:

The Pfizer Trovan drug trials in Nigeria went terribly wrong. This is an interesting topic because it explains how 2 sets of well-meaning people: the Pfizer drug company and the Nigerian health professionals, entered into an agreement that neither side understood at all. The situation deteriorated rapidly, with a third party that didnt understand the situation, the BBC, accusing Pfizer of wrong-doing. Watch movie "the Constant Gardener" and

1) list all the assumptions in the movie that are probably wrong. A good example is the underlying assumption that the international pharmaceutical industry has a conspiracy against Africans. That movie was unethical, has done more harm than a century of clinical trials conducted in and by the international pharmaceutical industry. Never underestimate the power of media to galvanize opinions.

2) Find out all you can about the Trovan drug trials and write a 300-500 page essay on it, putting it in context with other trials ongoing in Africa (use clinicaltrials.gov, pubmed to find data).

3) what happened to the Tuskegee airmen? How did the fallout from this drug trial affect the drug regulation process in the US?

4) Find at least one document (more is better) on the internet that are "informed consent" documents. When you prepare a clinical study shell from a protocol you prepare, you will also be preparing an informed consent document. The appendices to the clinical study report includes the protocol and the informed consent document.

Quiz 4

Link to access it.