Questions and Topics We Can Help to Answer
Paper Instructions;

In the research team presentation, you learned that the investigator must agree to the following when beginning a trial for an FDA-approval drug:

I agree to conduct the study(ies) in accordance with the relevant, current protocol(s) and will only make changes in a protocol after notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects.

I agree to personally conduct or supervise the described investigation(s).

I agree to inform any patients, or any persons used as controls, that the drugs are being used for investigational purposes and I will ensure that the requirements relating to obtaining informed consent in 21 CFR Part 50 and institutional review board (IRB) review and approval in 21 CFR Part 56 are met.

I agree to report to the sponsor adverse experiences that occur in the course of the investigation(s) in accordance with 21 CFR 312.64. I have read and understand the information in the investigator’s brochure, including the potential risks and side effects of the drug.

I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study(ies) are informed about their obligations in meeting the above commitments.

I agree to maintain adequate and accurate records in accordance with 21 CFR 312.62 and to make those records available for inspection in accordance with 21 CFR 312.68.

I will ensure that an IRB that complies with the requirements of 21 CFR Part 56 will be responsible for the initial and continuing review and approval of the clinical investigation. I also agree to promptly report to the IRB all changes in the research activity and all unanticipated problems involving risks to human subjects or others. Additionally, I will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.

I agree to comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in 21 CFR Part 312.

INSTRUCTIONS:

Write a 3 page paper with APA references

1) Introduction with investigator name (Elmore Alexander, DO) and summary of the noted violations (please see attached files).  

2) Did the investigator violate any of the commitments listed above? Explain which commitments he violated with his actions. 

3) Do you think that the investigator compromised the goals of proving safety and efficacy of the clinical trial by his actions? 

4) What are your personal thoughts on the investigator’s actions – why do you think he did it? Also, do you think that he is alone in his actions? Do you think that being disqualified is punishment enough?