CardioPharma Mecamylamine

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CardioPharma Mecamylamine Assignment Paper By Discussion Points: 1. a. The Hopkins incident uncovered some serious problems with the investigator and the IRB committee. As a sponsor’s representative you should make sure that your investigator submits complete and detailed study information to the IRB necessary for approval If your company is using a previously approved drug for a new route of administration you should consult with the FDA to see if an IND needs to be submitted prior to the start of a clinical trial. You must make sure the investigator keeps detailed records of any medications dispensed. All adverse or unexpected events must be submitted to the IRB in a timely fashion. If the investigator change any part of the protocol, specifically any dosing changes or additional medication you must submit to the IRB for approval prior to making any changes in the dosing to the subjects. 1. a i. The mecamylamine consent form includes the following Essential Elements: 1. Purpose of the study 2. Study Procedures 3. Risks 4. Confidentiality of Medical Records 5. Compensation & Treatment for Injury 6. Volunteer Statement 1.a.ii. The mecamylamine first-in human study protocol will be using a medication which 1. Not currently FDA approved 2. Will be tested in humans using an inhaled form of the drug 1. b. In the Hopkins incident the investigator failed to fulfill the following responsibilities: 1. To protect research subject - Earlier patients had reported side effects after the used of hexamethonium. 2. To inform patient new finding which may have changed the subjects mind about participating in trial 3. Failure to report serious adverse events to the IRB 4. To follow the pro... ... middle of paper ... ...and how if they have any questions or complaints about the study. If the subject chooses to participate in the study regardless of the risk, they should be informed on how treatment is handled if complications arise. 4. d. You need to be careful when deciding to participate in a clinical trial especially if you are an employee of the company conducting or sponsoring the trial. There is a potential for coercion or consent under duress, being e perceived when an employee volunteers for a study in which they have personal involvement. 2 Reference: 1Consent form for Protocol #H-21019 - “Does Glutamine Supplementation Increase Arginine and Nitric Oxide Synthesis?” at Baylor College of Medicine 21www.jmedethics.com The hexamethonium asthma study and the death of a normal volunteer in research J Savulescu, M Spriggs 1* 2* Mecamylamine Product Label

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