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How to Understand How Clinical Trials Work if You Are a Patient - Part 2

Patient
Patient
Member
By Sarah Wilson CCRP
eHow Community Member
(4 Ratings)

This article is Part 2 of How to Understand How Clinical Trials Work if You Are a Patient. Please read Part 1 to get a full overview of the process. A link is in the resource section below. This part will introduce you to the informed consent process and tell you what else is involved when you volunteer for a clinical trial.

Difficulty: Easy
Instructions

Things You'll Need:

  • Desire to volunteer for a clinical trial
  1. Step 1

    What is an Informed Consent?

    The Informed Consent is a document that tells you about the experiment they want you to take part in. It describes how often you have to see the physician (or dentist) and how often you must take the experimental medication or perform the experimental treatment. It tells you what to expect after you take the experimental product and what to do and who to call if needed. The informed consent should describe all your rights in writing and is required to be in YOUR language or one that you fully understand. You (or a legal representative) are required to "personally" sign AND date the informed consent form. No one at the clinical research center should sign or date your form for you. The doctor or person accepting your informed consent form are required by law to give you a copy of the informed consent form and you should keep your copy in a safe place.

  2. Step 2

    Is it safe to participate in a clinical trial?

    Clinical trials have risks. I would be lying if I said otherwise. However, good clinical trial sponsors and good clinical investigators do everything they can to make sure people are safe when participating in their clinical trial. If you have doubts, don’t sign the informed consent without talking it over with your family, spouse or significant other. Talk it over with your doctor. Tell him or her what your fears are. Chances are they have the answers and can tell you what you need to know. Go to the FDA website and send an email inquiry or heck, call them. They are public servants and their job is to protect the people. But I can tell you that the FDA probably reviewed that clinical trial recipe before the doctor got to you. If they didn’t think it was safe, you wouldn’t be hearing about it. Also, your informed consent form usually have the contact name of an ethics committee, call them.

  3. Step 3

    What is an “ethics committee”?

    An ethics committee is the same as an “Institutional Review Board” in the United States and an “Independent Ethics Committee” in Canada and other countries. Some countries are smart enough to have National Ethics Committees who approve the local ethics group and give them permission to operate. The Ethics Committee is responsible for making sure you, the person in the clinical trial, is protected and not mistreated or discriminated against in anyway. Their job is to answer any question or complaint from you, the volunteer.

  4. Step 4

    Minorities are the most under-represented group in clinical research because they do not take part in available clinical studies. This is a problem because different cultures may react differently to certain treatments, especially medication. Without minority participation, they end up taking drugs or having treatments that proved effective on their Caucasian counterparts but may not be effective for them.

    A wise man once said "you pay for what you don't know". I say "you miss out and then you pay for what you don't know". Now, you know.

Tips & Warnings
  • When signing up for a clinical trial, listen to your instincts. If you suspect something is wrong, get out and report it to the ethics committee and the FDA.
  • If any clinical research person badger you into participating, or offers you money, free medicine or any item not listed in your written informed consent, report it to the ethics committee and the FDA.

Comments  

khali321 said

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on 9/5/2008 good job

02SmithA said

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on 9/3/2008 Sarah, Any idea about how often clinical trials are paid and how often they are volunteer only? I've seen both.

Sixtwo24 said

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on 9/3/2008 Good Info. I always wondered how that worked. Thanks.

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