Sign In | Sign Up | Help | Invite    
Advanced Search Ask A Question Community Recent Changes
My:             Contributions   
Contributors
{for ul in pageInfo.page}
${ul.nickName}
{var al = toBreakWord(ul.adUrl,18)} {if ul.adSentence !=''}${ul.adSentence}
{/if} {if ul.adUrl !=''}${al}
{/if}
 
{/for}
Earn Free Advertising   +   Earn Money By Writing What You Know at WISTEME.COM
Question Discussion History

Edit
    Question ID:   23411         Current Version: 1
Question: What is the history of clinical trial informed consent and the system of protections?
Category: Diseases & Conditions > Other
Keywords: system, protection, history, clinical trial, informed consent
Type: what
Rating:(0 ratings)    Views: 69    Discussions: 0   In Watch Lists: 1  

 
    Answer:
Over the past half-century, the international and U.S. medical communities have taken numerous steps to protect people who take part in clinical research. The following timeline provides an overview of some of the key events that have contributed to the development of the current system.

1947 - The Nuremberg Code

Developed in response to the Nuremberg Trials of Nazi doctors who performed unethical experimentation during World War II, the Code was the first major international document to provide guidelines on research ethics. It made voluntary consent a requirement in clinical research studies, emphasizing that consent can be voluntary only if:

  • participants are able to consent;
  • they are free from coercion (i.e., outside pressure); and
  • they comprehend the risks and benefits involved.

The Code also states that researchers should minimize risk and harm, make sure that risks do not significantly outweigh potential benefits, use appropriate study designs, and guarantee participants' freedom to withdraw at any time. The Nuremberg Code was adopted by the United Nations General Assembly in 1948.

1964 - Declaration of Helsinki

At the 18th World Medical Assembly in Helsinki, Finland, the World Medical Association adopted 12 principles to guide physicians on ethical considerations related to biomedical research. It emphasizes the distinction between medical care that directly benefits the patient and research that may or may not provide direct benefit. These guidelines were revised at subsequent meetings in 1975 (Tokyo, Japan), 1983 (Venice, Italy), and 1989 (Hong Kong).

1974 - The National Research Act

The U.S. Congress signed this act into law, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission was charged with:

  1. identifying the basic ethical principles that should govern medical research involving people, and then
  2. recommending steps to improve the Regulations for the Protection of Human Subjects.

1979 - The Belmont Report

After four years of work, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research." The report sets forth three principles underlying the ethical conduct of research:

  1. respect for persons: recognizing the autonomy and dignity of individuals, and the need to protect those with diminished autonomy (i.e., impaired decision-making skills), such as children, the aged, and the disabled;
  2. beneficence: an obligation to protect persons from harm by maximizing benefits and minimizing risks;
  3. justice: fair distribution of the benefits and burdens of research.

The Belmont Report explains how these apply to research practices; for example, it identifies informed consent as a process that is essential to the principle of respect. In response to the report, both the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration revised their regulations on research studies that involve people.

1991 - Federal Policy for the Protection of Human Subjects

This policy was adopted to ensure a uniform system of protections in all federal agencies and departments that conduct research.

Sources:

[1] A Guide to Understanding Informed Consent, National Cancer Institute

Read more questions from WISTEME through
     Add to MSN Add to My AOL
 Rate this Question
   Add to Groups   Add to Watch Lists   Share Question
                          
 
    More Readings :
[QID:23430]    What will I find in the clinical trial informed consent document?  
[QID:23409]    What is a definition of informed consent of clinical trials?  
[QID:8841]    What does "Informed Consent" mean in clinical trials?  
[QID:23429]    What should I expect during the clinical trial informed consent process?  
[QID:23410]    What are some of the "Myth and Reality" about clinical trial informed consent?  
[QID:8839]    How are people protected in clinical trials?  
[QID:11092]    What is the history of radiation protection?  
[QID:23074]    What is the National Park System?  
[QID:10478]    What is the history of water treatment?  
[QID:8781]    What is the history of the jury trial system?  
     Question ID:  ${question.id}         Current Version:  ${question.version}

{for qh in questionHistory} {if qh.status == 'r'} {else} {/if} {/for}
Version Contributor Date (ET) Voting
${qh.version} ${qh.nickName} ${qh.date} Rejected
${qh.version} ${qh.nickName} ${qh.date} {if qh.status != 'c'} {if qh.status == 'a'} Approved {else} {if qh.rstatus == 'c'} On-going {else} Pending {/if} {/if} {else}   {/if}
Start a New Topic
ID Topics Replies Latest Post (ET)
{if dlist!=null} {for d in dlist} {/for}
${parseInt(d_index)+1} ${d.sentence} ${d.replyNum} ${d.lastestDate}
{else}
No discussion topic.
{/if}
Label Name:
 
Group Name:
 
 
{else}
     You have no group.
{/if}
Advertisements
{if advertisements.length > 0} {else} {/if}
{for ad in advertisements}
${ad.adTitle}
${ad.adSentence}
${ad.adUrl}
{/for}

Home | About Us | Terms of Use | Privacy Policy | Browse Questions | RSS Feed

Copyright ©2010 WISTEME LLC. All Rights Reserved.