MENTAL ILLNESS CONNECTED TO HUMAN RESEARCH SUBJECTS

Mental Illness Connected to Human Research Subjects

The mentally ill, spirited away to so-called Insane Asylums in the late 19^th and early 20^th centuries were some of our earliest victims of human research by Orthodox medicine in the United States of America.  Then our penal system began delivering up human research subjects in Orthodox medicine.  The United States Armed Service Members are often subjected to new medications and vaccines not yet available to the public and may be considered human research subjects.  University and College students are lured monetarily into being human research subjects.  However, even more alarming, is that the Food and Drug Administration is currently allowing testing of new medications and vaccines on the population at large.

We cannot have expectations that the Government or Big Pharma or Orthodox medicine have the best interest of the individual in mind.  Research subjects were not protected by any kind of law up until 1991, this shows a total lack of interest in the health and well-being of individuals who do or do not fair well after participating as human research subjects.

Get involved today. Too many people have been harmed by past and current medical research practices.  Read this news release by the Press Office of the U.S. Department of Health and Human Services and let your conscience be your guide.

News Release

FOR IMMEDIATE RELEASE July 22, 2011

Contact: HHS Press Office (202) 690-6343

HHS announces proposal to improve rules protecting human research subjects

Changes under consideration would ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight
The U.S. Department of Health and Human Services announced today that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects. Before making changes to the regulations – which have been in place since 1991and are often referred to as the Common Rule – the government is seeking the public’s input on an array of issues related to the ethics, safety and oversight of human research. The changes under consideration can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 25 Federal Register. The proposed changes are designed to strengthen protections for human research subjects.
“The adoption of the Common Rule two decades ago was a landmark event to ensure ethical practices and the safety of those individuals who participate in research,” said Howard K. Koh, MD, MPH, HHS assistant secretary for Health. “This regulatory review effort is primarily about enhancing protections for human subjects. The changes under consideration offer the promise of updating and enhancing those protections to keep pace with current challenges.”
The current regulations governing human subject research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Expansion of human subject research into many new scientific disciplines and venues and an increase in multi-site studies have highlighted ambiguities in the current rules and have led to questions about whether the current regulatory framework is effectively keeping up with the needs of researchers and research subjects.
Revisions to the current regulations are now being considered because HHS believes these changes will strengthen protections for research subjects in a number of important ways.
Comment is sought on the following:

1. Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
2. Using a single Institutional Review Board review for all domestic sites of multi-site studies.
3. Updating the forms and processes used for informed consent.
4. Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
5. Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient.
6. Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.
7. Providing uniform guidance on federal regulations.

The public’s input on these matters will be critically important to the government’s efforts to ensure that regulations keep up with today’s changing research environment, and will be considered by HHS as it develops new proposed rules, which will also be made public for comment.
To view the ANPRM, please visit http://www.hhs.gov/ohrp.
To submit a comment, visit http://www.regulations.gov, enter the above ID number, and click on “Submit a Comment.”
For additional information about the changes under consideration, visit
http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html.