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TO: Iowa Public Department of Health

FROM: Heather Adams, Assistant Attorney General

Date: October 28, 2009

RE: Public Readiness and Emergency Preparedness (PREP) Act for H1N1 Vaccination and Emergency Use Authorizations (EUAs) for H1N1 Countermeasures

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About the Alliance for Human Research Protection

Mission Statement

The Alliance for Human Research Protection (AHRP) is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to minimizing the risks associated with such endeavors and to ensuring that the human rights, dignity and welfare of human subjects are protected

Board of Directors

This year, more than 15 million Americans will be recruited into clinical trials.

The AHRP mission is to stand up - and speak out - for the human rights of research subjects - especially those who are vulnerable and /or susceptible to coercion, manipulation and exploitation. Those who are incapable of exercising their right to informed consent are in greatest need of protection from research abuse

Disadvantaged children are sought as human guinea pigs - even toddlers and infants, some living in foster care;
Elderly people with impaired reasoning capacity, some living in nursing homes;
People disabled by mental or physical illness;
Illegal immigrants and disadvantaged populations living in underdeveloped countries;
Prisoners, including members of the armed forces.

AHRP is the best-known, most visible, proactive citizens' watchdog organization bringing to public attention - through our daily Infomails - issues affecting the safety of people in clinical trials.

The AHRP's Unique Contribution:
We provide a public awareness forum through education, media exposure, and appeals to conscience and social justice, by,

Spearheading an educational campaign for informed consent to empower ordinary citizens with information they can use to better protect themselves and their children from undue risks of harm. Join our Campaign for Informed Consent.
Providing prospective research subjects with information and a questionnaire designed to inform them of their rights and responsibilities, thereby enhancing the process of informed consent. [link]
Sending alerts to professional groups, the media, and political leaders about violations of ethical standards in medical research.
Presenting the general public with timely, relevant information in a sustained educational effort.
Calling for reforms to improve clinical research designs and oversight.
Developing a web-based library and clearinghouse of resource materials for the use of both clinical investigators performing research on human subjects and the potential subjects themselves.

Insofar as nearly all of the AHRP's work is performed by unpaid volunteers, who are donating both time and other resources to the organization, we offer a unique point of view untarnished by conflicts of interest: none of us has a direct financial interest in any medical research enterprise.

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