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.
Medical research is not standard medical care: research involves uncertainty and, therefore, risk. Treatment is determined by a protocol that seeks to resolve uncertainty and contribute to generalizable knowledge—not necessarily in the best interest of the individual subject. The Alliance for Human Research Protection recommends 5 Essential Safeguards for ALL human subjects in clinical trials.
- Informed consent should never be abrogated for any research involving human subjects, under any circumstances, in any country, regardless of local standards and regardless of the type of research.
- Human subjects enrolled in research will always be subjected to some degree of risk; at a minimum, they may receive a placebo or less effective treatment than in standard care. In the worst case, subjects may be irrevocably harmed and may even die due to the treatment being tested or the experimental procedures used. Patients who volunteer to be human subjects must be fully informed about all the foreseeable risks—including the risks associated with randomization.
- Whenever protocols involve invasive interventions—whether to test a new treatment or a treatment used in some form in standard care—the foreseeable risks must be fully disclosed—regardless of whether the research is defined as “comparative effectiveness research” or any other classification of research.
- There are currently no mandatory licensure requirements for researchers conducting research on human subjects. AHRP recommends that physicians who conduct medical research involving human beings should be required to undergo rigorous training on how to minimize risks and demonstrate proficiency in ethical and clinical standards, BEFORE they can be licensed to conduct medical experiments in human beings.
- AHRP recommends that all clinical trials must include a standard of care comparator arm, to ensure the safety of the subjects, and in order to avoid adopting practices that fail to improve the current standard of care—and may even worsen it.
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.
- 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.
- 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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The Alliance for Human Research Protection is a nonprofit, tax-exempt educational organization under Section 501 C-3 of the Internal Revenue Code.