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Exploiting low income women as biological resources? Our globalised economy responds voraciously to biotech advances, but lax regulation risks turning the poor into biological resources to be used for profit
“Hi-C” will make it much easier and cheaper to assemble all of an organism’s genetic material from scratch
World-first transplant to treat macular degeneration could augur rise of iPS cell banks
By Nicolas Terry and Frank Pasquale Subscribe to TWIHL here! This week’s conversation featured Northeastern University School of Law Professor, Andrea Matwyshyn. In addition to her appointment on the law faculty, she is a professor of computer science (by courtesy), and co-director of the law school’s Center for … Continue reading →
The Research Involving Human Subjects Committee (RIHSC) FDA’s IRB, is looking for up to three individuals from the community to serve as public members on the committee.
FDA is committed to safeguarding the rights and welfare of all human beings who participate as subjects in research. The RIHSC reviews all research involving human subjects conducted, supported, or funded, in whole or in part, by FDA, to ensure that the research complies with applicable laws and ethical research standards.
What kind of members serve on an IRB?
Ideally, IRBs are made up of members from diverse backgrounds. Diversity assures a complete and thorough review of the research activities from a variety of perspectives.
We are seeking community members with different kinds of backgrounds than our current members. Some examples would be educators, members of the clergy, laborers, and previous government employees who have not worked in public health agencies.
RIHSC membership currently has scientists, health care professionals, social scientists, and regulatory counsel.
What are the qualifications RIHSC is seeking in a Public Member?
Although not required, it may be beneficial to have experience in:
- Health communication, health literacy, or plain language
- Consumer or patient advocacy
- Ethical analysis or
Community members who volunteer to be a public member for RIHSC may not be affiliated with FDA or be an immediate family member of a person affiliated with FDA.
What are the responsibilities of a public member of RIHSC?
The public members on a rotating basis will be asked to:
- Prepare for monthly committee meetings
- Attend monthly committee meetings (typically meets for 2-3 hours on the first Wednesday of the month, during business hours)
- Attend meetings
- Add to the discussion and vote on the proposed study based on certain criteria, such as if the risk to subjects is reasonable, minimized, and fully disclosed to subjects.
The public members will be modestly compensated for performing committee duties.
If you know of interested individuals who are not affiliated with the FDA or a part of the immediate family of a person affiliated with FDA, please encourage him/her to send a resume or CV to the RIHSC Program Management Staff via email at RIHSC@fda.hhs.gov.
Earlier this month, the Health Professions Appeal and Review Board affirmed the decision of the College of Physicians and Surgeons of Ontario to impose discipline on a physician who approached the issue of organ donation with a patient's family in an inappropriate manner.
by Craig Klugman, Ph.D.
The Republican-backed American Health Care Act was withdrawn before a vote on Friday when it appeared to lack the support needed to pass. The result is that the Affordable Care Act (Obamacare) remains the law of the land according to Paul Ryan. Both Ryan and Trump stated that health care is now on the backburner and they have moved on to other items like tax reform. The problem though, is that the ACA is showing its age and needs some work.…
Our Managing Editor, Bela Fishbeyn published a very moving account of her experiences as an immigrant to the United States. This highlights the schizophrenic nature of our nation’s attitudes and history towards immigrants and refugees. My father was a holocaust survivor. When he spoke about being a child in Germany, he commented on how all the children knew you wanted to be in the areas controlled by the Americans. The American GI’s would give the starving children their rations and sometimes a candy bar.…