The Food And Drug Administration (IRB)

Grady, C. (2010). Do IRBs protect human research participants? JAMA, 304(10), 1122-1123. Retrieved from http://jama.jamanetwork.com/article.aspx?articleid=186530

Institutional Powers have always affected my life in many ways. The main institutional power that control both positive and negative consequences of my life would be the FDA the Food and Drug Administration. The first way they control my life is they regulate all human and veterinary drugs in our country. Second, the FDA is responsible for protecting the public health and products. Lastly, they supply and control the entire United States Food supply. I believe that this specific governmental institutional power is 100% the authority over my life. The FDA needs to care more about the general health of the public and take into consideration how they play a major factor in the health of our bodies, minds, and environment as well.

| A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?

The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter.

The IRB is an independent committee that reviews all research proposals, ensuring all the participants welfare and rights are protected from the study (Polit & Beck, 2017). The committee has the option to approve, modify or deny any research proposal based on the participants’ rights.  An expedited review is utilized on a research proposal where it is proven there the has ‘no more than minimal risk’ (Polit & Beck, 2017), ensuring patient rights; this approval is performed by only 1 committee member at a reduced time.  I believe my proposal will quality for the expedited review as is will not harm any participant or violate their rights; the proposal has two different interventions which both potentially improve the participants’

Institutional Review Board is also known as IRB for short. The IRB is in charge of protecting the rights and welfare of the individuals involved in the research. The board reviews the plans for research involving human test subjects. The Food and Drug Administration (FDA) and the Office of Human Research Protection (OHRP) set the guidelines and regulations governing human subject research and IRBs is set.

The National Institute of Health (2014) listed the most common form of familial hyperinsulinism to be an autosomal recessive genetic defect that is common among the Ashkenazi Jewish population. This condition affects 1 in 66 carriers who are Ashkenazi Jews since they have reported consanguineous marriages (NIH, 2014). Among Ashkenazi Jews, two single ABCC8 mutations account for 90 percent of cases of familiar hyperinsulinism (Mazor-Aronovitch, et al, 2007). The incidence of FHI in individuals of northern European descendants is approximately 1:30,000 live births. The incidence is increased in genetically isolated populations with a high prevalence of consanguinity (UpToDate.com).

IRBs are committees that consist of 5 or more members with varying expertise and diversity that are responsible for reviewing and approving human subjects research activities on behalf of institutions.

PrEP treatment is taken in the form of a pill, called Truvada. Truvada is a combination of two HIV medications (tenofovir and emtricitabine). Truvadais a fairly new drug. It was approved for human use by the U.S. Food and Drug Administration (FDA) and allowed clinical practice guidelines for usage in the America by the U.S. Public Health Service and the Centers for Disease Control and Prevention (CDC) in May 2014. In order for Truvada to be effective, users of PrEP must adhere to taking one pill every day. They must also meet with their healthcare provider every three months to follow up. It is imperative that people who have been exposed to HIV by way of intravenous drugs use or sex seek PrEP to prevent the virus from spreading through the body.

Do you know what you eat every day? What chemicals are approved by the Food and Drug Administration, but are banned or heavily regulated in other countries for health reasons? Most people want to believe they do, but are shocked to find the truth. It has been estimated that seventy five to eighty percent of the foods and drinks sold in stores have been genetically modified (About Genetically Engineered Foods). Genetically modified food, or GMO’s, are a major health risk, and should be clearly labeled by companies, if not banned. My mother is in stage four kidney failure, meaning that she only has about fourteen percent of her kidney function left. She takes about half a dozen medicines a day for pain, hormones, and vitamins. She has been put on a vegan diet, a grain free diet, and was suggested a marine diet. No matter what she tried nothing seemed to help her kidneys or pain. Over the summer of 2013, for fourteen days, my parents, sister, her boyfriend, and I all went to Costa Rica. Costa Rica is a small country in Central America. In Costa Rica, the food was caught fresh, and fruits and vegetables were picked daily in the local garden. After two days being in Costa Rica my mother only had to take two pills for hormones. Her pain dramatically reduced, her migraines went away, and her kidneys could process all the food without problems. She ate meat, fish, bread, and anything she wanted with no side effects. The main difference between the food in the United States and the

Since the FDA has a lot of responsibility in our society with it regulating our food and drug safety it is best to come to understand it better.

U.S. Food and Drug Administration 2008, 'FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence ' U.S. Department of Health and Human Services, updated 2015, viewed 13 January 2016, .

discussed at some point. There are certain populations that must be protected when research is conducted. For further information on the HIPPA regulations related to IRB’s consult, consult the website HIPPA.

This unethical approach to research studies should be identified and put to an end. Research subjects should be protected and acknowledged for their courage to partake in such studies not be forgotten. The main source of protection for research subjects is a patchwork system of ethics committees known as institutional review boards, or I.R.B.’s (Elliot, 2011). To ensure that research studies are ethically sound the I.R.B., a small, federally empowered group, reviews research

The current DURC policy has several limitations in providing oversight due to its applicability only to institutions that receive federal funding and a defined list of agents, toxins and experiment categories. The policy burdens Institutional Review Entities (IRE) by placing on them the added responsibility for review and mitigation of DURC that is already performed by federal agencies. These added oversights could stifle potentially beneficial DURC projects.