An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a type of committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be conducted. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Along with developed countries, many developing countries have established national, regional or local Institutional Review Boards in order to safeguard ethical conduct of research concerning both national and international norms, regulations or codes. In the US institional review boards regulated by HHS are required for any research receiving US government support. See also. International Compilation of Human Research Protections, Office for Human Research Protections, U.S. Department of Health and Human Services.
The International Conference on Harmonisation sets out guidelines for registration of pharmaceuticals in multiple countries. It defines Good Clinical Practice (GCP), which is an agreed quality standard that governments can transpose into regulations for clinical trials involving human subjects.
Here is a summary of several key regulatory guidelines for oversight of clinical trials:
- Safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects, such as pregnant women, children, prisoners, the elderly, or persons with diminished comprehension.
- Obtain trial protocol(s)/amendment(s), written Informed Consent Form(s)(ICFs) and consent form updates the investigator proposes for use in the trial, subject recruitment procedures (e.g., advertisements), written information to be provided to subjects, investigator’s brochure, available safety information, information about payments and compensation available to subjects, the investigator’s current curriculum vitae and/or other documentation evidencing qualifications, and any other documents the IRB may need to fulfill its responsibilities.
- Review both the amount and method of payment to subjects to assure neither presents problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject. Information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, should be set forth in the written informed consent form and any other written information to be provided to subjects. The way payment will be prorated should be specified.
- Ensure that the proposed trial is reviewed within a reasonable time and document opinions and decisions in writing, clearly identifying the trial, the documents reviewed and recorded dates for approvals, required modifications prior to approval, disapproval of a proposed trial, or termination/suspension of any prior approval. Continuing review of ongoing trials is required at intervals appropriate to the degree of risk to human subjects, but at least once per year.
There are number of risks of COVID in the gut including but not limited to the following: COVID in the mouth can be spit on other people potentially spreading virus to others.
COVID has not been proven to spread from gut to the alveoli. However this has never been proven . COVID in mouth could be potentially aerosolized by power tools including vibrating or power tooth brushes . COVID in stomach might produce vomiting of live virus upon others or potential inhalation COVID pneumonia after aspiration of vomit containing live COVID virus. COVID in intestine could be aerosolized by power tools during autopsy. One coroner is suspected to have died from PULMONARY COVID after possibly using power tools in autopsy. It is well known that COVID lives in intestines for days or weeks.Power tools might aerosolize virus in sewage or stool. Sewage workers must take extra precautions around sewage containing virus especially whenever virus may be aerosolized. Some patients including those with cognitive defects may play with throw or smear feces . There are a number of other stool pathogens that can be spread and these must also be considered. Practicing stool hygeine is essential in evaluation of risk benefit analysis.
Children low mortality from COVID. Pediatric inflammatory disease syndrome in infancy has been associated with COVID exposure. It is not known how COVID inoculation would affect rare pediatric diseases. Risk benefit analysis must be done by qualified licensed healthcare professionals. Children and those with reduced cognitive performance should never be experimented upon.Prisoners who can offer informed consent were used in smallpox inoculation. Medical practioners must protect those with limited cognitive reserve. Any reasearch program should follow the guidelines of a institutional review board. For some subgroups the risk benefit ratio may exclude gut COVID.It takes real experience with inoculation before risks and benefits can be accurately predicted, This makes testing for side effects and efficacy essential. The real authority is local licensed medical practicioners who have experience in the area. Experienced intelligent individuals without a conflict of interest who have access to all data are essential for public protection.
This website does not authorize any use of COVID in any community. The local licensed medical practioners must study data and obtain permission before using any information on this website.It is the duty of reader to investigate and comply with all local rules and regulations The technology to use gut COVID is prohibited from unauthorized use by others based on current patent pending .