Institutional Review Board

As stated, clinical research is an important tool to bring basic medical research into practice. However, the safety of the patient needs to be paramount. This is the reason for the IRB (Institutional Review Board). It's purpose and function is to review the medical ethics of any institute that performs experimental research on human subjects and ensure patient safety. The irony here is that, tradionally, medicine has always used human subects for it's experiements. Further, they still do. Many patients don't understand that when a drug, or medical procedure is approved, it's still "experimental" and contains risks of failure. The difference between approval and "experimental" procedure is a ratio of risk to reward. If there is a low risk to high reward ratio - this is the key for approval. The problem is that (todate) the risk, although low, has never been zero. All approved drugs and procedures have side-effects.

Approval of national bodies like the FDA (which is the global standard and essentially a national IRB) defines the differnce between use in medical practice and use in clinical research. The basic difference between medical practice and clinical research is that, medical practice is the use of finalized clinical research by MD's (medical doctors). MD's are licensed by a government authority and/or medical association to practice medicine on the general public. While, clinical research is the research that is done to develop new treatments.

The purpose and function of this IRB is the same as the FDA, and functions under Democratic Earth, as a global American medical body. To this effect, new objective standards of qualifications have been developed;

  1. MD - (The old standard) a person with just an [MD] as a suffix to their name is practitioner, licensed by a local governing body under a old subjective standard
  2. PhD, DMSc, MD - is this IRB's new objective standard, indicating the path of research
    1. PhD - indicates that a PhD thesis has been researched and developed
    2. DMSc - (Doctor of Medical Science) indicates that the PhD has completed the four year post-doc phase, inwhich the PhD must defend the merit of their thesis. During the DMSc, the medical science of their PhD thesis must be fully developed and they are qualified to do medical studies.
    3. MD[Defending] - Dependending on the quality of work in the DMSc, the scientist proceeds to the clinical level of his research, where he must (like with the PhD, DMSc and all other designations) defend the his theory and work.
    4. MD - (The new objective standard) Has completed at least a year of defending his MD designation, but is determined by the progress and development of his research.
  3. The new objective standard requires open (public accessible) peer-review.

To better a better understanding of an IRB and our IRB, below are Guidelines from the FDA outlining the organization and function of an IRB. Our amendents are highlighted in red.

FDA Guidance for Institutional Review Boards and Clinical Investigators
1998 Update

I. IRB Organization

  1. What is an Institutional Review Board (IRB)?

    Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

    The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

  2. Do IRBs have to be formally called by that name?

    No, "IRB" is a generic term used by FDA (and HHS) to refer to a group whose function is to review research to assure the protection of the rights and welfare of the human subjects. Each institution may use whatever name it chooses. Regardless of the name chosen, the IRB is subject to the Agency's IRB regulations when studies of FDA regulated products are reviewed and approved.

  3. Does an IRB need to register with FDA before approving studies?

    Currently, FDA does not require IRB registration. The form FDA-1572 "Statement of Investigator" for a study conducted under an IND requires the name and address of the IRB that will be responsible for review of the study. IRBs that approve studies of FDA regulated products must be established and operated in compliance with 21 CFR part 56.

    With the recent problems with the drug Vioxx (from Merck) on Nov/Dec 2004, and continuing problems, it is our intention to operate parallel to the FDA, using it's regulation as a base to develop better standards for medical research and practice. This institute, the IRB and all sections under Delta R&D, Inc. (The Objective Theory - the 6th edition) operate as global American organizations of the Earth (Democratic Earth), not specific to any country.
  4. Must an institution establish its own IRB?

    No. Although institutions engaged in research involving human subjects will usually have their own IRBs to oversee research conducted within the institution or by the staff of the institution, FDA regulations permit an institution without an IRB to arrange for an "outside" IRB to be responsible for initial and continuing review of studies conducted at the non-IRB institution. Such arrangements should be documented in writing. Individuals conducting research in a non-institutional setting often use established IRBs (independent or institutional) rather than form their own IRBs. Also see the information sheets entitled "Non-local IRB Review" and "Cooperative Research."

  5. May a hospital IRB review a study that will be conducted outside of the hospital?

    Yes. IRBs may agree to review research from affiliated or unaffiliated investigators, however, FDA does not require IRBs to assume this responsibility. If the IRB routinely conducts these reviews, the IRB policies should authorize such reviews and the process should be described in the IRB's written procedures. A hospital IRB may review outside studies on an individual basis when the minutes clearly show the members are aware of where the study is to be conducted and when the IRB possesses appropriate knowledge about the study site(s).

  6. May IRB members be paid for their services?

    The FDA regulations do not preclude a member from being compensated for services rendered. Payment to IRB members should not be related to or dependent upon a favorable decision. Expenses, such as travel costs, may also be reimbursed.

    The journal Science has had continuous warnings on the effects of funding on the outcomes of medical research. To this effect we have instituted the following standards;
    1. Payment to IRB members cannot be related to, or dependent on, a favorable decision.
    2. Payments must be general in nature and not specific to any function or work of the IRB member.
    3. Payment are allowed from any source for consulting services
    4. To ensure independence (objective) decisions, IRB members must maintain a mirror database of medical data sets clearly showing the risk to reward ratio.
     Further, it's been shown that research outcomes have been, and are being skewed, to present funding favorable results, while hiding (or omitting) negative results. To this end we have altered our funding model to prevent this.
    1. We don't ask for specific amounts - we just anounce the research to various funding bodies and allow them to decide what, if any, amount will be provided.
    2. No sponsor will be charge a fee for any review or research. Requests for review can be submitted without any restrictions. Requests should be faxed to 501-646-4519
    3. We offer our IRB to other IRBs that need position(s) filled for only $12,000 per year or $1000/month (US). This means that IRBs can outsource any position for only $1000/month
  7. Is the purpose of the IRB review of informed consent to protect the institution or the subject?

    The fundamental purpose of IRB review of informed consent is to assure that the rights and welfare of subjects are protected. A signed informed consent document is evidence that the document has been provided to a prospective subject (and presumably, explained) and that the subject has agreed to participate in the research. IRB review of informed consent documents also ensures that the institution has complied with applicable regulations.

    8. Despite informed consent, and the standard put forward by the FDA, there have been significant failures. As such, a new standard is called for.

    1. All research under this IRB will be publicly listed and fully open to the public, not hidden behind a website requiring registration. All research done by this institute is public listed and fully open to the public - including a open peer-review medical science journal.
    2. Because research and uncertainty follows any drug or procedure into practice their is a public mechanism for patients to voice concern.
    3. Finally, informed consent is often comprimised by the payment of the subject. Many subject, like the homeless and poor submit themselves to medical research as a means of income - effectively nullifying the entire concept of "informed consent". No patient, person, can be paid for any participation in an experiment.
    4. Due to (3) no informed consent form is required. Compliance with ethics and standards listed here.
  8. This IRB will review, revise and maintain standards on a monthly basis - or as required.
  9. This IRB in conjunction with the Cybernetics Institute - Medical Science, will form the equivalent of the FDA for Democratic Earth. As such, we stand fully independent of the FDA, although we do with to develop a working relationship with the FDA.
  10. Degree requirements and standards (for anyone involved in medical research)
    1. Bachelor of Science - this degree is required prior to beginning any medical research
    2. PhD - this degree is required to begin bringing basic research into medical research. However, its merit must be demonstrated via 4 years of post-doc.
    3. DMSc - After the post-doc period, and the medical research has begun the main work of his PhD thesis, he may add the title of DMSc (Doctor of Medical Science)
    4. MD[Defending] - depending on the quality of the medical research (and the need for proper clinical study) the title MD Defending should be added. This title occurs after the "post-doc" period for the DMSc and is designed to provide the new MD researcher with the period need to demonstrate the quality of his MD (Medical Degree). However, this period has no fixed duration - it depends on the rate that the research develops.
    5. MD - This is the full Medical Degree and the point where clinical trials can begin. A name with both the DMSc and the MD suffix indicates that this person is a MD specific to medical research. A name with just the suffix MD is a general practitioner with no research experience.
  11. The minimum requirements;
    1. For the IRB - Anyone applying to participate in the IRB must be at the DMSc level and above.
    2. For Medical Study - the initial medical research (pre-clinical study) - the main researcher must have a minimum degree level of PhD.
    3. For Clinical Study - the main researcher must have a minimum degree level of MD[Defending]
    4. For Clinical Trial - the main researcher must have his MD[Defending]
    5. For Research Institutes/Centers wishing to affiliate with us - they must assign a researcher to participate on the IRB. For centers that don't meet requirements we will work with them to achieve the requirements.
    12.

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