Experimentation
RESEARCH AND EXPERIMENTATION-PARTICIPATION CONSENT
In most ways, the consent issues for participation in experimentation and research are not
very different from those surrounding any other medical treatment or procedure. The
research subject must be fully informed of the potential risks of the intervention as well as
the possible benefits. The subject or participant must be entering the trial voluntarily—
without coercion. If the subject is not an adult or lacks the capacity to understand the risk of
the trial, then a valid surrogate such as a parent or guardian must give consent.
The difference between participating in experimentation and receiving a treatment is that
the study medication may be given in a way that is known, in advance, to have no benefit and
the subject is participating simply out of other motives to advance the accumulation of
scientific data. The bottom line on experimentation is that participation must be voluntary.
PRISONER PARTICIPATION
The same rules apply to the participation of prisoners in research as apply to
nonprisoners. Prisoners have the same right of refusal and informed consent. There is to be
no removal or abridgement of rights simply because the patient is a prisoner.
INSTITUTIONAL REVIEW BOARD (IRB)
An Institutional Review Board (IRB) is an independent reviewing body that evaluates
investigational protocols prior to their implementation to ensure their validity and ethical
integrity. The IRB is comprised of representatives of different areas of the hospital or
medical school that include clinicians, educators, ethicists, clergy, and scientists.
The idea is to have a broad-based group that can evaluate not only the scientific
parameters of a protocol, but also ensure that the process of informed consent is accurate and
that the treatments and procedures being studied do not present an undue risk to the patients
being enrolled. The IRB also ensures periodic review of the data so that a trial can be stopped
early on occasion. A study cannot commence within an institution without IRB approval.
For example, a group of investigators studying the effects of antiretroviral
medications on patients with HIV/AIDS submits their study to the IRB for review and
approval prior to implementation. The planned protocol is to study whether giving
antiretroviral medications to patients with AIDS makes a difference in their outcome
when compared to starting the medications after discharge.
Half the patients will receive a placebo and the other half will receive the antiretroviral
medications. The study will randomize patients admitted to the hospital for acute
opportunistic infections. The IRB rejects the study on the basis that it would not be ethical to
withhold potentially lifesaving therapy from a group of patients in which the efficacy has
already been proven. In addition, the IRB rejects the study because the consent form was not
translated into Spanish.
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The IRB’s purpose is also to make sure that a study seeks to answer valid questions. It is
not valid to withhold proven effective therapy to gather data on how some patients are
harmed just, to produce a publication. There is no randomized, placebo-controlled trial
proving that antibiotics are better than placebo in patients with severe pneumonia. This is
because the concept of the randomized trial has only been in existence since the second half
of the 20th century. Because Penicillin was already the standard of care for pneumonia, it
would have been unethical to perform a study in which antibiotics were withheld from
patients with pneumonia and to watch these patients die. It would also be unethical to do a
study of steroids in minimal change nephrotic syndrome when the efficacy is clear.
The IRB is a response to the Nuremberg War Crimes Tribunal, during which the world
consensus that experimentation without consent is unethical and not allowable became clear.
Nazi experimentation during World War II was coerced, without consent of the participant
and collected data that involved the unnecessary and willful harm of human subjects. The
modern IRB is the method of ensuring safety, ethical integrity, and freedom from coercion in
clinical investigation.
FINANCIAL DISCLOSURE
When investigators publish or present research data, disclosure of all relevant sources of
financing for the work is required. If I am publishing a study comparing two different antiretroviral medications, it is important to disclose to the audience in a Grand Rounds that I
have received funding from antiretroviral manufacturers. If I am publishing a study on an
implantable defibrillator, it is mandatory that I reveal that I own part of the company that
manufactures the equipment. Financial disclosure is essential to help ensure an objective
interpretation of research data.
The reason for double-blind placebo controlled trials is that we know that the desire of
the people running the study and collecting the data can influence the study results.
Disclosure of financing helps understand a possible bias in a study. The most important
modern example is an article in the journal The Lancet on the dangers of the measles
vaccination. In addition to many other flaws in the study, the author failed to disclose, and
The Lancet failed to investigate, the financial arrangement of the author with a rival vaccine
manufacturer. The study was invalid, although published, because the author was attempting
to invalidate a current measles vaccine in hopes of acquiring approval for the marketing and
reimbursement of his own vaccine. This is an excellent example of why financial disclosure
can help preserve scientific integrity.