In most w?ys, the consent issues for participation in expcrimentation and research are not very different from those surrounding any other mcdical treatntent or procedure. Thc research subject must be fully informed of the potential risks of the intervention as well as the possible benefits. The sub.iect or participant must bc entering the trial voluntarilyilithout cocrcion. If the subject is not an adult or lacks the capacitv to unclerstand the risk of the trial, then a valid surrogate such as a parent or guardian must give consent.
The diffcrence between participating in experincntation and receiving a treatment is that the study medication may be given in a way that is knorvn, in advance, to have no benefit and the subject is participating simply out of othcr motives to advar.rce thc accumulatjon of scientific data. The bottom line on experimentation is that participation must be volunfary.
PRISONER PARTICIPATION
The same rules apply to the participation ofprisoners 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 thc patient is a prisoner.
TNSTITUTTONAT REVTEW BOARD (tRB)
An Institutional Review Board (IllB) is an independent reviei.ving body that evaluates investigational protocols prior to their implenrentation to ensure their validity and ethical
integrity. Thc IRB is comprised of representartives ofdifferent areas ofthe hospital or medical school that includc clinicians, educators, ethicists, clergl and scientists.
The idea is to l.ravc a broad based group that can evaluate not only the scientific pararneters of a protocol, but also ensure that the process of intbrmed consent is accurate and that the treatments and proccdurcs bcing studicd do lot present an undue risk to the patients being enrollcd. The IRB also ensures periodic revievv of the data so that a trial can be stopped early on occasion. A study cannot con.rmence rvithin an irstitLrtion without IRB approval.
For example, a group of invcstigators stud]-jng the eff-ects of artiretroviral medi cations on paticnts with HIV/AIDS submits their study to the IRB for revierv and approval prior to implementation. The pianned protocol is to study rvhether giv irg antiretroviral medicatiols to patients rvith AII)S makes a difference in their outcome rvher.r conpared to starting the rredications after clischarge.
Half the patients will rcceive a placebo and the other half rvill receive the antiretroviral nedications. The study r.vill randonize patients adnitted to the hospital for acute oppor tunistic infectior.rs. Thc IRB rejects the study on the basis that it would not be ethical to rvithhold potentially lifesaving therap,v from a group of patients in rvhich the efficacy l.ras already been proven. ln addition, the llll3 rejects the study because the consent fonr was not translated into Spanish.
The IRB’s purpose is also to make sure that a study seeks to ansrver valid questions. It is not valid to l.ithl.rold proven cffcctive 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 arc 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 thc 20th centuqr Recause Penicillin was already the stanclarcl of care for pneumonia, it rvould have been unethical to perforrn a study in which antibiotics rvere withhcld from patients with pneruronia and to watch these patieDts die. It would also be unethical to do a study of steroids in minimal change nephrotic syndrome when the efficacy is clear.
'l he I RU is a response to the Nuremberg War Crimes Tiibunal, tlurir.rg which thc rvorld consensus that experimertation rvithout consent is unethical and not allowablc bccame clear. Nazi experimentation during \Vorld War II lvas coerccd, without corsent of the participants, and collectecl clata that involvecl the unnecessary and willful harm of human subjccts. The moclern IRB is tl.re method of ensuring safcty, cthical integrity, and freedom from coercior.r in clinical investieatron.
FINANCIAI. DISCTOSURE \hcn in’estigators publish or present research data, clisclosurc of all relcvant sources of iinancinpl for the rvork is required. If r am p.brishing a study conparing two crifrcrent anti, retroviral medications, it is important to clisclose to thc audiencc in a Grand Rounds that I har.e recciyed fr.rndingl from antirctroviral rnanufacturcts. If I am putrlishing a stucly on an inplantable defibrillator, it is mandatory that I reveal that I ou,‘part of thc company that nanufactures the cquipr.nent. Financial clisclosurc is essential to help ensure an obJectiye jnte4)retation of research clata.
The reason for do’ble-blind placebo cor.rtro ccr triars is rrr.t we know that the cresire of the people running the study ar.rd collccting the data can influence tlte stlrdy results.
Disclosure of financi’g helps undcrstancr a possible bias ir.r a study. The m.st important modern cxample is an article in thc journal Thc Lo.tlcet oi the danplers ofthc measles vac_ cruation ln addition to nrany othcr flaws in the studl’, the author failed to crisclose. and The Laucet farled to inyestigate, the financiar arrangenent of the autrror with a rival vaccine nanufacturer. The study was invalid, although published, because the author was attempt_ iug to invalidate a current measles vaccine in hopes of acquiring approval for the nrarkct_ ing and rcimbursenent of his own vaccine. This is an cxcellcnt example of lvhy financial disclosure can help preserve scientific intcgrity.