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Cure Research Ethics / Risk to Patients Who Participate
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The pursuit of HIV cure research raises a number of important ethical issues [18,19].Small human studies limit the extent to which generalizations can be made about curing HIV. Such early trials may pose serious risks while initially producing little individual or social benefit.....Cure studies may be marked by a curative misconception among those who are HIV-infected and who hope to permanently rid their bodies of the virus.
"Researchers have the responsibility to report the associated lack of clinicalbenefits inearly-phaseHIV curestudies.
HIV cure research participants should know that interventions are experiments that evaluate basic safety and they are meant to generate knowledge for the benefit of society. Examinations, study interventions and laboratory tests should not be considered benefits of study participation."
from Jules: As I have said from the beginning of cure research but what i said was disregarded until now with these recent reports on "Ethics in Cure Research" including reporting at 2016 IAC Durban, there are crucial ethical concerns in recruiting patients to participate in these studies & in potential participants understanding fully what they are getting into - the risks of the studies along with potential benefits. It appears that at least some patients if not most are not fully aware or fully informed of the potential risks for themselves if they participate in a "cure research study". There are no real personal benefits for the patient to their health to participate, as I have said from the beginning. The main benefit is that as a participant you are contributing to the research that may one day lead to finding some sort of a cure or functional cure. But there are personal risks to one's own health. Often participation in the study requires interrupting HAART, ART therapy which in and of itself has risks associated with that the risks of therapy interruption were detailed years ago when it was finally decided & realized that interruption is NOT recommended & can cause problems for the patient. At that time I had warned interruptions were dangerous & others did as well, but many persisted in pushing for interruptions, and harm was done to patients who interrupted. When one interrupts therapy the HIV reservoirs that may have been reduced are likely to increase or be replenished, which I would not subject myself to HIV viral load had been reduced to below detection & now with interruption will increase, and previous studies from tears ago found this can cause a problem such as reactivation of old infections or conditions including some that may have been subclinical. HIV that may have been reduced or undetectable in the brain may upon interruption re-emerge. After stopping HAART CD4 decreases, what is the affect of this even if it increases upon restarting HAART. We know from the SMART Study that interruptions increase risks for cardiovascular markers to increase, inflammation makers to increase, kidney function to worsen. Even if in these cure studies ART is restarted as soon as CD4 get to 350, we do not know exactly what the risks are. At IAC Durban an Australian survey study asked patients what would deter them from participating in cure research studies and the responses reflect my concerns, where the majority of responses said they would not enter these studies if it could result in risk for illness, developing drug resistance, increased viral load for a persisting period of time. . In addition the risk of drug resistance after stopping HAART is a possibility too. Again the main benefit is the feeling you may be helping future generations IF a cure is found, but you also could be putting your personal health at risk. If after fully considering these issues one wants to participant fine. But a true well informed decision should be made. researchers should make sure patients understand everything before participating in the study. The cure studies are in very early stages & no patient will be cured by participating in a study today. PLUS there are potential safety & adverse events issues related to the drugs given to patients in these studies.
HIV Cure Research Ethics
"early-phase research does not confer projected direct clinical benefits and there is the possibility of harm while advancing medical knowledge. Results highlight the importance of managing expectations and thoroughly exploring the potential for therapeutic misconception."
Here is a poster at IAC Durban, take a look for yourself what motivates patients to participate in the cure studies. You can see in this Recommendations slide note is made that "interventions [interventions in these studies] are experiments that evaluate the basic safety of these interventions & these studies are meant to generate knowledge for the benefit of society" but the actual risks of participating need to be considered before entering the study. It is very important to understand the risks before participating in any study, including a cure study.
Following below are slides detailing the personal health risks of participating in these studies and the benefits some perceive - of note - potential to benefit society - that influence them.
The poster presents the results of a survey, poster says:
"An extensive, online cross-sectional survey was conducted among 400 American adults (22% females; 77% males; <1% transgendered) in September – October 2015. The sample was ethnically diverse (65% Caucasian, 17% African-American, 12% Hispanic, 4% mixed and 2% Asian) and 38 U.S. states were represented. We also conducted key informant interviews with 36 people living with HIV, researchers, bioethicists, members of Institutional Review Board(IRBs) and regulatory agencies to assess perceptions of benefits."
Here the poster authors say "Hope that health will improve may be a strong motivating factors; yet early-phase research does not confer projected direct clinical benefits and there is the possibility of harm while advancing medical knowledge.Results highlight the importance of managing expectations and thoroughly exploring the potential for therapeutic misconception"
"Despite no expectation of direct clinical benefit from participating in early-phase HIV cure clinical studies, the majority of potential volunteers value the societal benefit of furthering science and believe they will experience psychosocial benefits from their participation.
Data show that we should not underestimate the importance of socio-emotional benefits in HIV cure research participation. The perceived benefit of gaining knowledge about one's health raises questions about the need to communicate study data (in the aggregate) and advancements in science to study participants and highlights the importance of positive clinical contact factors. Hope that health will improve may be a strong motivating factors; yet early-phase research does not confer projected direct clinical benefits and there is the possibility of harm while advancing medical knowledge. Results highlight the importance of managing expectations and thoroughly exploring the potential for therapeutic misconception."
http://programme.aids2016.org/PAGMaterial/eposters/0_2406.pdf
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Ethics and HIV cure research......http://www.natap.org/2014/HIV/060114_02.htm
The pursuit of HIV cure research raises a number of important ethical issues [18,19].
Small human studies limit the extent to which generalizations can be made about curing HIV. Such early trials may pose serious risks while initially producing little individual or social benefit.....Cure studies may be marked by a curative misconception among those who are HIV-infected and who hope to permanently rid their bodies of the virus.
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Ethics of Cure Research
Cure studies in HIV+ patients have been ongoing and many patients in fact do volunteer to participate in these studies which can require interrupting HIV treatment called HAART. Here is review of the ethics of the studies including the risks of participating, and the potential benefits that may in the future result from all these studies IF a cure is found, and which could be 10-20 years from now, or never.
http://www.avac.org/sites/default/files/event_files/EthicsCure_SLIDES.pdf
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