1) Review what we know about the Zika virus. I've posted some info for you on our current events page and it is in the news almost constantly.
2) Play a character from The Lab, https://ori.hhs.gov/thelab
3) Imagine you are members of the TMC Institutional Review Board (IRB). The IRB reviews research projects for, among other things, ethical treatment of human subjects. U.S. researchers from TMC are going to run Zika treatment trials on pregnant women in Brazil. What are you most concerned about with that type of research? Use your readings on global research (3 essays pp. 78-292 and what you learn in The Lab) to assess the scenario. (You don't need to address everything in the readings -- there's a lot! -- but show me that you've read and played the game).
I feel like this is a very difficult post to write because you have to pull in so many things from different places and combine it into one post. If I were a IRB member doing trials on pregnant women with the Zika virus would be very difficult issue to handle. They are a population that needs to be handled with extra care and given great thought to what you may test. On one hand you have pregnant women that have the Zika virus and serious birth defects can be a result of having the virus such as microcephaly but it isn't always certain that the baby will have that defect. So you could say they would be willing to risk the health of themselves in maybe the hope of their child being born healthy. That's why I think that makes this a coercive offer in our book Baruch Brody wrote about ethical issues in other countries when it involves clinical trials and research. In that piece he talks about coercive offers which is the population have no alternative and they are desperate which basically forces them into the clinical trial. Which clinical trials are voluntary and these participants can't be that because of their circumstances. That's what this group of pregnant women in brazil would be in a desperate population and a real public health emergency since no one is immune from the disease. Pregnant women are already a vulnerable population to begin with and we are already very slow to do certain clinical trials with pregnant women because the results could be harmful to the mother or harmful or even fatal to the unborn child. When I played the game I played as the principal investigator and saw how important it was to oversee an entire lab to make sure it was running smoothly and ethically. It seemed that as a PI you are just as much as a manager of people as you are a scientist. Sometimes you have to help the young grad student with her methodology and other times you have to listen to concerns of your post docs. The big thing I drew from that exercise is if there is a mistake and flaw you are better off reporting it. If you don't end up reporting it and handle it "in house" and it gets leaked at a later date literally everything that your lab has ever done will have zero credibility. I really enjoyed that exercise.
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ReplyDeleteAlong with the Flint Water crisis, the spread of Zika virus atop the list of health concerns in the news lately.
ReplyDeleteZika was first discovered in Africa in the 1940s. The Zika virus itself, often goes undetected, or is exhibited by mild symptoms like a rash, red eyes or joint pain. Zika is also occasionally linked to guillian- barre syndrome, exhibited by temporary paralysis. The biggest fear spreading is that pregnancy and the Zika virus have been linked to microencephaly in babies to mothers who had Zika while pregnant. This warranted the declaration of a public health emergency by the WHO just this past month (Tavernise, 2016). Interestingly enough, Zika infection was first detected in the US in 2013 in New York City “— six months before the virus is thought to have reached Brazil — in a 48-year-old traveler who lives near Central Park” (McNeil, 2016). He had noted a pinkish rash for 14 days. Medical personnel had thought his illness to be something else, but after alerting them to his concern for Zika, they sent tests to the lab, and 20 days later those returned confirming Zika.
There are approximately 90 cases of Zika in the US, with none of those cases reported to be pregnant women. While around 25,000 babies are diagnosed with microcephaly each year in the United States, no cases have been linked to Zika (Tavernise, 2016) (Saint Louis, 2016). However, in Brazil more than 3,800 infants have recently been found to have microcephaly (Ramero, 2016). “The images pouring out of Brazil are haunting: struggling newborns with misshapen heads, cradled by mothers who desperately want to know whether their babies will ever walk or talk” (Saint Louis, 2016). This month, the Brazil government deployed over 200,000 troops to spread public awareness and educate about Zika (Ramero, 2016).
With the cases discovered in the US, the research has now revealed that Zika can be spread through semen and sexual contact. Sexual transmission had once through to be rare. However, with people who had not traveled outside of the US contracting the virus after having sex with those who had traveled to Zika regions and exhibited symptoms of the Zika virus, scientists feel this is the mode of transmission. They predict when summer approaches, there will be many more cases of this along the gulf coast of the US. The seriousness of this isn’t really known until mosquito season comes about and incubation and infectious periods are analyzed. In 2014, Zika was detected in the semen of a traveler 62 days after his symptoms started (Tavernise, 2016).
To keep from spreading Zika, it is recommended pregnant women avoid traveling to areas known to be infected, and to wear mosquito repellant during the season. Also, anyone fertile traveling to these areas should not practice unprotected sex. The same applies to those who can bear children not having unprotected sex with anyone who has recently traveled to these regions. There is already caution about the virus and concerns it might threaten the economy of Rio with the Olympics this summer. The virus and its potential side effects has also sparked ethical debates in countries that have a high catholic population about a woman’s right to birth control and abortion (McNeil, 2016).
Just like my lab character, Aaron Hutchins, Principal Investigator, it is important that this research is approached openly and ethically. It is important to assess what is happening, what the needs are, and listen to the staff about their procedures, questions and concerns. There is a special concern and more guidelines when conducting research involving pregnant women and children, and these steps and all the necessary paperwork will need to be diligently followed and completed. If there is anything uncertain, it should be immediately scrutinized and taken to appropriate individuals to help solve that process.
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DeleteAs a member of the TMC IRB there would be many questions to be asked. There would need to be an in-depth research proposal outlining what research they are planning. The items to be considered during the institutional review would include:
While Brazil has the largest economy in South America, it is still considered a developing country because it’s economy is very slow growing, making for a low gross domestic product , also due to low living standards, high infant mortality rate, and several other factors (Maddison, p.142-144). Therefore, consideration should be taken pertaining to “Rules for ethical research in developing countries” (Brand-Ballard et al, p. 281). According to these rules, it must be shown the research will provide a direct benefit to the residents of that country, perhaps like decreasing the rate of Zika virus in pregnant females, and lowering the rate of infants born with microencephaly. The researchers must demonstrate a realistic plan, identifying funding, to provide the “newly proven intervention to the population from which the potential pool of research subjects is to be recruited” (Brand-Ballard et al, p. 281). It must also be proven there will be no exploitation of subjects in developing countries. Exploitation is defined as one party receiving an unfair level of benefits as a result of that party’s interactions with the party conducting the research” (Brand-Ballard et al, p. 289). The benefits of the research must be closely scrutinized by looking at The Fair Benefits Framework. The fair benefits framework lays out that benefits to the participants during the research should include improvements to their health and the healthcare available; while benefits to the population during the research includes public health measures and employment and economic activity. After the research there should be reasonable availability of effective intervention, research and medical care capacity development, continued public health measures, long-term research collaboration and a sharing of the financial rewards. This will lead to a collaborative partnership with community involvement in all stages with un-coerced decision making allowed by the population in relation to the burdens of the research. The research study must also remain transparent and provide community forums about the research and agreements (Brand-Ballard et al, p. 291).
Tavernise, S. (2016, February 23). C.D.C. Investigating 14 New Reports of Zika Transmission Through Sex. The New York Times, Retrieved from http://www.nytimes.com/2016/02/24/health/zika-virus-sexual-transmission.html?partner=rss&emc=rss
Romero, S. (2016, Jan. 26). Brazil Will Deploy Troops to Spread Awareness of Zika Virus. The New York Times, Retrieved from http://www.nytimes.com/2016/01/27/world/americas/zika-virus-brazil-will-deploy-troops-to-spread-awareness.html?smid=pl-share
Saint Louis, C. (2016, January 31). Microcephaly, Spotlighted by Zika Virus, Has Long Afflicted and Mystified. The New York Times, Retrieved from http://mobile.nytimes.com/2016/02/01/health/microcephaly-spotlighted-by-zika-virus-has-long-afflicted-and-mystified.html?nlid=25414714&src=recpb&referer
McNeil, D. (2016, February 7). How a Medical Mystery in Brazil Led Doctors to Zika. The New York Times, Retrieved from http://mobile.nytimes.com/2016/02/07/health/zika-virus-brazil-how-it-spread-explained.html?emc=edit_th_20160207&nl=todaysheadlines&nlid=25414714&referer
Maddison, A. (2013). The World Economy: Historical Statistics. Retrieved from http://revista.drclas.harvard.edu/book/why-brazil-underdeveloped-and-what-can-be-done-about-it
Another resource
DeleteBrand-Ballard, J., Degrazia, D., Mappes, T. (2011). Biomedical Ethics 7th ed. pg. 402-404. New York, NY. MCGraw Hill.
New news per CNN as of Wednesday 2/24: "The state of Florida announced Wednesday that three pregnant women who had traveled outside the United States tested positive for Zika virus." So, the statement above about no pregnant women in the US testing positive for Zika is no longer true.
DeleteI'm just so thankful I'm beyond having children because this would worry ,e constantly while I was pregnant or trying to conceive.
Thanks for the great information. I enjoyed reading your post.
DeleteIn the lab game I chose to play the role of Elizabeth, the new research integrity officer. Let’s just say, I would not be very qualified to perform her job as I failed miserably on nearly every decision. It was eye-opening though, I did not realize a position such as hers exists. While it would be a very challenging job, I feel like it is also a very necessary one.
ReplyDeleteThe Zika Virus scenario is a very tough one for me. I personally would be extremely hesitant to partake in this study nor would I suggest it to anyone due to the possible outcomes that could be associated with or without treatment. If I was to pretend I am an IRB member reviewing this research study, I would have many questions and concerns. My first question would be, will the possible benefits to receiving this experimental treatment outweigh the possible risks? The authors of Research in Developing “Countries: Taking Benefit Seriously suggests that researchers will not conduct research unless it can be shown that a direct benefit will be bestowed on the participants and their country. I agree with this statement, so in the case of Ziki Virus treatment trials in Brazil on pregnant women, I would require a sufficient plan be in place from the researchers. The plan should include proper funding, interventions, and supporting evidence of the benefits. (DeGrazia, Mappes, Brand-Ballard, 2011, pg. 281)
My next question would be, are the participants of the study being coerced or pressured to participate due to their current condition? The essay written by Baruch Brody titled Ethical Issues in Clinical Trials in Developing Countries brings up a similar situation in relation to the Ziki virus and HIV during pregnancy. Brody states that critics argue, “The very desperation of women with no alternatives to protect their children from HIV infection can be extremely coercive”. (DeGrazia, Mappes, Brand-Ballard, 2011, pg. 286) As an IRB member, I would be very careful to examine the terms and conditions of the agreement between the researches and participants, paying close attention to the participants understanding of what is being offered and their knowledge of the risks involved. Lastly I would want to ensure that the treatment if proven safe and effective would be made available to these participants in order to avoid exploitation of the subjects.
DeGrazia, D., Mappes, T. A., & Brand-Ballard, J. (2011). Biomedical ethics. New York: McGraw-Hill Higher Education.
I played the game a few times, first playing the PI and next the grad student, and finally the RIO. I did surprisingly well. I'm not sure if its because I loved watching CSI: Las Vegas back in the day or if it is because of my background as a charge nurse. I feel like some days the charge nurse juggles many things on the unit, just as the PI does.
DeleteWhen I played the game as the PI I was shocked that one of the main things you need for that postion is to be a good leader and manager of people. Although you still need expertise in research and science.
DeleteThe position of the grad student would be very hard. You are trying to obtain your degree while working with your teachers and superiors. It would take a lot of courage to come forward and risk all the time and work you had done. Even in the lab game, she could not protect Kim who eventually left the university.
DeleteResearch Ethics:
ReplyDeleteA few things that are known about the Zika virus: Symptoms are fever, rash, joint pain, and red eyes. About 1 in 5 people infected become ill. Symptoms are mild and lasts several days to a week. Those infected rarely die and once infected - likely protected from a future infection of the same virus. Transmission is through the bite of a mosquito to a person. A mother can pass it to her unborn fetus. Zika affects pregnancy. No reports of infants getting Zika through breastfeeding. Steps to prevent getting Zika: avoid getting bit by mosquitoes. Use insect repellent, long sleeves, mosquito net if outside. It has been found the virus can stay present in semen longer than blood. Use condoms, or abstain from sex. Areas with Zika: Africa, South East Asia, Pacific Islands, and most recently Brazil. There are no local mosquito borne Zika virus cases in the US., but there are travel related cases. The out break in Brazil has revealed the most alarming link. The CDC reports "Some babies with microcephaley have been reported among mothers who were infected with Zika virus while pregnant. Researchers are studying the possible link between Zika virus infection and microcephaley".
When I played the game 'The Lab', I was the character of Beth, the Research Integrity Officer. As a member of the Thomas More IRB and in charge of the integrity of the research being conducted entitled 'Zika Treatment Trials on Pregnant Women in Brazil', I am most concerned whether the risks imposed on the participants would actually be offset by any real benefits. Guidelines published by the council for International Organizations of Medical Sciences argue that to justify the researchers in wealthy countries enrolling citizens of developing countries in clinical trials, the benefits must out weigh the risks. If this doesn't happen, then it is considered an exploitation. A pregnant woman who has the virus may be willing to undergo treatment, although experimental, to possibly prevent her baby from being born with microcephaley. The treatment may impose even greater risks of unknown proportion. This type of trial would be unethical at this point, because there still is not enough known about the implications of the virus in the various stages of a woman's pregnancy.
http://www.cdc.gov/zika/
DeGrazia, D., Mappes, T. A., & Brand-Ballard, J. (2011). Biomedical ethics. New York: McGraw-Hill Higher Education. (p 278).
I also played the RIO in the Lab Game. I found it entertaining although I failed miserably. Her job would definitely be a challenging one to say the least!
DeleteI really think not enough is known about this virus and pregnancy to begin a trial of treatment. I know there is a possible link between it and microcephaly, but it has not been proven. One of the best things we may be able to do to as a primary phase of prevention is to help supply these women with bug spray containing deet, teach them to eliminate areas where mosquitoes may breed and overall educate them the best we can.
DeleteThat is the role I assumed. I agree our role is to monitor the integrity of the research and follow up on any accusations that are made. That is were our role would end. The other team members would make decisions according to their theories and hypothesis.
DeleteZika research- As a labor and delivery nurse I have been following this case closely. Anytime an outbreak of a virus that has possible detrimental effects on pregnant women is issued, the hairs on my neck raise. I must admit I had never even heard about this disease. I have never traveled to any of the countries that this virus is affecting. Although the disease is not fatal to healthy patients, it may cause microcephaly of the newborn should a pregnant woman contract the disease. So far there are no reported cases in the Northern Kentucky area, but we are preparing for it, just like we did for potential Ebola cases.
ReplyDeleteZika virus disease is caused by a virus transmitted by Aedes mosquitoes. People with Zika virus disease usually have symptoms that can include mild fever, skin rashes, conjunctivitis, muscle and joint pain, malaise or headache. These symptoms normally last for 2-7 days. There is no specific treatment or vaccine currently available. The best form of prevention is protection against mosquito bites (WHO, 2016).
In January 2016, the U.S. Centers for Disease Control and Prevention (CDC) issued travel guidance on affected countries, including the use of enhanced precautions, and guidelines for pregnant women including considering postponing travel. Other governments or health agencies soon issued similar travel warnings, while Colombia, the Dominican Republic, Ecuador, El Salvador, and Jamaica advised women to postpone getting pregnant until more is known about the risks (Wikipedia, 2016). All countries should be recommending practicing safe sex with anyone in any of these areas that are infected.
If Thomas More College decided to research a Zika treatment on pregnant mothers in Brazil, it would first need to present a research proposal the Thomas More Colleges Institutional Review Board (IRB). Special regulations govern the participation of pregnant women in research. They are considered a vulnerable population and must be handled very carefully. Research involving women who are or may become pregnant receives special attention from IRBs because of women's additional health concerns during pregnancy and because of the need to avoid unnecessary risk to the fetus. Further, in the case of a pregnant woman, IRBs must determine when the informed consent of the father to the research is required. Special attention is justified because of the involvement of a third party (the fetus) who may be affected but cannot give consent and because of the need to prevent harm or injury to future members of society (U.S. dept. of health and human services, 1993).
Once a thorough assessment has been made and permission granted to do the research, the next big step takes place of assembling a research team to go to Brazil. During the Lab game one important theme that I noticed was how the PI was like a charge nurse. He not only plays a traffic controller, directing people and research, but he deals with social drama, legal drama, and the science of the whole thing. One wrong decision can have legal and ethical problems. Dealing with pregnant women will had a whole other level of complication. In the Declaration of Helsinki, it states that “In any medical study, every patient, including those of a control group, if any, should be assured of the best proven diagnostic and therapeutic method” (Brand-Ballard, pg 285). The PI will have to make sure that they have a rigorous experiment but provide that best treatment possible to all the women in this developing countries since they may have no other alternatives.
DeleteBrand-Ballard, J., Degrazia, D., Mappes, T. (2011). Biomedical Ethics 7th ed. pg. 285. New York, NY. MCGraw Hill.
Institutional review board guidelines. (1993). United States department of health and human services. Chapter IV, special classes of subjects. Retrieved from http://www.hhs.gov/ohrp/archive/irb/irb_chapter6.htm
World health organization. (February, 2016). Zika virus. Retrieved from http://www.who.int/mediacentre/factsheets/zika/en/
Zika virus. (2016, February 24). In Wikipedia, The Free Encyclopedia. Retrieved February 24, 2016, from https://en.wikipedia.org/w/index.php?
title=Zika_virus&oldid=706721233
I hope we do not see this virus in Northern Kentucky! I think it's wonderful that we are familiarizing ourselves with it so that we are prepared if we do see an outbreak, but it is so terrifying to think about for our patient's.
DeleteAccording to the reports, it's inevitable, it will hit NKY in the warm months. I know the news makes it sound like if you get Zika, your baby is going to have microencephalopathy without a doubt. They are still iffy on the statistics of will it or won't it and exactly how many, was it definitely Zika, or was it the pesticide in the water? It's not worth risking... I do know that if I was in my first two trimesters or planning to have a baby, I would bathe in DEET and wear a beekeeper suit.
DeleteAlthough I think Zika could be really bad for our area. I do want to remind everyone that they said ebola, swine flu, Mad cow, sars, and bird flu was going to cause an epidemic and yet we are still here.
DeleteI agree with you Alex, I really don't have much to say since everyone pretty much has that covered about the Zika virus. I played the game as well as the Research Officer Beth, I think my choices for the most part give of take one or two that I probably could have picked the better choice. She definitely showed independence in this role.
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DeleteExactly, Alex! That's actually a question I was going to propose here. How much of this is accurate medical crisis/ pandemic to truly be afraid of, and how much is hype?
DeleteThere’s an idiom that was the focus of a 1997 movie: “Wag the dog”. The meaning of “wag the dog” is to purposely divert attention from something important to something less important by making that item of lesser importance the media spotlight: usually with falsified information of different degrees. This steals attention from the more important, often controversial, issue. In the movie, it was election time and a candidate was amidst personal scandal. To divert attention from this scandal, they fabricated a war in Albania to divert media attention.
There’s so many unknown and unproven facts in this pandemic. There are hypotheses, but it’s too early; there are too many variables and unknown values, to make accurate conclusions. That leads me to question the validity of what we are being told. Is it as bad as they say, or are they just wagging the dog? Another possibility, is there the chance they’ve left all their virtues and all their moral ethics behind to cover up other possibilities? Based upon other readings I’ve encountered there could be a few other very viable contributing factors to this outbreak of microencephalopathy, one a mess-up that helped to spread Zika, and two others just plain cover-ups for mistakes.
One possibility I’ve read several articles on (some of those from valid sites), is that Zika was spread by using genetically mutated mosquitoes that were meant to reduce the incidence of dengue fever. Starting in July 2012, continuing into 2015, these genetically modified mosquitoes were released in Brazil. The company that manufactured the mosquitos added a genetic alteration to make the offspring mosquitoes released die before they matured. However, to do so, tetracycline could not be present. Interestingly enough, the food they fed the larvae had chicken that was raised with tetracycline. “Dr. Ricarda Steinbrecher published concerns in a report from September of 2010 that a known survival rate of 3-4 percent warranted further study before the release of the GM insects. Her concerns, which were echoed by several other scientists both at the time and since, appear to have been ignored — though they should not have been. She added, ‘the effectiveness of the system also depends on the [genetically-designed] late onset of the lethality. If the time of onset is altered due to environmental conditions … then a 3-4% [survival rate] represents a much bigger problem…’” WHO even confirmed mosquito populations soaring during that time due to El Nino (www.WHO.int). The mosquitoes were found to not “die off” as they were supposed to, and a sub-population of the genetically- modified Aedes mosquitoes were feared to have actually developed and flourished. Incidentally, this same time is when the reports of Zika and its birth defect rates started soaring.
Pandemics also call for big business opportunities for drug manufacturers. Incidentally, President Obama called for a massive research effort to develop a vaccine for the Zika virus. It might also lead to the call for expensive, money-making research, perhaps like that cited on January 19, by the MIT Technology Review: “An outbreak in the Western Hemisphere could give countries including the United States new reasons to try wiping out mosquitoes with genetic engineering” (www.technologyreview.com). Yesterday, the Brazilian city of Piracicaba said it would expand the use of genetically modified mosquitoes to try to wipe out the mosquitoes that could carry Zika. Was this Zika outbreak caused by genetic engineering? Was it an accident as government officials and scientists tried to control outbreak of another illness, or was it engineered to create revenue? Is it just a wag the dog to draw media attention from elsewhere?
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DeleteThere has also been raised the question of the pesticides used in Brazil being responsible for the increased microencephalopathy. Instead of the government taking responsibility, they have blamed it on Zika to cover-up.
While the conspiracy theories seem extreme, the fact is we do not know what goes on at government levels. We would like to think there is no way public officials would be lacking of morals, virtues and ethics to this degree. However, the Flint Water Crisis has proven that some conspiracy theories are indeed true, and that government officials do lack all those at times, and they are motivated financially despite the citizen’s health or knowledge.
When I played the game I chose the role of the Research Integrity Officer Beth. I like the administrated role she played. I did well on the choices I chose. It is a role were you have to be independent and bold. If not, those you were investigating would try lying and even bullying you. Having to enforce policy , for example, when the accused wanted a day to produce his data, and you had him with your team do it at that time. He was angry but she did not back down to him or the administration.
ReplyDeleteThe Zika virus, and all the information being gathered, would be a daunting task for a RIO. You would have a large group of researchers producing material that would have to be verified before publishing the results. Going through a few of the web sites relating to the Zika virus, they all seem to make the same statements about the virus. How it is spread and were it is affecting the population. What pregnant women should be doing to protect themselves and the babies. Even to abstain from being pregnant until they know more. The research seems to be now focusing on the newborns with microcephaly. Your job would be to monitor and investigate if anyone makes an allegation against someones work being altered of verified. As the RIO I would think working with such groups as the CDC with their reputation would be hard if an allegation did arise. From the video and the practice lab it would not be my responsibility to choose the experiments or what they are researching. My job is to make sure the data that is presented is correct and true. To protect anyone who has made the allegations from workplace violence.
http://www.cdc.gov/zika/
I think he fact that the summer Olympics are scheduled for Rio this summer is very interesting. I am anxious to see what they feel is warranted to make the Olympic games "safe" for those attending.
ReplyDeletethanks for all the information, may be useful for others. Do not forget to keep the spirit. http://kestip.blogspot.com/2016/02/obat-pereda-nyeri-persendian.html
ReplyDeleteWhen I played the game, I chose to play the Research Integrity Officer. As the investigator of claims, I often felt for the person who truly holds these positions. It was difficult, sometimes, to know when someone was trying to cover up an issue or trying to focus blame on another. As a RIO with the Zika Virus investigation, I would work closely with the government agencies to try and base all the findings on fact and not allow my personal feelings or experiences cloud the work at hand. The CDC arrived in Brazil in February to start the investigation of the outbreak. They will be investigating the significant increase in microcephaly since Zika started spreading in Brazil. However, the virus has only been found in a small number of brains of babies born with michrocephaly. As a RIO, I would work with the CDC to help investigate the mothers that gave birth since the outbreak of Zika began. My job would be to make sure their is integrity with the samples collected, the research collected and the data submitted. We would make sure there are no other factors that the women have been exposed to. I will make sure my team is protected and that no one is being harmed or coerced while conducting the research under my watch.
ReplyDeletehttp://www.npr.org/sections/goatsandsoda/2016/02/22/467374133/cdc-arrives-in-brazil-to-investigate-zika-outbreak
This was a difficult game to play and I didn't always chose the correct answer. :(
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