This was so informative! Although I was aware of the issue of informed consent I hadn't thought of the ethics AFTER the trial. You've really expanded my knowledge on this topic, thank you :)

How could anyone not like this? I don't understand

@isobel64

7 жыл бұрын

big pharma directors

@MrLawron2

7 жыл бұрын

Those are the evil people who often thinks that others are less human worthy of being guinea pigs

@paulwhybrow9367

7 жыл бұрын

There is a sad subsection of men who can't bear to see brilliant and intelligent women.

@dawncawthra3519

4 жыл бұрын

I agree

Thanks for expressing your views. I am a member of a University Institutional Review Board in the United States and there have not been a lot of reviews of proposals for research in developing countries or areas but I will remember what you have said when proposals for research partnered with those in developing countries are presented.

Boghuma Kabisen Titanji shares an informative and well-presented argument on the need to re-examine the informed consent process used in clinical trials, especially those involving participants from developing countries. I agree that informed consent in clinical trials should not only consist of participants freely volunteering for the study, but also that participants fully understand all the implications of the trial - the risks, benefits, and consequences of the treatment, how the data obtained from the trail will be used, and what happens after the trial has ended. In order for participants to fully understand, informed consent must be presented in a way that is culturally appropriate and addresses the individual needs of the patient. Failure to do so would violate the essential elements of informed consent. Informed consent is based on the patient’s right to their own autonomy - the ability to make decisions about their health and what happens to their body. The clinical trial that Tatanji discusses lacks a key component of informed consent, the patient’s full comprehension. When heed is not taken to ensure that patients fully understand what they have signed up for, patients are unable to make a fully informed decision. In addition, when involving populations that are vulnerable or illiterate, a subjective standard should be used that is specific to the patient’s needs. While the clinical trial that Titanji mentions brings up questions about the principle of informed consent, another ethical principle that could be called to question is the principle of justice. The principle of justice requires that individuals are treated fairly and equally. Carrying out research in developing countries risks violation of justice as performing trials in areas of widespread poverty and inadequate healthcare, like Sub-Saharan Africa, likely takes advantage of the disparities between developed countries and developing countries. Titanji mentions prime examples of how this occurs - participants are often illiterate, but willing to consent to receive any form of medical assistance and authorization of research studies are often easier due to lack of an ethical review board and lower ethical standards. I believe that research teams should strive to hold themselves to a higher ethical standard, especially when working with already vulnerable populations, to maximize the benefits for the participants while making sure to adhere to fundamental ethical principles such as informed consent and justice.

@naazfathima2896

Жыл бұрын

Thank you for the information 🙏

You know this is also a problem in south asia, mainly in india. Please spread more knowledge. Nice talk thank you.

Well balanced Tedx Talk .... it reflects the character of Boghuma as well. Lot of respect.

Excelent perspective!

Excellent, Dr. Titanji

Thank you for this talk. It is crucial in these Covid-19 pandemic times. For some reason, this situation also reminds me of the film "The Constant Gardener" starring Ralph Fiennes and Rachel Weiss.

Very good speech. The standard of care is a very difficult issue as developing countries have very poor health cover.

If here in Germany clinical trials still very concerning and can cause many collateral effects then imagine when its conducted like that?

This was very powerful.

Firstly, thank you Dr. Titanji for such a wonderful, informative and persuasive speech. Thank you for providing insight into ethics of medical research and how it is exploited in developing countries. The fact that researchers are violating medical ethics and taking advantage of poor, illiterate people from developing countries infuriates me. There are a number of ethical principles that should be taken into account when performing any kind of research work and I want to talk about two of them here. In practice, these ethical principles mean that a researcher needs to: (a) obtain informed consent from potential research participants; (b) minimize the risk of harm to participants. By not providing participants proper, understandable information and gaining informed consent from participants, researchers are violating their first ethical principle and also neglecting the participant's right to information. Just because the participant is illiterate and doesn't understands the heavy words used in ICF, doesn't allow researchers escape from their ethical principle. If patients can not read, or don't understand the written ICF, then it should be explained to them, in the language or in the form they understand. Just because actually informing people is difficult doesn't mean that it should not be a priority. ICF should not be looked at as a technical burden, out of respect for other human beings. The research work here mentioned was a successful one. So, the research didn't have any hazardous effects in participant ─who didn't have proper knowledge about what they were involved in. However, if the research work failed, how are the researchers going to compensate for the degraded quality of life of their participants? In this sense, researchers are also violating the second ethical principle mentioned above. It's good that research works are being carried out and people are getting something that can save their life for the time being, something they can never afford. However, I think the researchers and government involved should focus on the aftermath. Since its cheaper to carry put research work in developing countries, the researchers should also be obligated to do something beneficial to the participants, as a act of beneficence, a concept in research ethics which states that researchers should have the welfare of the research participant .

@avinashkumar2320

5 жыл бұрын

yeah

As the video is a bit old I hope things has got better. I'm now going to search about this doctor, I'm her admirer now.

@IamGodSon

4 жыл бұрын

She now lives on the US, in Atlanta at Emory, and is a postdoc fellow in infectious diseases.

Thank you so much for this. I am particularly concerned about your conclusion. Our govt in developing nations has a great role to play by instituting a good review board to be effective. Because we are many does not mean we should be taken advantage of. the moral and ethical way of conducting a trial should be applied otherwise the data collected will not follow the tenets of GCP. Corrupt investigators and pharmaceutical industries must be sanctioned. Vulnerability due to a complete lack of health care system is the main issue. Informed consent must follow due diligence, they are playing on the illiteracy level of the population. In the recent amendment, it has partly taken care of what happens after the trials

This is a great video and totally makes sense. How is it fair that we provide someone that cannot read/write a written concent form to sign? That doesn't seem to make sense. Perhaps, allowing them to log onto a prog, via a provided tablet, that they can consent that they listened, PRIOR to the study, would be better? Just an idea of how to provide the rist/benefits to someone that is illiterate, all the while meeting ethics.

This was very interesting.... I wonder if her health deteriorated quickly since stopping the meds... I think the same is done in the US too though... NIH conducts trials and after they're over that's it.

Create a local agency that will recruit participants for the pharma corporations, inform participants and regulate the whole industry, DON'T EXPECT BIG CORPORATIONS TO BE HONEST AND GENEROUS, they are not, give them the opportunity to abuse people and they will.

Preach 👏👏👏👏👏👍

Thank you Dr. Titanji for this thought provoking discussion. I worked for several months in a U.S. facility that performed clinical trials and I can attest the regulations are vigorous and numerous. With so many regulations, it made trials extremely complicated and expensive. I can understand the allure of performing a trial in another country where there are less regulations to worry about would be appealing. But to do that at the expense of patients is clearly unethical. By extension, funding and benefitting from such trials is also unethical. As physicians, we should be asking the hard questions and demand trials be conducted in ethical ways. I spent a couple of weeks in Honduras a few years ago helping to provide needed orthopedic procedures for people who otherwise couldn’t have afforded treatment. I witnessed circumstances similar to those Dr. Titanji described in Africa. Many of the patients had been suffering for months and were willing to do pretty much anything to find relief. I can understand how people in such circumstances would consent to trials no matter the risk when the alternative is no care at all. It’s unconscionable to take advantage of people in a desperate situation like that. It’s also clearly unethical to treat patients during the trial, giving them a taste of improved health, and then suddenly withdrawing all treatment at the end of the trial. They’ve offered a great service for all humanity and deserve at least continued care. I think it’s easy to blame others for the problems Dr. Titanji described. But if we’re in a developed country and patronizing or supporting in any way the companies and institutions finding trials in undeveloped countries, then we’re contributing to the funding of unethical research. And if as physicians we’re using the knowledge gained from these trials, we’re perpetuating the problem. I’m not saying we should stop the trials or refuse to use the lessons learned from them, but I think it our ethical obligation to demand that these trials use ethical practices and treat participants with respect.

An institutional review review board (IRB) needs to established oversee the trial as per the trial protocol. The IRB will also implement post-trial provisions as per Declaration of Helsinki. Deep knowledge and understanding needed by the participants/one giving consent.

Why aren’t more people talking about the importance of ethics in medical and technological advancements??? I have many thoughts. But would love to hear more

I appreciate the topic of this talk. Although it is 10 years old, it is something that is very relevant to today’s times. Developing countries are easier to target for clinical trials such as HIV where the prevalence rates are high and more people are willing to participate due to the lack of medical care available to them. Although, “Informed consent” is something we have in place and was used even in Celine’s case but as mentioned in the video, it is important to include in the consent form the plans after the research is over. There must be a standard of care set in place for the participants so that they can continue to get treatment for their illnesses after the trial ends. In the case of Celine, she was even unaware of the name of the drugs being given to her, and after the trial ended she had no way of excessing the drug. This I believe is a form of exploitation. To conform to the idea of non-maleficence, the participants should continue to have access to medical care that benefits them to prevent any health deterioration. These future plans after the study also need to be discussed with the participants in the language they understand, before they begin the trial so they can fully understand and make an informed decision.

Great mam ☺

Where was the ethical problem again? Some mechanics of the search for treatment can't be explained because they can't be understood, and if no direct harm comes to the subject because of the testing, there really is no issue, right?

These medical trials that leave the participants uninformed and left in despair truly is ethically and morally wrong. Medical researchers should be looking for ways to help and treat all people and not bury the ones that are desperate to be their "guinea pigs" and risk themselves for their trial and error. Also not fully informing the participants what their role in the trial is, in a way tricks the participants to agree to the terms and conditions that eventually leave them in the same or worse position than before. Deceiving for research testing is actually working against the moral goal of the medical researchers to help people. This is why there should be a global organization like the FDA in America to protect the participants in these trials from these types of situations and to limit the medical researcher's power.

@jay130

2 жыл бұрын

Hi, your comment is the best thing i have read in a while, i have personally been through this and feel exactly like you describe. Can I contact you personally to further elaborate?

In this presentation Boghuma Kabisen Titanji presents the topic of HIV treatment trials and the ethical challenges that are involved when the research is being competed in resource poor nations, specifically Sub-Saharan Africa. Titanji presents four areas to focus on the improvement of these trials and the outcomes for the participants: Informed Consent, Standard of Care, Ethical Review and Continued Assess to investigational treatments. The first area of informed consent, in my opinion, is the most important of the areas of improvement, although not simple. Informed consent is the cornerstone of ethical conduct of research and clinical trials. Informed consent is multifaceted; it relies on the competence and voluntariness of the participant, the quality of the disclosure and recommendations of the information of the study, and finally the understanding of the participant of the information given to them. Without proper evaluation of all of these variables the ethics of the final authorization is may be invalid. I feel that if researchers focus on the quality of disclosure and the understanding of the participant they would be able to make the most progress towards ethically acceptable research. I believe that the other three focuses are necessary and important, but without thorough and culturally relevant informed consent any and all trials are morally unacceptable. If the informed consent fully addresses the standard of care used and the continued access that may or may not be provided once the trial ends, and is presented in a way that is fully understandable to the research subject, then those areas of improvement are less relevant. The acceptability of the trial is then in the hands of the research subject and not subject to the cultural biases of the researchers or organizations backing the trials. The responsibility of overseeing the implementation of proper informed consent is the responsibly of the local governments, and if they are not capable of effective ethical review it is in the best interest of their citizens to not allow clinical trial in their countries. I believe that while ethics are important for researchers and clinicians, it is not solely their responsibility.

@taichitalks2414

4 жыл бұрын

Developing a new drug is expensive. The fiduciary responsibilities of the pharmaceutical companies prevent them to invest too much on the clinical trials, from which they could glean information, and develop new drugs thereafter. Spending money on those things she mentioned, such as creating a version of info for the participants in a culturally acceptable way, would inevitably skyrocket the cost of developing the drug, and thus disincentive those companies to do so in the future, which would foreseeably slows down the developing process of drugs, if not resulting in the total abandonment of the entire project. Given those reasons, I dissent. I would mention, however, that it is absolutely moral to provide those amenities and follow-up supply for those participants whenever necessary. Yet, when two things can not be achieved simultaneously, we would have to make a hard decision. These choices are painful, undoubtedly.

More relevant than ever with Covid now.

Developing a new drug is expensive. The fiduciary responsibilities of the pharmaceutical companies prevent them to invest too much on the clinical trials, from which they could glean information, and develop new drugs thereafter. Spending money on those things she mentioned, such as creating a version of info for the participants in a culturally acceptable way, would inevitably skyrocket the cost of developing the drug, and thus disincentive those companies to do so in the future, which would foreseeably slows down the developing process of drugs, if not resulting in the total abandonment of the entire project. Given those reasons, I dissent. I would mention, however, that it is absolutely moral to provide those amenities and follow-up supply for those participants whenever necessary. Yet, when two things can not be achieved simultaneously, we would have to make a hard decision. These choices are painful, undoubtedly.

That's my sister🙂

@prithvi6078

3 жыл бұрын

It's always good to have a family doctor.

Learning some of these things made me feel phsyically ill. What makes the individuals of developed countries any 'better' than those of developing countries?? People are people! And it's SO wrong to treat those in poorer countries with less respect and less care. Participants of clinical trials should all be given the same degree of care, and this includes firstly being informed of what exactly is going to ensue with the trial. Some people are more knowledgeable about medical procedures than others, and it's important to adhere to each patient individually, especially in a clinical trial. Also, why treat trial patients differently?; don't they all have the same disease? Isn't a successful outcome equally a hope for all participants? And in regards to what happens after the trial has concluded, how awful. The patient is essentially dumped. Dumped back into life with no resources of any kind; at that point, they're just a collection of biological data to researchers, not people. I'm honestly appaled at how poorly these people, who are clearly already suffering, get treated in clinical trials. Researchers need to have a PLAN!

@debbiecarter2

2 жыл бұрын

Well, 4 years later, I guess you understand that these experiments are not being done on just poor countries. It was just more obvious and not as well hidden. They have been testing on humans in general. They've done it in America since the 1920's if not before. They still do. They just pretend we make ourselves sick. Then our insurance may or may not pay to help with our medical care for what our government has done to us. Many have no insurance and many have to pay out of pocket or die. Most don't even realize that it's our own government in conjunction with WHO and the CDC killing us. And people like Gates and Fauci. They have used us for health experiments and psychological experiments for so long that we have forgotten what it's like to be natural human beings.

They make Test like with animals

Who do that's? Ooouh so 😔

Very beautifully but mostly utopia. If things were done the way she wants pharmaceutic companies move elswere and take their money with them. Governments of developing countries know that therefore permit them to do that they want, as long as they bring money in.

@ailecdreifuss8627

Жыл бұрын

No, is not an utopia. What could be more difficult to obatain is the provision of the after trial medication, which can be negotiated .

I’m glad I got Vaxxed

This is dystrpoian