From Tuskegee to Transparency: An Evolution in the Ethics and Accountability of Clinical Trials Involving Human Subjects

via RH Reality Check, by Anna Forbes and Kate Ryan

People who participate in clinical trials take the enormous step of volunteering to test a product that may be useful and, sometimes, life-saving if it turns out to be effective. They play an irreplaceable role in research to prevent, treat, and sometimes cure illness – as well as to find other ways to improve people’s health and lives.

Trial participants make a profoundly personal contribution and accept potential medical, social, and personal risks on behalf of others. An ethical trial is one that eliminates or minimizes participants’ risks as much as possible, invests in making sure that participants understand clearly what they are volunteering for, and protects their rights at every step.

For example, without clinical trials, we would not have seen recent advances in antiretroviral drugs to treat HIV, long-acting contraceptive choices that allow women greater control over their use, or microbicides that may be able to protect women from HIV.

The United States government has rules to protect people who participate in federally-funded biomedical and behavioral research. The rules vary depending on which agency is supporting the research, but they all share a starting point known as the Common Rule, a set of regulations for all federally-funded research involving human participants, whether it is conducted inside or outside the U.S.

But those rules have not always been in place, and there are some shameful chapters in the history of medical research supported by the United States that include violations of the most basic standards of ethical behavior.  This history has left some people deeply suspicious of clinical trials and the motives of those who conduct them. Many explain their suspicion with one word: “Tuskegee.”

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Mapping Pathways at the CDC's National HIV Prevention Conference

via AIDS United (a Mapping Pathways partner), by Jessica Terlikowski

Clinical trial results over the last year have demonstrated that new prevention approaches such as ARV-based microbicides, pre-exposure prophylaxis (PrEP), and expanded treatment of people living with HIV can significantly reduce a person’s risk of contracting or transmitting HIV. The findings give the HIV community new hope, but also raise new and critical questions of how, if, where, when, and to whom these new strategies will be made available.

To ensure sound decisions that best address the epidemic, being careful to preserve human rights and improve the health of those living with and at risk to HIV, AIDS United, AIDS Foundation of Chicago, Desmond Tutu HIV Foundation, and NAZ India are asking a number of questions regarding the multiple uses of ARVs for prevention. People living with HIV/AIDS (PLWHA), policymakers, government officials, advocates, clinicians, researchers, industry experts, and other stakeholders have important perspectives to share and must be at the table to discuss the complexities of these new strategies. This collective effort to create and support a research-driven, community-led global understanding of the emerging evidence around adoption of ARV-based prevention strategies is Mapping Pathways.

As part of this unique project, AIDS United and the AIDS Foundation of Chicago hosted a lively community input session at the National HIV Prevention Conference last week to learn what HIV prevention leaders think about implementing the diverse range of ARV-based prevention tools. The group generally agreed that we are in an exciting time, but also questioned how the HIV community and the U.S. government could even consider implementing a strategy that provides medications to HIV-negative people when tens of thousands of people with HIV in the U.S. cannot access the drugs they need to stay healthy. Various participants also noted that not all PLWHA are ready to start treatment. Some individuals expressed concern that the rights of PLWHA could be compromised in favor of the public’s health and stated that systems must be instituted to mitigate coercion and protect the rights of the individual. Advocates were equally concerned that interventions such as PrEP would only succeed in worsening HIV-related health disparities in the U.S. since the cost is so great, treatment access is already limited, and both state and federal governments continue to cut HIV programs. One advocate observed that the ARV-focused discussion has resulted in the marginalization of other bio-medical strategies including vaccines and non-ARV based microbicides.

We also asked participants to share their thoughts on the types of data, tools, and information they believe are needed to help answer the more complicated questions and better address the community’s concerns. Several suggestions were made, but common to all of them was a request that tools be simple, accessible, and useful for community stakeholders and decision makers, including:

• Simple factsheets explaining the various ARV strategies, how they work, and the outcomes of each of the clinical trials;
  
• An if-then tool to help stakeholders better understand the potential implications of trial results; and
  
• A voice of the community document that includes statements from diverse individuals explaining why access to a broad range of HIV preventions, including those that are ARV-based, are important.

AIDS United and its partners look forward to continuing these conversations with our stakeholders around the country. You can stay connected to Mapping Pathways and all the latest ARV-based prevention news through our blog, Facebook, and Twitter. We invite you to join the dialogue and contribute YOUR thoughts by taking the Mapping Pathways survey.




[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]