Many of you have shared with us your excitement about our plan to collect healthy breast tissue from Kenyan women, and have demonstrated by word and deed your willingness to assist and support our efforts. Unfortunately we are writing to inform you, with true and deep regret, that we have made a final decision to end the Kenya Project.
Acknowledging that there will be many questions about our choice, we will do our best to convey here the primary reasons:
- First and foremost, our protocol was not approved by the Kenyan Institutional Review Board (IREC). After answering several rounds of increasingly detailed questions about our study, we do not have a sense of optimism that even rewriting the protocol will yield any positive results.
- Idea of tissue banking is not perceived as research – the Kenyan authorities are more comfortable approving specific, defined projects.
- We encountered demonstrated discomfort with the idea of our data repository, particularly with respect to projects using Kenyan tissue.
- We possess a measurable concern for the long-term welfare of the participants
- There is a probable likelihood that we would find breast lumps in our donors.
- At this time, we find no viable solution to ensuring that further care would be available without prohibitive cost to a potential donor.
- We have identified several roadblocks to our collected samples being allowed to leave the country. With a new government recently elected in March, it is hard to predict how they will view requests to take samples out. Requests to ship biologic samples out of Kenya must be approved by a federal government agency, once regulatory approval is received. We feel that the probability of success in this endeavor is very low and we have no impact on the decision.
- More than half of the original grant funds have been spent. It is our overwhelming feeling that to spend the rest would not only yield underwhelming results; it would be an unwise use of resources which could be diverted toward other, more viable projects.
- As time progressed, and as we experienced two major postponements and growing certainty of more, we faced a probable reality that our desire to accomplish the Kenya Project is perhaps several years ahead of its time.
What lessons have we learned?
- Cultural differences and issues are a major concern, and can indeed be overwhelming.
- Any chance for approval on a future project would hinge upon identifying an actual project for use of the collected tissue, which would need to be included in a completely re-written protocol.
- Our American-style parallel task process was not the correct strategy for tackling this project. We should have used a more consecutive task completion approach to obtain regulatory approval before making any additional plans for travel and sending materials and equipment to Kenya.
- Inter-country travel between Kenya and the US was extremely beneficial during this process. Two groups of Kenyans traveled to the US to learn about the Komen Tissue Bank (lab staff including Dr. Emonyi, Dr. Buziba and Dr. Kirtika Patel in September 2012 and physicians, Dr. Busakhala and Dr. Lugaria to observe a Komen Tissue Bank collection event in November 2012). The KTB staff also traveled to Kenya in January 2013 on a site visit. This travel tremendously helped facilitate the progress that was made on this project through November 2013.
- Kenyan women are thirsty for knowledge about breast cancer. They know breast cancer has been occurring more often in their community, they are fearful about it and want to know more about prevention and a cure. They seem to be willing to provide their samples for research in an effort to find a cure.
- Shipping internationally is a complex and difficult process. We had invaluable help from a summer intern who navigated the entire process so effectively that our container, full of goods for this project, sailed through Kenyan customs, something that surely wouldn’t have been possible without the superior assistance we have had throughout this project.
- Our amazing colleagues, partners and volunteers have been unfailingly generous with their time, talent and treasure. We collected many donated items to send in the container to Kenya; everyone was willing to pitch in where needed to make this project a success.
- There may even be an academic paper written as a result of our experiences surrounding the cultivation and termination of this project.
Please understand that many painstaking – and painful – hours were spent assessing this complete situation; therefore, as stated in the opening of this letter, our decision is final. We cannot begin to express our gratitude for the supporters – both Kenyan and North American – who showed such belief in our cause; a belief which has been exhibited by everyone involved in trying to make this project a reality. We have not failed; rather, we have learned much about how to proceed another time, with another idea. That is, after all, what research is all about.