Over the past couple of weeks, LAL Solace has been overwhelmed by numerous research organizations who are requesting information (interviews) from patients and caregivers from those who are affected with LAL D. I have received several requests from your organization requesting participation. One of the people from your organization could not even tell me who the sponsor of the study was.
It is an honor that these organizations are looking for ways to help our patient community. As always, we are looking for others to help us in reaching our tactical and strategic goals. We are currently unable to honor all of the requests that we have received over these past few weeks. If you are requesting to partner with LAL Solace in researching ways to improve our community, please ensure that you have a confidential disclosure agreement that details the information that is being requested and who will be allowed to access this information. In order to fulfill the ethical obligations to the participants and the research community, our organization would need to obtain a copy of this confidential disclosure agreement.
Does the sponsor have an institutional review board, an independent ethics committee, ethical review board or research ethics board? In the U.S., the FDA has empowered these committees to ensure that ethical standards are being complied with. Studies of personal or social behavior, opinions/attitudes, or studies of how health care is delivered and might be improved typically require approval from an IRB.
As a patient advocate, I am encouraged that there are several organizations that claim to be looking out for the best interest of these patients. I would be more than happy to speak with the sponsor of the study to see if we can work together to meet similar goals and objectives.
The FDA is in the process of conducting information similar to what most of your organizations are looking for. The FDA has also been reaching out to patients to participate in a patient advisory board to discuss how LAL D affects them as patients and/or caregivers. They have a rigorous application process to ensure that those selected do not have any potential conflicts of interest.
How is everything with you, I picked interest on you after going through your short profile and deemed it necessary to write you immediately. I have something very vital to disclose to you, but I found it difficult to express myself here, since it's a public site.Could you please get back to me on ( firstname.lastname@example.org ) for the full details. Have a nice day Thanks God bless.
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