In a recent development, the regulations for safeguarding individuals participating in research programs have been updated. 15 federal agencies along with U.S. Department of Health and Human Services have issued the final ruling on January 18 allowing the researchers to conduct studies on samples with the consent of the patients.
As provided in the final ruling, the people considering to participate in a study will be given the consent forms that will include a detailed explanation at the beginning of the document and all the information that is important for the subject. The explanation has to include the purpose of the study, the benefits and risks involved and the alternative treatments that the subject can take.
Further adding to the ruling, the consent will not be required if the samples are used for other studies. The researchers will be able to use the blood, DNA, cell, tumour samples and other biospecimens acquired for other medical procedures without written consent from the patient. This ruling also applies to those samples that don’t have any identifying information, such as subject’s name.
The ruling has been welcomed by the researchers and scientists as this will be saving them a lot of money and time. Earlier the researchers had to track down the patient each time a sample was to be used in research. While the process of tracking the people down costs much, finding the donors of unidentified donors takes a lot of time.
While many are supporting the new ruling, there are many who are opposing this. Sans the consent of the donor, there are chances that the samples can be used for unethical and commercial purposes. Debra Matthews from the Johns Hopkins University raises concern over the trust of the people over scientific communities. Taking permission from the donor is a big part of the trust between the two.
In order to protect the interests of the patients, a single central ethics committee will be set up to oversee the studies.