As researchers are frantically looking for a COVID-19 vaccine and other treatments, safety, and health ethical issues of patients must be highly considered. Some ethical issues, like the anonymity of patients, must be handled with proper attention so as not to affect the esteem of any individual. As a researcher, before using any patient in your clinical trials, you must first obtain written consent from them. You may risk your job in acquiring the biospecimen from patients if you do not seek permission from them.
Also, you should familiarize yourself with your country’s legal and ethical laws regarding human subjects. For instance, several states have different bodies that give consent to research involving human subjects. However, it is always essential to remain professional and uphold high standards in every discipline that you are involved in.
Types of Specimen Researchers Collect
Potential samples that you may receive are excess materials from a process that your subject is already undertaking. In several countries, for you to obtain human biospecimen, you first need to get the donor’s consent. The remaining samples after the test have been conducted are not recollected for research again. However, other regulations that govern the re-use of these samples in a study must also be adhered to.
In the U.S., samples from corpses are not considered as human research; hence they can be exempted from the ethical issues regarding human subjects. In Europe, the samples from post-mortems are regarded as gifts, and if you have to use them in research, the ethical issues regarding human specimen must be strictly followed. In the UK, using samples from the deceased will require you as a researcher to seek informed consent from their next of kin and the samples to be used must also be stored at the Human Tissue Authority licensed headquarters.
Quality of Samples
Initially, biobanks were used as storage of the specimen for in-house studies. Since most of the researchers are putting their focus on personalized medicine, researchers require high-quality informatics specimen. Due to the differences in the specimen collection and storage methods, various researchers are focusing on standards to ensure they have quality and reliable samples.
Organizations, such as the International Society for Biological and Environmental Repositories, were established to focus on harmonizing and identifying quality standards. The body also ensures the researchers are well informed on the ethical issues and innovation by offering them some education.
Quantity of Samples
All research requires a large number of samples. Furthermore, the quantity should not affect their quality. The samples should also be of different varieties that match the situation under study. Besides, researchers also need to use demographics and clinical information to help support their research. The reliability of information obtained from human samples will depend on the consistency and quality to be analyzed.
Established biomedical companies like DarioHealth Corp. (NASDAQ: DRIO) have mastered all the research standards applicable in the U.S., and startups in this space need to borrow a leaf from these companies if they are to stay out of trouble.
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