What is informed consent for biospecimen research?
Informed consent pursuant to the human subjects regulations at 45 CFR Part 46 Subpart A [72] is designed to present potential human research participants with sufficient information — including anticipated procedures, risks, and benefits — to make an informed decision about whether to participate in research studies.
What is a waiver of informed consent?
A waiver of informed consent completely waives the requirement to obtain informed consent. It is not practicable to conduct the research without the waiver or alteration. Whenever appropriate, participants will be provided with additional pertinent information after their participation.
Is blood a biospecimen?
A sample of material, such as urine, blood, tissue, cells, DNA, RNA, or protein, from humans, animals, or plants. Biospecimens may be used for a laboratory test or stored in a biorepository to be used for research.
What is biospecimen collection?
Biospecimens are collected from donors for patient monitoring, care, and research studies. They have helped many medical advances such as those for cancer, heart disease, and AIDs.
What is an identifiable biospecimen?
• “Identifiable biospecimen” (2018 Common Rule definition) meaning a biospecimen for. which the identity of the subject is or may readily be ascertained by the investigator. or associated with the biospecimen.
When can you apply for waiver of consent?
A waiver of consent requires a researcher to seek approval from an ethical review body in order to use a person’s personal information or personal health information without actually obtaining consent directly from the individual in order to use that information in a research project.
What is a biospecimen repository?
The Biospecimen Repository Core Facility (BRCF) plays a vital role to support translational research by its ethical collection, storage, annotation, and distribution of high quality biospecimens, such as frozen solid tumors of varying histology and bodily fluids (blood, urine, ascites fluids).
Is informed consent required for tissue research?
The Common Rule requires publicly funded researchers get informed consent for two kinds of work. But if biospecimens don’t have any identifying data with them, like a name, consent is not required. Hospitals and clinics are major sources of these nonidentified biospecimens.
