Types of Biomedical Research
There are various considerations for different types of biomedical research. Each section below describes special considerations investigators may need to consider, depending on the type of research they are conducting and the various research procedures included in the protocol.
Guidance for Specific Types of Biomedical Research
Research Collecting Blood
IRB Review procedures for research involving blood sampling require careful assessment of sample collection methods and volume of collection. This assessment will inform whether the IRB may review a study via expedited mechanism as Minimal Risk or if convened review is required due to greater than minimal risk.
Research with Device Products
Research with device products is complicated and requires multiple-step considerations. FDA regulations may need to be applied in some cases.
Research with Drug Products
Any use of a drug product, except use of a marketed drug in the course of standard care, is an experiment. This is considered by the FDA to be a “clinical investigation.” This research requires consideration of FDA regulations.
A clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” Click to read more about associated requirements for clinical trials.
Certificates of Confidentiality
Certificates of Confidentiality allow the investigator and others who have access to research records to refuse to disclose identifying information about research participants in any civil, criminal, administrative, legislative, or other proceeding. Click for additional information.
NIH Data Sharing Policies
NIH expects researchers to broadly and responsibly share human data generated by NIH funds. This page describes associated IRB requirements related to the NIH Policy for Data Management and Sharing of scientific data generated from NIH funded research. Information is also presented on the NIH Genomic Data Sharing Policy and Institutional Certification processes.
Applicable State Laws in Research
Investigators are responsible for following federal, state, and local laws. This guidance describes PA and NJ state laws that may apply to different types of research.