- Common Types of Research Involving Human Specimens
- Prospective vs. Retrospective Collection of Specimens
- Consent Topics
Common Types of Research Involving Human Specimens
Because the federal definition of human subject extends to people who are sources of biological specimens and identifiable private information, research with these materials often requires review and approval by the IRB. The level of IRB review and oversight is based on the level of risk the study poses. Specimen research risks potentially include one or both of the following:
- The risk of harm from procedures used to obtain specimens, and/or
- The risk associated with the loss of privacy and confidentiality due to personally identifiable information that may be associated with specimens.
Some of the most common types of research involving human specimens are summarized in the tables below.
Other Considerations:
- NIH Genomic Data Sharing (GDS) Policy and the Genome-Wide Association Studies (GWAS): The NIH has strict standards for the data that it will accept. Review our guidance if you plan to submit data and/or specimens to the NIH.
- Collecting Specimens from Minors: Refer to the Children and Minors in Research page. There are also guidelines on Skin Biopsies in Children for the Purpose of Research.
- CLIA: Laboratories performing testing on human specimens and reporting patient-specific results must be certified under the provisions of the Clinical Laboratory Improvement Amendments of 1998 (CLIA).
Prospective vs. Retrospective Collection of Specimens
When specimens are obtained/collected may affect the level of review that is required for your study. If the research is not human subjects research, it does not matter whether or not the specimens existed or were collected before the study is proposed.
Consent forms used for studies proposing to collect specimens for research purposes and/or banking should include the following topics, as applicable.
Types of specimens that will be kept | Who will have access* to specimens and data (e.g. UCSF researchers only, other academic collaborators, industry sponsor) |
The name of the institution/department/laboratory where specimens will be housed (a basic description of the repository) | A description of the procedures for protecting the privacy of subjects and maintaining the confidentiality of data |
General descriptions of the types of research the specimens can be used for (e.g. cancer, diabetes, cardiovascular research) | Statement that specimens may be used in the development of tests, products, or discoveries that may have potential commercial value and that subjects will not be paid or receive money |
The duration of specimen retention | Instructions for donors to request destruction of remaining samples in the future |
Types of data or medical information will be collected with the specimens and for how long the information will be collected | If genetic testing will be performed, include information about the consequences of DNA typing |
* Based on current research trends, we strongly recommend including the genomic data sharing language in the consent form to allow future sharing, even if you don't anticipate it now. The existing consent templates include the GDS required language. If you develop your own verbiage, consult the NIH GDS consent checklist to document that all of the required elements are included.