|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Regulations, Policies & Guidance|
|Research w/Vulnerable Populations|
|Research Using Human Specimens, Cell Lines or Data|
|Human Subjects Protections Training|
|NIH Inclusion Policies and Procedures|
|Frequently Asked Questions|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
|NIH Staff FAQs|
Last Revised: February 12, 2010
||Related NIH Staff FAQs|
Research is considered to involve human subjects when an investigator conducting research obtains (1) data through intervention or interaction with a living individual, or (2) identifiable private information about a living individual. (45 CFR 46) If your research meets this definition, indicate “Yes” for involvement of human subjects and include a protection of human subjects section in your application as per the supplemental instructions for preparing the human subjects section of the research plan.
NO. According to the definition of "human subject," research is only considered to involve human subjects if the data/samples are from living individuals. If the data or samples you propose to use in your research are not from living individuals, indicate “No” for the involvement of human subjects in your application. You may wish to make it clear in the Human Subjects section of your application that none of your data/samples are from living individuals and your research, therefore, does not involve human subjects.
Research that proposes the use of human cell lines available from the American Type Culture Collection or a similar repository is not considered human subjects research because the cells are publicly available and all of the information known about the cell lines (perhaps, including the donor) is also publicly available.
Research that proposes the use of established cells from a donor whose identity cannot be readily ascertained by the investigator is not considered to be human subjects research, either for example, because there are written policies and procedures prohibiting release of identifiers and/or an agreement specifying that identifying information will not be shared with the investigator.
Research with Primary cells: If you are taking blood or other cells from living individuals for research purposes in order to create a cell line, the research involves human subjects.
Studies using specimens/data from a repository/database are not human subjects research if a study meets one or more of these criteria:
Non-Research Repositories & Databases:
If specimens or data were originally collected for non-research purposes AND were submitted to the repository/database without any links to identifiable private data or information, it is a non-research repository/database.
Studies using specimens/data from non-research repositories or databases are not human subjects research.
Research Repositories & Databases:
If specimens or data were collected for research purposes it is a research repository. Collection of specimens/data, repository storage or data management and use of specimens or disclosure of data are all considered “research activities”.
Please also see the OHRP guidance document, “Issues to Consider in the Research Use of Stored Data or Tissues”.
We have found that investigators tend to use three separate definitions for “focus group:”
One Human Subjects code is assigned each application, for the entirety of the project period. The code assigned will be the most protective code appropriate. If one of the proposed subprojects involves human subjects, indicate “Yes” for human subjects and complete the Human Subjects section in your application as per the supplemental instructions for preparing human subjects section of the research plan.
The research described in your application may include more than one research activity. Each research activity should be assessed independently to determine whether it meets the requirements for human subjects research, exempt human subjects research, or research that does not involve human subjects. The involvement of human subjects in your application is determined by the greatest involvement of human subjects in any single research activity. Examples are provided below to help you determine whether your proposed research involves human subjects.
Human Subjects Research
If you are not sure whether human subjects will be involved, or if the eventual research design is dependent on preliminary studies described in your application, indicate “Yes” for human subjects. In the Human Subjects section of your application, provide a description of possible planned human subjects research. After you have enough information to more completely describe the human subjects research, submit both a protocol and a revised Human Subjects section (as per the supplemental instructions for preparing the human subjects section of the research plan) to your Program Official for approval.
This situation is specifically covered in sections 46.118 and 46.119 of the HHS regulations.
Research described by the six exemption categories in section 46.101(b) of 45 CFR 46 is considered human subjects research but is exempt from the requirement for IRB oversight of the research as described in 45 CFR 46. If you believe that the research described in your application is exempt, you should indicate “Yes” in Item 4, and include a Human Subjects section in your application as per the supplemental instructions for preparing the human subjects section of the research plan, describing the involvement of human subjects in the research and why you believe the research meets the criteria for an exemption.
Yes. Research that meets the criteria for Exemption 4 is Human Subjects Research.
Exemption 4 includes research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Please note: human subjects research that meets the criteria for Exemption 4 is not considered “clinical research” as defined by NIH; therefore, the NIH policies for addressing inclusion of women, minorities and children do not apply to research that is determined to meet the criteria for Exemption 4.