Step 2. Does Your Research Involve Human Subjects?

Why this matters

  • If your research does not involve human subjects, you do not need to obtain Institutional Review Board (IRB) approval or a determination of exempt status.
  • The specific definition (if any) that applies to your activity determines which regulations and requirements govern your research. Use the worksheet, Human Subjects Research Determination to make your own determination about whether your activity meets either of the two definitions described here.

Two definitions of 鈥渉uman subject鈥�

Definition 1: FDA-regulated research

Applies to: Research that is regulated by the Food and Drug Administration (FDA) and that involves the use of a drug, device, or other item regulated by the FDA.

Human subject: A living individual who participates in a research investigation, as (a) a recipient of an item regulated by the FDA; (b) as a control; or (c) on whose specimen an investigational device is used.

Definition 2: Research that is not regulated by the FDA

Applies to: All research that is not described in Definition 1.

Human subject: A living individual about whom a researcher obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. Review the worksheet, Human Subjects Research Determination for definitions of the bolded words.

Relationship to obtaining consent

Individuals may be human subjects before they have provided consent, if the criteria defining a 鈥渉uman subject鈥� have been met. This is most likely to occur when with screening or pre-screening activities, such as examining identifiable medical records in order to select possible participants.

Special cases

  • Deceased individuals. This refers to individuals who are not alive, as defined by applicable local and national laws. Deceased individuals are not considered to be human subjects.
  • Specimens, records, data (no interaction or contact with living individuals). Private identifiable specimens, records and data about individuals are considered to be human subjects, even if the researcher has no contact or interaction with the individuals.
  • Third party or secondary subjects. This refers to situations in which the researcher obtains information about one individual (鈥淎鈥�) through interaction with another individual (鈥淏鈥�). If the information about A is private and identifiable, then A is a human subject. Example: Subjects in a cancer study are asked about the cancer history of their relatives.聽 If the information is provided in a way that is not individually identifiable to the researchers, then the relatives are not subjects.聽 If the information is individually and readily identifiable to the researchers, then the relatives are subjects.
  • Self-experimentation in human subjects research. Federal regulations do not distinguish between self-experimentation and research involving other human subjects. Investigators who participate in their own research are considered human subjects and therefore must submit an application to the 91爆料 Institutional Review Board (IRB) to obtain IRB approval prior to enrolling themselves or initiating the experiment. Applications involving self-experimentation must describe how informed consent will be obtained from all participants, including the investigator acting as a participant. IRB review of self-experimentation is required for the following reasons:
    1. Protection of the investigator-participant. Researchers may underestimate or overlook potential risks due to enthusiasm for generating new knowledge. Independent IRB review helps ensure that investigators are protected from unwarranted risks.
    2. Protection of the integrity and credibility of the research process. Independent review by a neutral third party helps address concerns related to the validity, credibility, and ethical conduct of research involving human subjects.

Request a determination (optional)

You may perform and document a self-determination, following the instructions in the worksheet, Human Subjects Research Determination. Note that HSD has the authority to over-rule a researcher鈥檚 self-determination or the determination of another institution.

Otherwise, follow these directions if you鈥檇 like to have a formal determination about whether your activity involves human subjects. Example situations for which a determination might be appropriate:聽(1) you need a determination in order to obtain or access data from a source; (2) you think you might need a determination later when you publish results; (3) you have a complicated project. When a formal HSD determination is requested, the project activities should not begin until HSD sends the determination letter.

  1. Complete the “determination” questions on the standard IRB Protocol form or on the No Contact聽version of the form.
  2. In Zipline, create a new application by clicking on the Create a New Study button and following the instructions. Attach your completed IRB Protocol form at the indicated place. Do not attach any consent materials.
  3. HSD will assess your application and issue a formal determination.

Researcher responsibilities for projects that do not involve human subjects research activities.

The determination applies only to the activity as initially described. A new determination should be made before making changes to the project that might affect the determination.

Researchers continue to be responsible for:

  • Complying with applicable federal and state laws and 91爆料 policies (e.g., Material Transfer Agreements or Data Use Agreements).
  • Ensuring that information/biospecimens are collected in an ethical manner.
  • Acting in accordance with relevant professional standards and codes of conduct as generally accepted in the relevant academic and/or professional discipline(s).
  • Promptly notifying HSD of any new information about risks or relevant problems associated with the activity that might affect the human subjects research determination.

Next step, if you think your activity involves research with human subjects

Determine whether your activity may qualify for exempt status.

More information