Human Subject Research FAQs

“Human subject” means a living individual about whom an investigator (whether professional or student) conducting research obtains

1. Data through intervention or interaction with the individual, or
2. Identifiable private information

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

(source: 45 CFR 46.102)

Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

(source: 45 CFR 46.102)

Projects that qualify for exempt approval include, but are not limited to, the following:

• research conducted in established or commonly accepted educational settings, involving normal educational practices.
• research involving educational tests, survey procedures, interview procedures, or observations of public behavior.
• research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens.
• taste and food quality evaluation and consumer acceptance studies.

Examples of projects that require an expedited or full IRB board approval, include, but are not limited to, the:

• Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture.
• Collection of data from voice, video, digital, or image recordings made for research purposes where the individual is identifiable.
• Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
• Prospective collection of biological specimens for research purposes by noninvasive means. Examples: hair and nail clippings in a nondisfiguring manner.

All researchers, including student researchers, engaged in human subjects research are required to complete the CITI training modules on either Social & Behavioral Research or Biomedical Research, depending on the study, prior to the commencement of the project. The Human Subjects Research committee will monitor completion of the training course for researchers with an approved application. 

You can link your CITI training records from a previous institution with Mines. Step by step instructions are available here: https://support.citiprogram.org/s/article/how-to-add-change-your-affiliated-institution-or-transfer-completions

Submit your application 4-6 weeks before approval is needed. The Human Subjects Research committee meets bi-weekly, this timeframe allows for any clarifications or modifications, and department chair approval.  

Don’t wait until you have a project pending to start the approval process – contact humansubjects@mines.edu at point in the process with questions!

Applications for Exemptions of Human Subjects Research are made through OneAegis, which can be accessed through the OneAegis app on my.mines.edu.

For assistance, please reference our User Guide. Contact humansubjects@mines.edu for any further assistance.

Only the minimum amount of data necessary to perform the research. If data does not need to be collected, it shouldn’t be. This should be reflected within your application or modification forms.

No. The data you collect can only be used for the approved purposes listed within your application or modification form. To use the data for other purposes requires submitting a modification through the approval process, and updating the research design and informed consent to reflect the changes. It should be transparent to participants how their data will be used.

Everyone. All Mines employees that handle student education records have the responsibility under FERPA to protect the privacy of those records. The Privacy Compliance Officer can assist employees with questions or concerns regarding FERPA-protected data (privacy@mines.edu).

FERPA limits the access and disclosure of student education records and gives students the right to control to whom and for what purpose those records may be disclosed. To use education records in your research project, student authorization must be obtained through the human subjects procedures and approval process (including consent to use such records).