Human Subjects Research

“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)

It depends. Publication or presentation is generally a benchmark of generalizable knowledge. However, activity involving human subjects that results in generalizable knowledge whether published or not may be considered research, depending on other factors. For guidance regarding whether your project is considered human subjects research, please contact Mines’ Human Subjects Research committee at humansubjects@mines.edu.

Some examples that do not qualify as human subjects research and do not require prior approval include the following:

• Surveys for evaluating the performance of faculty, staff, and students, or other studies for internal institutional use only. This does not meet the definition of “research.”
• Analysis of publicly available data. The de-identified data does not meet the definition of “human subjects.”
• Oral history of New Orleans jazz artists and memories of post-WWII era. This does not meet the definition of “research.”
• Video recording of interviews with alumni is created for viewing in the Admissions Office. This type of activity does not meet the definition of “research.” The creation of the videotape is not intended to prove a hypothesis, inform policy, or draw conclusions.

An FWA is an agreement between Mines and the United States Department of Health and Human Services (DHHS) where Mines assures that all of its activities related to human subjects research, regardless of the source of support, will comply with federal regulations concerning the protection of human subjects, including the ethical principles outlined in the Belmont Report  and the DHHS regulations 45 CFR Part 46. Mines’ FWA is 00006893.

An IRB is a federally-regulated committee charged with ensuring that research involving human subjects is ethical, equitable, and humane.  To this end, an IRB conducts both an initial review of a proposed research protocol as well as ongoing reviews of an approved research project.  During the initial review, an IRB will consider whether a proposed research protocol meets established criteria for minimizing risks to human subjects.  Based on this consideration, an IRB may approve or deny the protocol, or may alternatively condition approval upon certain changes to the protocol.

Mines is not registered with the Office of Human Research Protection (OHRP) for a full internal IRB. Under our current registration, Mines can only provide exempt approvals.

Research projects requiring an expedited approval or full IRB board approval must be sent to an IRB in good standing with OHRP. Mines currently has an agreement with the Colorado Multiple Institutional Review Board (COMIRB), based at CU-Anschutz.

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.

Research conducted in countries outside of the U.S. require approval from an external IRB. In addition to external IRB approval, there may be IRB protocols set by that country and are necessary to comply with and obtain, in addition to the Mines/COMIRB approvals.

Please email humansubjects@mines.edu with any questions.

As Department Head, you acknowledge that the proposed research meets the standards set by your department and assure that the principal investigator will meet all departmental and Mines requirements for review and approval of this research prior to initiation.

You are also responsible for reviewing the research design for sound research practices to reasonably achieve the desired outcomes for professional publication.

Maybe, if the following criteria are satisfied prior to Mines students being surveyed:

(1) The research has been reviewed and approved by an IRB (or equivalent) at the principal investigator’s home institution;
(2) The research project presents an identifiable benefit to our students and/or the university, and permitting the research activity on campus does not create an undue burden; and
(3) The Mines’ Human Subjects committee makes an independent determination that the research protocol provides adequate protection of Mines’ students.

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. 

• A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
• A description of any reasonably foreseeable risks or discomforts to the subjects;
• A description of any benefits to the subject or to others which may reasonably be expected from the research;
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be maintained;
• For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs, and if so, what they consist of, or where further information may be obtained;
• An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and to whom to contact in the event of a research-related injury to the subject; and
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the student is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Additional elements of informed consent are included within the regulations and can be included, as applicable. An informed consent template for exempt research is on the Resources page.

Subsection C of 45 CFR 46 states that if the information obtained “…is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects…” then an IRB must conduct a limited IRB review to make the determination that adequate provisions are in place to protect the privacy of subjects and maintain the confidentiality of data. Mines has contracted with COMIRB to perform these reviews for a fee.

Video recordings may not be used in exempt research unless you blur the participants’ faces, obscure any other identifiers, and maintain adequate protection of the privacy of subjects and confidentiality of the data/recordings. Participant’s explicit consent would still need to be obtained.

Yes. An additional consent form is needed when the recordings will be used in research. If audio is being recorded only for transcription purposes, often that can be included in the informed consent. Please contact humansubjects@mines.edu with questions on collecting audio recordings.

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.

Creating an Amendment in OneAegis

If there are any questions or requested clarifications/modifications from the HSR team or from the Department Head/Dean, you will be contacted. Otherwise, you will receive an approval letter within approximately three weeks of submission.

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.

Only those listed on the approved application or modification forms. Distributing data outside of these parameters may potentially violate a participant’s privacy rights and/or applicable regulations. If personal data is appropriately anonymized so an individual cannot be directly or indirectly identified, the data may be provided without violating a person’s privacy rights. If the data is not sufficiently anonymized, it could result in a data breach, which should be reported immediately.

Until no longer needed or upon expiration of the retention period outlined in the approved application and participant consent form.

Personal, sensitive data should be destroyed using confidential methods of disposal. Hard copy files should be shredded or disposed of using a third-party service. Electronic files should be removed from the electronic media. Assistance from CCIT should be sought to ensure all locations of temporary files have been removed, so the data is not recoverable.  Questions can be directed to Mines Help Center.

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).