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)

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.

Humans subject research can begin when the principal investigator has received an approval letter from the Mines Human Subjects Administrator, training has been completed, and signed consent forms have been obtained.

Investigators who begin their research project without approval from the Mines’ Human Subjects Administrator may be prevented from using any data obtained prior to receipt of written approval, and may be subject to discipline pursuant to the Faculty Handbook, and penalties prescribed by applicable federal and state law.

If you will be compensating human subject participants with gift cards, please follow the Controller’s Office policies located here.

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

Applications for Exemption of Human Subjects Research will be submitted online through the OneAegis system using your Mines Single Sign On.  Part of the application will ask you to attach, as it applies:

• Research Design (see the “Resource” section for templates)
• Informed consent form for you plan to use (see the “Resource” section for templates)
• Any surveys, interview questions, etc. that you plan to use

OneAegis will allow you to start an application, save it,  and come back to it before you submit.

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.

No! These identifiers are used so frequently on campus that anonymity is not assured. Consider using a random number generator.

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.

• 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.

The Resources menu tab has informed consent templates that can be used for exempt research.

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

Don’t wait until you have a project pending to start the approval process.

Yes with a separate consent from the participant. Mines requires a separate consent form to be obtained specifically for audio recordings in addition to the standard informed consent. The audio recording form is available here and can also be accessed on the “Resources” tab.

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 are adequate provisions in place to protect the privacy of subjects and maintain the confidentiality of data. Mines has contacted 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 identifiable indicia, 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.

Some sponsors require a copy of the approval letter before releasing the funding. If you are in this situation, please notify the human subjects team of any required deadline imposed by the sponsor as soon as possible.

Please contact humansubjects@mines.edu with further questions.

For assistance, please reference our User Guide.

Please contact humansubjects@mines.edu for any further assistance.

Principal investigators must submit an updated application form for previously exempted research for proposed changes to the human subjects protocol or for addition of new investigators.

This application should be submitted through OneAegis by clicking HERE.

The application for an Amended Application will ask for a  brief summary of the proposed modification explaining any changes to the previously approved study. Potential risks and benefits of a study and the overall risk/benefit ratio must be re-assessed and described, if applicable.

If your research was approved through OneAegis, please follow these DIRECTIONS.

If your research was previously approved through OnBase or our manual processes,  please follow these DIRECTIONS.

If you have any trouble or questions, please email humansubjects@mines.edu

After you submit an application, it will be automatically routed to the Human Subjects Research team for review.  If approved the application will be forwarded to your Department Head or Dean.

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.  

If you are needing a copy of a protocol submitting prior to OneAegis, please contact humansubjects@mines.edu.

Once an application is submitted, you can check its status by logging into OneAegis.

All applications will be listed on the dashboard by number, under which the status can be viewed, from “Pre-Review” to “HSR Team” to “Approved”

In OneAegis, you can start an application, save it, then come back to it prior to submission.  All projects will be listed on the dashboard.  Simply click on the number of the application you wish to continue.

Only the minimum amount of data necessary to perform the research. If data is not needed 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 would require a modification form to be submitted through the approval process, and the related communications (i.e., informed consent form) to participants to reflect such. Transparency should be used with participants for 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 participants 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.

Personal, sensitive data including copies of consent forms should be stored with the highest level of security on Mines’ owned infrastructure. Data should not be stored on a non-Mines’ owned computer or personal devices. Access should be limited to such data. Mines information security policies should be applied at all times. Questions around the security of data can be directed to Mines Help Center.

Care should be taken when utilizing third-party services and vendors to ensure they meet privacy and security standards. Use of third-party services and vendors should follow Mines’ standard procurement procedures, which include security and privacy reviews.

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.

Any reportable events must be reported to the VPRTT within five (5) business days of discovery of the incident. The VPRTT or authorized delegate will review the reportable event and determine if it warrants further investigation. Reportable events may include, but are not limited to:

• An actual unforeseen, harmful or unfavorable occurrence to participants or others that relates to the Research protocol;
• A problem involving data collection, data storage, privacy or confidentiality. (Any violations of privacy or confidentiality also need to be reported to the Privacy Compliance Director)
• A protocol violation (meaning an accidental or unintentional change to the Mines approved protocol) that harms participants or others; or that indicates participants or others may be at increased risk of harm;
• Any study related event that requires prompt reporting to the Research sponsor; or
• Any other problem that creates a risk to the participant or others.

Contact the Privacy Compliance Office to provide assessment and assistance with corrective actions. 

Sensitive data includes any information that can identify a person, directly or indirectly, by an identifier. 

The Family Educational Rights and Privacy Act (20 U.S.C. § 1232g; “FERPA”) gives students (including former students when they were enrolled) the right to inspect and review their own education records and to control the disclosure of those records (under this statute, ‘disclosure’ encompasses anyone other than the relevant student).  

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).

You may recruit subjects for your research from the students in the course you are teaching, however, to ensure that consent is freely given, a school official who is not associated with your research project should describe the research project to the students and make the requests for consent.

If a satisfactory level of de-identification is achieved, student data may be used without consent under § 99.31 (16)(b)(1) of the statute.

Best practice is to use an intermediary who can pull the relevant data, strip the identifiers, and then provide the de-identified and/or aggregated data to the research team. 

Only if this access was specified in the approved application and the participants were informed and consent received, regardless if the information is identifiable or de-identified.

Not Regularly. Extra credit as an incentive for participating creates an unfair situation for others in your class and is an unfair inducement into the research. There could be situations when extra credit could be approved if there are alternative ways for students to earn the same level of credit while not participating in the research project.  

Further, consent must be freely given. Individuals in a position of authority cannot obtain consent, nor can consent be coerced. 

Due to the inherent risk of bias in an Instructor and his/her treatment of the participants/nonparticipants when grading assignments, this is not allowed Adding a co-investigator to administer the project activities or to do the grading of the students may sufficiently reduce the risk.

No. This would not trigger FERPA requirements; however, it would require appropriate provisions for consent and confidentiality.

Contact either Mines’ Legal Counsel or the Mines’ Human Subjects Committee to advise. GDPR applies to the collection and use of personal data: (1) through activities within the borders of the European Economic Area (EEA), (2) that is related to offering goods and services to EEA residents, or (3) that involves monitoring the behavior of EEA residents.

Activities that are subject to GDPR include, but are not limited to, (1) activities involving identifiable information if personal data is being collected from one or more research participant physically located in the EEA at the time of data collection (even if the participant is NOT an EEA resident), and (2) activities involving the transfer of personal data collected under the GDPR from an EEA country to a non-EEA country.

Activities that are not subject to GDPR are those involving the collection of identifiable personal data from individuals who are physically located within the United Statesat the time of data collection (even if the participant is an EEA citizen).

See information on the General Data Protection Regulations and related guidelines here.