HSR Application Instructions

How to fill out the application in Oneaegis

Note: For non-exempt research, please submit directly to COMIRB. Links and instructions are located here.

General Instructions
Our application process is electronic. There are separate forms for the design piece of the research that will need to be uploaded, along with the informed consent form(s), survey/interview questions, etc.

The Principle Investigator (PI) should be the person submitting the application. Please fill out the information as it specifically as possible. Please write your answers so that if a research participant were reading it, they’d understand. Thoroughness will help the process go faster! We all know that speed impresses you!

Once submitted, your application will be directly routed to your Department Head before being routed to the committee. The committee will not see your application until it’s approved by the Department Head.

Our FAQ has more about information about the process.

Co-Investigators

Click the ‘add’ button and search on last name for other Mines’ students or faculty who will be involved with the research.

Research Project Information

Research Dates

The start date of your research should be a future date (to start after approval has been obtained). Retroactive research cannot be approved through the exempt process and will require a limited or full approval through COMIRB. If you are using data that is already in existence (public, etc.), but you have not started the research, please indicate the analysis will start.

The end date of your research should be as accurate as possible. The retention requirements have been setup based on this end date.

Publishing

If you do not plan to publish your research, your human subjects research does not need to be reviewed by the Human Subjects Research Committee as exempt research. Submitting limited information will only serve as an FYI to the Committee. You will not receive an approval letter.

If you plan to publish in the future or think you may publish in the future, the full application will be required to provide your exempt research approval.

Purpose & Procedures

Briefly describe the purpose and the procedures used in the research. Write it as if you are telling the research participant.

The design of your research, including the hypothesis which are to be tested and subject recruitment, are to be included on the “Research Design” form and uploaded to your application. The research design is to be reviewed and approved by the PI’s Department Head.

Research Category

Please identify the category that best fits your research. Please refer to the HHS Guidelines here (Section 46.104(d)) if you are unsure which category to pick. This is the category your research will be exempt under within your approval letter, so it’s important to select the correct category.

Select the category that you believe best reflects your research. These will be reviewed for accuracy during the approval process.

Collaboration with Trefny

Collaboration with Trefny includes the following:

  • Instructor(s) meet with Trefny collaborator to discuss research questions, study design, and data sources before the course runs and data is collected.
  • Instructor(s) meet with Trefny collaborator regularly during the research project.
  • Instructor(s) share drafts of presentations/publications with Trefny collaborator to confirm data is being presented appropriately (e.g., no risk of students being identified).
Associated with a grant

If yes, please search for your grant or contract number (or proposal). You’ll need to click to verify the grant number. This helps tie the information to your research to ensure research compliance requirements are being met and to assist when our research compliance processes are audited.

Mines Course or Program

Research that will be performed within a Mines’ course or program will need to ensure FERPA-compliance is met. Additionally, the informed consent will need to make clear that participation (or lack of participation) will not impact their coursework or grade, and that the student can withdraw from the research at any time by letting the PI know. The informed consent should be communicated to the class by someone other than the researcher, so the participants do not feel pressured to participate.

Note: the FERPA informed consent is located here.

Research Location

Please identify where the research will be performed. Select ‘multiple locations’ if there’s more than one place where the research will take place.

Reminder: For any research that occurs internationally, country/territorial approval from the IRB may also be required.

Data

Data Collection

Please select the option that best reflects the data that will be collected/used in your research:

  • Prospective data – data collected during the study
  • Existing data – data collected prior to the study (public, previous study, etc.)
  • Both

Please note, that if you are using publicly available, existing data ONLY, this is not considered human subjects research, and does not need approval through this process.

Data Types
Please select all data types that apply or affirmative select ‘none.’ Special notes on certain types of data:

  • Audio data – if you will be using audio data in your research, you will need to include the audio informed consent form in addition to your informed consent. If audio is being recorded only for transcription purposes, often that can be included in the informed consent without using this added form. Please consult with the Human Subjects Committee.
  • Video data – if you will be using video data, the faces of the subjects must be blurred and the videos cannot be used in publications/presentations.
  • Mines student data – if you will be using Mines’ student data, you will need to use the FERPA informed consent form in lieu of the informed consent form.
  • PII (personally identifiable information) data – data that can directly or indirectly identify a person.

Minors and special categories of data cannot be approved as exempt and will require limited or full approval from COMIRB.

Other

COVID-19 Compliance

Novel coronavirus may drive you to change research studies as necessary to protect participants. Federal regulatory and Mines policy requirements must still be met. Significant modifications to the ways you interact with human subjects must be reviewed and approved by the human subjects review (HSR) team before being implemented.

Please direct any such questions to humansubjects@mines.edu. For more on Mines research adaptations for novel coronavirus, visit https://research.mines.edu/coronavirus-advice-for-researchers/.

General Comments

If you would like to communicate anything specific to the Human Subjects Research Committee, please include those items in the ‘general comments.’

Attachments
The research design template will need to be filled out and uploaded to all applications. Please note, that depending on the type of data being collected/used, you may be required to use the FERPA form template in lieu of the informed consent template or the audio form in addition to the informed consent template. In the rare instance your research doesn’t require an informed consent form, please attach a document explaining why it won’t be used.

If you are working with the Trefny Center, the SIS template will need to be filled out and uploaded to all applications.

Note, you can upload as many forms as needed. Attachments will need to be uploaded one at a time. Click the ‘attach informed consent’ after each upload.