IRB Application

You MUST have IRB Approval BEFORE you can begin any project using human subjects.

IMPORTANT: Please complete this form and request a copy be sent to your email for your records. Then forward the email to the IRB Admin at irb@nmt.edu

PRINCIPLE INVESTIGATOR (PI)

Principal Investigator (PI) - is the academic or administrative staff member responsible for initiating and conducting an externally funded project. The individual may also be known as the Project Director or Administrator

Any questions that may arise while filling out this form should be directed to the IRB/Research Compliance Office via email: irb@nmt.edu

PI First Name

PI Last Name

NMT Email

@nmt.edu or @student.nmt.edu

Best Contact Phone Number

Department

Title of Project

Funding Source/Agency

Proposed Start Date

When do you expect to begin* your project?

*Note it may take up to a month for IRB Approval so start dates should reflect that gap.

mm/dd/yyyy

Proposed End Date

When do you expect this project to end?

mm/dd/yyyy

Is this for a Class or Practicum?

Yes

Additional Investigators

Who else will be working on this project with you?

Yes

MST or Independent Study?

Is this for the Master's in Science Teaching program or an Independent Study

Yes

SECTION I — HUMAN SUBJECTS PARTICIPATION

How will you interact with your project’s participants?

Please review NMT's Policy on Human Subjects Research for definitions: https://www.nmt.edu/policies/docs/vp-research/NMT-Policy%20on%20Human%20Subjects%20Research%202021.pdf

Private information

Are you collecting any Private Information from your participants? [45 CFR § 46.102(e)(4)]

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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

Yes

Identifiable Private Information

Are you collecting any Personally Identifiable Information from your participants? [45 CFR § 46.102(e)(5)]

Personal Identifiable Information includes: information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

examples:

Name
Identification Numbers (i.e., Social Security Number, Tech Student ID Number)
Contact Information (i.e., Physical Address, Phone Number, Email Address and/or IP Address)
Audiotape recordings, videotape recordings, or photographic images of participants

Yes

Identifiable Biospecimen

Are you collecting any Identifiable Biospecimen Information from your participants? [45 CFR §46.102(e)(6)]

Identifiable Biospecimen Information includes: Blood, tissues, bodily fluids, or DNA from participants sensitive health or medical information (i.e., HIV status; drug/alcohol use)

Yes

Information Type/s

Select all that apply to your project data:

Name

Identification Number (Social Security Number or Tech Student ID Number)

Sensitive health or medical information

Other sensitive information that could harm participants if it became known (i.e., criminal records, drug/alcohol use)

Physical address/ Phone number

Email Address and/or IP Address (for web-based survey research and/or user testing purposes)

Audio, video recordings, or photographic images of participants

Blood, tissues, fluids, or DNA from participants

Select if your project will NOT collect any of the data listed above

Research Data Collection Method/s

Select all that apply to your project data collection method/s:

SECTION II — TYPES OF DATA COLLECTED BY PROJECT

What type/s of data will be collected by your project?

Please review NMT's Policy on Human Subjects Research for definitions: https://www.nmt.edu/policies/docs/vp-research/NMT-Policy%20on%20Human%20Subjects%20Research%202021.pdf

New or Novel Data

Select all that apply

In-person surveys, interviews and video recordings are NOT anonymous data

Personally Identifiable Information and additional data gathered by survey/questionnaire/test/interview

Biological specimens or physiological data drawn or collected by the NM Tech researcher

Photographs, audiotape, videotape/ film of participants

Anonymous data gathered by survey, questionnaire, or test

Other

NOT APPLICABLE

Already-existing Data

Select all that apply from the following source/s you will utilize in your project.

Public data sources (library, archives, Census information, etc.)

Data from Social Networking sources (Facebook, Instagram, etc.)

Non-public data sources (personnel files, medical files, financial files, etc.)

Biological specimens provided by a non-NM Tech source

Other

NOT APPLICABLE

SECTION III – DATA SECURITY AND CONFIDENTIALITY

Data security and confidentiality are crucial parts of any research project

Please review NMT's Policy on Human Subjects Research for definitions: https://www.nmt.edu/policies/docs/vp-research/NMT-Policy%20on%20Human%20Subjects%20Research%202021.pdf

How will you keep your project’s data secure?

If your project is collecting Private Information, [in accordance with NIST 800.171] you MUST ensure that ALL such data is kept secure and fully confidential. Please explain how data will be kept secure below.

How will you handle the project’s data post study?

All Identifiable private information (IPI) MUST be destroyed at the conclusion of your research project but, you should keep de-identified data that doesn’t contain IPI for 2 years [in accordance with 21 CFR 812.140(d)]. Please explain how your data will kept or destroyed.

SECTION IV – YOUR RESEARCH POPULATION

What types of subjects are participating in your research project?

Research Subjects

Please check all applicable boxes

SECTION V – TRAINING REQUIREMENTS FOR RESEARCHERS

Have you completed the training requirements on Human Subjects Research? Federal law requires PIs to be adequately trained before starting Human Subjects Research projects in accordance with our NMT Human Subjects Research Policy. Please review NMT's Policy on Human Subjects Research for definitions: https://www.nmt.edu/policies/docs/vp-research/NMT-Policy%20on%20Human%20Subjects%20Research%202021.pdf

Completed COI Disclosure?

All individuals participating in human subject research must annually [42 CFR 50.604(e)(2)] disclose any Conflicts of Interest (COI) in accordance with our NMT Conflicts of Interest in Research Policy. [42 CFR 50.604(b)]. COI training is also annual.

Have you taken the training and completed the annual disclosure?

Yes

Completed RCR Training?

All individuals participating in human subject research must complete RCR training annually [42 CFR 50.604(e)(2)].

Have you taken the minimum required CITI Modules on Human Subject Research for NMT PIs?

Yes

SECTION VI – SUPPORTING DOCUMENTATION

Research Description: Please describe how your research project will use human participants.

Abstract / Project Summary

Summarize your proposed research project, using non-technical language that can be understood by non-scientific individuals.

Please include:

1) a brief statement of the research question and related theory supporting the reason for the research;

2) a brief but specific description of the procedure(s) involving human subjects.

3) For projects involving surveys, questionnaires, or interviews, describe the setting and mode of administering the instrument (i.e., via telephone, face-to-face, or in a group), and the provisions for maintaining privacy and confidentiality.

4) Duration, intervals of administration, and overall length of participation.

Solicitation of Participants

Please explain how participants will be contacted, selected, or recruited for your project.

Risk Assessment

What sort of risk will participants face as a result of their involvement in your research project?

Minimal – Participants will experience no greater than the risk than what they would encounter during a normal day

Greater than minimal – Participants in social/behavioral research might suffer embarrassment, loss of social standing, physical or psychological harm if collected data became known; participants in biological research might experience minor discomfort

Significant – Participants in social/behavioral research could experience physical / emotional /psychological injury, could be subject to legal or criminal risk if collected data became known; participants in biological research could become severely ill

Benefits to Participants

How might subjects benefit from participating in your research project?

Offer Alternatives

Human subjects must ALWAYS have the right to choose not to participate in the research study. What alternatives are reasonably available in the non-research and/or research context that may be beneficial to the potential subjects?

Confidentiality

How will you protect the confidentiality of those who participate in your project? How will you protect the collected data from being released without your knowledge or permission? How will you dispose of or destroy Personal Identifiable Data (PID) once your project is completed?

Consent Form

Project collects Identifiable Private Information

Project does not collect Identifiable Private Information

Debriefing

If it is necessary to deceive or mislead the participants in order to adequately perform your research project, a debriefing statement must be read or given to the participants at the conclusion of the project.

Elements that should be included in the Debriefing Statement:

1) Describe the nature and aim of the project;

2) Explain why the participants were misled;

3) Provide the name and phone number of the person to contact in case of questions regarding the project; and

4) Thank the participants.

Debriefing statement will be necessary

No debriefing statement will be necessary

Follow-up information letter will be necessary

No follow-up information letter will be necessary

Level of Risk?

What level of risk will your participants experience during your research?

MINIMAL – The potential harm or discomfort experienced are not greater than those ordinarily encountered during routine physical or psychological exams or tests

GREATER THAN MINIMAL RISK – The potential for harm or discomfort might cause a participant to feel unsure about participating, or could cause the participant to become ill or incapacitated.

Informed of Risk?

Will your project’s participants be informed of the risks involved with the procedure before they participate?

YES – A complete description will be provided to each participant

NO – Please email the IRB administrator for more information irb@nmt.edu

Emergency Procedures?

Do you have procedures in place for emergency care if a participant requires it?

YES – A procedure or provision for emergency care is included in this research project

NO – Please email the IRB administrator for more information irb@nmt.edu

Medical Guidance?

Has a qualified M.D. participated in planning this research project?

YES – The research project was planned with guidance from a physician

NO - The research project was not planned with guidance from a physician

ADDITIONAL REQUIREMENTS

Principal Investigator / Faculty Advisor Assurance

The IRB Signature sheet is available on the IRB site here: https://www.nmt.edu/research/IRB%20Signature%20Form.pdf Collect all relevant signatures (along with Faculty Advisor Assurance if necessary) and include the PDF document with the application.

By checking this box I confirm I understand that I am responsible for providing the signature/s necessary with all other documentation in the "All Necessary Forms" box below.

HSR & RCR Training Documents

I confirm I have provided copies of Human Subjects Rsearch & Responsible Conduct of Research training with my application.

IRB Signature Page

I understand my application will not be considered complete until I provide an IRB signature page with my documentation.

The IRB Signature page can be found here: https://www.nmt.edu/research/IRB%20Signature%20Form.pdf

I Understand

Please provide the following items:

Samples of all documents to be used in your project (including all relevant signatures, questionnaires, surveys, tests, advertisements, flyers, permission slips, procedure descriptions given to participants, etc.) After completing this Application Form, attach all additional requirements and CITI training certifications in the the "All Necessary Forms" box below.

Questions regarding any documentation or requirements should be addressed via email to irb@nmt.edu

By checking this box I confirm I understand that I am responsible for providing this information in a timely manner.

Send me a copy of my responses

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