Human Subjects Research

Informed Consent MUST always be sought from the participants in your research project. The informed consent requirements found in HHS 45 CFR 46 Regulation for the Protection of Human Subjects in Research provide a bedrock protection for individuals participating in research studies.  The department of health and human services provides excellent examples of consent form requirements.

• Office for Human Research Protections

• Students involved in HSR Research (inside & outside the classroom) at NM Tech MUST complete their CITI training in order to participate. This is to ensure a strong understanding of responsible and ethical research practices and project design. These training modules should only be taken once every 4 years. Students must complete the following training: 

1. Responsible Conduct of Research (RCR) Curriculum
   1. NMT Student/Postdocs
2. Human Subject Research Curriculum
   1. NMT Student/Postdocs

New Mexico Tech's IRB Administrator reviews all Human Subjects Research- including classroom or practicum projects that will not be published. Please complete the IRB Application Form.

• Your project could be eligible for an Administrative Review, which will only take a short amount of time.
• Please be aware that you cannot start your project until you have the signed Approval Form.

Students involved in research at NM Tech must complete their CITI training in order to participate. This is to ensure a strong understanding of responsible and ethical research practices and project design. Students should complete the following training: 

• Responsible Conduct of Research (RCR) Curriculum
  • NMT Student/Postdocs
• Human Subject Research Curriculum
  • NMT Student/Postdocs

If your research project will NOT collect any Personally Identifiable Data from your participants:

• Your project could be eligible for Administrative Determination for exemption.
• Please be aware that you cannot start your project until you have the signed Approval Form in hand.

If your research project WILL collect certain types of Personally Identifiable Data from your participants:

• Your project could be eligible for an Expedited Review, which is performed by the IRB Administrator and one other IRB member. This can take up to three weeks to complete, depending on the availability of board members.
• Please be aware that you cannot start your project until you have the signed Approval Form. 

Personally Identifiable Data is defined by federal regulation as the following information:

• Name (i.e., names on survey or questionnaires)
• 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
• Blood, tissues, bodily fluids, or DNA from participants
• Sensitive health or medical information (i.e., HIV status; drug/alcohol use; mental/physical disorders; illicit or criminal behaviors; or other information that could cause harm to the participant if it became known in their community.

Violating the requirements of Title 45 – Public Welfare Part 46 of the Code of Federal Regulations (45 CFR 46) can lead to serious consequences. Penalties may include written warnings, reprimands, fines, and sanctions against the institution or researchers involved. In some cases, federal funding for all sponsored projects may be withdrawn.

• Title 45 CFR U.S. Dept. of Health & Human Services, Part 46: Protection of Human Subjects 
• Title 45 CFR, Part 46, Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
• Title 45 CFR, Part 46, Subpart C: Additional Protections Pertaining to Biomedical & Behavioral Research Involving Prisoners as Subjects
• Title 45 CFR, Part 46, Subpart D: Additional Protections for Children Involved as Subjects in Research

Studies that fall under any exempt category as outlined in 45 CFR 46.104(d) may be eligible for an exempt review. 

Exemptions cannot be granted for research involving prisoners or children that includes:

• Surveys,
• Interviews, or
• Observation of public behavior—unless the observation involves public behavior in which the investigator does not participate.

If the IRB determines the study is not exempt, it will require either expedited or full board review. Although certain research activities involving human subjects are exempt from 45 CFR 46 regulations, they must still be submitted to the IRB for review and approval.

New Mexico Tech's IRB Administrator reviews all Human Subjects Research- including classroom or practicum projects that will not be published. Please complete the IRB Application Form.

If your research project will NOT collect any Personally Identifiable Data from your participants:

• Your project could be eligible for Administrative Determination for exemption.
• Please be aware that you cannot start your project until you have the signed Approval Form in hand.

If your research project WILL collect certain types of Personally Identifiable Data from your participants:

• Your project could be eligible for an Expedited Review, which is performed by the IRB Administrator and one other IRB member. This can take up to three weeks to complete, depending on the availability of board members.
• Please be aware that you cannot start your project until you have the signed Approval Form. 

Your project may require Full‐Board Review.

This will require a meeting of the full Institutional Review Board, which can take up 1 month to arrange. You may be asked to provide more information to the Full Board before it decides to approve or disapprove your project.

Please be aware that you cannot start your project until you have the signed Approval Form from the full IRB.

Students involved in research at NM Tech must complete their CITI training in order to participate.

This is to ensure a strong understanding of responsible and ethical research practices and project design. Students should complete the following training: 

• Responsible Conduct of Research (RCR) Curriculum
  • NMT Student/Postdocs
• Human Subject Research Curriculum
  • NMT Student/Postdocs

Should you need to modify some part of your original IRB Approved project/research you will need to complete the IRB Modification Form. The following are reasons why you would need a modification:

• Requesting a temporary IRB study expiration date extension

OR

• Making changes to the following:
  • Research personnel
  • Research procedures used
  • Informed consent documents
  • Types of human subjects participating
  • Types of data collected

IRB Modification Request Form

IRB Modification Form Instructions: Fill out this SmartSheet form to request an IRB Modification Review of your research project. All supporting documentation must be attached to application before it is considered complete. Should you need to submit more information please email it directly to irb@nmt.edu

Multi-year projects are initially approved by the IRB for a 12-month period, any research expected to extend beyond that date must file yearly to renew the IRB approval. The PI is responsible for not allowing their IRB Approval to lapse. It is recommended the renewal application be filed 60 days or 2 months prior to the expiration date. 

This Renewal must include:

• A list of any changes proposed to the following areas of the original Approved project/research:
  • Research personnel
  • Research procedures used
  • Informed consent documents
  • Types of human subjects participating
  • Types of data collected
  • The IRB also asks that you provide a written explanation for these changes.
• An Annual Progress Report
  • The report should detail your project/research such as your progress/setbacks/breakthroughs/etc. so the IRB can quickly assess the work and avoid delaying your approval renewal.

IRB Annual Renewal Form

IRB Annual Renewal Form Instructions: Fill out this SmartSheet form to request an IRB Annual Renewal Review of your research project. All supporting documentation must be attached to application before it is considered complete. Should you need to submit more information please email it directly to irb@nmt.edu

Use this form to report unanticipated events or problems caused by or related to a human subject's participation in your research project. 

• Adverse events are extremely unlikely since NMT does not perform clinical research of any kind, but we make this form available as required by federal law.

IRB Adverse Event Reporting Form 

IRB Adverse Event Reporting Form Instructions: Use this SmartSheet form to report unanticipated events or problems caused by or related to a human subject's participation in your research project.