Frequently Asked Questions

Basics

Research is defined as a systematic investigation designed to develop knowledge that can be generalized. If you plan to present or publish the work or otherwise share results of the study, it is probably research.

If NO: your project is not considered research and does not require IRB review.

If YES: your project is considered research and requires IRB review. It may however be EXEMPT.

Note: If your project is not hypothesis-driven, does not use research protocols or methodologies, and the anticipated data is not intended for publication of an article in a newspaper or magazine, no IRB review is needed.

Note 2: If no public dissemination is planned at the time the data is gathered, but the possibility of future dissemination exists, you are advised to submit the project for IRB review and approval before initiating the research project.

Under the U. S. Department of Health and Human Services, Code 45 of Federal Regulations Part 46.102 (d) defines “research” as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

Human participants are defined as: living individual(s) about whom an investigator conducting research obtains (1) data through intervention or interaction (including online interaction) with the individual or (2) identifiable private information.

Some examples of subjects/participants include:

• individuals who are asked to complete questionnaires, participate in interviews, or whose behavior is observed in daily activities
• oral history interviewees whose subjective perceptions are studied
• students and teachers observed in the classroom for the study of various teaching methods or development of curricula

If NO: Your project does NOT need IRB approval.

If YES: Your project most likely needs IRB review.

Under the U.S. Department of Health and Human Services, 45 CFR 46.102 (f) a “human subject” is a living individual about whom an investigator (whether professional or student) conducting research obtains data or any identifiable private information through intervention or interaction with the individual.

Yes. In many cases, the instructor can complete a human subjects application for the “generic” project, detailing the kinds of procedures, recruitment, subjects, risks, benefits, etc. The Board then reviews and approves this application and delegates responsibility to the instructor to act as a proxy reviewer. Students in turn complete the application, or otherwise present sufficient information to the instructor so that s/he can make a judgment: does this project fall within the boundaries of what was approved, generically, by the IRB? If so, the project may proceed. If not, the student is referred to the Research Office to decide whether a separate application is needed.

Certain activities have the characteristics of research but do not meet the regulatory definition of research needing IRB review.

Examples of activities that may not need IRB review are:

• Data collection for internal departmental, school, or other University administrative purposes (e.g. teaching evaluations, course evaluations, outcomes assessment).
• If your research is a class project or term paper and will not be published in any form at any time.
• Reviews and Searches of existing literature and research involving a living individual, such as a biography, that is not generalizable beyond that individual.

Use the following guidelines to determine if your activities in the classroom are subject to IRB application and review. An IRB Request for Class Project Waiver form is required for notification purposes if all of the following are true:

a. The project is limited to surveys/questionnaires/interviews/observations of public behavior directly related to topics being studied in an official college course.
b. The above surveys/questionnaires/activities, etc. contain no sensitive personal questions (e.g., no questions about drug use, sexual behavior or attitudes, criminal activity, grades, medical history) or other personal information that could stigmatize an individual.
c. No identifying information is recorded to link a person with the data such that it could reasonably harm the individual’s reputation, employability, financial standing, or place them at risk for criminal or civil liability.
d. The participants in the project are not from a vulnerable or special population (e.g., pregnant women, prisoners, minors, cognitively impaired individuals).
e. The collected data does not leave the classroom setting, or if the project involves collecting data on an organization, agency or company, the data are shared only with that entity.
f. No New Mexico State University employee or student is receiving financial compensation for collecting, organizing, analyzing, or reporting the data.

If ALL of these conditions are not met, or if your project does not fall into any of these categories, your project will require IRB notification and formal IRB approval before you can start with your project.

The following are examples of projects that do require IRB notification but are exempt from IRB review. Nonetheless, formal paperwork needs to be submitted to the IRB prior to the start of the project since the decision on the exempt status is the sole responsibility of the IRB.

• The study of or comparison among instructional techniques, curricula, or classroom management methods.
• The use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless this involves any one under the age of 18.
• The collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or the information is collected in a way that cannot be linked either directly or through identifiers to an individual.

1. ALL research with children, including adolescents, must be reviewed by the IRB. Children are considered a vulnerable research population under Title 45 CFR Part 46 They are less able to give fully-informed consent with respect to the research involved. Safeguard procedures and considerations are, therefore, required by the Federal regulations for the review of research involving children. In almost all cases, written consent from a parent or legal guardian must be obtained if the research involves children under the age of 18.

2. Even in the case where a project is not subject for review, the instructor/faculty member is responsible to uphold all applicable (e.g., American Psychology Association, American Counseling Association, National Institute of Health, etc.) ethical standards and guidelines in course-related research activities when it comes to the treatment of human subjects.

3. It is the responsibility of the supervising instructor/faculty member to determine whether projects are subject to review. It is always best to err on the safe side and seek consultation from the IRB if a question arises regarding human subjects, research and classroom activities.

The IRB approves protocols with the understanding that the work will be conducted only by the investigators named in the application. If your colleagues would like to work on your project, you may modify your existing protocol by contacting the NMSU Office of Research Compliance. Otherwise, they must make their own application.

Yes. All research involving interaction with human subjects requires informed consent regardless of who the subjects are. There are exceptions to this rule: in some studies, subjects are not given complete information about all procedures or hypotheses because full prior knowledge would affect their responses. Deception of subjects must be justified in each case, and subjects should be provided with a full explanation or debriefing as soon as practicable. The Board does not routinely approve such projects (in particular we do not believe it is an appropriate exercise for undergraduate researchers), and prior explanation of risks must never be withheld.

Confidentiality means that information is private, but that it is possible for you, or a determined person familiar with your subjects and/or able to gain access to your data, to figure out a subject’s identity. Anonymity means that it is impossible for you–or anyone else–to connect a subject with the data they’ve provided. Common conditions that make data confidential rather than anonymous include:

• the use of audiotapes to record interviews
• demographic data such as date of birth; use of small descriptive categories, e.g. black female senior official in a police department, Asian male executive nurse in a healthcare organization
• qualitative studies of few subjects with highly individual information, e.g. three school teachers describing what drew them to teaching, or their assessment of their school’s principal
• the use of ID numbers on subjects’ data with a separate name/number list

Ethical Problems

Investigators and laboratory or department heads are responsible for reporting promptly to the Board any serious or continuing noncompliance with university policies or federal regulations. In addition, every approval of a research project is granted with the stipulation that any unanticipated problems and risks, changes in the research plan, and any injury to subjects be reported to the Board.

Requirements

p>Yes, if human subjects are involved. Student researchers must have a faculty sponsor for each research project.

IRB Review Process

Final Report of Research Protocol. Fill this form once your project has concluded. That means that you have gone through the research including data analysis.

IRB New Application to Use Human Subjects in Research (Expedited or Exempt). If you are initiating a new project. Make sure you provide concise and brief answers.

Modification of Protocol. Modification forms should be filled out when any of the following occur: a change in team members, change in the recruitment, the measurement instruments, the informed consent, or any change in the research procedures. Please make sure to include updated and any additional information related to the modification in the submission.

Status Reports. This form should be filled out on an annual basis. The purpose of this form is to inform the IRB that the project is still undergoing. The IRB will check the last approved consent form, the human subject training, and the team members associated with the project. Please make sure to include this information in the application.

Request for Classroom Research Project Waiver of IRB Application. Fill this form if you have a classroom project that will be used to teach or demonstrate a research element, but data will not be used for any other purpose.

1. Choose this form if your study does not use minors or vulnerable populations (prisoners, persons lacking capacity to give informed consent) as defined by Title 45 CFR, Part 46;
2. If you do not plan to publish your findings;
3. If you do not plan to videotape the participants; and
4. If the risk is minimal, you can submit this type of project.

Adverse events Fill this form when unexpected events occurr during the project. A reportable event is one in which a participant(s) is/are exposed to an unanticipated harm or risk. An actual injury to the participant is not required. Any social and psychological risk or harm to the participant(s) should be reported. While social harm may result in well-defined events such as loss of employability, loss of insurability, and criminal or civil litigation, usually it disrupts interpersonal relationships by causing embarrassment, humiliation, discrimination, or stigmatization. Social and psychological risk or harm can be caused by such events as a breach of confidentiality, loss of records, or participant information.

All forms are submitted electronically through Maestro, a web-based workflow record management system developed by NMSU. MAESTRO is used to automate and streamline the human subject research, IRB protocol submission, and review process. Emails are automatically sent via Maestro to notify users when action is needed from the users.

No. You must not do human subjects research until you receive an email notification from Maestro which contains a copy of the approval packet and the IRB approval letter.

Absolutely. The IRB wants to continue to be a resource to NMSU research community. Note that human research determinations are not made via phone or in person. If you would like a written determination, please e-mail a synopsis of the proposed activity (approximately 1 page) to the IRB at ovpr@nmsu.edu. Please include the following in the synopsis:

• Study funding
• Purpose
• Study procedures
• Any draft study measurements (survey, questionnaire, and interview guide).

The IRB will take responsibility for providing guidance and making a determination.

All modifications must be approved by the IRB before implementation of the modification. If you want to change the protocol (conduct of the study) or any other aspect of the study (e.g., research personnel, consent form edits, recruitment changes, or number of subjects), please submit the modification of protocol form request using MAESTRO. Please upload any new documents and any previously approved documents that are affected by the modification, (e.g., initial review application that serves as the protocol; consent form; recruitment materials; survey, questionnaire, interview guide). After the IRB reviews, approves it, and you receive the approval email notification from Maestro, you can implement the change to your research.

Once IRB approval expires, you must stop all research activities. This includes recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information. The Principal Investigator (PI) needs to submit a final report to close out the expired project submission before continuing the research. If the PI wishes to continue with the same research, he/she must then submit a new IRB and wait for the IRB review and approval before continuing the research.

You're welcome to call the Office of Research Integrity and Compliance (575-646-7177) or email us at ovpr@nmsu.edu or stop by the Office of Research Integrity and Compliance at Anderson Hall located on the corner of Espina and Stewart St. An IRB representative is almost always in the office. An appointment is not required to meet with a representative from the Office of Research Integrity and Compliance.