Submission Guidelines For All New Studies
The principal investigator is responsible for preparing a proposal for Institutional Review Board review prior to initiation of research, and is advised to allow adequate lead time for the Institutional Review Board process, since it is not uncommon to be required to amend some aspects of the proposal to bring it in line with federal regulations prior to approval.
1. The principal investigator (PI) and all co-investigators must satisfactorily complete the research with human subjects training. A copy of the verification of a passing test score will be required prior to Institutional Review Board approval. Doing this and forwarding verification along with other materials FIRST will alert the PI to issues that will need to be addressed in the proposal.
2. The principal investigator should carefully assess the proposed research with regard to whether it best fits as exempt, expedited, or full committee review. The Institutional Review Board will make the final determination about the appropriate level of review. In cases where the level of review is in question, the higher level of review will be required by the NMSU Institutional Review Board.
What Needs to Be Reviewed?
IRB review is required for all human subjects research conducted by faculty, staff, and students, on- and off-campus, regardless of the funding support, if any, for the project.
Two initial questions researchers should consider are:
(1) Does my particular project meet the definition of research in the regulations? and
(2) Does my particular project involve human subjects?
(1) According to Federal regulations governing research with human subjects (45 CFR 46), Research is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities." [45 CFR 46.102(d)]
The core of this definition is "a systematic investigation...designed to develop or contribute to generalizable knowledge." It should be noted that the IRB considers the definition of "a systematic investigation" to vary widely depending on the discipline of the investigation and recognizes that it might be more appropriate in some fields to refer to research results as transferable, rather than generalizable.
The IRB relies on the judgment of the PI (Principal Investigator) when considering whether or not a project is "contributing to generalizable knowledge," rather than making a determination of whether or not a project constitutes research based solely on the criterion of public presentation / publication. We do this because we recognize that many factors other than public access play into the generalizability or transferability of particular studies. And we work under the assumption that the PI is the person who is most likely to be able to make an accurate judgment as to whether or not a particular project will be contributing to generalizable knowledge.
(2) Human subject means "a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information" [45 CFR 46.102(f)].
Generally speaking, information coming from experience or opinions is not likely to be replicable across people, even in similar situations, and thus means the data are "about" the individual from whom they are gathered. In contrast, factual information should not vary depending on the respondent. Thus the collection of factual data generally does not result in the "informant" becoming a human subject. A few examples of questions that are likely to elicit responses drawing on experience or opinions are "What is your projection of next year's sales data?," "What would be the best ways to improve this system?," and "Has this change in policies impacted the morale of employees?" A few examples of factual questions are "Does this organization have a policy for parental leave?," "What is the annual input into this system?," and "When did this company implement its new inventory structure?"
For assistance in determining whether or not a particular project constitutes research involving human subjects, please contact us.
Determining What Level of Review to Apply For:
Exempt Studies: Only the Institutional Review Board can determine if an application meets exempt status. The PI must submit an exempt IRB application for consideration. While research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from the 45 CFR 46 regulations, they must still be submitted to the IRB for their review and approval. Click here for a detailed explanation! The application must demonstrate:
1. The research is minimal risk, and
2. Fits into one of the exempt categories:
A. Educational Practices
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
a. research on regular and special educational instructional strategies, or
b. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
B. Surveys, Questionnaires, Interviews, Observational Studies
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior unless:
a. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
b. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
C. Educational Tests
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, if:
a. the human subjects are elected or appointed public officials or candidates for public office; or
b. federal statue(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
D. Existing Data or Specimens
Research involving the collection or study of existing data documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
E. Research and Demonstration Projects
Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate or otherwise examine:
a. public benefit or service programs;
b. procedures for obtaining benefits or services under those programs;
c. possible changes in or alternatives to those programs or procedures; or
d. possible changes in methods or levels of payment for benefits or services under those programs.
F. Taste and Food Quality and Consumer Acceptance
Taste and food quality evaluation and consumer acceptance studies,
a. if wholesome foods without additives are consumed, or
b. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Expedited Studies: Briefly, these studies may be reviewed by the Institutional Review Board through expedited review procedures. Click here for a detailed explanation! The application form must demonstrate:
1. No more than minimal risk to subjects, and
2. Involve only procedures listed in one or more of the following categories:
a. Collection of hair and nail samples
b. Collection of excreta and external secretion
c. Recording of data from subject 18 years of age or older using non-invasive procedures
d. Collection of blood samples in minimal amounts
e. Collection of dental plaque and calculus
f. Voice recording
g. Moderate exercise by healthy volunteers
h. Study of existing data
i. Research on an individual or group behavior that involves no manipulation of the subjects and is not stressful; and
j. Certain kinds of research on drugs and devices
Note: Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research setting is not greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological tests.
Informed Consent Guidelines
The Informed Consent is one of the primary ethical responsibilities of the researcher, and it protects both the research subject and the researcher. The Informed Consent should be written in language that is understandable to the subjects. When research involves individuals who are not able to provide an informed consent (such as minors), informed consent from a legally responsible party should be obtained. In such situations, the best practice is to also use an assent document. If an investigator believes that one or more elements of the Informed Consent does not apply, the PI must indicate rationale for this in writing and request a waiver.
ALL NMSU investigators must submit an application detailing the involvement of human subjects in the research project. All documents must be typed (10-12 point font) on a current edition of the forms and personally signed by the principal investigator and the faculty sponsor, when required, or the application will be returned to the investigator.
Requests for approval to use human subjects should be submitted to the NMSU Institutional Review Board in the Office of Compliance. The forms must be completed according to the instructions provided. Downloadable forms are available on the NMSU Institutional Review Board Website.
Starting Your Research
Research may not begin until and unless final written approval or acceptance has been received from the NMSU Institutional Review Board. This includes any and all contacts with human subjects (or work with documents on, or from, human subjects) and all categories of research. This restriction applies not only to the initial application, but also to any amendments or continuations.
Investigators may not institute changes to their research prior to receipt of written final approval for the change. The regulations governing research involving human subjects and our Letter of Assurance with the federal government preclude the granting of retroactive approval.
Subjects should not be recruited in any manner before Institutional Review Board final approval is received. Any documents recruiting subjects must be submitted to the Board with the application. This includes: fliers, e-mails, letters, newspaper and other media advertisements. Offers of compensation must not be in print larger than that used in the document generally. Other benefits cannot be over-emphasized.
Reports to the Institutional Review Board
The principal investigator is required to provide written documentation of:
1. Any changes to the study protocol
2. Any changes to the informed consent
3. Termination of the study (if the study is prematurely halted)
4. Continuation of the study (at designated intervals)
5. Completion of the study
6. Adverse events
7. Changes in protocol or consent must be approved before being implemented.
Researcher Responsibilities Regarding Studies In Progress
Investigators are required to report any proposed changes to their research study via a Modification Request Form. Investigators must report any changes, regardless of the level of the original review and the significance of the change.
Reference the original title of the study, the principal investigator, and the proposal identification number. Any changes to the title, project beginning or ending dates, or the investigator should be described in section 1. If the investigator's appointment does not carry an approved rank code, then both the investigator and the sponsor must sign the form.
Amendments involving minor changes that pose no more than minimal risk to subjects will be reviewed on a weekly basis according to the weekly review schedule. Amendments involving more than minor changes or more than minimal risk will be reviewed by the full NMSU IRB, according to the full committee review schedule.
Changes may not be implemented until final written approval is received from the NMSU IRB.
Continuation Request Report
Studies are approved for a designated period of time that will not exceed one year. For studies that will continue beyond one year or beyond the designated study period, a Continuation Request must be completed by the PI and approved by the NMSU Institutional Review Board prior to the end of the designated time.
Studies involving greater risk may be reviewed at a shorter time interval, as designated by the Institutional Review Board and specified on the Institutional Review Board approval.
Exempt studies do require continuing review.
The NMSU Institutional Review Board will send out a call for continuing review or completion with a copy of the Continuation Request form with a copy of the Approved Consent Form(s) approximately one month before it is due in the NMSU IRB office.
Principal Investigators who disregard the call for continuing review should recognize that the Institutional Review Board approval is only valid for the specified period of time, and the Institutional Review Board has the authority to halt research that does not comply with the guidelines.
When the study is completed or terminated the Principal Investigator must complete and submit the Final Report Form. The NMSU Institutional Review Board will send out a call for this approximately one month prior to the anticipated completion date.
Principal Investigators who are completing studies at all levels are required to comply (exempt, expedited, and full reviews).
The NMSU Institutional Review Board considers a study complete when data analysis is completed, or when all data have been collected and all the data have been de-identified so that there is no link whatsoever between the data and any subjects.
Reporting Adverse Events
Any adverse experience associated with a study must be reported to the NMSU Institutional Review Board. Severe events must be reported by the Principal Investigator within 24 hours of the event. All other unanticipated problems or adverse events must be reported to the IRB within 5 working days of the researcher becoming aware of it, if the event occurred at a local site. If the event occurred at another location, it must be reported within 30 days of the researcher becoming aware of it. Complete and submit the Adverse Event Report Form.