Three types of review (administratively-reviewed exempt, expedited IRB review, or full IRB review) are possible for research involving human participants. Although only the IRB can determine the appropriate level of review, research directors are provided the following criteria for each level of review, to assist in preparing appropriate documentation for the IRB committee. Application to the Chadron State College IRB is required for all research projects involving human participants.
Special consideration needs to be provided for research participants who are unable to sign for themselves or who are in a situation where coercion or undue pressure may be exerted for their participation. These potential participants include minors, fetuses as represented by inclusion of pregnant women, incarcerated individuals, individuals with questionable capacity to consent, individuals over which the researcher holds a position of power (such as students within the researcher’s class), the terminally ill, comatose patients, etc. Full consideration for involving participants from vulnerable populations can be found at the following website: http://www.hhs.gov/ohrp/. Research considerations for working with minors are presented below.
Children or minors are defined in federal regulations as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” Nebraska State law defines a minor as an individual under the age of 19. Regardless of the category of research, special measures should be implemented to ensure that participation does not stigmatize children in the present or in the future.
Information below is provided to help you determine which type of application to forward to the IRB. Click here for a flow-chart to help you determine the category in which your research may fit.
Research activities involving human participants in which there is minimal or no risk may be exempt from further IRB review, although initial project review by the IRB is required prior to initiation of the research and subsequently upon any modification of the project. The research must fully and completely meet the conditions described below to qualify for exempt certification.
Click on the following links to obtain the appropriate documents to complete your application.
Research that provides no more than minimal risk to participants but does not meet the administratively-reviewed exempt category will require either expedited or full-board review. The specific circumstances of the proposed research will be reviewed to determine the level of risk to the human participants. Select activities that may fall under the expedited IRB Review category includes the following (listed below). Please note that these listed activities are not deemed to be of minimal risk simply because of their inclusion on the list; inclusion merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human participants.
Expedited-reviewed research can involve minor participants, as long as the particular activity does not require that the participant be at or above the age of majority (19), and as long as appropriate permission is obtained prior to the research participation. Permission must be obtained from at least one parent/guardian (both, if the risks are above minimal), and building supervisors as appropriate (principal, superintendent, etc.) If the minor is eight years old or older, their assent must also be obtained.
Click on the following links to obtain the appropriate documents to complete your application:
3. Full IRB Review
Full review by the IRB is required for all research involving human participants that is not specified for administratively-reviewed exempt certification or through expedited review approval. For research with participants younger than 19 years, consult Appendix IV for additional conditions that must be met. If the IRB Chair determines that a research project application falls into the full-board review category, a quorum of IRB members (including at least one non-scientist) will consider the application, determining that participant integrity and welfare have been appropriately considered and that the risks to the participants are justified by the benefits gained from the research.
Four weeks from receipt of the completed application should be allowed for thorough review of a completed application. The IRB may require modifications or provide stipulations for the research, and continuation oversight may be needed for the project. The Chair will notify the researcher in writing regarding the status of the application once formal IRB action has been taken.
Vulnerable Population Considerations:
Click on the following links to obtain appropriate documents to complete your application: