IRB FAQ General Information
Generalizable knowledge is date and or conclusions that can be applicable beyond a particular place, person, or setting and or may be intended for publication or presentation:
Example of activities that typically are not generalizable:
The implementation of rule based methods that are repeated with multiple participants in a consistent manner across the participants. Alternatively, the method may be implemented according to specified rules with a single participant for certain types of investigations. For example, case studies designed for publication are systematic investigations of a single person.
Oral histories that are designed solely to create a record of specific historical events
Service or course evaluations, unless they can be generalized to other individuals
Services or concepts where it is not the intention to share the results beyond KSU or any agency supporting the research
Classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
Quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond KSU-e.g. teaching evaluations, customer service surveys
HIPAA stands for Health Insurance Portability and Accountability Act. There are two general considerations to think of when working with HIPAA.
the addition of required elements in order to waive informed consent if protected health information is used, and
specific information related to the use of subject data must be contained in the consent form.
*For additional information please contact the research compliance office.
NO! Engaging in human subject research without IRB approval has serious ethical implications and violates university and federal policy. Students, faculty and staff are required to have a KSU approved IRB before collecting any data. Even pilot studies must be approved by the IRB. IRBs cannot grant retroactive approval. If you are unsure if your project needs IRB approval, please contact Research Compliance.
Anonymous-data does not contain any information that would permit identification of the individuals about whom the data were collected.
Confidential-data contains information that would permit identification of the individuals about whom the data were collected, but is maintained in a manner that protects the information from release to unauthorized individuals.
De-identified: All direct personal identifiers are permanently removed from the data, no code or key exists to link the data to the original source or to the individual, and the remaining information cannot be used to reasonably identify the individual.
Coded: Direct personal identifiers have been removed (e.g., from data or specimens) and replaced with words, letters, figures, symbols, or a combination of these for purposes of protecting the identity of the source, but the original identifiers are retained in such a way that they can still be traced back to the source. Note: Sometimes also referred to as a "key," "link," or "map."
A CoC is issued by a federal agency when protection against compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical, and other research is necessary. For additional information, review the information posted by the US department of Health and Human Services on the OHRP website at: http://www.hhs.gov/ohrp/policy/certconf.html
Investigators who are considering submitting an application for a CoC are advised to plan well in advance, as the process is very lengthy. If participation in research is likely to place an individual at risk of criminal liability, the IRB may require that a CoC be obtained.
Risk is minimal when the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests - 45 CFR 46.102.i and 21 CFR 50.3.k. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of a routine physical examination.
Research is defined in the federal regulations 45 CFR 46 as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Second floor, Cartwright Hall