Questions: What qualifies as "Research" requiring IRB review? What is the definition of "Human Subject"? What about research conducted as a class project? How long does it take for CHS review? Do I need to have training before being eligible to conduct human subject research? What do I need to do if I want to change something in my research? Is there someone I can call if I need assistance or have questions? Answers: What qualifies as "Research" requiring IRB review? Research means 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. top of page What is the definition of "Human Subject"? Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. top of page What about research conducted as a class project? Often students at all levels are required to conduct "research" as part of class responsibilities or activities. Most of this research does not qualify for CHS review. These are the essential questions to be answered: Will this research be published? If yes, the research is required to be reviewed prior to implementation. What will be done with the data / information? If the information is identifiable to an individual or may be used or published in the future, the research may require CHS review prior to being implemented. If you have any questions about this area please check with CHS staff before conducting or planning "class project" research. top of page How long does it take for CHS review? Applications / proposals that require full Committee review may take up to as long as two months for Committee review depending on when the application is received and the Committee schedule and agenda. Many applications take longer if the Committee requires amendments / revisions or additional material. Federal guidelines allow for some research to be exempt from IRB review or eligible for expedited review. Please check the Section on Exempt / Expedited Review. If the research qualifies for exempt or expedited review, this will normally take about seven days if all required information and documents are provided and there are no revisions or additional information required. top of page Do I need to have training before being eligible to conduct human subject research? Currently the University of Hawaii does not require training on human subject research to be eligible to submit a proposal for research. However, some federal agencies do require this training and applicants should check with any funding agency for their requirements. We do strongly recommend that University courses include human subject training within their curriculum. We also recommend anyone involved in human subject research read The Belmont Report prior to designing their research or applying for CHS review. In addition the NIH on-line training is also recommended and may be required by others. The University does occasionally conduct special training for investigators and in the future, documentation certifying the completion of this training may be required to submit a proposal for CHS review. top of page What do I need to do if I want to change something in my research? Approval to conduct proposed research is given only on the application and protocol as presented or amended at the time of approval. If there are any changes to the research protocol after this approval has been granted these proposed changes must also be reviewed by the Committee before being implemented. This includes, but is not limited to, any changes in the selection of subjects, additional questions or additional survey items, changes in the approved protocol or any deletions or additions in the approved consent forms. This applies to research approved by full Committee review, expedited review, or exempt approval. To notify the Committee of an amendment to a protocol, use the status report form.  If the protocol was originally approved as exempt, you may notify the Committee of changes using a letter detailing the changes, rather than with the status report form.  Bear in mind, if the amendment to an exempt project is sufficient to alter its exempt status, an expedited or full review may be required. If you have any additional questions about this, please contact CHS staff prior to any changes in your research. top of page Is there someone I can call if I need assistance or have questions? Yes. Please do not hesitate to contact CHS staff at 539-3955 if you have questions about any aspects of the application requirements, required forms, or eligibility criteria. You may also use the contact link to send e-mail inquiries. top of page