Following is a summary of the research categories that determine the type and level of review required. Instructions for submitting research applications are posted in the How to Apply for IRB Approval section of this website.
1. Not Human Subjects Research
The UH Human Studies Program has authority under federal regulations and through an agreement between the University of Hawaii and the federal Office for Human Research Protections (OHRP) to review, approve and provide oversight to human subjects research . If a study is does not qualify as human subjects research, it does not require review and approval by the UH Human Studies Program or a UH IRB.
To qualify as human subjects research, as defined by federal regulation, a project must meet the following standards:
- It must qualify as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. By definition, if study results will be published in a scholarly journal, book, or online; placed in a library (such as dissertation research) or presented at an academic meeting, the study meets the generalizable knowledge test. Projects that are designed to answer a research question, draw conclusions about a specific hypothesis, or apply study results beyond the specific focus of the research are also considered to meet the generalizable knowledge standard. AND
- It must involve obtaining information about living individuals:
- Through intervention or interaction with these individuals, or
- By accessing private information from which individuals can be identified directly or indirectly through a link or code. This includes accessing existing private data that identifies individuals even if these individuals will not be contacted under the project.
If the project involves only the analysis of publicly available data (e.g., census data, large public survey datasets with no individual identifiers, or public information available on the internet), it is not considered to be human subjects research.
If this is a UH class project from which data will only be submitted to your instructor for a class grade and will not be published, presented at an academic conference, provided to an agency as a formal report, or used to qualify for a graduate degree, it is also not considered to be human subjects research.
Typically, if a focus group is being convened to develop a study instrument, this is not human subjects research, even if the study instrument will eventually be used to conduct a research project that will qualify as human subjects research.Back to Top
2. Exempt Research
Federal regulations permit some human subjects research to be exempt from IRB review, approval and oversight. Most human subjects regulations do not apply to exempt research; however, exempt research must be performed according to the principles described in The Belmont Report. Consistent with these principles, informed consent is generally required unless specifically waived by the Human Studies Program. For more information, see Informed Consent: Model Forms and Guidance on this website.
Research involving prisoners, fetuses, pregnant women, or in vitro fertilization do not qualify as exempt. Categories that qualify a study as exempt include:
- Research conducted in established or commonly accepted
educational settings, involving normal educational practices, such
- Research on regular and special education instructional strategies, or
- Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures, interview
procedures or observation of public behavior, unless:
- Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
- 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. (Note: If research involves anyone below the age of 18, this category does not apply and the research is not Exempt.)
- Research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures, interview
procedures, or observation of public behavior that is not exempt
under the paragraph above, if:
- The human subjects are elected or appointed public officials or candidates for public office; or
- Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- 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. (Note: Such materials must already exist at the time the research is proposed.)
- Research and demonstration projects which are conducted by or
subject to the approval of Federal or State Department or Agency
heads and which are designed to study, evaluate, or otherwise
- Public benefit or service programs;
- Procedures for obtaining benefits or services under those programs;
- Possible changes in or alternatives to those programs or procedures; or
- Possible changes in methods or levels of payment for benefits or services under those programs. (Note: This applies only to Federal agencies or departments, not State or Local agencies)
- Taste and food quality evaluation and consumer acceptance
- Wholesome foods without additives are consumed; or
- 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.
Only the UH Human Studies Program may approve a study as exempt. If you believe that your research qualifies for exempt status, complete the Human Studies Program, Application for Exempt Status for Human Subjects Research. This application form is only for exempt research. If it is determined that the research is non-exempt, a completed Application for Approval of a New Study Involving Human Subjects is required.
Exempt research does not require continuing review. However, if changes in the study design, methods or IRB-approved documents are proposed, the Human Studies Program must be contacted, prior to implementing the change. See How to ApplyBack to Top
3. Non-Exempt Research
Non-exempt research is governed by federal regulations, including the DHHS regulations (45 CFR 46, Protection of Human Subjects) also known as the Common Rule. Non-exempt research may also be governed by US Food & Drug Administration regulations (21 CFR 50, Protection of Human Subjects and 56, Institutional Review Boards). Other regulations may apply.
Non-exempt research must be reviewed by the IRB, either in a convened meeting or through an expedited review process. The type of review process used is determined by federal regulation as interpreted by the Human Studies Program staff.
Approval of a non-exempt study cannot exceed one year. Prior to expiration of IRB approval, the PI must submit an IRB Continuing Review Application. If IRB approval expires before the IRB has re-approved the study under a continuing review process, all study activities must stop except those necessary to prevent apparent immediate hazards to study subjects or others.
In order for non-exempt research to be approved, the IRB must determine that all of the following criteria are satisfied:
- Risks to subjects are minimized;
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result;
- Selection of subjects is equitable;
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative;
- Informed consent will be appropriately documented (generally by a signature on the consent form);
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects;
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data; and
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
The IRB has several options following review of a proposed study. It can:
- Approve the study (for a period no greater than one year);
- Approve the study with stipulations, which must be satisfied before the study can receive the final approval necessary to initiate study activities;
- Disapprove the study; or
- Defer decision-making on the study until further information or documents are received from the principal investigator. When they are received, the review process will continue until the IRB determines whether to approve or disapprove the proposed study.
3.A. Expedited Review
Federal regulations permit some non-exempt research to be reviewed under an expedited review procedure. Initial and continuing review applications must qualify as minimal risk and fulfill at least one of the expedited review categories defined by federal regulations. Applicable regulations and UH policies and procedures on the expedited review process is documented in SOPP 106, Expedited Review of Human Subjects Research.
Minor modifications to IRB-approved research may also qualify for expedited review as described in the Human Studies Program SOPP 103, Submitting Modification Requests to the IRB .
Expedited review is performed by the IRB Chair or an experienced member of the IRB designated by the Chair. All applications received by the Human Studies Program are screened to determine if they qualify for expedited review. The decision to use the expedited review procedure is made by the Human Studies Program staff. Even if the staff determines that a study qualifies for expedited review, the IRB expedited reviewer may request that the study be forwarded to the IRB for review at the next convened meeting.
Approval under an expedited review procedure does not guarantee a faster turn-around time than review by the full IRB at a convened meeting. Turn-around time is determined by a number of factors including the complexity of the research, the workload of the reviewer, and the quality of the IRB submission.
Studies approved under an expedited review procedure are subject to all applicable regulations, including requirements for informed consent and continuing review.Back to Top
3.B. Full IRB Review
Research that does not qualify for exempt status or expedited review must be reviewed and approved by a quorum of IRB members at a convened IRB meeting. The convened IRB may perform initial review of proposed research studies, continuing review of IRB-approved studies, review of proposed study modifications, as well as review of unanticipated problem and protocol violation reports. Each of the UH IRBs meets monthly and has the authority to:
- Approve or disapprove proposed research;
- Require modifications in proposed research as a condition of approval;
- Require modifications to ongoing research and/or to research documents based on considerations of participant protection;
- Suspend or terminate ongoing research as necessary to protect current or potential participants;
- Require that specific information be provided to participants to fully inform them of study procedures, risks, and benefits that may affect their willingness to participate in the research;
- Require, waive, or alter informed consent (or documentation thereof) consistent with federal regulation; and
- Monitor any part of the research process.
The process for applying for full IRB review is the same as for expedited review; except, for full IRB review, submission deadlines apply. For information on the application process, see the How to Apply for IRB Approval section of this website.
When the IRB has completed its review, the Human Studies Program will communicate the IRB’s decisions, stipulations and recommendations to the Principal Investigator (PI) in writing. Study activities may not be initiated until the PI has received written documentation of final IRB approval.
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