Is My Proposal *Research*? What Level of Review Would My Project Require?
Below is some general guidance to get you started. If after reading this and seeking guidance from your advisor, if you have any questions, please call the IRB office.
1. First, determine if your project proposal is federally protected research and therefore if you need to file an application with the Belmont IRB. Some studies and projects do not meet the federal definition of protected research, which is:
"a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
Generalizable means universally or widely applicable.
Many projects at Belmont University do not qualify as research as defined by the federal government and therefore fall out of the IRB purview. Examples include some classroom projects and quality assessment or improvement studies. If you are unsure, please check with the IRB.
2. If what you propose to do is human subjects research under federal definition, try to assess your level of review based on the projects proposed risks versus benefits for participants.
The IRB examines the level of risks versus benefits to the potential participant in your proposal.To a limited extent, the IRB will consider the scientific merit of the study design, since it would be unethical to place human subjects at risk with a study where methodological procedures are flawed such that little or no reliable information will be obtained. Primary responsibility for the review of scientific merit of your proposal rests with the school or department that is sponsoring the research.
Risk means the probability of harm, whether physical, psychological, social, legal or economic. Both the probability and magnitude of possible harm may vary from minimal risk to greater than minimal. Risks also include immediate risks of study participation, risks of breach of confidentiality, inadvertent disclosures, and risks of long-term effects. A benefit is a valued or desired outcome, an advantage. Benefits of research may accrue directly to the individual participating in the research, or benefit society as a whole, as is often the case in social, behavioral, and educational research.
3. Any study or proposal that is determined by the IRB to pose less than or equal to minimal risk to participants qualifies for exempt verification review or an expedited review. Most applications submitted to the Belmont University IRB qualify for either exempt or expedited review.
Under federal rules, minimal risk means
"that the probability and magnitude of harm or discomfort anticipated in the 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."
The IRB considers minimal risk studies as comparable to the following examples:
- tests and measures of mental status or memory functioning outside of a clinical setting;
- standardized IQ tests;
- personality inventories; or
- consumer preference surveys;
- other routine information that is not sensitive such as data gathered for educational or employment purposes where there is an expectation of standardized tests or routine examinations.
4. Any proposal that is determined by the IRB to pose greater than minimal risk to participants will be subject to a full review (a review by a quorum of IRB Committee members at a convened meeting).
Greater than minimal risk studies include the gathering of personal information that is sensitive or where the conditions are similar to those where an individual might seek professional care or counseling, such as:
- parenting problems and practices,
- depression, grief,
- illicit drug use,
- alcohol abuse,
- self-reporting of criminal behavior,
- eating disorders,
- sexual behavior,
- termination of pregnancy, and
- sensitive cultural, racial or gender issues.
Greater than minimal risk studies may also include research procedures that employ
- covert observations in settings where privacy is expected,
- collection of data that could result in embarrassment or other personal harms due to a breach of confidentiality,
- infliction of pain or physical discomfort,
- use of medical records or protected health information, or
- the enrollment of participants with impairments, disabilities or psychological disorders.
It is important to note that projects that qualify for an exempt and expedited review are reviewed on a rolling basis, whereas those that require a full review are reviewed once a month and have application deadlines as noted in the calendar.
Once you have become familiar with the general overview and directions regarding IRB applications, you may need more specific information. The menu to the right will take you to detailed guidance and instructions for your particular situation.