Categories of Research
Research team never has contact with subjects OR personally identifiable data (may obtain coded data from another source if a confidentiality agreement is signed and submitted).
Research team has contact with subjects OR personally identifiable data, but risks to subjects are minimal and the research falls into one of the following categories (these two are most commonly applicable):
- Educational, observational, or survey research that either
- Collects identifiable information (not only name but also dates, medical record numbers, geographical information, etc) about the subject but the result of disclosure poses no risk to subject’s employability, insurability, reputation, or
- Information for the study is recorded in an anonymous manner such that it is impossible to identify the subjects; OR
- Review of identifiable data that all exists at the time of submission to the IRB, AND data is recorded in an ANONYMOUS manner for the research (no codes).
This is a frequent category for medical record review, but only has limited power because all the records must exist upon submission to the IRB and your research records cannot contain any identifiers or codes. Once approved you can never add future data or link data on these subjects. If you think you may want to do this you should submit you research as Expedited (see category III. (D) below) rather than Exempt.
- Educational, observational, or survey research that either
Research team has contact with subjects OR personally identifiable data, but (1) risks to subjects are minimal and (2) the research falls into one of the following categories (these four are most commonly applicable):
- Collection of blood samples;
- Collection of other biological specimens for research purposes through noninvasive means;
- Collection of data through noninvasive procedures routinely used in clinical practice; OR
- On materials (data, records, specimens, etc) collected or will be collected for nonresearch purposes. This is the other, more powerful category for approving medical record review research. Under this category you may collect identifiable information, and you may look at information from any point in time – past, present, or future. You may add new data points to correlate to previously collected data. Because this is more powerful, additional protections are needed. Not only is the paperwork longer, but if you wish to collect information out of the medical record in the future, you will probably need to obtain consent from the subjects! (Remember – as a clinician you have the right to review your patient’s records for treatment, but that right does NOT extend for research purposes). To review medical records for research you must either obtain permission from each individual or a waiver from the IRB!
All research where risks to subjects are more than minimal or which does not fit in any of the categories above. Includes not only experimental medical research (drugs/devices), but also research that collects identifiable information that could adversely affect the subject’s insurability, employability, reputation, etc if accidentally disclosed; psychological research that could adversely affect subject’s mental/emotional well being; etc. The Full Board usually meets on the first and third Wednesday of each month. There is a hard deadline to submit your paperwork to the IRB-01 office for each Full Board meeting. Exceptions are usually only granted for subject safety or extenuating circumstances.
Tissue and/or Data Banks
Many researchers want to collect and store tissue or data in order to use it for different research questions in the future. Banks are very powerful tools once approved by the IRB, particularly if subjects consent to having their information/samples stored for research purposes. If the banking consent also details that the subject is willing to be contacted about future research, the bank can also be a powerful recruiting tool. How information goes into the bank determines how it can come out. In particular any information that goes into the bank without subject consent must come out de-identified – meaning it can’t be linked to other records and subjects can’t be contacted about participating in other projects. Taking the time to obtain consent makes the bank a much more powerful tool.
HUD/HDE: Humanitarian Use Device / Humanitarian Device Exemption
Certain devices are not yet approved by the FDA but have been granted a Humanitarian Device Exemption (HDE) for use in patients. The FDA requires clinicians to obtain IRB approval prior to using Humanitarian Use Devices (HUDs). HUDs can be used in two different ways
- for treatment purposes only (e.g. not to answer a research question or to collect any information for publication purposes); OR
- as part of a research protocol.
In the event that you are using a HUD as part of a research protocol you must submit Full Board paperwork (since this would be considered greater than minimal risk). Otherwise, if you only wish to use the HUD for treatment purposes, we have special paperwork for submission. Of note – you must seek initial and continuing (usually annual) approval to use the HUD.
Sometimes patients have a life-threatening or possibly severely debilitating condition where there are no acceptable treatment alternatives. In such a case a clinician may use an unapproved treatment/article (drug, device or other) prior to obtaining IRB approval. The clinician however must submit the IRB’s Emergency Use paperwork within 5 days of the using the unapproved article.
- Usually the manufacturer of the unapproved article requires the clinician to obtain an acknowledgement from the IRB chair that this meets Emergency Use conditions. You may contact our chairs directly to obtain such an acknowledgement. Our Chairman, Dr. Iafrate, can be reached at 352-273-9600.It is important to note: Emergency Use is not identical to Compassionate Use or Treatment INDs. The usual difference between Emergency Use and these categories is (a) the patient doesn’t have a life-threatening/severely debilitating condition, and/or (b) there are alternative treatments available.
- View the Emergency Use Checklist
- Within five days of using the unapproved treatment submit the Report of Emergency Use of a Test Article without IRB Review.
- Patients/legally authorized representatives should be consented prior to using the device. The manufacturer of the test article usually has a sample Informed Consent form. If not, you may use our sample Emergency Use Informed Consent form.
- Lastly, if the subject cannot consent for themselves or if a legally authorized representative is not available, you may use the unapproved article without consent provided you obtain certification from an independent physician (use and submit this form).
NOTE: the regulations indicate that each institution may only use an article Emergently once. Regulations indicate that researchers at the institution must obtain IRB approval prior to any subsequent uses of the article. What happens if another patient arrives and needs the test article emergently? If you or another investigator chooses to use the unapproved article on a second or greater occasion, follow the steps described above. Be advised however that the IRB will have to report this additional use to the FDA. It is possible that the FDA may choose to take action against you if you had the opportunity to obtain IRB approval prior to using the article.