Activities That are Typically NOT Human Subjects Research
Research involving cadavers, autopsy material, or biospecimens from now deceased individuals does not meet the regulatory definition of ‘human subject research,’ i.e., “a living individual…” However, if the research leads to information about living relatives, such as genetic studies, IRB review may be required. Contact the IRB for further information.
Description of the clinical features and/or outcome of a single patient or limited series of patients is not considered research, even if the purpose is for publication, and does not require IRB review ( see also Privacy in Research: Special Considerations for Case Studies)
No IRB review is required when data are collected from and about living individuals as part of a class exercise or assignment designed specifically for educational or teaching purposes. IRB review is required only if the intent of data collection is to develop or contribute to generalizable knowledge outside of the classroom. Nonetheless, students should be instructed in the ethical conduct of such activities and advised to obtain informed consent from their practice subjects.
Although not meeting the regulatory definition of human subject research, the privacy rights of deceased individuals are protected under the Privacy Rule. Such research does not require IRB review, but may require approval of the Privacy Board (IRB) if the research requires use of decedent Protected Health Information (PHI) and a waiver of HIPAA authorization.
To obtain a waiver, the investigator must provide documentation that:
- The PHI use/disclosure is being sought solely for research purposes;
- The PHI is necessary for the research purposes; and
- Provides documentation, upon request of the IRB, of the death of the individuals.
De-identified (or Anonymous) Data or BioSpecimen
To be considered not human subject research, the data or specimen must meet one of the following standards:
- Exists without ANY personal identifiers (see list of HIPAA identifiers) or links to identifiers.
- Provided by a research repository (Biospecimen bank, data bank, medical record system, etc.) which takes responsibility for removing any identifiers, including a code linked to identifiers, prior to providing the BioSpecimen or data to the researcher. Researcher cannot be one of the parties responsible for collecting or maintaining the source material.
- Provided by a supplier who maintains a firewall security preventing recipients from receiving access to identifiers.
A Discard Specimen is that portion of a human specimen specifically collected for medical care (diagnosis, treatment, surgery) of a patient but remains after all such purposes have been met. To qualify as Not Human Subject Research, all the following criteria must be met.
- If research specimen is to be obtained prospectively at time of this IRB submission:
- No excess specimen will be taken from the patient for research purposes at the time of specimen collection.
- Surgeon or other medical personnel collecting the specimen for medical purposes cannot be an investigator on the study.
- Specimen must be de-identified prior to research samples being provided to any of the investigators listed on this application.
- If research specimen already exists (‘on the shelf’), it resides without identifiers.
- No commercial development will result from this research.
- May include Autopsy Specimen if above criteria are met.
External Requests to Administer Surveys
Being a health science center with a faith-based mission makes LLU and its entities an attractive site for research, whether initiated by LLU or external investigators. In this case, LLU is not engaged in research and IRB review at our institution is NOT required for access by an external investigator to LLU’s students, faculty, and employees if the activity is limited to the following conditions:
- The activity is an anonymous survey or questionnaire
- The investigator does not require contact with subjects or their identifiers.
- Participation is at the discretion of the dean for the school who will:
- review the purpose the research (may also wish to see the survey tool itself) to assure that participation does not pose a conflict with institutional values or intrusion on rights of proposed subjects
- provide a mechanism for distribution of the survey in such a way that the investigator does not receive contact information (including email addresses)
- obtain evidence of appropriate IRB review at the originating institution
- communicate with the requesting investigator regarding agreement to permit distribution, including any limits or stipulations to this agreement.
Innovative therapy is not considered research when the purpose of the intervention is solely to enhance the well being of an individual patient or client. It is usually limited to a particular patient or class of patients and has no research intent.
Medical Record Preparatory Review
Reviewing patient records in order to design a research study, or to determine the feasibility of a research study, is considered preparatory to research. The Privacy Rules allows access to records containing PHI without obtaining authorization or waiver of authorization from the IRB/Privacy Board. See website and Data Request Form (see also Data Request Instructions).
Non-Clinical Program Evaluation/Improvement
The collection of data with the limited intent of evaluating and improving existing services and programs or for developing new services or programs does not require IRB approval (e.g. course evaluation, satisfaction surveys, pre- and post-data comparisons, etc). Activities receiving research grants, however, will require IRB approval because of the external sponsorship involving reporting of results.