Research involving the collection or study of biodata and on biological materials such as human tissues or specimens.
- The submission is first confirmed as covered research with living human subjects or their identifiable, private information - review Research on Data
- Then, eligibility for exemption is determined.
- If review takes place under expedited procedures or by the full board, these Criteria for Approval will need to be met in addition to any applicable state or local laws and University/HRRC policies.
Harms that occur from research on biodata or biospecimens typically occur from a breach of confidentiality as most materials exist at the time the research is proposed or will exist in the future for non-research purposes. Risk of harm from research procedures utilized for the collection of biodata/biospecimes for research purposes will be evaluated apart from procedures employed during clinical practice for treatment purposes. Also see the Intervention methodology section.
Additional considerations for Biobank Repositories
Researchers are advised to address the following criteria for approval in their materials
- Identifiability (to the researcher) of individuals to their material:
- Initially upon data collection
- Retention of direct identifiers to the data
- Retention of indirect identifiers if the researcher has access to the linking code/key
- Ability of the researcher or others outside of the research context to identify individuals based on demographic clusters
- Plan to protect participant privacy and the confidentiality of information obtained
- Privacy - would a reasonable member of the research population consider the information being collected to be private? Would the release of that information without their permission be considered an invasion of privacy?
- Does the data security plan provide adequate confidentiality in order to manage the risk of a study to minimal?
- 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
- Informed consent:
- Is there a plan to obtain informed consent or will a waiver be requested?
- Has the Privacy Rule/HIPAA been considered? <link>
- If consent will be obtained, has the following been communicated:
- intended use of material collected, including excess tissue, project purpose and scope
- request for future use, if any
- any plan to share research findings or individual results; appropriateness of referrals for genetic counseling
- risks to breach of confidentiality
- see Biobank Repositories for additional considerations
- Any risk involved in biodata collected for research purposes vs. procedures performed during the course of medical care
- Benefits to the individual, if any
A note about genetic studies: germline cell studies represent the inherited potential of the individual so the IRB may not only consider implications to the specimen-donor, but also to future immediate and extended family along with ethnic groups. Somatic cell studies of diseased tissues may carry mutations as a result of many extrinsic factors so their is generally little to consider with regard to others beyond the donor. Researchers should attempt to anticipate and facilitate the conversation surrounding these unique issues within their research plan.
Additional considerations for biodata obtained via Intervention.
Reviewers will also be interested in assessing
- Whether the PI is qualified to conduct the methods described
- Adequate maintenance, calibration, training and use of biodata collection instruments or devices
- Whether FDA regulations apply <link>
- Appropriate physical space or resources utilized
Level of Review Distinctions
Researchers often request assistance in determining whether their interaction-based research is eligible for exemption or if it will be reviewed under expedited procedures or by the full board. Protocols may be eligible under multiple categories; the most protective standard will be applied.
More on Levels of Review
Exemption Criteria for Research on Biodata / Biospecimens
De-identified data (exempt cat. 4)
- May involving the collection or study of existing materials, where existing means existing at the time the research is proposed or that will exist in the future for non-research purposes (collection occurs primarily for another purpose)
- May include data, documents, records, pathological specimens or diagnostic specimens -IF-
- the sources are publicly available -OR-
- the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects
More about Research on Data
NOTE: Research involving prisoners may not be exempt. Research to which FDA regulations or policies apply are not eligible for exemption categories 1-5.
Expedited Criteria for Research on Biodata / Biospecimens
Prospective collection of biological SPECIMENS for research purposes by noninvasive means (expedited cat. 3)
- MUST be minimal risk (procedures may be managed to minimal risk)
- Examples: hair and nail clippings in a non-disfiguring manner; deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; permanent teeth if routine patient care indicates a need for extraction; excreta and external secretions (including sweat); uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or wax or by applying a dilute citric solution to the tongue; placenta removed at delivery; amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; sputum collected after saline mist nebulization
Collection of DATA through noninvasive procedures routinely employed in clinical practice (expedited cat. 4)
- MUST be minimal risk (may be managed to minimal risk)
- May NOT involve general anesthesia or sedation, or procedures involving x-rays or microwaves
- If employing a medical device, it must be cleared/approved for marketing and being used in accordance with the FDA clearance (may not be testing safety/efficacy or new indication)
- Examples: physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subjects privacy; weighing or testing sensory acuity; magnetic resonance imaging (MRI); electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for NONRESEARCH purposes (such as medical treatment or diagnosis) (expedited cat. 5)
- Risk of breach of confidentiality must be minimal risk (may be managed to minimal)
- Includes the recording of identifiers, otherwise eligible for exempt cat. 4
Research on biodata/biospecimens that do not fit into an exempt or expedited category must be reviewed and approved during a convened full board meeting.
Is this human subjects research? OHRP Guidance: