UMBC investigators may propose research that involves the use of previously collected data and/or specimens. Certain secondary uses of previously collected identifiable data or biospecimens may be defined as “research involving human subjects” and will require IRB review or exemption and/or may require HIPAA authorization if that data contains protected health information. The UMBC IRB is using a separate review procedure for such projects that fall under Federal exemption category (§46.104(d)(4)) [Research with identifiable private information (data, documents, records, ) or identifiable biospecimens] OR Expedited Category # 5 [research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis)].
It’s important to note that exemption category (§46.104(d)(4)) may only be used when the research with identifiable private information ( data, documents, records, ) or identifiable biospecimens where no consent is required and at least one of the following criteria is met:
- information or biospecimens are publicly available;
- recorded information cannot readily be identified(directly or indirectly/linked);
- investigator does not contact subjects and will not re-identify the subjects;
- information collection and analysis involving identifiable health information when used is regulated by HIPAA “health care operations” or “research” or “public health activities and purposes”
The IRB looks for specifics about the protocol, including:
- What is/was the primary purpose of the collected data or biospecimens?
- Who is the owner and how will the investigator acquire the data or biospecimens?
- What were research participants told regarding the use and confidentiality of their original data or biospecimens?
- Is a Data Use Agreement (DUA) required?
- Will any HIPAA Identifiers be obtained or recorded?
- Is the purpose of the research “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b)?
The final point relates to HIPAA. UMBC is NOT a HIPAA Covered Entity, therefore the exemption category may NOT be used unless the research will take place at a covered entity and that entity determines through their IRB procedures that the exemption applies or UMBC formally enters into a Business Associate Agreement with the HIPAA Covered Entity.
Please access your Kuali protocols dashboard to create an application describing the use of secondary use of data. The OPRC has created a Kuali Protocol User Guide to assist you in creating a protocol. Data or biospecimens used in the protocol would not require additional consent from participants.
Have a Kuali technical issue or problems with access? Contact the ORPC on this online form and we’ll send your issue to VPR Research Administrative Systems
Examples of secondary data and specimens that do not require IRB review or exemption
- Laboratory research with commercially available tissue specimens, cell lines, or other human cells
- Research with autopsy specimens
- Research with previously collected anonymous data and/or specimens only when the data/specimens to be studied were not collected specifically for the current research. An investigator may not de-identify data and/or specimens under his or her control (e.g., data collected by the investigator for another study) for future research uses without IRB review.
- Research with previously collected coded data and/or specimens only when all of the following conditions are met:
- The data and/or specimens to be studied were not collected specifically for the current research
- Investigator(s) cannot “readily ascertain” the identity of the source(s) of the coded data or specimens because at least one of the conditions below is met:
- The investigators and the holder of the “key” enter into an agreement prohibiting the release of the key to the investigators under any circumstances (until the source individuals are deceased)
- IRB-approved written policies and procedures for the repository or data coordinating center prohibit the release of the key to the investigators under any circumstances (until the source individuals are deceased).
Researchers are advised to review the following guidance from The Office for Human Research Protections coded private information or specimens “ Guidance on Research Involving Coded Private Information or Biological Specimens at http://www.hhs.gov/ohrp/policy/cdebiol.html .”
Additional information and regulatory guidance and proper biohazardous materials waste disposal procedures may be found on the UMBC Institutional Biosafety Committee web site.
Please contact the ORPC at compliance@umbc.edu with any questions.