The Office of Research Compliance, Human Research Protection Program and the Chief HIPAA Privacy Officer would like to announce a recent change made to the requirement for ancillary review. Ancillary review by the Chief HIPAA Privacy Officer is now only required if there is a Limited Data Set necessitating a Data Use Agreement.Limited Data Sets are Protected Health Information (PHI) that exclude 16 categories of direct identifiers and may be used or disclosed for purposes of research without obtaining either an individual’s Authorization or a waiver or alteration of an Authorization. A Limited Data Set can include city; state; zip code; elements of date; and data that is coded.Data Use Agreements are agreements into which the covered entity (SB) enters with the intended recipient of a Limited Data Set that establishes the ways in which the information in the Limited Data Set may be used and how it will be protected.Even if the person requesting a Limited Data Set from a covered entity is an employee or otherwise a member of the covered entity’s workforce, a Data Use Agreement must be in place between the covered entity and Limited Data Set recipient. Meaning, if you are an employee and you want to do research using patient information that could be part of a limited data set, you would need to sign a Data Use Agreement.
The Office of Research Compliance, Human Research Protection Program would like to announce recent changes made to the Standard Operating Procedures. These changes include the following:
Added regulatory information about medical device research and in vitro diagnostics
Added language about research not beginning until all necessary approvals have been obtained
Added information about drugs and device storage and maintenance; specifically that the research pharmacist or other designated individual will maintain the following:
Records of the product's delivery to the trial site. Records will include:
- Batch/serial numbers
- Expiration dates (if applicable)
- Unique code numbers assigned to the investigational products and trial participants
- Inventory at the site
- Use of the product by each participant
- Return or the product to the sponsor or alternative disposition of unused products (as applicable)
Added information about conducting satisfaction surveys with research study personnel regarding the service from the Human Research Protection Program
Added information about consent for exempt research. This includes the requirement for the following information:
- The activity involves research
- Description of the procedures
- Participation is voluntary
- Name and contact information for the researcher
- Adequate provisions are in place to maintain the privacy interests of the participants
Added language regarding requirements for continuing review. This includes the following:
- Data safety monitoring board reports
- Gov’t or sponsor audit/monitoring reports
- The status report on the progress of the research includes:
- The number of participants accrued.
A summary since the last IRB review of:
- Adverse events and adverse outcomes experienced by participants.
- Unanticipated problems involving risks to participants or others.
- Participant withdrawals.
- The reasons for withdrawals.
- Complaints about the research.
- Amendments or modifications.
- Any relevant recent literature.
- Any interim findings.
- Any relevant multi-center trial reports.
- The researcher’s current risk-potential benefit assessment based on study results.
Added information about the designation of an individual as a legally authorized representative:
- The Office for Human Research Protection (OHRP) and Food and Drug Administration (FDA) regulations state that designation of a subject’s legally authorized representative is to be determined by “applicable law” (45 C.F.R. 46.102(c); 21 C.F.R. 50.3(l)), which typically means state or local statutes, regulations or cases. OHRP guidance states that it would consider an individual to be a subject’s legally authorized representative for research as long as that state or local law provides a “reasonable basis” for allowing that individual to provide informed consent for the subject.
Added definitions for children, guardians and legally authorized representatives
Added information stating that the Investigator’s Brochure cannot be used to validate the IND or IDE and that an IND goes into effect 30 days after the FDA receives the IND, unless the sponsor receives earlier notice from the FDA
Added information that an emergency use of a test article, other than a medical device, is considered to be a clinical investigation, the patient is a participant, and the FDA may require data from an emergency use to be reported in a marketing application
Added information that there must be adequate resources to carry out research safely. This includes, but is not limited to, sufficient research time, appropriately qualified research team members, equipment, and space
Added information that PIs and members of the research team including students:
- Must take CITI training for conflict of interest:
- Required every 4 years (regardless of funding)
- Education is required immediately when:
- Financial conflict of interest policies are revised in a manner that changes research requirements
- A researcher is new to the organization
- A researcher is non-compliant with financial conflict of interest policies and procedures
Requests for a “review preparatory to research” must receive prior approval from the HIPAA Privacy Officer. The Institutional Review Board does not need to review this request.
The National Institutes of Health have indicated that they will not issue discretionary Certificates of Confidentiality for the establishment and maintenance of data/biospecimen repositories where the main original source of the data/biospecimens was for clinical care or commercial purposes, rather than research sources. NOTE: a Certicate of Confidentiality (CoC) request for individual studies using data or biospecimens from the repository will be considered for a CoC.
The protocol template for human subject exempt research is now available for use. This template is short and includes only those questions that pertain to exempt research. A corresponding consent document for exempt research is also available. Both of these newly designed documents can be found in the myResearch IRB library.
Additionally, the protocol template for research that requires regulatory oversight has been redesigned to better meet the needs of researchers and study team members. Questions that were redundant or not applicable have been removed. Questions that were difficult to understand were re-written. Template questions have been organization into sections that pertain to the content of the question. The protocol template is shorter and easier to use. You can find the newly designed template in the myResearch IRB library.
During the fall of this year, the Office of Research Compliance (ORC) in conjunction with the Chief Medical Officer Stony brook University Health Sciences Center developed a new system for Quality Improvement projects. As of November 1, 2021 all Quality Improvement projects must be submitted in the Qualtrics system. Quality Improvement projects that are already in IRBNet will remain in IRBNet. The portal to the Qualtrics system is located at https://research.stonybrook.edu/myResearch.php/.
In an effort to make this transition as smooth as possible, the ORC has been offering informational sessions for the campus community beginning in September. If you would like an informational session on changes to the Quality Improvement process, please contact Rebecca Dahl at email@example.com.
A quality improvement webpage was created to assist those individuals interested in developing a Quality Improvement project. The webpage is located at