HSPP-Newsletter January-February-March 2021
NIH Releases New Policy for Data Management and Sharing
On October 29, 2020, the National Institute of Health (NIH) published the final policy for data management and sharing (DMS). This policy applies to all research funded or conducted by NIH that results in generation of scientific data. As stated in this policy “data sharing enables researchers to rigorously test the validity of research findings, strengthen analyses through combined datasets, re-use hard-to-generate data, and explore new frontiers of discovery.” The NIH DMS Policy requires researchers to submit a plan to preserve, to share the data and to show compliance with said plan.
To learn more about the scope of this policy and the details of data management and sharing plans, please review the Final NIH Policy for Data Management and Sharing.
Limited Data Sets and Data Use Agreements
A limited data set (LDS) contains protected health information that is associated with indirect identifiers as defined in the HIPAA privacy rule. The indirect identifiers that may be included in an LDS are: town, city, state and five digit or more zip code, dates directly related to an individual such as date of birth, admission date, discharge date and date of death.
Before an LDS can be received by a UConn Health employee or disclosed to another institution, a data use agreement (DUA) must be in place between the sender and receiver of the LDS. This DUA is required under the HIPAA Privacy Rule. This agreement establishes the ways in which the information in the limited data set may be used, the purpose for which it was disclosed, and identifies who is permitted to use or receive the information.
Moreover, the DUA stipulates that the recipient will use appropriate safeguards to maintain the confidentiality and protect the data from further disclosures.
Since the data use agreements establish institutional obligations and bind the institution to the terms of the agreement, investigators are not authorized to execute research DUAs. UConn Health DUAs for research related activities are processed through the Office of Sponsored Programs Sponsored Program Services (SPS) or the Office of Clinical and Translational Research (OCTR). The specific contacts in these offices are listed below:
- If the DUA is related to a Clinical Trial contact: Cherron Payne chpayne@uchc.edu
- If the DUA is unrelated to a Clinical Trial contact: Jennifer Pomales pomales@uchc.edu
IRB Forms – Update
The Main Consent Form Template .doc has been revised to include instructional text about the option to decline payment for participation. The Main Consent Form Checklist .doc has also been revised to reflect this option.
Which Initial Application Form is the Correct One for Your Study?
Once an investigator has determined that his/her project is a human subject’s research project, the next step for the investigator is to submit the project for review and approval to the IRB. This task will require that the investigator complete the “Initial Study Application Form” within the Integrated Research Information System (iRIS).
The investigator creating a new study application in iRIS will need to select one of the three available Initial Study Application Forms listed below:
- Application for a General Study
- Application for a Humanitarian Use Device
- Application for a Registry and /or a Repository
The following section provides a description of the three Initial Application Forms available in iRIS along with examples of when each one should be selected.
Application for a Humanitarian Use Device (HUD):
According to the U.S. Drug and Food Administration (FDA) a Humanitarian Use Device (HUD) is defined as a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year. An HUD is an FDA approved device. Because the HUD device is approved for use in such a small population, the FDA regulations requires that an IRB approve the use of the HUD in accordance with its approved label even though the use of the HUD is not research.
If you are requesting approval for use of an HUD, select the application specific for HUDs.
Application for a Registry and /or a Repository:
A registry/repository is used for the collection and maintenance of information/biospecimens on individuals who have a similar condition and who will consent to being contacted for future studies. The investigator must develop a protocol that describes how the data/biospecimens will be collected, how they will be maintained, and how release of information from the registry or biospecimens from the repository will occur.
If you are requesting approval for a Registry and /or a Repository, select the application specific for Registry/Repository.
Application for a General Study:
The Application for a General Study form is the most commonly used application type. The investigators should select it when their research is categorized as either biomedical research, social & behavioral research or community based participatory research. These projects may qualify for Exempt Status or Expedited review in accordance with regulatory criteria, or otherwise they will be review by the convened board.
Examples of human subject research projects that should be submitted with this General Application Form are:
- Minimal risk studies (e.g. studies limited to a survey, studies limited to a retrospective or prospective data review, clinical studies of drugs and medical devices when the conditions for expedited review are met, studies on individual or group characteristics or behavior including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior).
- Studies submitted for full board review (e.g., investigational new drug (IND) studies, investigator new device (IND) studies, social & behavioral studies including more than minimal risk to subjects).
Research with Children
When children are to be involved in non-exempt research, the investigator must address the additional protections for the inclusion of children in research. The investigator does this by completing IRB Form D – Additional Protections for Children Involved as Subjects in Research. The additional requirements set forth on this form are derived from DHHS and FDA regulations.
On Form D the investigator makes the initial assessment of risk level and sets forth plans for obtaining parental permission and assent. The IRB reviews this form and makes the final determination as to whether the requirements for additional protections have been satisfied. Depending on the level of risk of the study, UConn Health IRB will determine whether one or both parents (or legally authorized representatives) must give their permission. The IRB will also make the final determination as to whether assent of the child is required and if so how that assent will be obtained. In making this determination the IRB will take into consideration the age and maturity of the children, and the psychological state of the children involved.
Per UConn Health policy, 2011-006.3.pdf – Additional Protections – Children the additional protections for children apply to all non-exempt research (e.g., Expedited and Full Board Submissions) that is federally funded or supported, and/or that involves an intervention or interaction with a child regardless of funding source. Therefore, the additional protections do not apply to non-federally funded or supported chart review studies that qualify for exempt status.
OHRP New Video
Research with Children: What Parents Need to Know
The Office of Human Research Protection (OHRP) has posted a new video on its public outreach website. This short video titled “Research with Children: What Parents Need to Know” is for parents/legal authorized representatives who may be or have been approach about permitting their children to participate in research. It provides an explanation as to why research-involving children is necessary, its importance and what parents should expect if considering enrolling their child in a study. This video is found under the category of Videos on Protecting Human Research Volunteer