Source: https://blog.primr.org/record-keeping-and-data-security-for-irbs-and-researchers/
Timestamp: 2019-12-15 03:04:28
Document Index: 262525131

Matched Legal Cases: ['§ 46', '§ 46', '§46', '§46', '§46', '§46']

Record-Keeping and Data Security: Insights for IRB Administrators and Researchers - Ampersand
Since the National Archives in Washington were founded they have solved historical mysteries, provided key information, and unlocked a great deal of forgotten knowledge. The power of records and record keeping is influential at all levels of human existence, but also may be harmful to the least empowered individuals in society (such as refugees or the elderly).
Speakers Ada Sue Selwitz, MA, Lisa Buchanan, MOAM, and Janet Donnelly, RAC at the 2018 Advancing Ethical Research Conference (AER18) offered insights into essential documentation and stressed the importance of good record keeping and data management.
“An Institution, or when appropriate, an IRB, shall prepare and maintain adequate documentation of IRB activities, including copies of…(§§ 46.115(a) and 56.115(a)) research proposals reviewed; scientific evaluations, if any; approved sample consent documents; progress reports submitted by investigators; and reports of injuries to subjects (§§ 46.115(a)(1) and 56.115(a)(1))”
The panelists described some of the records IRB administrators should maintain.
The IRB should maintain IRB meeting minutes, actions taken by the IRB, the vote on IRB actions, basis for requiring changes in or disapproving research, a written summary of controverted issues, discussions, and resolutions (§§46.115(a)(2) and 56.115(a)(2)).
IRB’s should also maintain records of continuing review activities, correspondence between IRB and investigators (§§46.115(a)(3)(4) 56.115(a)(3)(4)), list of IRB members, written IRB procedures, and statements of significant new findings provided to subjects (§§46.115(a)(5)-(7) 56.115(a)(5)-(7)).
How Long Shall Records Be Kept?
Records must be retained for a minimum of three years after the closure of the study.
New Documentation Requirements in the Revised Common Rule
Rationale for conducting continuing review of research that otherwise would not require continuing review.
Rationale for expedited reviewer determination that research on expedited review list is more than minimal risk.
Responsibilities that an organization operating an IRB each will undertake to ensure compliance with reliance requirements in (§§46.103(e)).
The conference panelists also described the importance of good record keeping and data management by emphasizing that every record or archive in the world is vulnerable to unauthorized access regardless of security measures.
Unauthorized access to records or archives may result in the theft of records, their alteration or destruction, and the manipulation of information. Data management is a group effort and comprised of planning, developing, implementing, and administrating consistent storage, security, retrieval, archiving, and disposal of data.
Below is a brief summary of some general data management practices and a general data security plan:
Experiences and data management practices varies widely. However, administrators and researchers can institute a data security plan by first
Reviewing existing records and determining the relevance of the documents.
Reviewing management and preservation challenges within the institution.
Refining file naming practices.
General Data Security Plan
Create a record-keeping plan
Designate roles and determine who has access to the data
To ensure the integrity of the data, access to accounts and security of logins should be regularly reviewed
Data administrators should ensure project staff are set up with unique user accounts and personal secret passwords
Project staff no longer involved in the project should have access removed immediately
Regulate physical access to fixed and removable data (e.g., hard drives, laptops, paper files, etc.).
Individual files on computers in shared offices should be secured and encrypted.
Effective record keeping, (physical and digital) data storage, and authentication offer great help in securing all holdings. Emboldening administrators and researchers to adhere to good data security practices and record keeping protects vital information for the future.
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