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Does the researcher make adequate provisions to maintain the confidentiality of data?

Robert Hood

03/06/2008 04:35 pm

IRB Committee Member Help: Does the researcher make adequate provisions to maintain the confidentiality of data?

Belmont principle Respect for Persons, Beneficence
Where to start: initial application Subject Data section, Question B
Where to start: continuing review application Confidentiality Protections section, Questions K, L
Required IRB determinations Describe specific procedures to ensure the confidentiality of participants data.
The research makes adequate provisions to maintain the confidentiality of data.
Points to consider Confidentiality refers to maintenance of the investigator's agreement with the participant about how the participant's identifiable private information will be handled, managed, and disseminated. Confidentiality refers to data; privacy refers to persons.
  • How will the data be collected, stored, used and shared? Who will have access?
  • What are the researcher’s plans for storage, handling, and sharing of data?
  • How is the data protected? (for example, through encryption, limitations on who can access, legal agreements such as data use agreements, and physical security like storing data behind locked doors and in locked cabinets)
  • Is there significant risk of harm to participants (like criminal penalties) if the data were released? Is a confidentiality agreement indicated?
  • Sometimes the only identifier linking a participant and the data (like in a survey) is the written informed consent document. If so, is an alteration or waiver of consent indicated to protect confidentiality?
Accreditation Element Element II.3.E. The IRB or EC has and follows written policies and procedures to evaluate proposed arrangements for maintaining the confidentiality of identifiable data, when appropriate, preliminary to the research, during the research, and after the conclusion of the research.
DOH Policy  
Regulations 45 CFR §46.111(a)(7); 21 CFR §56.111(a)(7)
Guidance
OHRP Guidebook Chapter 3: Basic IRB Review, Section D: Privacy and Confidentiality

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