This module covers only a select few of the regulations and should not be seen as an authoritative legal source for the HIPAA Privacy Rule. A breach of confidentiality violates a person’s rights and poses a risk of dignitary harm to the research participant, ranging from social embarrassment and shame, to stigmatization, and even damage to social and economic status, such as loss of employment and health insurance. We are now conducting more research in the behavioral sciences, the social sciences, economics, and psychology, resulting in increasing amounts of personal information being collected. (*In this module, the term “research participant” is used synonymously with 'research subject.”)ĭignitary harms are those caused by an invasion of privacy they are an insult to a person’s respect and control.

Since the earliest days of medicine, the notion of privacy and confidentiality has been the cornerstone of the patient-physician relationship more recently, it has become a crucial consideration in the research participant*–researcher relationship.

Given our modern research setting, with growing dependence on computers, the Internet, and the need for databases and registries, protection of an individual’s privacy is now one of the greatest challenges in research. Whatsoever things I see or hear, in my attendance on the sick or even apart there from, which on no account one must spread abroad, I will keep to myself holding such things as sacred secrets. 1: Why are privacy and confidentiality of fundamental importance in research?Ģ: Federal Regulations, Guidance, and ProtectionsĢ.1 Code of Federal Regulations Title 45 Part 46: The Common RuleĢ.2 Food and Drug Administration Regulation: 21 CFRĢ.3 Certificates of Confidentiality (CoC)Ģ.4 HIPAA Privacy Rule: Relevance for ResearchĢ.4.2 Recruitment: Identifying and Contacting Research ParticipantsĢ.4.3 Authorization to Use Protected Health InformationĢ.4.4 Transition Provisions: Research that started before April 14, 2003Ģ.4.11 Public Health Surveillance Research and HIPAAĢ.4.12 Minor’s Rights to Keep Certain Categories of ProtectedĢ.4.14 Fines Imposed for Violation of HIPAAĤ: Data Protection: Protecting Data is Key to Reducing RiskĦ: Genetics Research: The Uniqueness of Genetic InformationĦ.1 Genetic Privacy of Individuals and Databasesħ: Special Considerations in the Application of Privacy and Confidentialityħ.2 Social Sciences and Behavioral Research (SSBR)ħ.9 High-Profile Research: Disclosure in the MediaĨ: Reporting Breaches of Confidentiality to the IRB and the Privacy Officer/Board

Breach of confidentiality