Clinical Research Topics in this section: Data and Safety Monitoring for Clinical Research Drugs and  Biologics Used in Clinical Research Medical Devices Used in Clinical Investigations Human Gene Transfer Research

Vulnerable Populations Requirements When Children are Research Participants Children are considered a vulnerable research population because their intellectual and emotional capacities are limited and therefore, they are legally incompetent to give valid informed consent. Investigator’s interested in enrolling children are required to address specific additional questions when completing the electronic IRB Application or when requesting…

Protected Health Information (HIPAA) HIPAA and Human Subject Research The Health Insurance Portability and Accountability Act of 1996 (HIPAA) contains provisions to protect the confidentiality and security of personally-identifiable information that arises in the course of providing health care. The intention of HIPAA is to protect patients from inappropriate disclosures of Protected Health Information (PHI)…

The General Data Protection Regulation What is the General Data Protection Regulation (GDPR)? The General Data Protection Regulation (GDPR) is a European privacy law in effect as of May 25, 2018. GDPR protects the personal data of individuals located in the European Economic Area (EEA), which includes the European Union, the United Kingdom, Iceland, Liechtenstein and…

Data Security California law requires that residents be notified when their electronic medical or health insurance information has been exposed. The costs of notification can be significant and departments may be at risk for notification costs if identifiable medical data are lost, stolen, or otherwise exposed.  The below covers data security procedures to help prevent…

Privacy and Confidentiality The criteria for IRB approval require that there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data. In addition, for certain research, the National Institutes of Health will issue a Certificate of Confidentiality (CoC) to provide additional privacy protections to human research participants. Certificate of Confidentiality (CoC) Guidance –…

Use Of Surrogate Consent In Research If a prospective subject cannot consent on his/her own behalf, federal regulations permit researchers to obtain consent from a legally-authorized representative. California Health & Safety Code 24178 defines the categories of individuals who are legally authorized in California to provide surrogate consent for research. In order for researchers to…

Consenting Subjects Who Do Not Read, Speak or Understand English or Who Are Differently Abled The purpose of this guidance is to explain how researchers should obtain and document informed consent for subjects who: Are non-English speakers and require an interpreter and translated consent materials, or Understand English but cannot read due to blindness or…

Drafting the Informed Consent Form Format and Style of Informed Consent Documents- Key Points The IRB strongly encourages Investigators to use the standard UCI IRB consent template, which is available on the Applications and Forms page. The template is written in the 2nd person. IRB requires that the consent and assent documents be written in…

Required Elements Of Informed Consent 45 CFR 46.116   General requirements for informed consent. (Note: UCI will not be implementing broad consent.) (b) Basic elements of informed consent. Except as provided in paragraph (d), (e), or (f) of this section, in seeking informed consent the following information shall be provided to each subject or the legally authorized…