Who are the IRB members?

An IRB consists of at least five members of varying backgrounds. IRB members should have the professional experience to provide appropriate scientific and ethical review. An IRB must have at least one scientist member and at least one member whose primary concerns are nonscientific.

What are the responsibilities of the IRB?

The IRB is a university committee that performs ethical review of proposed research involving human subjects and monitors continuing research. The IRB is also responsible for providing training on the protection of human subjects in research.

What is an IRB chair?

In addition to their responsibilities as a voting IRB member, the IRB Chair and Vice Chair oversee IRB meetings to ensure reviews and approvals consider with regulatory requirements, the Belmont Report, state laws, and University policy.

What is IRB composition?

Composition of IRB Each IRB committee includes persons able to ascertain the acceptability of the proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. Each IRB committee includes members of more than one profession.

Does Hipaa prohibit physicians from discussing recruitment into studies with patients for whom involvement might be appropriate?

Does HIPAA prohibit physicians from discussing recruitment into studies with patients for whom involvement might be appropriate? Physicians can continue to discuss such options with their own patients, since this would be part of treatment.

Which data can a monitor Remove from the site with the subject authorization?

The following identifiers must be removed from health information if the data are to qualify as a limited data set:

• Names.
• Postal address information, other than town or city, state, and ZIP Code.
• Telephone numbers.
• Fax numbers.
• Electronic mail addresses.
• Social security numbers.
• Medical record numbers.

What is the difference between consent and authorization under the Hipaa privacy rule in terms of research studies?

If you do decide to obtain consent, you have complete discretion to design a process that best suits your needs. By contrast, the Privacy Rule requires an “authorization” for uses and disclosure of protected health information not otherwise allowed by the rule.