Storage of electronic data in the Human Research Box folder or paper records filed in a locked cabinet in a locked office is an example of this type of protection.

An investigator who wishes to gain access to participant charts after they are in enrolled in the research study is required to obtain ________ before they begin collecting PHI. Hint: This language can be found in the Informed Consent Document.

A review body established to act upon requests for a waiver or an alteration of the Authorization requirement under the Privacy Rule for uses and disclosures of PHI for a particular research study. This review body may waive or alter all or part of the Authorization requirements for a specified research project or protocol.

Refers to an individual’s desire to control who has access to their data or identity.

Telephone numbers, e-mail addresses, names, and social security numbers are types of ____ that should be removed from datasets when de-identifying data.

An IRB acting as the Privacy Board may grant a _____ given an investigator meet the criteria outlined by the federal regulations (45 CFR 164.501).

This pertains to the treatment of information that an individual has disclosed in a relationship of trust. The expectation is that it will not be divulged to others without permission or in ways that are inconsistent with the understanding of the original disclosure.

An investigator plans on reviewing the medical chart of individuals in a medical clinic to see if they are eligible to be in their study. In order for the investigator to use this method of recruitment, they must first obtain a _______.

Ensuring investigators obtain the minimum necessary for data collection is an example of protecting participant ____.

When evaluating for this, the IRB must consider how the investigator will access information from or about participants. For example, an investigator collecting sensitive information from a participant in a busy, open area would violate this.

The ____ establishes the conditions under which protected health information may be used or disclosed by covered entities for research purposes.

An investigator plans on recording participant interviews without their knowledge to gain more honest answers to participants. This is a violation of participant ____.