Home
Forms Library
The HIPAA Privacy Rule, Research, and IRBs The - Applied Clinical

Get the up-to-date The HIPAA Privacy Rule, Research, and IRBs The - Applied Clinical 2025 now

The HIPAA Privacy Rule, Research, and IRBs The - Applied Clinical Preview on Page 1

Show details

4 out of 5

23 votes

The document discusses the implementation and implications of the HIPAA Privacy Rule for clinical research, particularly focusing on the responsibilities of covered entities and Institutional Review Boards (IRBs). It outlines the requirements for obtaining patient authorization for the use and disclosure of protected health information (PHI) in research, differentiates between authorization and informed consent, and explains how the Privacy Rule interacts with federal human research policies. The article also addresses various scenarios related to subject recruitment, data handling, and compliance obligations under HIPAA.

Here's how it works

01. Edit your form online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send it via email, link, or fax. You can also download it, export it or print it out.

The easiest way to modify The HIPAA Privacy Rule, Research, and IRBs The - Applied Clinical in PDF format online

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Working on paperwork with our comprehensive and user-friendly PDF editor is straightforward. Adhere to the instructions below to fill out The HIPAA Privacy Rule, Research, and IRBs The - Applied Clinical online quickly and easily:

Log in to your account. Sign up with your email and password or register a free account to test the service before choosing the subscription.
Import a form. Drag and drop the file from your device or import it from other services, like Google Drive, OneDrive, Dropbox, or an external link.
Edit The HIPAA Privacy Rule, Research, and IRBs The - Applied Clinical. Quickly add and underline text, insert images, checkmarks, and icons, drop new fillable fields, and rearrange or delete pages from your document.
Get the The HIPAA Privacy Rule, Research, and IRBs The - Applied Clinical completed. Download your modified document, export it to the cloud, print it from the editor, or share it with other participants through a Shareable link or as an email attachment.

Benefit from DocHub, the most straightforward editor to quickly manage your documentation online!

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

Who does HIPAA not apply to?

Under the preparatory to research provision, no PHI may leave the covered entity. Under the preparatory to research provision, covered entities may use and disclose PHI to researchers to aid in study recruitment. They may allow a researcher to identify, but not contact, potential study participants.

Does HIPAA apply to Irbs?

The IRB must review combined consent/authorization documents to ensure that the language meets the requirements of HIPAA. While the IRB does not approve stand-alone HIPAA documents, it does check them for accuracy and that they contain the required elements.

What is the HIPAA privacy rule for clinical research?

Under the Privacy Rule, covered entities are permitted to use and disclose protected health information for research with individual authorization, or without individual authorization under limited circumstances set forth in the Privacy Rule. Research Use/Disclosure Without Authorization.

Does HIPAA apply to research studies?

Research Health Information (RHI) is defined as data used in research that would be personally identifiable but not considered PHI and is therefore not subject to the HIPAA Privacy and security Rules.

How does the privacy rule benefit the IRB process?

The Privacy Rule permits a covered entity reasonably to rely on a Privacy Boards or an IRBs documentation granting a waiver or alteration of the Authorization requirement so long as the documentation is proper.

What does the HIPAA privacy rule apply to?

The Privacy Rule applies to covered entities,9 which are individuals or organizations that electronically transmit health information in the course of normal health care practices. Covered entities include health care providers, health plans, and health care clearinghouses.

Get the up-to-date The HIPAA Privacy Rule, Research, and IRBs The - Applied Clinical 2025 now

Here's how it works