General Topics

Not every topic is easy to categorize!  Start conversations here about general topics related to clinical trial accrual.

HIPPA concerns re EMR

Last Updated: Feb 8, 2013

Using the cancer registry to identify potential clinical trial candidates.

Mindenconsultant's Image

I am a Commission on Cancer-trained cancer program consultant, oncology RN, and former cancer program manager. Currently working with client hospital to assist them in increasing accrual to cancer-related clinical trials. They are working on the screening process so as to identify candidates who are/may be eligible for accrual to specific trials. I have suggested using the cancer registry to identify patients with appropriate diagnoses, who have not had prior treatment, etc. The Quality Manager and some of the clinical staff are quite hesitant to "go looking" for candidates using the registry and cite some concerns about HIPPA. I feel that the patient is already in the system and that the information can be used in this way and is not a HIPPA violation. I would appreciate hearing from others who may have addressed this issue or who may be able to tell me if this is, indeed, a HIPPA violation. Thanks to all who can shed some light on this for me.


Sona Thakkar's Image

Great question. I looked up cancer registries and HIPPA in AccrualNet and found a couple of articles, but only the second one mentioned some concerns with HIPPA. You might take a look at this article that I've linked to below. Hopefully others in the community can provide some additional thoughts.




This is a provocative question! I agree that it would be great to hear how members of the AccrualNet community of practice deal with this question.  That said,  like with most human subjects protection questions, the bottom line is that before using the registry, I would check with your local IRB about exactly how you plan to proceed. The HIPAA Privacy Rule’s “preparatory to research” provision permits covered entities to use or disclose protected health information for purposes preparatory to research, such as to aid study recruitment BUT only under certain conditions.  At the federal level, the official authority for questions related to HIPAA Privacy Rule compliance, is the U.S. Department of Health & Human Services’ Office for Civil Rights (OCR) which enforces the HIPAA Privacy Rule and according to their web site, they can be contacted at

Regarding state registries, according to the Centers for Disease Control, “The approval process for research requests for access to confidential data is specific to each state cancer registry. The approval process may require cancer registry, institutional review board (IRB) and/or regulatory group approvals.”  For listing of  each state cancer registry's requirements regarding research, by level of regulatory approval required, as of January 2012, go to Cancer Registry. Please let us know if this helps and what your IRB says. Good luck!  

Mindenconsultant's Image

Thank you both so much for this info. I will try all suggestions. I will clarify specific rules through the cdc link as well as OCR and approach the IRB for my client. Will send an update. Appreciate the help.



We'll look forward to hearing from you. Your lessons learned could save other AccrualNetters' time and energy!

Mindenconsultant's Image

For Sona Thakker - I have tried to access the article you advised me to look at but do not have access to it. Can you tell me what they referenced as far as "concerns with HIPPA"? Thank you.

Linda Parreco's Image

Responding for Sona; I repaired the link on our webpage to the pdf article, so you may be able to access it now.

If not, the discussion section of the article described one of the lessons learned in registry research as the need to factor in time and other resources necessary to recruit from different registries.For example, for researchers working outside institutions that host registries, the registry staff assumes significant responsibility for information processing and quality control. This can be challenging if staff are undertrained or overburdened. The article further states that using registries is labor intensive due to local IRB and HIPPA requirements. In this study, the registries made the first contact with a letter notifying registrants of the study and their choice to give the registry permission to share their contact information. 

Hope this additional info is helpful!

Please Login or Register to post comments.