Are you looking at patient data before they consent to a study?

Do you ever find yourself in the position of needing to look at patient data before those patients have consented to be in a study. Two examples:

• You’re thinking about writing a grant on adrenoleukodystrophy, but you need to know if we see enough patients at OHSU to be able to design a single site study or if you need to collaborate with colleagues at the Children’s Hospital in Washington, DC. Are you allowed to do a query through the Research Data Warehouse to get a list of all the OHSU patients with adrenoleukodystrophy before you have IRB approval of the research study?

• You just got an industry study for a new treatment for Type 1 Diabetes with kidney failure and they need you to enroll FAST. You want to look at your clinic records and make a list of the possible patients to call, but you have to look at their medical record to see if their renal function labs are abnormal. Obviously, they haven’t consented yet for me to collect this data…

What should you do?

Federal law recognizes and accommodates situations in research projects where it is necessary to look at patient data BEFORE they have consent. These include situations such as those above, and are termed, “Activities Preparatory to Research.” These activities are those necessary to prepare a research protocol, develop a hypothesis, write a grant application or identify participants who may be recruited for research.

Whenever protected health information (PHI) is going to be used for one of these activities, the law requires that the investigator notify the OHSU IRB of what they propose to do, and certify that certain requirements are met, specifically that PHI is going to be used solely for these preparatory activities and is necessary for those activities, and that they will not remove the PHI from OHSU (Note: if sending the PHI to an outside collaborator is needed for one of these activities, then the investigator should request a waiver of HIPAA authorization instead). For more information, see the OHSU Research Integrity Policy: HIPAA Activities Preparatory to Research or the NIH’s HIPAA Privacy Rule: Information for Researchers

How do you do this?

If you are preparing a grant application or research protocol and don’t yet have an IRB submissions, the Certification for Activities Preparatory to Research form must be submitted to the IRB by creating a new study submission using the Request a Determination route via the eIRB system. Note that anyone on the study team can be named as the PI for a Request a Determination submission; however, the person listed as the PI must submit the request.

However, the PI of the research study is required to sign the Certification for Activities Preparatory to Research form. The signed document can be scanned and uploaded to the Request a Determination submission (preferred), faxed to the Research Integrity Office (503-346-6808), or sent to the Research Integrity Office via campus mail (L-106RI).

When the IRB Chair approves this request, study staff will receive a formal notification via the eIRB notifying researchers that they may begin their prep to research activities. The IRB signed prep to research form will be uploaded in the eIRB for researchers to access.

If you are preparing a recruitment list, the Certification for Activities Preparatory to Research form should just be uploaded with the rest of the study documents for the IRB New Study submission. If you want to start your recruitment list before you have final IRB approval, use the “Contact Reviewers” function on the left bar on the main study page in the eIRB to let the IRB analyst know that you would like to start preparing your recruitment list before the study has final approval. They will notify you that you may begin your prep to research activities.

If you have questions, please feel free to call the helpdesk at 503-494-7887, option 1.