Investigator Guidance for the Implementation of Documenting and Reviewing Research Related

Investigator Guidance

Investigator Guidance for Creating or Amending ICF Documents and HIPAA Form B to include Medical Tests Ordered for Research Purposes in UChart

DEFINITIONS: 1. “health-care studies” are narrowly defined in this project as being those involving drugs, devices, biologics or an investigational agent 2. research participants affected by this change are only those who: a) are currently in active treatment (or who will be enrolled in the future) in a UM health-care study

b) are or will be patients at a UM clinical care facility c) have a UM medical record

d) are receiving (or will receive) research-related health-care tests ordered through the UChart system

GENERAL PRINCIPLE:

Effective December 1, 2010, the University of Miami (UM) Health System implemented an important project of advantage to patients at a UM facility who have a UM medical record. This includes currently (or future) enrolled participants in UM health-care research studies. This project is known as UChart, an electronic system which will maintain medical records and improve access to medical information. To lessen any possibility of conflicts between medical care and research activities, the consent forms signed by current (or future) participants in UM health-care related studies will be included in the UChart electronic medical record system and the system will now denote whether an individual is a current research participant. In addition, some study-related research information ordered through UChart by research personnel (e.g. the results of standard testing, imaging procedures, treatment-related interventions etc) may also be placed in the UChart system. This will be done to supply as complete a record as possible to health-care providers and other authorized University of Miami staff who may not be engaged in the research study but who are involved in the provision of medical care to the participant.

Participants and investigators should be assured that the confidentiality and privacy of UChart records will continue to be governed by laws such as HIPAA.

12/10/10 Investigator Guidance

REGULATORY REQUIREMENTS

Current research informed consent and HIPAA authorization documents do not notify research participants who are receiving research-related tests ordered through the UChart system that their laboratory (or radiology etc) test results will be included in UChart. To comply with federal regulations governing research, these documents must be amended (and future documents created) to specifically notify applicable participants that their research-related test results will be included in UChart and that these results will be viewable by their clinical care providers and others. The Human Subject Research Office (HSRO) has prepared this notification to provide guidance for the submission of documents required for IRB approval of future (new) studies and to facilitate the submission of required amendments to existing studies. .

FORMS AFFECTED BY THIS POLICY:

NEW FORMS

i. UChart Notification letter (for previously enrolled subjects) ii. ICF UChart Addendum (For enrolled subjects in active treatment)

EXISTING FORMS i. Revised ICF UChart template language (For new studies) ii. Revised HIPAA Authorization Form B (for new and existing subjects in active treatment)

REQUIREMENTS FOR EXISTING HEALTH-CARE RESEARCH STUDIES

Principal Investigators of on-going health-care research studies are responsible for the following: 1. Notify subjects in active treatments by mail that they will be identified in the UChart system as a research participant and that the results of research-related health-care tests ordered through the UChart system will be included in their UChart medical record. NOTE – the standardized language for this notification may be found on the HSRO Website (www.HSRO.miami.edu), under “Recent Updates” and “UChart Forms & Guidances”. This language has been approved by the UM IRB and may not be changed. The IRB has determined that this notification must be sent to all appropriate research participants no later than January 30, 2011. 2. Currently enrolled subjects (in active treatment) must be asked on their next regularly scheduled research encounter to review and sign two documents:

12/10/10 Investigator Guidance

a) An addendum to the original informed consent documents. This addendum will explain the UChart project and inform research participants that their research- related test results will be included in their UChart medical record. An amendment must be submitted to appropriately add this form in eProst. An approved template of the ICF Addendum is provided for immediate use until April 30, 2011. This form is to be used until the amendment adding the Addendum to the study is approved. This addendum entitled (Addendum to Medical Informed Consent Form) may be found on the HSRO website (www.HSRO.miami.edu) under “HSRO Forms and Documents”. b) A revised HIPAA authorization Form B (Revised 12/10//2010). This form may be found on the HSRO website (www.HSRO.miami.edu) under “HIPAA”. If currently enrolled subjects are unwilling to consent to the inclusion of research-related test results in UChart, the PI/ study team must either cease that person’s participation in the study or conduct the research using tests ordered through systems other than UChart.

3. Submit an amendment to include the notification letter, ICF addendum, revised ICF and HIPAA form B.

4. Use the revised informed consent and HIPAA documents to enroll new subjects into the currently on-going health-care study.

NOTE – it is recognized that some new participants may be enrolled in the period between UChart implementation and the time the amendment is submitted for review and receive IRB approval. During that period, the participants may sign current documents but they must also be given the ICF addendum and the updated HIPAA Authorization form.

REQUIREMENTS FOR FUTURE (NEW) HEALTH-CARE RESEARCH STUDIES

Applications for health-care research studies submitted after December 14, 2010 must include informed consent and HIPAA documents revised per templates dated 12/10/10.

For further clarification, please feel free to contact the Human Subject Research Office at 305-243-3195.

12/10/10