Interest” means holding any executive position in, or membership on a board of a business entity, whether or not such “Business activities are compensated. 4.1 Do any of the investigators or personnel listed on this research project have a business interest or a financial interest of $10,000 or more ($5,000 or more if research is funded by a Public Health Service (PHS) agency or researcher is involved in clinical health care) associated with this study when aggregated for themselves and their family members? No. Yes. If yes, identify the individual(s) and complete section 4.3: 4.2 Do any of the investigators or personnel (when aggregated for themselves and their family members) listed on this research have: Ownership interests less than $10,000 ($5,000 if research is funded by PHS or researcher is involved in clinical health care) when the value of interest could be affected by the outcome of the research? No. Yes. Ownership interests exceeding 5% interest in any one single entity (or any equity interest in a traded entity if research is funded by PHS or researcher is involved in clinical health care)? No. Yes. Compensation less than $10,000 ($5,000 if research is funded by PHS or researcher is involved in clinical health care) when the value of the compensation could be affected by the outcome of the research? No. Yes. If yes, identify the individual(s) and complete section 4.3: 4.3 Has the business or financial interest been reported? N/A (No business or financial interest indicated in 4.1 or 4.2) No. Yes. If yes, have you been informed that a Conflict of Interest Review Committee is reviewing the information you reported? No. Yes. The IRB will verify that a management plan is in place with the Conflict of Interest (COI) Program. If the COI Program does not have an approved management plan in place for this research, they will contact the individual(s) listed in question 4.1 for additional information. Final IRB approval cannot be granted until all potential conflict matters are settled. The IRB receives a recommendation from the Conflict of Interest Review Committee regarding disclosure to subjects and management of any identified conflict. The convened IRB determines what disclosure language should be in the consent form. 5. Use of Protected Health Information (PHI): HIPAA Requirements
“Business Interest” means holding any executive position in, or membership on a board of a business entity, whether or not such activities are compensated. 4.1 Do any of the investigators or personnel listed on this research project have a business interest or a financial interest of $10,000 or more ($5,000 or more if research is funded by a Public Health Service (PHS) agency or researcher is involved in clinical health care) associated with this study when aggregated for themselves and their family members? No. Yes. If yes, identify the individual(s) and complete section 4.3: 4.2 Do any of the investigators or personnel (when aggregated for themselves and their family members) listed on this research have: Ownership interests less than $10,000 ($5,000 if research is funded by PHS or researcher is involved in clinical health care) when the value of interest could be affected by the outcome of the research? No. Yes. Ownership interests exceeding 5% interest in any one single entity (or any equity interest in a traded entity if research is funded by PHS or researcher is involved in clinical health care)? No. Yes. Compensation less than $10,000 ($5,000 if research is funded by PHS or researcher is involved in clinical health care) when the value of the compensation could be affected by the outcome of the research? No. Yes. If yes, identify the individual(s) and complete section 4.3: 4.3 Has the business or financial interest been reported? N/A (No business or financial interest indicated in 4.1 or 4.2) No. Yes. If yes, have you been informed that a Conflict of Interest Review Committee is reviewing the information you reported? No. Yes. The IRB will verify that a management plan is in place with the Conflict of Interest (COI) Program. If the COI Program does not have an approved management plan in place for this research, they will contact the individual(s) listed in question 4.1 for additional information. Final IRB approval cannot be granted until all potential conflict matters are settled. The IRB receives a recommendation from the Conflict of Interest Review Committee regarding disclosure to subjects and management of any identified conflict. The convened IRB determines what disclosure language should be in the consent form. 5. Use of Protected Health Information (PHI): HIPAA Requirements
chart-review.docx