12. Reporting to Regulatory Agencies and Institutional Officials

12 Reporting to Regulatory Agencies and Institutional Officials

12 Reporting to Regulatory Agencies and Institutional Officials 

CUHS staff will initiate the following procedures as soon as the CUHS: 

a) Determines that an event may be considered an unanticipated problem involving risks to subjects or others; 

b) Determines that non-compliance was serious or continuing; or 

c) Suspends or terminates approval of research. 

1) The Executive Officer or designee prepares a letter that contains the following information: 

a) The nature of the event (unanticipated problem involving risks to participants or others; serious or continuing non-compliance; suspension or termination of approval of research) 

b) Name of the institution conducting the research 

c) Title of the research project(s) and/or grant proposal(s) in which the problem occurred 

d) Name of the principal investigator on the protocol(s) 

e) Number of the research project assigned by the CUHS and the number of any applicable federal award(s) (grant, contract, or cooperative agreement) 

f) A detailed description of the problem(s) including the CUHS’s findings, whether preliminary or final, and the reasons for its decision (if applicable) 

g) Actions the institution is taking or plans to take to address the problem (e.g., revise the protocol, suspend subject enrollment, terminate the research, revise the informed consent document, inform enrolled subjects, increase monitoring of subjects, etc.) 

h) Plans, if any, to send a follow-up or final report by the earlier of 

(1) A specific date; or 

(2) When an investigation has been completed or a corrective action plan has been implemented 

2) The Executive Officer or designee sends the letter to some or all of the following persons or entities, after consultation with the CUHS Chair: 

a) The CUHS (by including the letter in the next agenda packet as an information item) 

b) The Institutional Official 

c) The following agencies:10 

i) OHRP, if the study is subject to DHHS regulations or subject to a DHHS federalwide assurance. 

ii) FDA, if the study is subject to FDA regulations. 

iii) If the study is conducted or funded by any Federal Agency other than DHHS that is subject to The Common Rule, the report is sent to OHRP or the head of the agency as required by the agency. 

d) Principal investigator 

e) Sponsor, if the study is sponsored 

f) Contract research organization, if the study is overseen by a contract research organization 

g) Department chair and/or supervisor of the investigator 

h) The Privacy Officer of a covered entity (as defined by HIPAA), if the event involved unauthorized use, loss, or disclosure of individually-identifiable patient information from that covered entity 

i) The Information Security Officer of an organization if the event involved violations of information security requirements of that organization 

j) Harvard’s Division of Risk Management and Audit Services 

k) Harvard’s Office of the General Counsel 

l) Others as deemed appropriate by the CUHS Chair 

The Executive Officer ensures that all steps of this reporting policy are completed promptly, and in all cases within 30 days of the initiating action. For more serious actions, the Executive Officer will expedite reporting.