Research & Ethics Compliance Information
Researchers affiliated with UConn ISM who are planning on conducting research must review & complete all necessary ethics training prior to submitting any data requests.
CITI Program Basic Courses in the Protection of Human Research Subjects: Biomedical Research (every 3 years). Additional information about CITI training can be found on UConn’s OVPR Required Trainings in Human Research Protections page
If you have any questions about IRB submission, whether your project falls under the category of human subjects research or any other IRB related questions, please familiarize yourself with UConn IRB submission protocols and researcher resources found on the UConn’s OVPR IRB website.
UConn ISM Contact Database request information
Researchers wanting to request data from the UConn ISM Contact Database in order to gather contact information for research recruitment of a specific population of patients (i.e. ACL injured patients who have undergone reconstruction between the ages of 15-25) should first acquire IRB approval for their proposed research. Following approval, researchers must submit a formal data request to gain access to contact information of the specific population and upload all appropriate forms.
UConn ISM Clinical Database request information
Researchers wanting to request data from the UConn ISM Clinical Database to conduct research clinical patient information should first determine if their project falls into the category of human subject research. Investigators who are unsure if their proposed activity constitutes “human subjects research” according to federal regulations, should review the information on UConn’s OVPR website or may submit a Human Subjects Research (HSR) Determination Form through InfoEd. The IRB Chair and/or their designee will determine if the meets the definitions of “human subjects” and “research”, and advise as to next steps regarding need to secure formal exemption or approval from the IRB. The IRB HSR determination process usually takes 2-3 weeks.
The ISM clinical database routinely collects partial patient identifiers such as dates of service, surgery etc, and therefore it is possible that combined with other patient information (DOB, age, etc) that a patients identity may be determined. Thus, researchers requesting patient data from the Clinical Database with these partial identifiers (including dates of service, surgery, DOB, etc) will be required to secure an exempt determination from the IRB prior to data distribution.
Researchers may also request fully de-identified data, removed of all 18 types of patient identifiers (including the removal of dates) via the safe harbor method. In this situation, no IRB approval or determination form is needed, unless the researcher(s) are still unsure of whether their research meets the criteria as non human subjects research.
To request data from either database, please complete the data request form and upload all applicable materials. Incomplete submissions will be returned for clarification, so be sure to have all the appropriate documentation at the time of submission.
If you have any questions, please contact the Director of Research, Julie Burland: firstname.lastname@example.org