IRB | IRB Members | IRB Meeting Dates | Policy and Procedure Manual

The HRPP and IRB offices have moved!  We are now located in Suite 2E at 80 Jefferson Street.  If you have any questions, concerns, or helpful information that may be added to this directory, please contact Sarah Kiskaddon, JD, HRPP Director, or Kim Neild at (860) 545.9980. Email skiskad@ccmckids.org or kneild@ccmckids.org.

Investigators please take note:
All forms have been revised as part of our accreditation process.  New forms are posted below and are also available on the g:drive and should be used.  Old forms will no longer be accepted.  Please contact the IRB Office for assistance if you need assistance or have any questions. Also, the IRB Office has begun implementing an electronic submission system, IRB Manager.  Sandi Hale, database manager, is available to meet with investigators and research staff to offer training and assistance in the use of the new system. Please contact her at 545-9916, or via email at shale@ccmckids.org.  The IRB will continue to accept forms in paper format as needed while the research community adapts to the new system.

The documents below are provided in Microsoft Word format (doc). If you are on the CCMC network, you can also access these documents on the g drive in G:/Ccmcdoc/Research/Irb. In order to ensure the most recent version of each form is being utilized, please refer back to this website or the g drive each time you make a submission to the IRB.

SPECIAL NOTE TO RESEARCH PARTICIPANTS: If you have any questions or concerns about your role and rights as a research participant, would like to obtain information or offer input, or would like to register a complaint about a specific study, please contact (anonymously if you wish) Sarah Kiskaddon, HRPP Director, at (860) 545-9980, or via email at skiskad@ccmckids.org.

Additional information and resources for participants are listed below:

OHRP Pamphlet: Becoming a Research Volunteer: It’s Your Decision
• http://www.hhs.gov/ohrp/education/index.html#materials

The Belmont Report (outlines ethical considerations for research with human subjects:
• http://www.hhs.gov/ohrp/

Federal government websites and guidance documents:
• DHHS Office for Human Research Protections (OHRP): http://www.hhs.gov/ohrp/
• OHRP Guidance Documents: http://www.hhs.gov/ohrp/policy/index.html
• FDA Information Sheets for Investigators and IRBs:  http://www.fda.gov/oc/ohrt/irbs/default.htm

Federal Regulations pertaining to Human Subjects Research:
• 45 CFR Part 46 (DHHS Human subject Regulations):
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
• 21 CFR Part 50 (FDA Protection of Human Subjects)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50
• 21 CFR Part 56 (FDA IRB Regulations): http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56