Research is defined in 45 CFR 46.102(d) as follows:
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human subject is defined in 45 CFR 46.102(f) as follows:
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) data through intervention or interaction with the individual, or
(2) identifiable private information.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
NEW:
Application for Exemption from IRB Review - Please download, complete and submit this form for research projects believed to meet the requirements for exemption. Guidance for the form's use can be found in the FAQ's.
IRB Membership List- Please use this letter when the sponsor or outside institutions request the IRB membership list for CMH.
AHHRPP -- The CMH Institutional Review Board (IRB) is in the process of seeking accreditation for the human research protection program by the Association for the Accreditation of Human Research Protection Programs (AHHRPP, www.aahrpp.org). By becoming AAHRPP accredited, we are recognized as achieving high ethical and professional standards that few institutions have attained.
In preparing the application, you may see some changes and updates to our forms, policies and procedures. We will make sure you notify you of significant changes but it is important that you regularly check the IRB website to ensure you are current with our requirements, policies and templates.
The Office of Research Integrity and Compliance (ORIC) and the IRB appreciate your patience as we go through this process and we welcome your input and feedback.
OSP Form Signatures -- If your research is a collaborative effort and involves investigators from multiple Divisions and/or Departments, the OSP form should be signed by each investigator’s Department and/or Division Head.
Paper Copies -- The IRB would like to remind you that only one paper copy of each submission needs to be delivered to the IRB. Please see the FAQs for more information.
Frequently Asked Questions -- Can't find the information you need? Please take a look at our new FAQ section.
Deadlines and Meeting Schedules
The IRB and the Office of Research Integrity and Compliance are committed to serving the CMH research community and to facilitate the timely review of human subject research proposals. We reserve the option to schedule further additional meetings to accommodate heavy submission cycles and special requests.It is subject to further change.
CMH Initial Submission Checklist --This form is used by the IRB staff to determine if expedited or full board submissions are complete. Please feel free to double check your own submission using these guidelines.
Please submit the Research Personnel Form with all initial submissions and continuing reviews. Please also include it if you are submitting an amendment that includes changes in research personnel.
Education Certification Dates -- For your convenience, we are listing education certfiction expiration dates on our site. If your name is on the second list, please re-certify at your earliest possible convenience by completing one of the continuing education requirements listed below. Each list will be updated periodically.
For your continuing education requirement, please complete one of the following:
Attend a CMH IRB outreach session
Contact the IRB staff for a copy of the continuing education articles
Contact the staff for other options
In addition, here is a list of educational opportunities that you may find useful. Please contact the IRB staff to determine if attendance at a specific conference may fulfill your continuing education requirement: 2008 Educational Conference Schedule
When you call us, please have the IRB number handy (once it has been assigned). When sending an email, please include the PI and IRB number in the subject line.
IRB Mailbox for Electronic Submissions and General Questions or Concerns
