R Fe Training
R Fe Training
R Fe Training
RFE
Penn's 25 research centers and institutes bring together researchers from multiple departments, schools, and disciplines. The scale and interdisciplinary character of our research activities make Penn a nationally-ranked research university. In pursuing this research mission, we are constantly seeking new ways to efficiently use resources.
Over 400 new exempt research studies are begun each year at Penn.
What is RFE?
The PennERA (Electronic Research Administration) team, in cooperation with the Office of Regulatory Affairs, developed a web-based application that will allow Human Subjects investigators to electronically submit their claim of exemption information for research they feel is eligible for IRB exemption status. This application, known as Request for Exemption (RFE), is targeted for rollout in 2006. Eventually the application will replace the paper Claim of Exemption Form that is currently in use. Anticipated benefits include:
-Streamlines the submission, review, tracking, and approval process for Human Subjects Requests for Exemptions -Provides, manages, and tracks Departmental approval and routing of the information -Reduces data entry by automatically creating a protocol record in PennERA -Integrates the Request for Exemption module with the PennERA Human Subjects module for tracking and reporting of review activities and protocol status -Populates Investigator data, addresses, and e-mail from Penn Community -Eliminates the need for paper submissions
Determination of Exemption
Research activities in which the only involvement of human subjects will be in one or more of the categories specified by Federal Regulations 45CFR46.101(b) are exempt from the requirements of 45CFR46. In order for research to qualify for exempt status, the Claim of Exemption form must be submitted and approved by the Office of Regulatory Affairs before initiating any study procedures, including recruitment. Final determination of review category and submission requirements will be determined by the Office of Regulatory Affairs. Incomplete submissions or inappropriate use of the Claim of Exemption form may result in delay of IRB review.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. (4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. (6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
How do I Begin?
On the left hand side, select Create New. You will be guided through a series of screening questions designed to help identify the appropriate exemption category. You will then be able to fill out the request for exemption form on-line.
You will be notified of the category under which you may qualify
Complete face sheet information on the study and investigator. You can save the draft at this point or continue to the protocol summary.
Information on the purpose and procedures of the study is collected next. Attach supporting documents.
Additional information
Attach
You Will Next Be Directed to the Assurance Page. If You are a Staff Member, You Will Give the Submitters Assurance.
If you are a Faculty Member, You will Give the PIs Assurance.
Now What?
Staff and student submissions require a faculty member to act as PI on the study. The faculty member must give the PI assurance. Non-student submissions also require an assurance from the department head or dean of the school. Email notifications keep you informed of where the submission is in the approval process. If the departmental reviewer cannot review the electronic submission, you can always print it out for signature and delivery to ORA.
2. Under the "Reviews" menu on the left hand side of the page you should see a link called "Submissions awaiting review." Click on that link.
3. Find the RFE submission that you wish to review and click on the glasses icon to view the submission. 4. Once you have completed your review return to the list menu (#2) and you should see a "Certify and Sign" link in the Certify column (you must open the submission as described in step 3 in order for this link to appear) 5. Click on that link to begin the approval process 6. Click the button to either provide the appropriate assurance or send it back to the submitter
YES?
No?
Remember, you can always return to the RFE home page to check the status of your submission, or to view your approval letter. Only the person who originally created the application will be able to view the current review and approval status.
Reviewers can track the history of items they have reviewed. The your decision column will show if an application was accepted or rejected but will not show any future review status. The status column will show if changes have been made after departmental review, but not final approval or reclassification status.
Questions?
Email RFE@pobox.upenn.edu Or Call 215-573-2570