1. Request For Exemption RFE

2. A Review of Penn’s Commitment to Research Research is a substantial and esteemed enterprise at Penn. The research community includes: -2,000 faculty -1,000 postdoctoral fellows -3,000 graduate students -5,000 support staff -a budget of more than half a billion dollars each year. 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.

3. 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

4. What Does it Mean to be Exempt? The Office of Regulatory Affairs oversees all research involving human subjects for the entire university. Each new protocol undergoes an initial review in this office to determine the applicable federal regulations and level of risk posed to the research participants by the protocol. The Code of Federal Regulations includes an “exempt review” category. This category is used for research protocols that involve human subjects, but present little if any risk to the participants. Exempt review means that the Code of Federal Regulations and ongoing oversight/monitoring by the Office of Regulatory Affairs do not apply. The University of Pennsylvania, however, has a local policy that limits the exemption to three years from the IRB review date after which reapplication will be necessary for the study to continue. It is always the responsibility of the Principal Investigator to inform the Office of Regulatory Affairs of any changes to the protocol and to terminate the file when all study procedures and data analysis have been completed.

5. 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.

6. What are the exemption categories? (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

7. What are the exemption categories? ( 3) 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.

8. How Do I Begin an Electronic Submission? You can access the RFE application from the ORA webpage at: http://www.upenn.edu/regulatoryaffairs/ Click on the news item link or select IRB, then forms, for the Claim of Exemption Application.

9. You Will Need to Log in with Your PennKey and Password

10. You Will Be Directed to the RFE Home Page Who to contact for help

11. What Am I Looking At? The left hand side of the page is the navigation bar. You can choose to create a new submission, view a submission you have already begun, or track the status of a submission. A history of all your electronic submissions will be maintained here for your records.

12. 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.

13. First, Review the Instructions

14. Answer the Yes/No Questions as they Apply to Your Research Study

15. You will be notified of the category under which you may qualify

16. Complete face sheet information on the study and investigator. You can save the draft at this point or continue to the protocol summary.

17. Information on the purpose and procedures of the study is collected next. Attach supporting documents. Attach Additional information

18. You Will Next Be Directed to the Assurance Page. If You are a Staff Member, You Will Give the Submitter’s Assurance.

19. If you are a Faculty Member, You will Give the PI’s Assurance.

20. 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.

21. What Does the Departmental Reviewer Need to Do? After the Principal Investigator has given his or her assurance, the submission is electronically routed to the departmental reviewer. This reviewer may do a scientific validity check or confirm that this project is an appropriate use of departmental resources. The reviewer could accept the application as is, or send it back to the submitter for modifications. The reviewer must first go to “submissions awaiting review” to open and view the submission. He or she then needs to return to this section to accept or reject the application.

22. RFE Approver Steps 1.Logon to the RFE application 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

23. How does the Review Process Go? The submitter completes the RFE submission, the PI gives assurance Scientific reviewer checks for validity YES? No? Sent back for revisions The information is sent via nightly download to PennERA

24. Can I Begin the Research? Once all necessary assurances have been obtained and the submission has undergone any necessary revisions, it is sent to the Office of Regulatory Affairs. There it will be reviewed. If it is determined to meet the exemption criteria, an email message will be sent out and the approval letter will be available on the RFE web page. Then you may begin the study.

25. Is it Possible to Not Be Approved? The principal investigator or the departmental approver may require changes before a submission is forwarded to ORA. ORA may require changes or determine that the study does not meet the criteria for exemption. Email notifications will be sent to keep you informed in these instances.

26. 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.

27. 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.

28. Log Out and Close Your Browser to End Your Session Questions? Email RFE@pobox.upenn.eduRFE@pobox.upenn.edu Or Call 215-573-2570