The Compliance Protocol Submission Process

1. The Compliance Protocol Submission Process A “how to” guide to protocol submission using the Protocol and Compliance Management System Updated August 3, 2011 Cindy Corbett

2. Every road has a beginning…

3. What do you want to research? Determine what your research will entail… ** Human subjects- to what does this apply? Code of Federal Regulations TITLE 45, PUBLIC WELFARE DEPARTMENT OF HEALTH AND HUMAN SERVICES, PART 46 PROTECTION OF HUMAN SUBJECTS, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101 **Animal subjects **Recombinant DNA **Radiation

4. Review Committee Information View Compliance Committee information http://www.wm.edu/offices/grants/preaward/policies/compliancereqs/index.php By accessing the information here, you will find additional resources about each committee including policies and useful links. IACUC (Institutional Animal Care and Use Committee) PHSC (Protection of Human Subjects Committee) IRSC (Institutional Radiation Safety Committee) IBC (Institutional Biohazard Committee) EDIRC (School of Education Internal Review Committee)

5. Speak with your Advisor • As a student, you musthave a faculty member listed as PI (Principal Investigator) on your protocol submission in order for the protocol to be considered for review. • Usually, but not always, this is your faculty advisor. • In cases where a faculty advisor may be unavailable for an extended period of time, you may need to speak with the department Chair who should be able to help you find an alternative. • In order to facilitate a speedy review, the named PI should assist you in developing the protocol, informed consent, questionnaire and other components of study. • The PI should thoroughly review the protocol prior to endorsing it in the Protocol and Compliance Management system.

6. Training • For human subjects protocols, you need to access CITI training modules • http://www.wm.edu/offices/grants/preaward/policies/compliancereqs/onlinetrainmod/index.php *PHSC rules mandate all researchers must be properly trained in Human Subjects rules and regulations. • You will indicate in the body of the protocol that you have completed human subjects training • CITI:  Collaborative Institutional Training Initiative is a subscription service providing research ethics education

7. Training • Animal research modules are available directly for you through CITI training. • You and your PI of record are responsible for maintaining copies of your training records and should be able to produce them upon request. • The course meets the federal (USDA, OLAW) requirements for basic training in the humane care and use of animals in research and teaching.

8. Once you have completed your training, you are ready to start your protocol submission Log in to myWM at: https://mywm4.wm.edu/cp/home/displaylogin • Locate the Self-Service tab within myWM • On the Self-Service tab, view Protocol and Compliance Management • Double click this link to go in to protocol development • Select the committee to which you wish to submit your protocol PHSC-Human subjects SOE-School of Education IACUC-Animal Care and Use Committee IBC-Institutional Biosafety Committee RAD-Radiation (not functional at this time, contact Chair)

9. Why reinvent the wheel? • Often, one of the most misunderstood components of the Human Subjects Protocol is the Informed Consent. Did you know there is a sample Informed Consent form under PHSC Information? All you need to do is tweak it the sample Informed Consent as necessary for your needs….please be sure to indicate the entire approved protocol number on the Informed Consent form prior to giving it to research subjects, e.g., PHSC-2011-08-03-7013-XXXX

10. Sample Informed Consent The College of William & Mary • The general nature of this study entitled " ____ (title here) ___ " conducted by ____ (investigators names here) _________ has been explained to me. I understand that I will be asked to _______ (specific procedures regarding the subject participation here, including any potential risks) ________. My participation in this study should take a total of about _________ hours/minutes. I understand that my responses will be confidential or that anonymity will be preserved (include appropriate term; “confidential” indicates that subjects’ identities and responses will be known to investigator but will not be divulged; “anonymity” indicates that subjects’ identities will not be known or connected to responses) and that my name will not be associated with any results of this study. I know that I may refuse to answer any question asked and that I may discontinue participation at any time. I also understand that any grade, payment, or credit (include one of these situations, if applicable) for participation will not be affected by my responses or by my exercising any of my rights. Potential risks resulting from my participation in this project have been described to me. I am aware that I may report dissatisfactions with any aspect of this experiment to the Chair of the Protection of Human Subjects Committee, Dr. Lee Kirkpatrick, 757-221-3997 or lakirk@wm.edu. I am aware that I must be at least 18 years of age to participate. My signature below signifies my voluntary participation in this project, and that I have received a copy of this consent form. • _________________________                         ____________________________                Date                                                                          Signature •                                                                            ____________________________                                                                                               Print Name • NOTE: After the project is approved under EXPEDITED or FULL REVIEW, please insert the following statements in the footer of the informed consent form: • THIS PROJECT, protocol number (e.g., PHSC-2011-08-03-7013-XXXX) WAS APPROVED BY THE COLLEGE OF WILLIAM AND MARY PROTECTION OF HUMAN SUBJECTS COMMITTEE (Phone: 757-221-3966) ON [INSERT DATE] AND EXPIRES ON [INSERT DATE]. • If study subject has any questions in regard to this project, please contact the Principal Researcher directly: (name, contact information). • If project is determined to be EXEMPT FROM FORMAL REVIEW under 45 CFR 46.101(b), please insert this statement in the footer of the informed consent form: • THIS PROJECT WAS FOUND TO COMPLY WITH THE APPROPRIATE ETHICAL STANDARDS AND WAS EXEMPTED FROM THE NEED FOR FORMAL REVIEW BY THE COLLEGE OF WILLIAM AND MARY PROTECTION OF HUMAN SUBJECTS COMMITTEE (Phone: 757-221-3966) ON [INSERT DATE].   • If study subject has any questions in regard to this project, please contact the Principal Researcher directly: (name, contact information). • NOTE: Additional procedures concerning informed consent, along with additional sample consent forms, can be found in the Guidebook of Policies and Procedures for Research Involving Human Subjects on the Protection of Human Subjects Committee web site.Revised 9/15/08

11. Just answer the questions…. * Answer questions in a succinct manner * If a question doesn’t apply, indicate N/A so the reviewer knows you just didn’t omit a response. • Be sure to include any questionnaires to be used in the proposal. This may be accomplished by adding as an attachment or embedding questions within the Methods section of the protocol form. * If you have any questions when completing the protocol, you can stop and save your submission. You may come back and edit as many times as you wish. * Keep it simple, write to a lay audience • REMEMBER to SAVE your work….

12. Whathappens after you submit yourprotocol? • Don’t be surprised when you receive a warning telling you that you don’t have sufficient permissions to submit a protocol. • If you have been attentive, you know you should have named a faculty member as a PI. • The named faculty member will receive an email informing them they have been named as a PI on a protocol. The faculty member must agree to serve in this capacity in order for the protocol to move forward to committee for consideration. Once the PI has “accepted” his/her role, an automated email will be sent to request your acceptance of the protocol. Please note: the faculty member will receive cc emails on all correspon-dence associated with your protocol.

13. It will look like this…. • View Email • From:compli@wm.edu • To:apsmit@wm.edu, jmjone@wm.edu, • Cc: • Date Sent:2011-08-03 08:51:42 • Subject:Your assistance needed for protocol DRAFT-5479-apsmit • Message:Do you wish to be the Principal Investigator (PI) for protocol DRAFT-5479-apsmit titled Honors Thesis: Civic Education Survey?One of the PIs of this protocol was unable to submit this Protocol due to insufficient permissions -- i.e., the compliance committee(s) requires Faculty or Staff to submit, and one of the PIs is a student.If you have the authority to submit to the committee and wish to serve as the Principle Investigator, click on this link:DRAFT-5479-apsmitAlternatively, you may access the Protocol and Compliance Management channel on the Self Service tab within myWM ( http://my.wm.edu/ ). From "Search my protocols" you can filter for a status of "draft", look for DRAFT-5479-apsmit in the list, and click on "Edit". You must use the "Edit" function to submit this protocol.If you have questions, please contact the Office of Sponsored Programs at (757) 221-3966 or email Cindy Corbett at cacorb@wm.edu.-------------------------PI / STATUS-------------------------Smith, Allison (apsmit) Status: tentativeJones, Paul M (pmjone) Status: tentative

14. And then, student signs off…. • View Email • From:compli@wm.edu • To:apsmit@wm.edu, pmjone@wm.edu, • Cc:apsmit@wm.edu • Date Sent:2011-08-03 09:15:32 • Subject:Your response needed for protocol PHSC-2011-08-03-5479-pmjone set to contingent • Message:This is to notify you that you have been named as a Principal Investigator (PI) for protocol PHSC-2011-08-03-5479-pmjone titled Honors Thesis: Civic Education Survey. This protocol will be submitted for committee review upon acceptance by all PIs. Work on this protocol shall not begin until all named PIs have accepted this role and you have received notice of committee approval. For your reference, the current status of each named PI is listed at the bottom of this email.To respond to this request, you will need to access the Protocol and Compliance Management channel on the Self Service tab within myWM ( http://my.wm.edu/ ). In order for this protocol to move forward through the compliance system, you will need to log in to myWM, select the Self-Service tab, then go to Protocol and Compliance Mgmt and Login to submit and manage protocols.Once you are in the system, you will need to scroll to the bottom of the page, looking to view all your protocols. In this list, you should find (1) protocol requesting your agreement to serve as PI. You will see the protocol name and other identifying features then on the bottom line, you will see two verbs, View and Clone. Please select View. Once you open the protocol, hit the "Expand All" in the upper right hand corner. This will open the body of the protocol. Once expanded, look for "Actions." In the action field there is a drop down box indicating "Awaiting Acceptance." Click the arrow at the drop down box, then make your selection, "accept" or "decline", then SAVE PI Status. Once you have done this, you have completed the endorsement process and the protocol will move forward.If you have questions, please contact the Office of Sponsored Programs at (757) 221-3966.-------------------------PI / STATUS-------------------------Smith, Allison P (apsmit) Status: awaitingJones, Paul M (pmjone) Status: accept

15. Once PI and student have agreed to serve on protocol, the submission is complete and will forward to committee • An email will be sent to both the PI and the student with a copy of the successful submission. This is your record the protocol has progressed to the committee for review. • Each committee has different turn around times. • Allow sufficient time for review/revisions…not just a day or two. • PHSC turn around time is approximately 3-4 weeks. Additional time will be necessary if revisions are required.

16. Sample email… • View Email • From:compli@wm.edu • To:apsmit@wm.edu, pmjone@wm.edu, phsc-l@wm.edu, • Cc:apsmit@wm.edu • Date Sent:2011-08-03 09:50:27 • Subject:Original submission for protocol PHSC-2011-08-03-5479-pmjone • Message:Committee Chair,Protocol PHSC-2011-08-03-5479-pmjone titled Honors Thesis: Civic Education Survey has been submitted for committee review. Please visit the Protocol and Compliance Management channel on the Self Service tab within myWM ( http://my.wm.edu/ ) to review and take action on this protocol.-------------------------BASIC INFO-------------------------Title: Honors Thesis: Civic Education SurveyStart Date: 2011-08-20Year Number: 1Years Total: 1Campus: MainCommittee(s): PHSC Cc: Emails: apsmit@wm.edu-------------------------PI INFO-------------------------W&M UserID: apsmitFull Name: Smith, Allison PRole: Undergraduate StudentDepartment: GovernmentDay/Work Phone: 757 XXX XXXXExt:Alternate Phone:------------W&M UserID: pmjoneFull Name: Jones, Paul MRole: FacultyDepartment: GovernmentDay/Work Phone: +1 757 221 XXXX • Ext:Alternate Phone:

17. After going to committee… • The protocol will undergo thorough review. • If revisions are necessary, you will receive notice via the automated Protocol and Compliance Management system. Please note: both you and the PI (faculty member) will receive copies of all compliance related information . • Be sure to check your WM email regularly. • If you are advised to revise your protocol, the committee Chair will indicate the nature of the revisions required.

18. Revisions required? • After receiving notice of Revisions required, you will need to go in to myWM and “revise” your protocol. • This entails opening the protocol awaiting revisions in your queue (ruled “Revisions required”) • Make changes necessary as indicated by Chair. • Save and submit protocol again… • Then the process starts all over….

19. Revisions required email will look like this… • View Email • From:compli@wm.edu • To:jlcoin@wm.edu,txxxxx@wm.edu, phsc-l@wm.edu, • Cc:mrmcin@wm.edu, jmtayl@wm.edu, wxjian@wm.ed • Date Sent:2011-08-03 10:59:50 • Subject:Status of protocol PHSC-2011-08--03-4961-txxxxx set to revise • Message:This is to notify you that protocol PHSC-2011-08-03-4961-txxxxx Assessing Implicit Versus Explicit Attitudes Towards A Materialistic Lifestyle requires revisions in order to be approved. YOU SHOULD NOT BEGIN WORK ON THIS PROTOCOL UNTIL IT HAS BEEN APPROVED.You will need to access the Protocol and Compliance Management channel on the Self Service tab within myWM ( http://my.wm.edu/ ) to submit your revisions. If revisions are not received within six months of this date, this protocol will become void.If you have questions about this action, please contact the Office of Sponsored Programs at (757) 221-3966.-------------------------COMMENTS-------------------------2011-08-03 10:59:39 (Kirkpatrick, Lee)Dear Prof and students,The Protection of Human Subjects Committee has reviewed your recently submitted proposal entitled "Assessing Implicit versus...". Accordingly the committee wishes the following changes/amendments to be made before submitting a revised proposal for further review.

20. You may start your research, upon notice of a an “Active” protocol. In the case of human subjects, your protocol will be ruled “Exempt” or “Expedited”

21. Highly Unlikely…but not impossible • In the unlikely event your human subject protocol requires full committee review, you will be notified directly by the Chair of the Protection of Human Subjects Committee.

22. How can I be sure… • You will receive explicit notice the protocol has been approved and you may begin your research. • When in doubt, ask. ** Do not begin your research without a written approval from the appropriate committee .

23. If at any time during this process you need help, remember the resources which are available to you: • Your Advisor (or Co-PI on protocol) • The Office of Sponsored Programs liaison-Cindy Corbett, cacorb@wm.edu • The Compliance committee webpages have information on regulations, training, and sample documents