1. Completing a Questionnaire B Form (and beyond…) Office of Research and Project Administration 1

2. We strongly recommend that you view the “Introduction to the IRB and Human Subjects Research” training presentation at the IRB Website before you view this training! Whether you are new to human subjects research or not, this presentation will provide you with a very worthwhile information! 2

3. This training module was prepared by the Research Compliance Group to provide you with:  Guidance on how to complete a Questionnaire B (Q-B) Form. Tips are given sequentially for each of the eight Q-B questions!  Useful information on what to expect after you’ve submitted your Q-B Form. IMPORTANT NOTE: All faculty, staff and students are required by law to perform NIH training prior to conducting human subjects research. Failure to comply with this requirement can put Princeton University’s research program at risk. Therefore, research projects will not be approved until the IRB Office has received the required training documentation from each member of the study team. A link to this training can be found at: http://phrp.nihtraining.com/users/login.phphttp://phrp.nihtraining.com/users/login.php 3

4. Please contact the IRB Office at any time should you have questions during the completion process: irb@princeton.edu 4

5. When completing a Q-B Form, always…  Use the most current Form (2009-2010), located at the IRB Website.  Read all questions carefully before answering  Ensure that you have selected the appropriate exempt category (listing is located at the end of the Q-B Form)  Provide a response to all questions! DO NOT leave a question blank!  Note: “N/A” is NOT an acceptable response!  Email one electronic copy of the Q-B to the IRB office at irb@princeton.edu and follow up with one signed original via campus mail irb@princeton.edu 5

6. Question 1 1.a.”State the title of the proposed research.” Tip: Keep the title brief and meaningful 1.b.“If applicable, please list the agencies (University or other) that have been asked to fund this research.” Tip: This will assist the IRB staff to fulfill compliance obligations regarding funded projects. 6

7. Question 2 “State approximate dates for starting and ending this research project. (Note: The project may not start until it has been approved by the Board.)” Tips:  Once submitted, your Q-B will be put into the review queue. Depending on the time of year, it may take several weeks before a review is conducted. Therefore, be realistic when estimating your proposed start and end dates!  Qualify your start date; for example: “October 1, 2009 or following IRB approval”. This covers you in the event that your IRB approval comes after the proposed start date. 7

8. Question 3a 3.a “State the name of the Investigator(s), departmental address(es), e-mail address(es), fax number(s), and campus phone number(s). All applicants other than professors must list the name, departmental address, e-mail address of a faculty advisor. Use the abbreviations listed on the cover page to identify all names listed.” Tips:  Don’t forget to indicate your status in your response (e.g. graduate student (GS), undergraduate student (year), etc…)  Be sure to give the best phone number where we can reach you if we have questions (e.g. cell phone). 8

9. Question 3b 3.b“Is this a student project? If yes, please check the appropriate box: □ Junior Project □ Senior Thesis ” Tip:  This information will help the IRB better manage these time-sensitive research projects. 9

10. Question 4 “Provide a detailed description of the research including a characterization of the nature and context of research interaction with subjects, respondents or informants. If applicable, include a sample of your survey. If you are claiming exemption under category 4, the study of existing data or specimens, please provide the source, the type, and your research objectives and methodology.” Tips:  Since this is the only opportunity in the Q-B Form to describe your research, please be as detailed as possible. This will greatly facilitate our review!  Include methods for subject recruitment, if applicable. 10

11. Question 4 (continued) Tips:  Exempt research does not necessarily mean that a waiver of consent process is given. It may be acceptable to conduct exempt research without consent if the following criteria are met: 1. The research involves no more than minimal risk to the subjects; 2. The waiver will not adversely affect the rights and welfare of the subjects; 3. The research could not practicably be carried out without the waiver; and 4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation. 11

12. Question 4 (continued) Tips:  In some cases, oral consent (i.e. waiver of signature) may be more appropriate and may be used as follows: 1. When the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. 2. When field research is being conducted in areas where cultural or religious beliefs where written consent documentation would be a principal risk for potential harm to the subject. 12

13. Question 4 (continued) Tips:  If you will be using oral consent, please provide the IRB with the elements of the oral consent. (See the IRB website for samples of oral consent.) www.princeton.edu/ria/human-research-protection/ www.princeton.edu/ria/human-research-protection/  A “Contact” page must be provided with oral consents  If PU students will be recruited via email, then a letter of permission (or email) from the Dean of the College, Nancy Malkiel, is required to be sent to the IRB Office prior to the start of the research. This permission should specifically state what is being authorized. The purpose of this policy is to monitor the research participation (via email) among PU students to prevent excess demands on their research availability. 13

14. Question 4 (continued) Tips:  If you plan to use recruitment materials, for example, emails, flyers, etc., please attach copies. 14

15. Question 5 “Does the research proposed meet all criteria for protected subject population exemption review (see list at end)? □ Yes □ No If the answer is “no”, please complete a Questionnaire A Form and/or consult with the IRB Office” Tip:  Consult the list at the back of the Q-B Form to review the “Criteria for Exemption”. 15

16. Question 6 “Check the appropriate exemption claim category. Read carefully the Criteria for Exemptions located at the end of this document before completing.” Tips:  Consult the list at the back of the Q-B Form to review the “Criteria for Exemption”. 16

17. Question 7, a-c “Training and Certification. All University personnel who interact with human subjects or with identifiable subject data as part of this research project must complete the University's training program and be certified prior to initiating contact with subjects or identifiable subject data. Furthermore, all third- party contractors or subcontractors or collaborating institutions whose personnel will interact with human subjects or with identifiable subject data as part of this research project must certify to the IRB that their personnel have undergone appropriate training as well. Please respond to the following questions:…” See next slides for specific “Tips” on Question 7, a, b and c… 17

18. Question 7a “…Please respond to the following questions: a. Have all investigators identified above completed the University's training program (please check appropriate box): □ Yes □ No. If No, please complete the training program immediately after reviewing ORPA's homepage information about this procedure and provide a copy of the training certificate to the IRB office.” Tips:  Include a copy of human subjects training certificates for any outside agency personnel to be involved in the study.  If training has not yet been completed, indicate that training will be done and the certificate will be forwarded to the IRB Office. Note: The IRB will not grant exemption for a study unless all proper training is completed and the certifications are received. 18

19. Question 7b “…Please respond to the following questions: b. Are there any current or anticipated future employees or students working on this project who will interact with human subjects or with identifiable subject data? □ Yes □ No. If Yes, please state that you understand that such personnel must complete the University's training program before they may interact with subjects or identifiable subject data.” Tips:  List the names of current employees or students that are involved with the study.  If you anticipate employees or students will participate in the future, state that you understand that such personnel must complete the University's training program before they may interact with subjects or identifiable subject data.  Include a copy of human subjects training certificates for those involved in the study. Note: The IRB will not approve a study unless all proper training is completed and the certifications are received. 19

20. Question 7c “…Please respond to the following questions: c. Are there or will there be any third party contractors or subcontractors or collaborating institutions working on this project whose personnel will interact with human subjects or with identifiable subject data? □ Yes □ No. If Yes, please append the appropriate training certification information from that entity.” Tips:  List the names of third party contractors, subcontractors or collaborating institutions that may be involved with the study.  Include a copy of human subjects training certificates for those involved in the study. Note: The IRB will not approve a study unless all proper training is completed and the certifications are received. 20

21. Question 8 “Include the signature of the Investigator(s) and the date. Also include the advisor’s signature, if applicable.” Tips:  Note that this question is broken down into 2 sections: Faculty Projects and Student Projects. Ensure that you sign in the right section!  An advisor signature is required for all undergraduate and graduate student projects. 21

22. Final Tips…  Read through the entire application for clarity, grammar and typos.  Ensure that there is agreement between responses to related questions. Many times, changes are made to a response that are not carried through to other relevant responses in the Q-B! This lack of cohesiveness will create confusion and delay the process!  Use the checklist located on the first page of the Q-B Form to ensure that all required elements have been addressed! 22

23. I’ve handed in my exempt protocol (Q-B)….NOW WHAT?  Please note that Q-B forms do not required full IRB review and therefore are not subject to submission deadlines  The IRB Office will put your Q-B in the review queue. Turnaround times generally run from 1-2 weeks. At peak times (October-January), turnaround times can be longer.  The IRB Office will email you feedback if corrections to your protocol are needed.  If your protocol requires CORRECTIONS, read on… 23

24. Should your protocol need any type of correction, here’s what you can do to speed up the review:  Use the assigned protocol number on all correspondence with the IRB. This number should appear in the subject line of all emails, cover letters, etc…  Highlight all changes being made (Q-B form, consent documents, surveys, etc.).  Organize your corrections in a logical fashion.  Provide a cover letter (if the corrections are complicated) to assist reviewers with locating and understanding the changes that have been made. 24

25. 25 The IRB Staff is here to assist the faculty, staff and students with research compliance at Princeton University. Please feel free to contact us at irb@princeton.eduirb@princeton.edu If you…  Have questions concerning the status of your review  Are unsure of how to categorize your research  Need assistance with filling out a Q-A or Q-B Form  Want to set up a consultation meeting  Have specific questions or concerns you would like to discuss