Princeton University

Completing a Questionnaire A Form(and beyond…)

Office of Research and Project Administration

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Before You Begin…

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!

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Training Goals

This training module was prepared by the Research Compliance Group to provide you with:

Guidance on how to complete a Questionnaire A (Q-A) Form. Tips are given sequentially for each of the eighteen Q-A questions!

Useful information on what to expect after you’ve submitted your Q-A 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.php

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Ask For Help!

Please contact the IRB Office at any time should you have questions during the completion process:

irb@princeton.edu

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Completing a Q-A Form…General Tips

When completing a Q-A Form, always…

Use the most current Form (2009-2010), located at the IRB Website .

Read all questions carefully before answering.

Provide a response to all questions! DO NOT leave a question blank!

Note: “N/A” is NOT an acceptable response!

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Question 1: Tips

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.

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Question 2: Tips

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-A will take approximately 4-6 weeks to get approved, so 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.

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Question 3a: Tips

Question 3a

3.a “State the name of the Investigator(s), departmentaladdress(es), e-mail address(es), fax number(s), and campusphone number(s). All applicants other than professors mustlist the name, departmental address, e-mail address of a facultyadvisor. Use the abbreviations listed on the cover page toidentify 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).

 

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Question 3b:Tips

Question 3b

3.b“Is this a student project? If yes, pleasecheck the appropriate box: □Junior Project □ Senior Thesis ”

Tip:

This information will help the IRB better manage these time-sensitive research projects.

 

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Question 4:Tips

Question 4

“Check if data will be collected from or about any of the following protected populations:□ minors □ prisoners □ pregnant women □ fetuses □institutionalized mentally disabled (individuals residing aspatients in an institution who are mentally ill or retarded;emotionally disturbed; psychotic; or senile).

For additional requirements regarding these categories ofprotected subjects, consult the Secretary of the Board.”

Tip: Special consideration is given when vulnerable populations are used

as research subjects. Please contact the IRB if you have questions.

 

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Question 5: Tips

Question 5

“State briefly the purpose of the intended research, specifyingthe problems addressed, what is to be learned, and identify thespecific objectives of the research. A paragraph or two usually suffices. Please use lay language.”

Tips:

Be brief!

Do not copy information from your grant proposal into this response!

Be sure to use lay language!

 

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Question 6: Tips

Question 6

“Describe in detail the procedures that will be used toachieve the objectives of the research project; includecopies of the consent form, letters, survey forms,questionnaires or other applicable documentation.”

Tips:

If the research involves multiple phases, please clearly describe each phase.

Ensure that all applicable documentation is attached.

 

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Question 6:Tips (continued)

Question 6 (continued)

Tips:

Include a written permission from the head of any organization or group that is used in the study. This permission should specifically state what is being approved and the title/contact info of the signatory. An “email” version of permission is also acceptable, as long as it contains the necessary elements as described above.

 

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Question 7: Tips

Question 7

“Describe in detail the method of subject selection. Special attention shouldbe paid to subject selection and affiliation when Princeton students will notbe used for the subject sample. Also include information about any compensation rates to subjects. Please be sure to report everything that the subject will be told about the study prior to participating in the research. If you plan to use recruitment materials, for example, emails, flyers, etc., please attach copies.”

Tips:

If PU students will be recruited via email, then a letter of permission (or email) from the Dean of the College, Valerie Smith, 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.

 

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Question 7 :Tips (continued)

Question 7 (continued)

Tips: Compensation should be reasonable; payments or

incentives should not be so large as to induce prospective subjects to consent to participate against their better judgment.

 

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Question 8: Tips

Question 8

“Do you plan to obtain signed consent from all study participants? If not, please explain why. If you plan to use a consent form, please complete thetemplate on the IRB website and attach a copy for IRB review. If you will beusing oral consent, please list the elements of the oral consent. (See theIRB website www.princeton.edu/ria/human-research-protection/ for consent templates and for samples of oral consent.).”

Tips:

Written consents MUST be in the standard PU format.

Include explicit permission for subjects to be audio or visually recorded, if applicable.

Include compensation information in the consent form.

 

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Question 8: Tips (continued)

Question 8 (continued)Tips:

Oral consent may be used :

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 would preclude obtaining written consent documentation because it would be a principal risk for potential harm to the subject.

If you will be using oral consent, please include the elements of oral consent with your Q-A Form. (See the IRB website for samples of oral consent http:// www.princeton.edu/ria/human-research-protection/ ).

 

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Question 8:Tips (continued)

Question 8 (continued)

Tips:

A “Contact” page must be provided with oral consents and incorporated into web-based surveys.

Ensure that the project description in the consent form is written in the first person from the point of view of the subject, because it is the participant who signs the entire first-person statement (e.g. “This interview will discuss some of the factors that I believe have enabled me to succeed…” etc.).

 

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Question 8:Tips (continued)

Question 8 (continued)

Tips:

If there is potential for study subjects to reveal information concerning illegal activities during the course of the study, ensure that you include the following statements in the consent form: I understand that I should not reveal information concerning any illegal activities on

the part of myself or my family members. The information given will be kept confidential and protected to the fullest extent

allowable by law.

 

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Question 9:Tips

Question 9

“Does the proposed research involve deception, e.g., throughprovision of misinformation, withholding information, etc.? Explain why it is necessary to involve deception(s) in theresearch. Withholding the full hypothesis does not count asdeception.”

Tip:

If deception will be involved in the research, ensure that you also provide a suitable debriefing form.

 

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Question 10:Tips

Question 10

“Provide a full account of the debriefing procedures to befollowed, if appropriate. Note that all psychology departmentParticipant pool subjects must receive a full debriefing foreducational purposes. If you plan to debrief, please attach acopy of the written debriefing or the debriefing interviewprotocol.”

Tips:

Ensure that your debriefing script reduces the risk of harm and corrects any misconceptions that participants may have.

Be sure to use lay language when writing a debriefing script.

 

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Question 11: Tips

Question 11

“Does participation by human subjects or informants place anygroup or class of individuals in physical, legal, social and/orpsychological jeopardy? If so, how can the potential risk beminimized? Please specify whether this research involves minimal risk (risks no greater than those ordinarilyencountered in everyday life) or greater than minimal risk.”

Tips:

“N/A” is NOT an acceptable response to this question!

Please give careful thought to this question and provide a meaningful response.

Be sure to include how potential risk can be minimized.

 

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Question 12:Tips

Question 12

“Does the research place individual subjects at risk? If so, please describe fully the ways in which the risk will be controlled. Please specify whether this research involves minimal risk (risks no greater than those ordinarily encountered in everyday life) or greater than minimal risk.”

Tips:

“N/A” is NOT an acceptable response to this question!

Please give careful thought to this question and provide a meaningful response.

Be sure to include how potential risk will be controlled.

 

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Question 13: Tips

Question 13

“In a few sentences, please address the benefits of the research, both to the participant and to society. The ethical review requires the IRB to balance how any possible risks that may be involved in the research, even though the risks may be minimal, are justified by the potential benefits resulting from the investigation.”

Tips:

“N/A” is NOT an acceptable response to this question! If there are no benefits to the research, then the IRB will not approve the project!

Please give careful thought to this question and provide a meaningful response. Consider the impact, or potential impact, of the project.

 

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Question 14a: Tips

Question 14a

“Study material must be stored securely… in a faculty member’s office or a project office accessible only to members of the research team certified to work with human subjects. In addition, signed consent forms must also be stored securely and separately from completed questionnaires and other study materials. Please respond to the following questions:

 a. Describe what procedures will be used for secure storage of consent forms and the secure and separate storage of all other study materials. Who will have access to these materials?”

Tips:

Please be specific when describing where consent forms and study materials will be securely stored.

 

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Question 14b: Tips

Question 14b

“Study material must be stored securely… Please respond to the following questions:

b. Describe the ultimate disposition of all study material including audio and video recordings, field notes, transcripts, etc.”

Tips: Ordinarily, primary sources are destroyed at the end of the project. In some cases, for

example, when the primary sources are to be retained as part of a permanent archive, it may be appropriate to store these study materials. In all cases, the material must be stored securely and any future use must be provided for in the consent.

 

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Question 15: Tips

Question 15

“In the event that outside agencies are involved (in datagathering, processing, and storage), how will the rights of thesubjects be guaranteed by that agency?”

Tips:

Describe the role of the outside agency.

Be sure to include a copy of human subjects training certificates for any outside agency personnel to be involved in your study.

 

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Question 16:Tips

Question 16

“Describe the process being undertaken to secure IRB and/orother appropriate institutional approval necessary to conductresearch with subjects at another institution or organization.”

Tips:

Provide the name of the Institution. If no other institutions are involved, then write “None”.

Describe the role of the collaborating Institution.

Include a copy of relevant IRB approvals from collaborating institutions.

 

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Questions 17a-c: Tips

Questions 17a-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 Questions 17a, 17b and 17c…

 

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Question 17a:Tips

Question 17a

“…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 approve a study unless all proper training is completed and the certifications are received.

 

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Question 17b:TipsQuestion 17b

“…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.

 

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Question 17c:Tips

Question 17c

“…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.

 

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Question 18:Tips

Question 18

“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.

 

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Before Submitting Your Q-A Form… Final Tips

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-A! This lack of cohesiveness will create confusion and delay the approval process!

Use the checklist located at the very end of the Q-A Form to ensure that all required elements have been addressed!

 

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What to Expect After Submission

I’ve handed in my IRB protocol….NOW WHAT?

The IRB will review your protocol at the next convened meeting (typically the 3rd Monday of each month from September to June).

The IRB Office will email you feedback near the end of the month in which your submission was reviewed.

Your protocol can either be approved at the IRB meeting or corrections will be requested.

If your protocol is APPROVED at the meeting, then you should receive notification from the IRB Office within a few days of the meeting.

If your protocol requires CORRECTIONS, read on…

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What If the IRB Requests Corrections?

If your protocol requires corrections, they will fall into one of the following categories:

Administrative Corrections: In this case, simple corrections to the protocol are needed. The corrections are reviewed by the IRB Office (not the full Board ).

Minor Revisions: In this case, more complex revisions to the protocol are needed. The PI’s response has to be reviewed by the original readers (not the full Board), which could add an additional 3-5 working days before he/she receives additional feedback .  

Substantive Revisions: In this case, substantial revisions to the protocol are needed. The PI’s response has to be reviewed by the full IRB at the next convened meeting. This could add 4-5 weeks before additional feedback is provided by the IRB. Therefore, the PI is advised to submit a response before the next month’s IRB deadline.

Disapproved: In this case, the protocol is not approvable as written. The PI has the option of withdrawing the application or rewriting the proposal, incorporating the revisions defined by the IRB in the initial review.

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Speeding Up the Review of

IRB-Requested Corrections Should your protocol need any type of correction, here’s what you can do to speedup 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-A form, consent documents, surveys, etc.).

Organize your corrections in a logical fashion.

Provide a revised Q-A form if the IRB-requested corrections affect your original responses. Remember to highlight the changes!

Provide a cover letter to assist reviewers with locating and understanding the changes that have been made.

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Once IRB Approval is Received…

Once you have received IRB approval of your research project, please remember to:

Notify the IRB Office should you make ANY changes to the protocol. Approval of amendments must be received before implementation. Submit amendments via email to irb@princeton.edu. Please clearly describe the changes you are making !

Renew your protocol on an annual basis (after the first and second year of the study). You will receive a reminder email from the IRB staff a few months before your IRB approval expires.

Submit a new protocol for IRB review if your research will extend beyond three years from initial approval. Once again, you will receive a reminder email from the IRB staff a few months before your protocol expires.

Note that IRB approval is not only needed for data collection phase, but also the data analysis phase of the study!

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One Last Word…

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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.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