princeton university n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Princeton University PowerPoint Presentation
Download Presentation
Princeton University

Loading in 2 Seconds...

play fullscreen
1 / 38

Princeton University - PowerPoint PPT Presentation


  • 142 Views
  • Uploaded on

Princeton University . Completing an Expedited or Full Board Questionnaire A Form ( and beyond…) Office of Research Integrity and Assurance. Training Goals. This training module was prepared by the IRB Staff to provide you with:

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Princeton University' - geneva


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
princeton university
Princeton University

Completing an Expedited or Full Board Questionnaire A Form (and beyond…)

Office of Research Integrity and Assurance

training goals
Training Goals

This training module was prepared by the IRB Staff 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 to complete training in the conduct of human subject research. The Princeton IRB has adopted the CITI “Course in the Protection of Human Research Subjects” as the primary means of training (https://www.citiprogram.org) and as a requirement before protocol approval. Please review Princeton IRB instructions on the website and provide documentation of your training along with the Questionnaire.

ask for help
Ask For Help!

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

irb@princeton.edu

completing a q a form general tips
Completing a Q-A Form…General Tips

When completing a Q-A Form, always…

  • Use the most current Form 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!
question 1 tips
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.

question 2 tips
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: “December 1, 2012 or following IRB approval”. This covers you in the event that your IRB approval comes after the proposed start date.
question 3a tips
Question 3a: Tips

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. Indicate the status of each study investigator.” (use appropriate abbreviation)

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).

question 3b tips
Question 3b:Tips

Question 3b

3.b “Is this an undergraduate 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.
question 4 tips
Question 4:Tips

Question 4

“Will data be collected from or about any of the following protected populations:

□ minors □ prisoners □ pregnant women □ fetuses □

institutionalized mentally disabled (individuals residing as

patients in an institution who are mentally ill or retarded;

emotionally disturbed; psychotic; or senile).

For additional requirements regarding these categories of

protected subjects, consult the IRB Office.”

Tip:

  • Special consideration is given when vulnerable populations are used as research subjects. Please contact the IRB if you have questions.
question 5 tips
Question 5: Tips

Question 5

“State briefly the purpose of the intended research, specifying

the problems addressed, what is to be learned, and identify the

specific 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!
question 6 tips
Question 6: Tips

Question 6

“Describe in detail the procedures that will be used to

achieve the objectives of the research project; include

copies 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.
question 6 tips continued
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.
question 7 tips
Question 7: Tips

Question 7

“Provide a detailed description on how subjects will be selected. Describe the method that will be used to select subjects, how many subjects will be included in the study, and specify the affiliation of the subject population when Princeton students will not be 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 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.
question 7 tips continued
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. If the study involves multiple study visits, compensation should be pro-rated per visit.
question 8 tips
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 the

template on the IRB website and attach a copy for IRB review. If you will be

using oral consent, please list the elements of oral consent. (See the

IRB 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.
question 8 tips continued
Question 8: Tips (continued)

Question 8 (continued)

Tips:

  • Oral consent may be used :
  • 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.
  • 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 provide an oral consent script including all the elements of informed consent with your Q-A Form. (See the IRB website for samples of oral consent http:// www.princeton.edu/ria/human-research-protection/ ).

question 8 tips continued1
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.).
question 8 tips continued2
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.
question 9 tips
Question 9:Tips

Question 9

“Does the proposed research involve deception, e.g., through

provision of misinformation, withholding information, etc.?

Explain why it is necessary to involve deception(s) in the

research. Withholding the full hypothesis does not count as

deception.”

Tip:

  • If deception will be involved in the research, ensure that you also provide a suitable debriefing form.
question 10 tips
Question 10:Tips

Question 10

“Provide a full account of the debriefing procedures to be

followed, if appropriate. Note that all psychology department

Participant pool subjects must receive a full debriefing for

educational purposes. If you plan to debrief, please attach a

copy of the written debriefing or the debriefing interview

protocol.”

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.

question 11 tips
Question 11: Tips

Question 11

“Does participation by human subjects or informants place any

group or class of individuals in physical, legal, social and/or

psychological jeopardy? If so, how can the potential risk be

minimized? 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 can be minimized.
question 12 tips
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.
question 13 tips
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.

question 14a tips
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.

question 14b tips
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.
question 15 tips
Question 15: Tips

Question 15

“In the event that outside agencies are involved (in data

gathering, processing, and storage), how will the rights of the

subjects 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.
question 16 tips
Question 16:Tips

Question 16

“Describe the process being undertaken to secure IRB and/or

other appropriate institutional approval necessary to conduct

research 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.
questions 17a c tips
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 projectmust 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…

question 17a tips
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 the IRB webpage 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. Access CITI site here.

question 17b tips
Question 17b:Tips

Question 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. Access CITI site here.

question 17c tips
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. Access CITI site here.

question 18 tips
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.
before submitting your q a form final tips
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 protocol preparation tips at the beginning and the checklist located at the very end of the Q-A Form to ensure that all required elements have been addressed!
what to expect after submission
What to Expect After Submission

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

  • The IRB will review your protocol using expedited review procedures or 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…
what if the irb requests corrections
What If the IRB Requests Corrections?

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

  • Administrative Corrections: In this case, simple corrections to the protocol are needed. The corrections will be reviewed expeditedlyand not at 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 reviewers (not the full Board), which could add an additional 5-7 working days before he/she receives additional feedback.
  • Substantive Revisions or Tabled: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.

or

  • 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.
speeding up the review of irb requested corrections
Speeding Up the Review of IRB-Requested Corrections

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-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.
once irb approval is received
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 mustbe received before implementation. Submit amendments via email to irb@princeton.edu. Please clearly describe the changes using the Modification Request Application !
  • Renewyour protocol on an annual basis using the Continuation Application. You will receive a reminder email from the IRB staff a few months before your IRB approval expiresalthough it is ultimately the PI’s responsibility.
  • Close your study once all data analysis is complete or if you no longer have access to personal identifiable information. This means all links to codes have no longer exist.

Note that IRB approval is not only needed for data collection phase, but

also the data analysis phase of the study!

one last word
One Last Word…

The IRB Staff is here to assist the faculty, staff and students with IRB needs 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
  • Need assistance with research design within an IRB context
  • Have specific questions or concerns you would like to discuss