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Tips for Completing the New Protocol Submission

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Presentation on theme: "Tips for Completing the New Protocol Submission"— Presentation transcript:

1 Tips for Completing the New Protocol Submission
The Nova Southeastern University Institutional Review Office has created this guide to facilitate completion of the New Protocol Form ( Version August 8st, 2013

2 New Protocol Submission
This form (adopted March, 2009 and most recently revised in August, 2013) replaces the previous New Protocol Submission Form and the Research Protocol Usage of this form is effective immediately

3 Form Instructions Please take a moment to review the instructions.
Helpful Information: Please directly answer the questions that are asked; do not copy and paste from your thesis/dissertation proposal or grant proposal as that may not directly answer the question. If your study is funded by an external agency, please include a copy of funded proposal with your submission. You are to complete all BLUE sections of the form. If something is not applicable to your study, mark the section “N/A.” New: You will note that for Full Review, 2 copies plus 1 original are needed.

4 Protocol General Information
Part 1

5 Protocol Information Please be sure to insert the Principle Investigator’s last name and the date of submission in the footer area. In all versions of Word you do this by double-clicking on the footer. This will open the Header/Footer edit tool which will allow you to provide the information.

6 Protocol Information Please provide the complete title of your study.
In the this section, briefly describe the study. Provide a general overview so that the person reviewing the submission understands the “big picture”. We will not reject your submission just because it contains 251 words, but please try to honor the word limit – keep this an overview. You will be asked for specifics in later sections of this form.

7 Research Team Information
Include your complete contact and demographic information. CITI Training is valid for three years. No resumes or curriculum vitae! Please provide the information requested as a narrative. The purpose is allow the IRB to determine if you are qualified to carry out the research. Students should include research courses completed.

8 Research Team Information
All Co-Is affiliated with NSU must have current CITI certification under one of the NSU CITI Learner Groups. For non-NSU affiliated researchers, please provide a hardcopy of their CITI certificate Include the complete contact information for your co-investigators. NOTE: If you are a student, Co-Investigator 1 should be your faculty adviser/dissertation chair.

9 Research Team Information
If the study team includes Research Assistants (RA’s), please list those here. If there are more than three, please copy the box and paste another copy in the form.

10 CITI Training All individuals affiliated with NSU who are a part of the research team must have current CITI training. For Co-Is not affiliated with NSU, their home institutions’ human subjects training information should be provided. Your center representative may ask for a copy of your training certificate(s). As PI you must confirm that any co-investigators or assistants have completed their training and you should have a copy of their completion certificates in your research records. For more information on CITI visit the NSU IRB Web site at

11 Funding Information Indicate whether or not the proposed study is funded. If the study is funded, or you are applying for funding, please complete this information.

12 Conflict of Interest Conflicts of interest, both perceived and actual, are of concern to the NSU IRB. Please take a moment to review NSU policy. Please initial that you have reviewed the NSU policy and answer the question accordingly.

13 Dates and Phases of Study
Indicate the proposed start date. While the study may be multi-year, IRB approval may only be granted for a maximum of 364 days (or less, as determined by the IRB).

14 Dates and Phases of Study
If a study has multiple parts, that function as one research project, then the IRB may need to review all the parts at one time. If this is a stand alone study, that if successful may lead to future research, then that is not “multi-part”. A multipart study might interview people, have focus groups on the same topic, and then develop and implement a treatment plan based on that information. We would not wish to review the survey alone in that case.

15 Multiple Site Information
Specify the NSU location. Please provide information as to whether the study will be conducted at a non-NSU locations. The IRB will check for administrative approval or IRB review by another IRB if the study takes place at another institution.

16 Cooperative Research Complete the cooperative research information This section is particularly important if you are a student at NSU but employed at another organization/institution, especially one with a Federal Wide Assurance (FWA) as it may mean your research activity will cause that other organization to be engaged in research.

17 Subject/Participant Information

18 Subject/Participant Information
Provide the IRB with a breakdown of the proposed subjects/participants of the study. The IRB recognizes that there may be variation in the number of subjects in a particular subgroup (i.e., children ages 2-6, children ages 7-12, etc.). You may elect to either use ranges to indicate number of subjects or a indicate the maximum number you plan to enroll in a particular category.

19 Subject Vulnerability
Special consideration is needed if your subjects are particularly vulnerable; in this section we ask the researcher to think carefully about the issue of vulnerability. Vulnerability is not limited to just the federally recognized vulnerable groups, but also includes groups that are vulnerable because of their status or relationship to an investigator -- they may be vulnerable to coercion. Please review our policies and guidelines.

20 Study Design and Methodology
In this section you are asked to detail the design and methodology of your study. In doing so, you should provide a detailed account of the steps involved in your research after subjects have consented to participate. Provide a detailed accounting of the time commitment for the participants for each study related activity.

21 Study Design and Methodology
In this part, provide a detailed list of all your data collection instruments. Remember, that except for instruments that have restricted access (e.g. SAT, FCAT), you will need to provide a copy of each instrument. Surveys and interview question lists must be provided with the submission.

22 Study Design and Methodology
In this part, please note that “de-identified” means that the data cannot be linked back to the participant in any way. If using a “coding list”, this makes the data identifiable. Check off “No” to this question. If you will be removing all identifiers or collect anonymous data and your subjects cannot be linked back by any means, then, check off “Yes” to this question and describe the de-identification process. For anonymous surveys, do not solicit potential identifiers in the survey and turn-off IP address recording. Potential Identifiers: Name Date of birth Mailing/ address Phone/Fax # Social Security # Medical Records License, vehicle ID IP address Biometrics ID Photo/image/audio recording Signature, handwriting sample Any other type of identifier not mentioned above.

23 Additional Study Information
Part 3

24 Clinical Testing Studies that will use FDA-regulated products or will yield data that is intended for submission to the FDA require certain procedures. Studies using procedures or devices not routinely used in clinical care require special attention and may affect level of review.

25 Sensitive Information
If you are asking about sensitive information, please be sure to provide a detailed account. In completing this section, PIs should be particularly sensitive to the fact that individuals may view information differently. While the PI may not consider certain data as sensitive, a participant or subject may disagree. Please discuss the type of recording that will be used. Additionally, mention how you plan to: safeguard the recording(s), how and when the recordings and transcript(s) will be stored, and the location of both the recording and the transcript (if applicable). Please also discuss how and when the recordings and transcripts will be destroyed.

26 Non-English Speaking Participants
It is important that subjects/participants be presented a consent form written in a language that they readily understand. If your study involves translated consent materials, please note the following: Translation of forms into languages other than Spanish may necessitate the use of a certified translator to conduct the translation. PIs are advised to contact their center representative or the IRB Administrator to discuss this issue. Do not translate your forms until the IRB has notified you to do so. We don’t want you to have to retranslate the forms if the IRB requires revision.

27 Subject Compensation This section asks you to outline any compensation that subjects will be getting for their participation. In discussing the compensation, any prorating or tiered payment should be discussed. If payment will be by check, and you will need to notify other departments (such as accounts payable) then this disclosure process must be included in the consent form.

28 Inclusion/Exclusion Criteria
This section should contain a detailed list of exclusion and inclusion criteria for all potential subjects of your study. In addition, the section should also reflect how you will determine that a subject meets the stated criteria.

29 Subject Recruitment The IRB should be able to determine exactly how you will recruit all of your subjects. If your study involves multiple populations that will be recruited using different procedures, be sure to discuss the procedures for each group in detail. The IRB should be provided a copy of all fliers, online narrative posts, website blog entries, and (s) that will be sent to recruit participants.

30 Potential for Coercion in Subject Recruitment
This section requires that you consider and respond to the potential for coercion of subjects. In completing this section, consider your relationship to the potential subjects.

31 Informed Consent – Part 1
Describe in detail the process of informed consent. Recall that informed consent is a dialog between you and prospective subjects that begins at the time of recruitment and ends when the work with participants has ended. It is not simply handing a subject a consent form to read. If different groups of subjects will have different processes please describe the process for each group. This section should include who will conduct the consent process, where, when, and the opportunity participants will have to ask questions and consider their involvement in the research. Discuss the study procedures, risks and benefits, confidentiality, the right to withdraw or refuse to participate. Mention that participants will be allowed to ask questions prior to enrolling in the study. Also, mention that participants will be provided with an signed copy of the consent form for their records.

32 Informed Consent – Part 2
There are times when consent forms are not used; this section discusses these circumstances and provides you with an opportunity to explain why such a waiver/alteration is applicable to your research. Please note that in order for the IRB to grant waiver/alteration of the consent process or of the signed document of informed consent, it must meet certain requirements that are outlined on the IRB’s Informed Consent Policy ( and researchers are advised to address these items as they describe their rationale.

33 Informed Consent – Part 3
In this section, provide information about the actual consent and assent documents.

34 Protected Health Information
Protected Health Information (PHI) as defined by HIPAA also affects the conduct of research. In this section, you are asked to provide information related to PHI use in your study. NOTE: The NSU IRB now requires a separate HIPAA authorization for use and disclosure of PHI for research at the NSU Clinics. For outside institutions, the PI must verify the procedures with the applicable HIPAA officer.

35 Protected Health Information
The NSU IRB now requires a separate HIPAA authorization for use and disclosure of PHI for research at the NSU Clinics. For outside institutions, the PI must verify the procedures with the applicable HIPAA officer.

36 Student/Academic Information Use
Please provide information as to any student/academic information that you plan to obtain as a part of the research study.

37 Risks, Discomforts, & Inconveniences
Discuss the potential risks, discomforts, and inconveniences one can reasonably expect are associated with your study. Carefully considering risks in advance helps to avoid the situation where the PI experiences, and must report, unanticipated events. One of the primary roles of the IRB is to assess the potential risks to the potential benefits. It can only do so if you provide a detailed account of the potential risks.

38 Benefits to Subjects As with the risks, the potential benefits one might reasonably expect subjects to receive are an important element of a comprehensive IRB review. PIs are encouraged to be judicious in assessing the potential benefits to subjects associated with their research.

39 Data Analysis Plan Discuss your tentative plans for data analysis. The IRB recognizes that actual data analysis may differ as a result of later research activities and the characteristics of the data. This section may help the reviewer in determining the scientific benefit of your study. You do not need to submit a study amendment if the only change is to your data analysis procedures.

40 Scientific Benefit In this section, the IRB requests that you describe the scientific benefits that may result from the research. Recall that one of the responsibilities of the IRB is that it contrast the risks presented by the study to the potential benefits. Since some studies do not present benefit to subjects, the only other type of benefit may be scientific. Therefore, as a PI, you should consider the scientific benefit of the proposed study. As a part of that process, you should examine the proposed methodology to maximize the potential benefit of your research.

41 Risk/Benefit Ratio In this section, the IRB asks you, as the PI, to consider the ratio between the potential risks of your study and the potential benefits. In this section you may include both benefits to subjects, if any, as well as benefits to science. The IRB may or may not agree with your assessment, but the information you provide here may further enhance the IRB’s understanding of your study. If there are only minimal risks, and there are no subject benefit, but scientific benefit, you can simply state that.

42 Safety Monitoring Plans
The monitoring of safety of human subjects is important in research. In many cases, studies that involve significant risk have detailed plans associated with data safety monitoring. Use this section to provide the IRB with information related to any safety monitoring plans.

43 Other Information We hope that this form has provided you with the opportunity to completely describe your proposed research. There may be information that was not appropriate for one of the prior sections that you believe is important for the IRB to have as it considers your research. Use this section for that purpose.

44 Principal Investigator Assurance and Obligations
In this section, you are attesting to the IRB a number of items. Read each carefully. Please note that any revision to this document requires re-signature by PI and Co-I (when applicable).

45 Co-Investigator Assurance and Obligations (for Student PIs)
If the PI is a student, the advisor attests to his/her review of the completed IRB submission and verifies that the information presented is accurate across all documents and that the submission is a valid reflection of the proposed research approved by the students thesis/dissertation committee.

46 Contact your Center/College Representative: http://www. nova
Contact your Center/College Representative: We look forward to reviewing your submission! Nova Southeastern university institutional review board (IRB) staff: ms. Jennifer dillon, irb director (x25311) Ms. inga hess, irb support Staff (x25369) Mr. randy denis, irb specialist (x25368)

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