Protocol Application Form (An Eleven Step Process - Template A)
Complete applications plus LRB review must be submitted to Sara Gulbrandsen by the 15th of each month for review that month. Applications submitted after the 15th will be reviewed in the following month. Contact your LRB Chair for additional information.

(download this file or contact Sara Gulbrandsen at (773) 325-2593 or at sgulbran@wppost.depaul.edu )
For office use only:

IRB Protocol No.:                                                       Date of IRB Review:

 
Step I: Please provide the following information:
Project Title:

Project Begin Date: 

Project End Date:

Principal Investigator(s):

Degree: 

University Status:

Department: 

College/School:

Telephone Number:                                       E-mail Address:

 
List all Faculty Sponsors and Co-Investigators, including those from other institutions.

Co-Investigator           Faculty Sponsor                   NA            (Check one)

Name:

Degree: 

University Status:

Department: College/School:

Telephone Number:                                               Email Address:

 
Contact Information

Who should be contacted for further information about this protocol?

Name:

Title: 

Telephone Number:                                     E-mail address:

 
Step II: Funding Sources
Check all of the appropriate boxes for funding sources for this research. Include pending funding source(s).
    None

    Federal - If federally funded, provide name and address of individual to whom certification of IRB should be sent:

    Extramural (non-fed. funding sources) - provide name & address of individual to whom IRB certification should be sent:

    University Research Council (URC)

    Other (describe):

 
Grant Information
P.I. of Grant or Contract: 
                
Name of Funding Source: 
        
Grant/Contract #: 
(if available)		 
        
Grant/Contract or Project Title: 
        

 
Performance Sites
List all collaborating or performance sites:

 
Provide letters of cooperation or support   Attached    Pending    Not Applicable:
Provide letter of other IRB approval:   Attached    Pending    Not Applicable

 
Step III: Abstract (no more than 200 words)

Summarize the proposed research using non-technical language that can be understood by any generally informed layperson:

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 

 
Step IV: Goals and Objectives of the Project (not more than two pages)

Describe the specific aims of the research. What new information does the Principle Investigator intend to obtain by conducting this research? Demonstrate that the goals and objectives described are worthy of investigation and require the use of human research participants.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 

 
 
Step V: Description of the Human Participants and the Recruitment Procedures
Participant Population
1.      Anticipated number: Male______  Female______   Total______
This number should be the number of participants you will enroll in order to get the adequate data sets you will need. If multiple sites are to be used, provide an estimate in this space of the number in each category to be recruited from each site. In addition, if you plan to study only one sex, provide detailed rationale in the inclusion/exclusion section under "Recruitment Procedures" of the application.

 

 
    2.      Age Range (check all that apply)
          0 -7 yrs. (submit parental permission form – template C)
          8 - 17 yrs. (submit child’s assent form –template D and parental permission form – template C)
          18 - 64 yrs. (submit informed consent form – templates B or F)
          65+ yrs. (submit informed consent form – template B)
3.      Source/type of participants:     hospital/medical patients
    volunteers from the general population
    DPU employees (submit informed consent form – template F)
    DPU students (submit informed consent form – template F)
    community institutions: specify___________________________________
    other: specify________________________________________________
    4.      Location of participants during research data collection (check all that apply):
          participant’s home
          hospital/clinic: specify__________________________________________
          DPU locations: specify_________________________________________
          community locations: specify____________________________________
          elementary schools: specify_____________________________________
          secondary schools: specify______________________________________
          other: specify_________________________________________________
    5.      Special populations to be included in the research (check all that apply):
          minors under age 18
          pregnant women
          prisoners
          economically disadvantaged
          other: specify___________________________________________________
6.      Provide rationale for using special populations---
The groups listed in (e) above are considered "vulnerable" or require special consideration by the federal regulatory agencies and by the IRB (see special populations criteria in the DPU Policies and Procedures Handbook for Research Involving Human Participants):

 
 
 
 

 

 
Recruitment Procedures
1.       Describe how participants will be identified and recruited---
Attach all recruitment information, e.g., advertisements, bulletin board notices, scripts for telephone recruitment, and recruitment letters for all types of media (printed, radio, electronic, TV, or Internet):

 
 
 

 
2.      Initial Contact---
Describe who will make initial contact and how. If participants are chosen from records, indicate who gave approval for the use of the records. If records are "private" medical or student records, provide the release forms, consent forms, letters, etc., for securing consent of the participants for the records. Written documentation for cooperation/permission from the holder or custodian of the records should be attached. (Initial contact of participants identified through a records search must be made by the official holder of the record, i.e. primary physician, therapist, public school official.)

 
 
 

 
3.      List criteria for inclusion and exclusion of participants in this study---
Describe populations to be excluded from the research. Please describe procedures to assure equitable selection of participants. Researchers should not select participants on the basis of discriminatory criteria. Selection criteria that exclude one sex, racial, or ethnic group require a clear scientific rationale for the exclusion.
      • Inclusion:


 
      • Exclusion:


 
      • By whom will the inclusion/exclusion criteria be determined? (E.g., principal investigator, research assistant, medical personnel, school officials):


 
4.     Will participants receive inducements before or rewards after the study? 
          (Note: this information must be outlined in the consent document.)
  YES   NO

If yes,explain: 

 

 

 
Step VI: Risks and Benefits of the Research
1.     Risks---
Identify the risks (current and potential) and describe the expected frequency, degree of severity, and potential reversibility. Include any potential late effects. (Note: risks can be psychological, physical, social, economic, or legal.)

 
 

 
2.     Does the research involve (check all that apply):
    use of private records (medical or educational records)
    possible invasion of privacy of participant or family
    deprivation of physiological requirements such as nutrition or sleep
    manipulation of psychological or social variables such as sensory deprivation, social isolation, stresses, mood induction
    the collection of personal or sensitive information in surveys or interviews
    use of a deceptive technique, e.g., placebo, double-blind, etc. (If use of deception is part of the experimental protocol, the protocol must include a "debriefing procedure" [provide this procedure for IRB review] which will be followed upon completion of the study, or withdrawal of the participants.)
    presentation of materials that participants might consider offensive, threatening, or degrading
    changes in diet or exercise
    other risks: specify____________________________________________________
3.     Describe the precautions taken to minimize risk:

 
 

 
4.     Why are the risks and inconveniences mentioned above reasonable?---
What is the expected scholarly yield from the project? Please justify the risks in relation to the anticipated benefits to the participants and in relation to the importance of the knowledge that may reasonably be expected to result from the research.

 
 

 
5.     Benefits of participation---
List any anticipated direct benefits of participation in this research project. If none, state that fact here and in the consent form. The knowledge gained from the study could produce a benefit to society.  However, if there are no direct benefits to the subject, you may state the benefits to society but only after stating that the subject does not directly benefit from participating.  Payment or course credit is not considered to be a benefit of participation. Remember, any benefits of the specific research procedures should be listed as "potential benefits".

 
 

 

 
Step VII: Confidentiality of Data

Describe provisions made to maintain confidentiality of data.
  • Who will have access to raw data?
 
        
  • Will raw data be made available to anyone other than the Principal Investigator and immediate study personnel (e.g., school officials, medical personnel)? If yes, who, how, and why?
 
        
  • Describe the procedure for sharing data(if applicable):
 
        
  • Describe how the participant will be informed that the data may be shared:
 
        
  • If data are collected, stored, or analyzed on computers, describe the security measures used to ensure confidentiality:
 
        
  • Where will the data be kept and for how long? How will paper records, computer files, audio and videotapes be disposed of? (Disposition of audio and video tapes should be included in consent form.)
 
        
  • Will data identifying the participants be made available to anyone other than the principal investigator, e.g., FDA, study sponsor, Institutional Review Board? (Note: when explaining this in the consent form use appropriate language.)
      YES   NO
  • Will the research data and information be part of the medical chart or other permanent record? (Explain here and in the consent form.)
     
         YES     NO
  •  If participants are students, will school officials receive the data with identifiers attached? (Explain here and in the consent form using appropriate language.)
     
        YES      NO

 
 
Step IX: Informed Consent Process

Simply giving a consent form to a participant does not constitute informed consent. The following questions pertain to the process. Researchers are cautioned that consent forms should be written in simple declarative sentences. Forms should be jargon-free (see consent form template). Foreign language versions should be prepared for any applicable research and procedures for back-translation into English identified.
 
1.     Capacity to consent---
Will all adult participants have the capacity to give informed consent? 
 YES     NO
If not, in this space describe the likely range of impairment and explain how, and by whom, their capacity to consent will be determined. Note: in research involving more than minimal risk, capacity to consent should be determined by a psychiatrist, clinical psychologist, or other qualified professional not otherwise involved in the research. Individuals who lack the capacity to consent may participate in research only if a legally authorized representative gives consent on their behalf.

 

 
2.     Describe what will be said to the participants to explain the research--- 
(Note: do not say "see consent form.") Write the explanation in lay language. If you are using telephone surveys, telephone scripts are required.

 
 
 
 
 
 
 
 
 
 

 
3.     How will participants’ understanding be assessed?---
What questions will be asked to assess the participants’ understanding? (Note: the purpose of this question is to have you describe how you will assess participants’ understanding of the consent process. Questions requiring "yes/no" answers are not appropriate. Please ask participants to explain the purpose of the study to you along with the risks and benefits to themselves as participants. Their answers to these questions should allow you to determine whether they understand the study and their part in it. It they do not understand, informed consent has not been achieved irrespective of whether the participant signed the consent document.)

 
 
 
 

 
4.     For consent forms not written in English, have they been translated back into English to assure appropriate translation?
  YES    NO
Please attach translated and back-translated consent forms to this protocol.
5.     In relation to the actual data gathering, when and where will consent be discussed and documentation obtained, for example several days before? Be specific.

 
 

 
6.     Will the Investigator(s) be securing all of the Informed consents?
  YES    NO
If no, name the specific individuals who will obtain informed consent and include their job title and a brief description of your plans to train these individuals to obtain consent and answer participants’ questions.
7.     Consent and Assent Forms (see templates C & D)
Prepare and attach DPU consent form(s) for IRB review (see sample consent form and, follow it carefully). If there is a specific consent form for a research-sponsor, include a copy and prepare the DPU IRB consent form by editing the sponsor form to include DPU IRB standard language.
8.     Are you requesting Waiver or Alteration of Informed Consent?
  YES    NO
The IRB may approve a research protocol that does not include, or alters, some or all of the elements of standard DPU informed consent form. Answer the following questions to justify your request for a waiver of written informed consent.
  • Why does the proposed research present no more than minimal risk to the participants?
 
        
  • Why will a waiver of informed consent not adversely affect the rights and welfare of participants?
 
        
  • Why is it impracticable to carry out the research without a waiver or alteration of informed consent?
 
        
  • How will pertinent information be provided to the participants, if appropriate, at a later date?
 
        

 
Even if waiver of written informed consent is granted, you may be required to obtain verbal permission which reflects elements of the written consent (if appropriate). Please specify below the information to be read/given to the research participants.

 
 
Step IX: Plan of Work

Describe the tasks/tests or procedures participants will be asked to complete. (Suggestions: explain step by step what the participants will be asked to do and distinguish those which are experimental from those which comprise routine tasks encountered in everyday life). Specify exactly how these tasks/tests or procedures will generate the data that will permit achievement of the goals and objectives of this research.  Attach all forms, surveys, and questionnaires that the subject must complete.  For interviews, specify the types of probe questions to be used.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
1.     Is classroom time being used for any part of the study? 
  YES    NO
If yes, justify the use of classroom time. Also describe in detail the activity planned for non -participants during the class session:

 

 
2.     Attach the research proposal/protocol that was, sent to the external agency, or local review board for peer review of methodological and ethical merit. For federally funded research include all sections of the proposal/grant except the budget pages

 
Step X: INVESTIGATOR’S ASSURANCE
I certify that the information provided in this application is complete and correct.

I understand that as Principal Investigator, I have ultimate responsibility for the protection of the rights and welfare of human participants, conduct of the study and the ethical performance of the project. I agree to comply with all IRB policies and procedures, as well as with all applicable federal, state and local laws regarding the protection of human participants in research, including, but not limited to, the following:

  • The project will be performed by qualified personnel according to the DPU IRB certified protocol,
  • No changes will be made in the protocol or consent form until approved by the DPU IRB,
  • Legally effective informed consent will be obtained from human participants if applicable, and
  • Adverse events will be reported to the DPU IRB in a timely manner.
I further certify that the proposed research is not currently underway (except for those protocols of research previously approved and currently seeking renewal) and will not begin until approval has been obtained.
 
 


Principal Investigator’s Signature                                                    Date

 
Faculty Sponsor’s Assurance for Student or Guest Investigators
By my signature as sponsor on this research application, I certify that the student or guest investigator is knowledgeable about the regulations and policies governing research with human participants and has sufficient training and experience to conduct this particular study in accord with the approved protocol. In addition,
  • I agree to meet with the investigator on a regular basis to monitor study progress,
  • Should problems arise during the course of the study, I agree to be available, personally, to supervise the investigator in solving them,
  • I insure that the investigator will promptly report significant or untoward adverse effects to the DPU IRB in a timely manner,
If I will be unavailable, as when on sabbatical leave or vacation, I will arrange for an alternate faculty sponsor to assume responsibility during my absence and I will advise the DPU IRB by letter of such arrangements. I further certify that the proposed research is not currently underway and will not begin until approval has been obtained.
 
 


Faculty Sponsor’s Signature:                                                                 Date:
The faculty sponsor must be a member of the DPU faculty. The faculty member is considered the responsible party for legal and ethical performance of the project.

 
 
 
CHECKLIST FOR INVESTIGATORS

Applications will be returned if not complete.
 
  • These Documents are Required for All Expedited or Full Board Reviewed Projects:
      •      Completed Protocol Application
           Completed Local Review Board Evaluation Form
           Consent Form (unless requesting a waiver of written consent)
  • The Following Documents are Required When Appropriate:
      •      Parental Permission Form
           Child Assent Form
           Translation of Consent/Assent Forms
           Back Translation of Consent/Assent Forms (required for all translated material)
           Grant Proposal
           Advertisements
           Surveys/Questionnaires/Interview Questions
           Letters of Collaboration
           IRB Approval from Other Institutions
           Debriefing Information