IRB Protocol No.:                                                       Date of IRB Review:

Course Begin Date: 

Course End Date:

Instructor(s):

Degree: 

University Status:

Department: 

College/School:

Telephone Number: 

E-mail Address:

Who should be contacted for further information about this protocol?

Name:

Title: 

Telephone Number: 

E-mail address:

Summarize the proposed research activities that the students will be doing in the course.

Describe the specific types of skills or knowledge that the classroom research activities are intended to provide for the students.

1.      Anticipated number:  Male______  Female______   Total______

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) 

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 (5) above are considered "vulnerable" or require special consideration by the IRB (see special populations criteria in the DPU Policies and Procedures Handbook for Research Involving Human Participants):

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. 

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. 

• Inclusion:

• Exclusion:

• By whom will the inclusion/exclusion criteria be determined? (E.g., instructor, teaching assistant, student, etc.)

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: 

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?---

5.     Benefits of participation---

Describe provisions made to maintain confidentiality of data.

Instructors and students should be cautioned that simply giving a consent form to a participant does not constitute informed consent. The consent forms should be written in simple declarative sentences. The following questions pertain to the process.
 

1.     Capacity to consent---

Will all adult participants have the capacity to give informed consent? 

 YES     NO

If not, explain in the space provided:

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. If they do not understand, informed consent has not been achieved irrespective of whether the participant signed the consent document.)

4.     In relation to the actual data gathering, when and where will consent be discussed and documentation obtained, for example several days before? Be specific.

5.     Will the Instructor(s) be securing all of the Informed consents?

  YES    NO

If no, name the specific individuals who will obtain informed consent and include a brief description of your plans to train these individuals to obtain consent and answer particpants' questions.

6.     Consent and Assent Forms (see templates C & D)

7.     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 the standard DPU informed consent form. Answer the following questions to justify your request for a waiver of written informed consent.

• Why does the proposed classroom research activity 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?

Describe the typical tasks/tests or procedures participants will be asked to complete. (Suggestions: it may help to explain exactly what sorts of information the students will not be permitted to obtain when conducting their clssroom research activities.)
Specify exactly how these tasks/tests or procedures will generate the data that will permit achievement of the goals and objectives of this classroom research activity.  Attach all forms, surveys, and questionnaires that the subject must complete.  For interviews, specify the types of probe questions to be used.

I understand that as the Instructor, 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 supervised 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.

Applications will be returned if not complete.
 

• These Documents are Required for All Expedited or Full Board Reviewed Projects:
     Completed Classroom 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