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Institutional Review Board

Project Details Research Proposal Guidelines
(For Non-Exempt Expedited and Full Review)

Please note that your IRB proposal MUST be headed by an NDNU IRB Application Cover Page

Please provide the following on a separate sheet(s) of paper:

Principal Investigator: (Your name)

Research Supervisor:  (Faculty, Staff, or Administrator)

Project Title:

Course: (Only if relevant)

Date of Application:

Funding source/Representative of study: (if applicable) (e.g., Roche Pharmaceuticals, $5000, dispensed through Development Office, NDNU)

Statement of purpose: (One paragraph)

What is the rationale for the proposed study you plan to conduct?

Specify your question of interest and research objective.

Brief introduction/literature review:

Please cite relevant research, theory, and results.

Start with general question of interest and go on to describe background and rationale.  (2 pages max) (If easier to attach entire literature review, then please do so).  Nevertheless, briefly describe rationale for your study in this section.

Hypothesis (es): /General question of interest:

In a couple of sentences, state your hypothesis(es) /expected outcomes, relaying the general question stated.

Method Section:

Participants: (who, how many, how and where recruited, appropriate permission letters need to be attached for sites, agencies, organizations, schools).  Note: Please check with site/organization/institution where you plan to gather participants as many places have their own IRB requirements and/or will require permission before data collection can begin.  Specify if through random means, where, how, not any friends, family, etc. or anyone with whom there may be conflict of interest and possible dual-role or implicit coercion, or where they will feel or be compromised in any way.  If there will be adverse repercussions if a participant decided to withdraw from the study, restate here.

Design: Type of research design, variables of interest, how measured, data collection, analysis.  State how data will be collected, analyzed, coded, stored (ethically, i.e., in locked file) – and expected analyses and outcomes. In other words, specify anonymity of demographic data detached from collected information, how will investigator ensure confidentiality of data, etc.  The signed informed consent form(s) must be stored separately from the participant’s data.  You may want to number code informed consent form(s) to match each participant’s data.   Keep a separate log to ensure anonymity and confidentiality, while maintaining accurate records of obtained informed consent.

Materials: Any survey, manipulations, (i.e., film clips, text, pictures, etc.) describe in full detail and provide in Appendix all materials (or samples thereof) that participants will be exposed to. (For samples of letters, please refer to Forms: Sample on the website.)

Note: NDNU IRB Board requires either your entire materials (e.g., Survey) or samples in format to be presented to participants.

Procedure: From the beginning to the end of research project/study, describe what you will do with the participants.  For example:  informed consent, read instructions, administer survey, materials, debrief, answering questions, comments.

Be sure to include projected number of participants and demographics, design, listing specific variables, levels, etc, type of materials, apparatus, measurement tools, and procedures.

Attach your measurement tool as Appendix (i.e., copy of survey–if preliminary, description of stimuli –must provide sample questions).  Be sure to include an informed consent form and debriefing statement.

Specify any anticipated risks or benefits (even if in informed consent, restate here separately for IRB purposes) – if none, specify none.

Implications:

Please state what your expected outcomes and their implications are with respect to prior research, theory and rationale.

References:

Provide a reference section for the studies, theories cited in introduction, brief literature review.

Note: ORI & DHHS require an abstract (1 paragraph) or a summary (1-2 pages) of findings, inclusive of any potential deviations from original approved proposal for IRB record keeping purposes. Please submit a brief summary of findings and any potential changes/deviations from original approved IRB proposal no later than two weeks after study’s completion to the IRB Chair. Kindly provide your name, title of investigation, project number and date of IRB approval.

Preferred sequence of documentation:

  • Application Cover Page
  • Non-Exempt Checklist
  • Project Details
  • Permission letters
  • Consent forms
  • Debriefing statement
  • Any additional appendices (i.e., stimuli or samples)

Please allow a minimum of 2-3 weeks from date of IRB meeting for processing time for Full Review or a minimum of 1-2 weeks from date of IRB meeting  for processing time for Expedited Review, and submit to your school IRB representative.