Office of Responsible Research Practices
The Ohio State University

Appendices

Contents


Appendix 1: Submission Guide
Appendix 2: Guide to Writing a Research Protocol/Proposal

Appendix 1: Submission Guide

Prior to submitting a protocol for IRB approval, investigators may wish to use this guide for planning purposes to help determine whether all steps have been completed and all necessary submission information has been gathered and/or created. Note that this checklist should not be used as a substitute for familiarity with the official Ohio State University IRB guidelines found on the ORRP website, which contain specific information about current submission requirements. This guide is intended to address materials often overlooked during the initial submission process.

1. All research submissions

  • Have all investigators and key personnel completed the required CITI human subjects training?
  • Is protocol, proposal, or relevant section(s) of the thesis/dissertation attached?
  • Does the project description, in lay terms, clearly discuss all procedures in which human subjects are involved?
  • Is the purpose of the research described clearly?
  • Are the participant population and size justified appropriately?
  • Are frequencies of intervention and data collection methods described clearly for each type of participant?
  • Do the protocol and participant materials describe how subjects will be identified in written reports?
  • Is the level of confidentiality, anonymity, and privacy of participation clearly described to participants?
  • If recordings will be made, do the application and participant materials explain how the recordings will be handled, stored, transcribed, and/or destroyed or archived?
  • Have consent forms been translated into the appropriate language(s) for non-native English speakers (as applicable)?
  • Have these translations been verified for accuracy by a person fluent in the language but not affiliated with the research?
  • Are all supporting documents attached, including the following (as applicable):
    • Consent, assent, and/or parental permission forms, and verbal scripts, including translated documents
    • HIPAA research authorization forms
    • Data collection forms
    • Recruitment materials (e.g., ads, flyers, telephone or other oral script, radio/TV scripts, internet solicitations)
    • Scripts or information sheets, including debriefing materials
    • Instruments (e.g., questionnaires or surveys to be completed by participants)
    • Other committee approvals/Letters of support
    • Complete grant application or funding proposal
  • Are any potential conflicts of interest indicated?
  • If a known conflict exists, do investigators have a conflict management plan in place?

2. Research protocols involving children

  • Are parent permission and child assent (as applicable) forms attached?
  • For research at day-care centers or schools, is a letter of support from the school principal attached?

3. Research protocols involving vulnerable populations (e.g., minorities, prisoners, pregnant women, elderly, economically disadvantaged, adults requiring a legally authorized representative)

  • For pregnant women or fetuses, is documentation (e.g., prior research) provided for assessing potential risks to participants?  Has Maternal-Fetal Welfare Committee approval been granted (as applicable)?
  • For prisoners, are risks comparable with those acceptable by non-prisoner volunteers?
  • Are the prison IRB or Ethics committee approvals attached?
  • Have the prison research criteria been met or addressed?
  • Has a plan to minimize coercion been clearly defined?
  • Have specific risks to the population been addressed and minimized?

4. Research protocols involving students

  • Have students given voluntary, informed consent?  Note: Student subject pool participants must provide consent for each individual study (i.e., consent to participate in the student pool is not consent to participate in a specific study).
  • If course credit or extra credit is offered as an incentive for research participation, is there a non-research alternative that allows students to gain the same credit if they do not wish to participate in research?  Is this explained both in the application materials and participant materials?
  • If incentives will be offered, does the consent form or script specify that the incentive will be given even if a participant withdraws?  Incentives, including course credit, can be pro-rated, but cannot be based on study completion.
  • If the investigators are performing research with their own students, is there a detailed description of how the possibility for coercion is minimized and/or a detailed plan to protect the identity of the students who choose to/not to participate in the research?

5. Research protocols involving human biological specimens

  • Do protocol and consent form disclose the specific types of tests to be done, what type of information will be collected, and what happens to the specimens at the end of the research?

6. Research protocol at multiple sites

  • Are letters of IRB approval or other agreements for each site attached?

7. Deception research

  • Have deception research criteria been met or addressed?
  • Is justification for deception research provided?
  • Is the participant debriefing process adequate (i.e., are subjects informed about the necessity/purpose of the deception)?

8. Internet Research

  • Has permission been obtained from the list owner or administrator to recruit participants, use archived data, or post messages to the site?
  • Will encryption software be used, and if so, how will participants be informed?
  • What specific security measures will be employed (e.g., SSL encryption)?
  • Are participants informed about the inherent insecurity of Internet/email data collection (as appropriate)?

9. Externally funded research

  • Is grant or sponsor protocol attached?  Note that the entire grant (including all face pages, budget info, etc.) must be submitted.
  • If a grant is pending, is there a plan in place to update the IRB of the award via an amendment request?

 

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Appendix 2: Guide to Writing a Research Protocol/Proposal

To ensure an effective review by the Institutional Review Board, a full description of the planned research must be submitted with the Application for Initial Review.  A research protocol/proposal provides the reader with background information of the problem under study, including the study rationale, a detailed plan for conducting the research involving human research participants, and a discussion of the potential importance of the research.  Different disciplines and projects may not require all of the elements below.  The outline below is only intended as a guide.

I.   Objectives

The purpose of the study (research questions and/or study objectives) should be clearly and succinctly stated.  In experimental designs, objectives will be stated as hypotheses to be tested.

II.  Background and Rationale

Summarize and synthesize the available research (including published data) to provide justification for the study. Evaluate prior research for relevance to the research question under study. When the proposed research is the first of its type to involve human participants, the results of relevant animal studies must be included. Discuss the anticipated results and potential pitfalls.  Describe the significance of the research, including potential benefit for individual participants or society at large. Discuss how public health and social welfare might be enhanced.

III.   Procedures

The procedures should include the following:

  • A.  Research Design
    The research design should be identified and should be appropriate to answer the research question(s) under study. Describe the type of research proposed (e.g. experimental, correlational, survey, qualitative) and specific study design that will be used (e.g. pre-test/post-test control group design; cross-sectional design; prospective longitudinal cohort design; phase III, double-blind, randomized control group design, etc.).
  • B.   Sample
    Describe the sampling approach. For experimental designs, include justification for sample size determination. Identify the procedures that will be used to recruit, screen, and follow study volunteers. Specifically define the study sample (number of participants to be enrolled, characteristics of participants to be included in and excluded from the research).
  • C.   Measurement/Instrumentation
    Identify the variables of interest and study endpoints (where applicable). Justify measurement techniques selected.  Provide validity and reliability data for selected measures.
  • D.   Detailed Study Procedures
    Methods for study data collection and for avoiding/minimizing participant risks should be included. Include a timeline for participant evaluations and the duration of subject participation in the project. Identify the proposed safeguards for participant confidentiality (plans for coding data and for securing written and electronic participant records). Indicate how long personal information will be stored once the study is completed.  Note: Methods will vary with the research approach used (qualitative, quantitative). The selected methods should be sufficiently described to justify the use of the approach for answering the defined research question. Methods should also be described in adequate detail so that IRB members may assess the potential study risks and benefits.
  • E.   Internal Validity
    Threats to internal/external validity should be considered. Describe measures that have been taken to avoid study bias.
  • F.  Data Analysis
    Specify the analytic techniques the researcher will use to answer the study questions. Indicate the statistical procedures (e.g., specific descriptive or inferential tests) that will be used and why the procedures are appropriate. For qualitative data, specify the proposed analytic approaches.

IV. Bibliography

Include a reference list of literature cited to support the protocol statement.

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