The University of Oklahoma Health Sciences Doctor of Science in Rehabilitation Sciences Student Handbook

7.4 - DOCTORAL THESIS PROPOSAL DEVELOPMENT

The proposal presents a detailed plan of the student’s proposed doctoral thesis. The doctoral thesis includes revised and expanded content from the prospectus based on requirements of the OUHSC IRB requirements. The length of the proposal will vary, but typically ranges from 6-12 pages, excluding references. The committee must consider the proposal product ready before the student can proceed with data collection. The Proposal includes the following headings based on OUHSC Research Protocol Outline, Version 3.12.2019 or the most current on the OUHSC IRB website. For additional information see OU HRPP Policies and Procedures, including Standing Operating Procedures Maintenance (SOP).

Instructions:

  • Proposals are formatted according to the following outline (single-spaced, size 12 font).
  • Include all of the below elements, as applicable to the proposed study.
  • Remove blue instructional text and examples throughout.

Title of Project:
Principal Investigator:  Name; Degree; Department 
Abstract: In fewer than 250 words, identify the problem, the hypothesis, and the importance of the research.   

1. Specific Aims

Suggested length: One or two paragraphs

State the hypothesis and specific aims.  List the long-term objectives and what the proposed research will accomplish. For additional information see NIH Draft Specific Aims

2. Background and Significance

Suggested length: One-half page

  1. Sketch the background leading to this study, evaluate existing knowledge, and identify gaps this study will fill.  State the importance of the research by relating the specific aims to the long-term objectives.
  2. Briefly describe pre-clinical and clinical data, current experience with procedures, drug, or device, and any other relevant information to justify the research.

3. Preliminary Studies/Progress Report 

Suggested length: Less than one-half page

  1. Provide an account of previous studies and/or information that establishes the experience and competence of the investigator to pursue the protocol.

4. Research Design and Methods (What, When, How, Where)

This section should explain the basic components of the study, answering ‘What, When, How, and Where’ questions as they apply to the research. Tables, graphs, or other visual aids may be used. For guidance on a specific category of research, see SOP 502A-502L.

Identify sources of research material in the form of biospecimens, records, and/or data from interaction with participants. 

NOTE: Qualtrics cannot be used if the survey information covered by FERPA.

  1. Describe study design, including sequence and timing of study procedures. Distinguish research procedures from those that are routine care. Provide a flow diagram or timetable.
  2. Include the study duration and number of study visits required.
  3. Describe blinding, including justification for blinding or not blinding the trial. 
  4. Include justification for inclusion of a placebo or non-treatment group.
  5. Describe what happens to participants receiving therapy when study ends or if their participation in the study ends prematurely.
  6. Indicate where the procedures will be completed.
    1. Include all sites where research activities will be conducted (consenting, interventions, chart reviews, data analysis, etc.).
    2. Indicate that all required approvals are already obtained or will be obtained at each research location prior to project implementation.

Note for non-OU sites: If the site is engaged in research, an IRB must provide oversight. OUHSC can be the oversight IRB. If the site is not engaged in research, a letter of support from the site is required.

  1. Indicate whether clinically relevant research results, including individual research results, will be disclosed to participants. If so, under what conditions?
  2.   INCLUDE ONE OF THE FOLLOWING STATEMENTS:
    1. Identifiers might be removed and the de-identified information may be used for future research without additional informed consent from the subject.
    2. The subject’s information will not be used or distributed for future research studies even if identifiers are removed.

5. Chart Review

This section should clearly identify whether the chart review is retrospective and/or prospective in nature, where the data is housed, how the investigator will obtain the data, and, specifically, the data points that will be used.

  1. List the data that will be used from the chart review. Alternatively, attach a separate data collection tool.
  2. Describe the databases that will be utilized, including specific sites from which you will collect data.
  3. Describe the process for obtaining and recording the records and at what point (if at all) the data is de-identified.

Examples:

  1. The PI conducts a review of records from their practice and collects medical records based on inclusion/exclusion criteria. Records will be de-identified during data analysis;
  2. The PI conducts a review of records within the hospital and collects records based on inclusion/exclusion criteria. The records will not be de-identified.
  3. The PI sends inclusion/exclusion criteria to EMR Staff, EMR Staff de-identifies the records, and then sends the records to the study team.
  4. Explain how access to the data will be controlled and whether the access is logged. (Ex. REDCap user controls and logged access)
  5. What happens to the data at the end of the study?

6. Biospecimens (if applicable)

This section should clearly identify whether the biospecimen review is retrospective and/or prospective in nature and where the biospecimens are housed. Bullet points #3 and #4 are required per the Revised Common Rule.

  1. Describe the biospecimens to be collected.
  2. Describe the process for obtaining the biospecimens and at what point (if at all) the data is de-identified.
  3. State whether the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit.
  4. State whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

7. Banking/Repository/Database

  1. If data and/or biospecimens will be banked for future use:
    1. Describe why the data will be stored for future use, where the data or biospecimens will be stored, how long they will be stored, how the data or biospecimens will be accessed, and who will have access to the biospecimens.
    2. List the data to be stored or, in the case of biospecimens, what information will be linked to each biospecimen, specifically regarding the identifiability of biospecimens.
    3. If storing data in a repository outside of OUHSC, describe the agreement arrangements with the outside entity (Ex. Data Use Agreement, Business Associate Agreement).

REMINDER: All agreements must be processed through the Office of Research Administration.

  1. If storing data electronically, include a plan for managing the long-term storage of the data.

8. Inclusion / Exclusion Criteria

  1. List the criteria that will define who will be included in the study
  2. List the criteria that will define who will be excluded in the study.
  3. Provide early termination criteria. 

9. Gender/Minority/Pediatric Inclusion for Research

All protocols must include documentation of the inclusion of women and minorities in the research protocol. If a segment of the population is excluded from the study, provide clear rationale for their exclusion.

10, Recruitment and Enrollment

In this section, address how you will recruit and enroll participants. If this study may qualify for a waiver of consent or waiver of documentation of consent, explain your rationale for requesting one here. Refer to SOP 410: Research Project Recruitment for guidance.

  1. Describe the plans for recruitment.
    1. Methods to identify and recruit potential participants
    2. If this is a multicenter study where subjects will be recruited by methods not under control of the local site (call centers, national advertisements), indicate this here.
  2. Describe the consent procedures to be followed (Ex. screening procedures, consent documentation, the process and rationale for the consent form being mailed to participants, the process for obtaining consent when a waiver of signed consent is obtained, etc.).
  3. Describe the location where consent is most likely to take place (Ex. will consent be obtained while an inpatient, in the ER/ICU, will consents be mailed with follow-up meeting to discuss the consent, etc.)
  4. Describe provisions for recruiting non-English speaking participants.
  5. Describe measures to decrease participant coercion (Ex. allowing adequate time to review the consent, avoiding recruitment of your own private patients – or have a qualified assistant assist with the consent of these individuals, avoid recruiting employees or staff to serve as controls, etc.).

11. Risks and Benefits

  1. Describe risks and assess their likelihood and severity.
    1. Risks may include physical, mental, social, financial, etc.
    2. For chart reviews only, address the risk of confidentiality.
  2. Describe procedures for protecting against or minimizing potential risks.
    1. Address measures instituted to protect the privacy and/or confidentiality of participant PHI (Ex. locking cabinets for participant records containing PHI, use of password protected programs, limited access to PHI, etc.).
  3. Describe potential benefits and importance to the participants and others.
  4. Discuss why risks are reasonable in relation to benefits. 

12. Multiple Sites (if applicable)

  1. If this researcher is the lead researcher involving multiple sites, describe the roles of each site in the study. Specify which site will serve as the lead site, if appropriate.
  2. Indicate whether all required approvals are already obtained or will be obtained at each site prior to site activation.
  3. Describe the processes in place to ensure successful coordination of activities among sites. (Ex. How will all sites have the most current version of the protocol, consent form, and HIPAA Authorization?)
  4. If the study involves Single IRB review, provide a communication and oversight plan for the collaborating sites, including the following:
    1. What research activities will occur at each site
    2. The communication plan with the sites (Ex. How will all sites have the most current version of the protocol, consent form, and HIPAA Authorization?)
    3. The plan for ensuring study and regulatory compliance of each site.
  5. Describe how information management related to risk, interim reporting and implementation of amendments will be carried out.
  6. Confirm that all non-compliance with the study protocol or applicable requirements will be reported in accordance with policy and/or reliance agreement.

13. Statistical Methods  

Provide biostatistical design, power calculations determining the number of participants, and the proposed analysis.

When appropriate, a statistician should be involved in study design, sample size planning, and statistical method. 

14. Data and Safety Monitoring Plan

All protocols must have a Data and Safety Monitoring Plan (DSMP).

For some minimal-risk studies, addressing Privacy and Confidentiality may meet DSMP requirements (which must also be included in the Privacy and Confidentiality Section of the application).

For DSMB reporting requirements see SOP 802: Sponsor Responsibilities.

  1. For minimal risk studies, describe the plan to periodically evaluate the information collected regarding risks or harms to determine whether participants remain safe (ex. What is your plan to monitor severity if collecting data on depression or suicidality?).
    1. What information/data are reviewed, including safety data, untoward events, and efficacy data?
    2. How the safety data be will collected (case report forms, study visits, telephone calls with participants).
    3. The frequency of data collection, including when safety data collection starts.
    4. The frequency or periodicity of review of cumulative data.
    5. Describe conditions where the research team may intervene and the plan for intervention (ex. a participant identifies harm to self or others).
    6. Describe conditions that might trigger an immediate suspension of the research.
  2. For clinical studies, describe the Data and Safety Monitoring Plan (DSMP)
    1. Reporting mechanisms for adverse events to the IRB, FDA, and NIH.
    2. Adverse event (AE) grading
    3. Plan for unanticipated AE reporting
    4. Plan for annual reporting of AEs
    5. Interim efficacy analysis where appropriate
  3. If applicable, describe the Data and Safety Monitoring Board (DSMB) that will be responsible for monitoring the study.
    1. Institutional studies must provide:
      1. Chair, members
      2. Frequency of safety reviews
    2. Phase III, NIH Studies, or Co-Operative Studies (e.g. ECOG; CTG), or Drug-Sponsored (D) Studies provide:
      1. Contact name
      2. Brief description of Sponsor’s plan

15. Data Sharing

  1. If data will be shared with an outside entity, name the outside entity and describe/identify the following:
    1. The process for data transfer;
    2. Whether the data shared is identifiable, coded, or de-identified. If the data to be shared will be identifiable, you must provide a justification;
    3. How the data will be used (Ex. research purposes, teaching, etc.).
    4. Whether an agreement is in place (Ex. Data Use Agreement).

16. Confidentiality

Research records must be maintained for inspection of government agencies, the sponsor, the University, and other applicable entities. See the HRPP’s record keeping FAQ for additional information.

  1. Where and how data or biospecimens will be stored.
    1. Specifically, state where the study records will be stored (electronic and paper study documents including signed consent and HIPAA Forms).
  2. How long the data or biospecimens will be stored.
  3. If departments or entities outside of research team will potentially have access to the data or biospecimens, explain here.
  4. How data and biospecimens will be transported.
  5. The state of the data (will it be identifiable, coded, or de-identified, and at what point)?
  6. Other considerations:
    1. Verify that University IT Security requirements for research software development or use of mobile devices in research have been met.
    2. Verify that use of the Cloud and external data storage meet university requirements.
  1. Literature Cited: Follow APA format
    Suggested length:  No more than 12 references
     
  1. Time table: Provide a sequence or timeline for project completion

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