7 - DOCTORAL THESIS

Each student will complete a doctoral thesis (RS 8430) that will culminate in an oral defense and preparation of a manuscript for publication. The purpose of the thesis is for the student to conduct and present an in-depth study on a topic or question related to practice, education, or policy. Examples include:

1. original research
2. secondary analysis
3. scoping research
4. systematic review or meta-analysis
5. retrospective study

A minimum of six (6) credits are required for the doctoral thesis. A student who does not complete the thesis after registering for 6 credits must continue to register for at least 2 credits each semester until completing the thesis. Any doctoral thesis credits earned in addition to the 6 required credits are not applicable toward the total number of credits required for the degree. The course grade is X, S, or U. Because the student will register for consecutive semesters in RS 8430 to receive the total 6 credits, the student will receive a grade of “X” each semester if satisfactorily progressing, until the doctoral thesis is completed. An "X" is a neutral conditional grade indicating that satisfactory progress is being made. Each number of credits should reflect the amount of work and expectations for that identified number of credits. Once the student satisfactory completes and defends the doctoral thesis, the student will receive a grade of S for the final RS 8430 semester. If the student is not progressing or if the student’s work is unsatisfactory, as determined by course instructor, an intermediate grade of "U" indicating unsatisfactory progress in thesis or dissertation research may be given if circumstances warrant. This will result in no credit for the corresponding semester’s thesis coursework being granted.

The student will work with their advisor/committee chair to identify the topic and timeline for their thesis and use the following steps to guide the process. The student in collaboration with their advisor, may choose to select an alternate DSc faculty member, other than the student’s advisor, to be the Doctoral Thesis Committee Chair. Such decisions are made in collaboration with the student, advisor, alternate faculty member, and the DSc Program Director. 

Following the outlined steps of the doctoral thesis process, the student will:

1. Collaborate with advisor/committee chair to determine student research focus.
2. Explore literature and identify research gap/research question.
3. Develop the written prospectus (see Section 7.2) with advisor/committee chair. Advisor/committee chair will work with student to refine prospectus prior to sending to potential doctoral thesis committee members (see 4. & 5. below).
4. Work with advisor/committee chair to identify doctoral thesis committee members (see Section 7.3).
5. After receiving advisor/committee chair prospectus approval, email prospectus to committee members and invite them to serve on committee; cc advisor/committee chair. 
6. Within two weeks of emailing prospectus, confirm with advisor/committee chair the committee members’ willingness to participate on doctoral thesis committee.
7. Develop doctoral thesis proposal in collaboration with advisor/committee chair (see Section 7.4).  
8. Forward doctoral thesis proposal, approved by advisor/committee chair, to committee for review and revisions.  Allow two weeks for committee members to review.
9. Prepare doctoral thesis proposal oral presentation for committee members.
10. After committee approval, initiate IRB, if required, and implement study. Draft and revise doctoral thesis with committee chair (this will likely require several revisions). 
11. Submit well-written doctoral thesis manuscript draft for committee review following committee chair approval, and refine until committee approves thesis for defense. Allow two weeks for each committee members to review and request revisions. Establish defense date/time/place in collaboration with committee.
12. Advisor/committee chair will notify the Department of Rehabilitation Sciences (DRS) Student Program Coordinator of date/time/place for defense, at least one week in advance of the defense. The DRS Student Program Coordinator will email student doctoral thesis announcement to student, student’s doctoral thesis committee, DRS faculty members, DSc students, and any others as requested by advisor/committee chair at least one week in advance of the defense.
13. Prepare oral presentation (ppt) of doctoral thesis defense, in collaboration with advisor/committee chair. 
14. Defend thesis. Plan on 2 hours (30-minute ppt presentation; 15-minute attendee question and answer; 15-minute committee question and answer; remaining 1 hour for defense with committee members only)
15. Incorporate changes noted during the defense into a final draft (NOTE: Student is allowed no more than 60 days after defense to incorporate revisions).

A prospectus is the student’s first opportunity to explore and present a thesis topic. The prospectus is a two-page preliminary description of the student’s proposed research, for review by potential committee members.

The prospectus includes the following headings:

1. Title: The title should appear centered on the top of the page, followed by the student name and date.
2. Problem Statement: Provide a one- to two-paragraph statement that is the result of a brief literature review and analysis of research findings. Include the following:
   • Identify a gap in the rehabilitation research literature and provide a logical argument for the need to address the gap.
   • Present preliminary evidence that provides justification that this problem is meaningful to the discipline or professional field. Provide three to five key citations that highlight the relevance of the problem.
3. Study Purpose:
   • For quantitative studies, state on what basis you determine the topic needs to be studied by describing two or more factors (variables) and propose a relationship among them related to the identified gap or problem.
   • For qualitative studies, describe the need for improved understanding about the issue to be studied, based on the identified gap or problem.
   • For mixed-methods studies that include both quantitative and qualitative data, clarify how you will combine the two approaches and justify the use of the two forms of data as a means of enhancing your study.
4. Aims/Significance:  Provide one to two paragraphs, informed by the topic in the problem statement, which describe how the proposed study will contribute to filling the gap identified in the problem statement—what original contribution will this study make?
5. Research Question(s): List the research question or a series of related questions that are informed by the study purpose, which will lead to the development of research methods used to accomplish the study purpose and aims.
6. Methods:  Provide a concise paragraph describing the methodology that you will use to address the research question(s) Note: Student may also use the Specific Aims format frequently used for NIH grant proposals.
7. Tentative Timeline: Provide a tentative timeline for completion of Doctoral Thesis.

Following development of the prospectus, the student and advisor/committee chair will identify additional doctoral thesis committee (committee) members.  Committees are comprised of the student’s advisor/committee chair and at least two other faculty members, one of whom must be from the Department of Rehabilitation Sciences. Students and their advisor/committee chair may request an outside (non-OUHSC) committee member who by reason of professional expertise or special qualifications can be a contributor to the doctoral thesis committee. The student should contact the Program Director, including their advisor in the correspondence, requesting approval for the external committee member. The external committee member may be considered as one of the two required additional faculty members, besides the advisor, or may be considered an additional non-faculty member in excess of the required committee member makeup. The request should include a brief description of the requested external member, including their credentials, current employment, previous experiences with the student thesis topic (if applicable), and the reason for the request.

The student will submit (email) the prospectus to potential faculty committee members for review. Potential committee members will review the prospectus and determine whether or not they agree to become a member of the student’s doctoral thesis committee. 

The committee in collaboration with the advisor/committee chair will inform the student about the process and timelines the committee requires for submission of work to committee members. Usually, the advisor/committee chair reviews and approves drafts of a student’s work before the student gives it to the rest of the committee for review and discussion. Advisor/committee chairs and committees typically require at least two weeks to review student work and provide student feedback.

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

The student should schedule the thesis defense no later than 30 days prior to the end of the semester to be considered a graduate of that semester. For completion the student must successfully pass an oral doctoral thesis presentation and complete a final written doctoral thesis manuscript that meets committee approval. The student may be required to complete modifications to the written manuscript following their defense. The student’s final completed written doctoral thesis manuscript is due before the last day of the semester to recommend satisfactory completion of and graduation from the program.  The student’s doctoral thesis advisor/committee chair, via the DRS Student Program Coordinator will notify all DSc faculty, staff, and students, and any additional relevant participants of the upcoming oral defense prior to the defense date.

Recommended Student Timeline:

• Week 1 of last semester expected to graduate – Meet with advisor/committee chair and begin preparing written doctoral thesis manuscript draft (Advisor/committee chair, in collaboration with student, will propose individual student timeline for completion of doctoral thesis).
• On-going within final semester – Prepare, with advisor/committee chair, doctoral thesis draft(s) for committee review (generally expect to allow 2 weeks between submission to, and review of, drafts by advisor/committee chair and committee members).
• Mid-semester – Schedule oral defense date, with advisor/committee chair and committee. 2 weeks (at a minimum), prior to oral defense – Submit final written draft of doctoral thesis to committee.
• 30 days prior to end of semester – Orally defend doctoral thesis.
• Last day of semester– Submit approved doctoral thesis manuscript/publishable product. Verify rubric for final approval and pass Doctoral Thesis.
• Following graduation – Students are encouraged to work with advisor/committee chair to refine and submit doctoral thesis manuscript for publication.

1. The doctoral thesis is the student’s culminating product and reflects the training, technical, analytical, and writing skills developed in the doctoral program. The purpose of the Doctoral Thesis Guideline is to guide the student and the doctoral thesis committee as they work together to develop a high-quality manuscript and oral presentation. (The recommended timelines are located in 7.5.)
2. The chair of the committee will sign the Doctoral Thesis Signature Form and secure signatures of each committee members. The Doctoral Thesis Signature Form will be secured and maintained by the DRS Student Program Coordinator.

Each committee member will use the five-level rating scale to score the doctoral thesis manuscript and defense, using the Doctoral Thesis Rubric. In general, ratings of 3 or above are considered acceptable, while ratings of 4 or 5 do not achieve minimal standards for passing. The committee members may provide more extensive notes or feedback to the student as a separate attachment or as a marked-up copy of the manuscript.

Definitions of Ratings for Doctoral Thesis Rubric:

Acceptable:

1. Approved with commendation, the level of scholarship in the manuscript/oral presentation is exceptional.
2. Acceptable as written, all crucial elements are included and adequately described.
3. Approved, although revisions are strongly suggested in one or more important components of the manuscript/presentation that are of markedly lesser quality than the other areas of the manuscript/presentation. Comments on how to enhance quality are provided by the thesis committee chair.

Unacceptable:

1. Must be revised and resubmitted/represented because one or more essential components are not satisfactorily described/presented. DT Committee determines rewrite opportunities and timeline.
2. Must be revised and resubmitted/represented because one or more required elements are missing or previous requests for revision were ignored. DT Committee determines rewrite opportunities and timeline.