Long Dissertation Proposal Requirements

State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology.

Length: One page or less

Include the following subsections:

Significance: Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

Innovation: Explain how the application challenges and seeks to shift current research or clinical practice paradigms. Describe any novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation or intervention(s). Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions.

Approach: Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate. Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work. Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised.

Preliminary Studies. Include information on Preliminary Studies as part of the Approach section. Discuss the PI’s preliminary studies, data, and/or experience pertinent to this application.

Length: Up to 12 pages, depending on the complexity of the hypotheses and methods used to address them

Describe your role in the project (e.g., idea, design, data collection, data management, analysis). Describe how the requirement of original data collection will be met by this project (see previous section in this document for details of acceptable data collection).

Length: One page or less

Risks To The Subjects

1. Human Subjects Involvement and Characteristics

• • Describe the proposed involvement of human subjects in the work outlined in the Research Design and Methods section.
  • Describe the characteristics of the subject population, including their anticipated number, age range, and health status.
  • Identify the criteria for inclusion or exclusion of any subpopulation.
  • Explain the rationale for the involvement of special classes of subjects, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations. Note that ‘prisoners’ includes all subjects involuntarily incarcerated (for example, in detention centers) as well as subjects who become incarcerated after the study begins.
  • List any collaborating sites where human subjects research will be performed, and describe the role of those sites in performing the proposed research.

2. Sources of Materials

• • Describe the research material obtained from living human subjects in the form of specimens, records, or data.
  • Describe any data that will be recorded on the human subjects involved in the project.
  • Describe the linkages to subjects, and indicate who will have access to subject identities.
  • Provide information about how the specimens, records, or data are collected and whether material or data will be collected specifically for your proposed research project.

3. Potential Risks

• • Describe the potential risks to subjects (physical, psychological, social, legal, or other), and assess their likelihood and seriousness to the subjects.
  • Where appropriate, describe alternative treatments and procedures, including the risks and benefits of the alternative treatments and procedures to participants in the proposed research.

Adequacy Of Protection Against Risks

1. Recruitment and Informed Consent

• • Describe plans for the recruitment of subjects (where appropriate) and the process for obtaining informed consent. If the proposed studies will include children, describe the process for meeting requirements for parental permission and child assent.
  • Include a description of the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent. Informed consent document(s) need not be submitted to the PHS agencies unless requested.

2. Protection Against Risk

• • Describe planned procedures for protecting against or minimizing potential risks, including risks to confidentiality, and assess their likely effectiveness.
  • Where appropriate, discuss plans for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects. Studies that involve clinical trials (biomedical and behavioral intervention studies) must include a description of the plan for data and safety monitoring of the research and adverse event reporting to ensure the safety of subjects.

Potential Benefits Of The Proposed Research To The Subjects and Others

• Discuss the potential benefits of the research to the subjects and others.
• Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and others.

Importance Of The Knowledge To Be Gained

• Discuss the importance of the knowledge gained or to be gained as a result of the proposed research.
• Discuss why the risks to subjects are reasonable in relation to the importance of the knowledge that reasonably may be expected to result.

NOTE: Test articles (investigational new drugs, devices, or biologicals) including test articles that will be used for purposes or administered by routes that have not been approved for general use by the Food and Drug Administration (FDA) must be named. State whether the 30-day interval between submission of applicant certification to the FDA and its response has elapsed or has been waived and/or whether use of the test article has been withheld or restricted by the Food and Drug Administration, and/or the status of requests for an IND or IDE covering the proposed use of the test article in the Research Plan.

Data And Safety Monitoring Plan

• If your research includes a clinical trial, create a heading entitled “Data and Safety Monitoring Plan.”
• Provide a general description of a monitoring plan that you plan to establish as the overall framework for data and safety monitoring. Describe the entity that will be responsible for monitoring and the process by which Adverse Events (AEs) will be reported to the Institutional Review Board (IRB), the funding I/C, the NIH Office of Biotechnology Activities (OBA), and the Food and Drug Administration (FDA) in accordance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) regulations. Be succinct. Contact the FDA and also see the IND requirements and IDE requirements.
• The frequency of monitoring will depend on potential risks, complexity, and the nature of the trial; therefore, a number of options for monitoring trials are available. These can include, but are not limited to, monitoring by a:

1. 1. PD/PI(required)
   2. Independent individual/Safety Officer
   3. Designated medical monitor
   4. Internal Committee or Board with explicit guidelines
   5. Data and Safety Monitoring Board (DSMB). NIH specifically requires the establishment of Data and Safety Monitoring Boards (DSMBs) for multi-site clinical trials involving interventions that entail potential risk to the participants, and generally for Phase III clinical trails. Although Phase I and Phase II clinical trials may also use DSMBs, smaller clinical trials may not require this oversight format, and alternative monitoring plans may be appropriate.
   6. Institutional Review Board (IRB – required)

• A detailed Data and Safety Monitoring Plan must be submitted to the applicant’s IRB and subsequently to the funding IC for approval prior to the accrual of human subjects. For more information, view the NIH Policies and IC Guidance for Data and Safety Monitoring of Clinical Trials.

Length: As many pages as are necessary to address the topics

Provide a bibliography of any references cited in the previous sections. Each reference must include the names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. Include only bibliographic citations. The references should be limited to literature that is current and/or relevant to the proposed research.