GUIDANCE FOR COMPLETION OF A RESEARCH PLAN
Institutional Review Board
Human Subjects Research
Naval Medical Center Portsmouth, VA
Contact Clinical Investigation Department at 953-5939
This is not the application. The application is a separate document which can be located in the on the CID SharePoint page. Please do not return this guidance document with your application.
APPENDIX A: RESEARCH PLAN
1. OBJECTIVES/SPECIFIC AIMS
Objectives/Specific Aims are concise statements of the major and minor questions that the protocol is designed to answer. The objectives allow a reader to understand the purpose and design of the entire study and should be feasible, clear, and concisely written.
1) Describe the problem area or issue addressed by the protocol and your long-term objectives.
2) Define the working hypothesis.
3) Describe the procedures that you will undertake to test your hypothesis. It is recommended that you limit these to between one and three specific aims and that you use only 3-4 sentences to describe each of them.
2. BACKGROUND AND SIGNIFICANCE
The Background and Significance section is used to provide a reason for the project to be conducted and an historical background and literature review about the topic under study. Specify the reasons for conducting the research in light of current knowledge. It should include a well-documented statement of the need/problem that is the basis of the project, the cause of this problem, and its possible solutions. It should answer the question of why the research needs to be done and how it is relevant medically, scientifically, and relevant to the Navy. Explain how your expected results will support your hypotheses. Three to five pages are recommended for this section.
This section should demonstrate your literature search for currently published research that directly pertains to your proposal. It is not sufficient to attach a search that someone else has done on behalf of the PI. This is intended to be a thoughtful search - the committee is interested in your interpretation of the literature that you have reviewed. Provide a statement evidencing that the proposed work does not unnecessarily duplicate previous or ongoing work.
While you do not have to provide an exhaustive review of the literature, this section will provide the IRB with evidence of a scholarly understanding of published literature (by citing references in the text).
3. RESEARCH DESIGN/METHODS/SUBJECT JUSTIFICATION
a. General Approach
Identify the experimental design, methods, and procedures planned to test each hypothesis or specific aim of the project. Explain the appropriateness of the study design to the project. Identify specific design attributes that characterize the study design (e.g., randomized, cross-sectional survey, case/control, cohort, focus group, chart review, etc.).
Distinguish between procedures that are experimental and those that involve routine care. Include a description of each experimental group that comprises the overall study. This discussion must be sufficiently detailed, including appropriate citations, to allow valid scientific review of the overall project and each contributing procedure. Examples of data collection sheets, questionnaires, or other exhibits must be included in the submission.
(1) Research Objective
Re-state the research objective(s). If different research objectives employ experimental practices which are not shared among all of the objectives, it may be worthwhile to present each objective and the descriptions separately. NOTE: Be certain to use lay-language understandable by non-medical personnel.
(2) Detail how many groups or arms are in the study and what each receives
Define study groups. Detail how many groups or arms are in the study and what each arm will receive in the form of interventions, procedures, assessments, etc. for each group.
(3) Randomization Procedures
Identify the method that will be used to randomly-assign subjects. By lottery? Through a computer-generated list? Randomized deck of cards? Convenience sample?
b. Methods and Materials
Identify all procedures, both experimental and standard of care, which will be performed. Describe in detail all screening procedures, interventions, (pre-/-post assessments, diagnostics, laboratory tests, study visit procedures [including surgical procedures] and use of instruments or assessment tools [satisfaction surveys, QOL surveys, etc.]). A description of procedures to be undertaken at each study visit is strongly recommended. Identify the expected duration of procedures, and the anticipated results from the procedures. {Diagrams or reference articles may be helpful.} Provide specific information about what procedures each member of the research team performs.
If study drug will be used, define the dose, route of administration, and who will administer the drug. Specify if drugs to be used are approved for the condition under study, for the population to be enrolled, and at the dose and means of administration to be used in the study. Describe any wash-out periods or escalated dosing regimens that are required.
Describe any new methodology to be used and its advantage over existing methodologies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims.
(1) Experimental Procedure
Identify all procedures or interventions that are experimental. This includes experimental drugs and/or devices, unapproved treatment procedures, non-standard behavioral and/or educational interventions, and instruments which are not validated. Explain how the experimental procedure tests the hypothesis. Define how outcomes will be measured (physical measurements, performance assessments, questionnaires, perception assessments, etc.).
A visual presentation (such as a table) that describes the timing of study visits and what procedures occur at each visit is ideal.
An example might look like this:
DAY 0Study Visit 1
4 hours / DAY 5 (+/- 1)
Study Visit 2
1 hour / DAY 14 (+/- 1)
Study Visit 3
1 hour / DAY 60 (+/- 1)
Study Visit 4 (Final)
1 hour
Informed Consent signed / X
Eligibility review and confirmation / X
Medical History / X
Physical Examination / X / X / X / X
Vital Signs / X / X / X / X
Blood and Urine analysis / X / X / X / X
Randomization / X
Dispense study drug / X / X / X
12-Lead ECG / X / X
Psychometric testing / X / X / X
Study Drug Accountability / X / X / X
Review adverse events / X / X / X
Review patient diary / X / X / X
A table such as this could also be incorporated into the consent form to help subjects understand the timing of study visits and what they will experience at each visit.
(2) If this project is collaborative, describe what research activities occur at each location
Indicate if this is a multicenter or collaborative study, describe what each collaborator will do, and how data will be collected, combined and shared. Summarize what activities occur at each collaborative institution (subject recruitment, subject consenting, data collection, data analysis, etc.).
For example:
NMCP will be responsible for the following tasks:
1.
2.
…and so on
Collaborator (write out) will be responsible for the following tasks:
1.
2.
…and so on
NMCP & Collaborator jointly will be responsible for the following tasks:
1.
2.
…and so on
(3) Research Material To Be Collected
Identify sources for specimens, records, and data. Specify if the data or procedures generating data are being performed for research purposes only or are done per standard of care. Specify how identifiers will be maintained, including the coding of data sheets. The description of data to be collected should reflect data fields on data collection tool.
i. If requesting a Waiver of Authorization for the Use of PHI…
State if a Waiver will be requested for a retrospective and/or prospective data review involving existing specimens, records, or data. “Existing data” is defined by the federal regulations as data that exists before the study is proposed to an institutional official or to an IRB. As such, the collection of retrospective data requires that a data window be established stating that data collected for the study is limited to data, documents, records, or pathological specimens in existence prior to DATE OR collected between DATE and DATE OF IRB SUBMISSION. If prospective Waiver of Authorization is requested, then a data window for such data must also be identified. It is possible for a project to involve both retrospective and prospective data windows, although the request for waiver of must be specific to each time period.
(4) Data Collection Tools
Tools such as assessment instruments, questionnaires, subject diaries, data collection sheets, case report forms, and screen prints of data spreadsheets must be submitted for IRB review and approval. Provide information in this section about what tools will be used.
(5) Protection and security of data and identifying information
Explain what measures will be taken to maintain the security and integrity of collected data. Are data in both electronic and hard copy format? Where will data be stored? Under what conditions? Who will have access to data?
(6) Disposition of data and identifying information at end of project
DHHS protection of human subjects regulations require institutions to retain records of IRB activities and certain other records frequently held by investigators for at least three years after completion of the research (45 CFR 46.115(b). HIPAA requires storage for six years. Additional periods of time may also be required by a study sponsor or department record retention policy. Study documents should be disposed of per Navy instruction at the conclusion of the storage period. This section should explain how data will be stored at the conclusion of this project.
(7) Gender and Ethnicity
Identify if the study population will be comprised of a specific gender or of specific ethnicities. Justify why it is appropriate to exclude any group of individuals.
c. Subject Population
(1) Subject Inclusion and Selection Criteria
Describe all inclusion criteria. A bulleted list is recommended.
(2) Subject Exclusion
Describe all exclusion criteria. A bulleted list is recommended.
(3) Subject Recruiting Methods
Describe how prospective subjects will be identified and recruited. Explain who performs recruitment and what in what setting. All recruitment materials, including email text, posters, flyers, videos, telephone scripts, presentations, etc. must be submitted for IRB review. It is strongly recommended that a visual representation of the timing for recruitment and screening procedures which lead to the consent process be included (such as a diagram, flow chart, or table).
An example might look like this:
(4) Informed Consent Procedures
Describe plans the process for obtaining consent. Who performs the consent, under what timeline, and in what setting? Are subjects consented individually or in a group? How is consent documented? If minors are being enrolled in a long-term study, will their consent be obtained upon reaching the age of majority? If subjects are unable to consent for themselves due to emergent situations or impaired status, will a Legally Authorized Representative (LAR) be approached? How will decisionally-impaired subjects be assessed to determine if they are competent to consent? How will ongoing consent be ascertained over the course of the study? Describe how and where signed consent forms will be stored. Keep in mind that active duty participants may need the permission of their Commanding Officer to be given time for study visits and procedures. This is particularly true if travel is needed or if the duration of participation is lengthy.
i. If requesting a Waiver of Consent…Be sure to differentiate between waiver of consent for retrospective data collection, and waiver of consent for prospective data collection or active subject participation.
(5) Justification of Subject Population
Explain why the population to be studied is appropriate for the project. Describe the characteristics of the subject population, such as the age range, gender, ethnic background, if they are military or civilian, all officers or all enlisted personnel, military health beneficiary status, and health status. Rationale for the use of special classes of subjects, such as pregnant women, children, prisoners, or others who are likely to be vulnerable must be given.
(6) Vulnerable Populations
Define vulnerable populations to be recruited into the study, including (but not limited to) children, pregnant women/fetuses, prisoners, decisionally-impaired individuals, economically disadvantaged persons, educationally disadvantaged persons, tribal populations, non-native or ESL speakers, persons in emergency situations, persons with fatal or incurable diseases, persons in hierarchical social structures (such as employees, students, or members of the military), and persons who are marginalized in society (such as the homeless).
(7) Number of Subjects and Justification
State how many subjects are needed to complete the study to achieve statistical significance, and explain how the power analysis was done to arrive at this number.
d. Risks
Describe potential risks to subjects. Remember that risks may be physical, psychological, social, economic, professional, etc. Identify both the likelihood and magnitude of potential harm. Differentiate between risks related to standard of care procedures and risks stemming from procedures performed for research purposes only. Describe alternative treatments or procedures that are available to subjects (if any).
(1) List and document risks
It is recommended that risks be presented in a “Likely, Less Likely, and Rare” model. A bulleted list is recommended. Remember that research generally involves a risk associated with the accidental release of PHI.
(2) Justification of Risks
Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and in relation to the importance of the knowledge that may reasonably be expected to result.
(3) Minimization of Risks
Describe procedures for minimizing potential risks and assess their likely effectiveness. Discuss provisions for ensuring necessary medical or professional intervention in the event of adverse events. Describe the provisions for monitoring data collected to ensure the safety of subjects. If the only risk associated with participation is the possibility of accidental release of PHI, describe how PHI will be protected during collection and maintenance of the information.
e. Benefits
Describe any anticipated benefits to subjects. It is possible that subjects may not receive any benefit from participation. Pay particular attention to the likelihood of benefit to subjects who are enrolled in research through third party consent (children, decisionally-impaired individuals, individuals in emergency situations, etc.). If subjects will be compensated for participation, describe the means of compensation and amount (compensation of $50 cash for a blood draw; compensation of $100 by check for time and travel, etc.). Refer to the RSPD SOPs for guidance on subject compensation.