GUIDANCE FOR COMPLETION OF A NEW PROTOCOL APPLICATION
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 on the CID SharePoint page. Please do not return this guidance document with your application.
IRB APPLICATION
Determine which application is most appropriate to your research activity: Exempt, Expedited, or Full Board. Contact CID for guidance or review the RSPD SOPs on SharePoint. The IRB will make the final determination as to the appropriate level of review for your project.
Study Title: Be certain that your study title matches across all documents. Please remember to include your IRB# as the beginning of your study title (NMCP.2017.0001 “TITLE”)
Principal Investigator: Enter your Rank, First and Last Name, and degree (MD, DO, PhD, etc.) in the appropriate field.
Command: Identify your Command.
Department: Identify your Department.
Phone/Pager: Identify the best phone number/ pager number to reach you.
Email Address: Identify the best email address to reach you.
Status: Indicate if the PI is Active Duty or a Civilian. Contractors cannot serve as the PI on a protocol.
PRD: Identify the month and year of your Projected Rotation Date. Enter N/A as appropriate.
CITI: Identify the date of completion of your “Investigators and Key Research Personnel-Biomedical” CITI training in month / day/ year format. CITI training expires every three years. Include the CITI certificate in the submission packet.
CV: Identify the date of your CV in month / day/ year format. CVs should be updated every three years. Include the CV in the submission packet.
Research Integrity Training: Identify the date of your RIT in month / day / year format. RIT but can be found on SWANK. Once completed, RIT does not expire. Include the RIT certificate in the submission packet.
Research Team Members: Identify other members of your Research Team following the guidance above.Remember to indicate if the RTMs are Active Duty, Civilian, or Contractors.
Research Monitor: Identify your Research Monitor (mandatory for greater than minimal riskFull Board protocols only) following the guidance above.
Basic Study Information
Proposed Start Date: When do you propose to begin your project? This date cannot be in the past.
Protocol Duration (Years): How long do you anticipate that it will take for you to complete your project? This can be an estimate.
Command where the Research Will Take Place: Which command is “hosting” the project? Where will the research physically take place?
Disclosures
Funding:
- Does the project receive internal funding, such as from BUMED-DSG, BUMED-WII, or the Commanders Fund? Does the project receive external funding, such as from NIH,NSF, RDT&E P6, academia, or industry?
- Is this a collaborative project? Identify if you are collaborating with any institutions or commands outside of NMCP.
- If yes, identify the collaborating institutions. Identify the name of your collaborating institution(s).
- Please provide the agreement number. List the agreement number. This is obtained from the Research Agreements Officer.
- Please outline the following:
For the items below, clearly outline the scope of work for each site, and identify which activities will be done jointly (for example, data analysis, manuscript writing, etc.).
- What activities will be done at NMCP?
- What activities will be conducted at the collaborating institution?
- What activities will be done jointly?
Conflict of Interest (COI): Indicate if any members of the research team have a COI. If yes, be certain to include a management plan with the protocol application.
Subject Population Information
Age of Subjects: Identify the age range. Children are aged 0-17; Adults are 18 and older. For HIPAA compliance, all subjects aged 90 and above must be identified in aggregate (“18-89, 90 and above” would describe a population of all adults older than 18).
Vulnerable Populations: Identify vulnerable populations to be targeted for participation. Pediatric studies will enroll minors and may enroll newborns, depending on the protocol. Labor and Delivery studies will enroll pregnant women/fetuses and may enroll newborns, depending on the protocol. Alzheimer’s, mental health, or PTSD studies may enroll decisionally impaired persons, depending on the protocol. For studies enrolling prisoners, please contact the IRB office for assistance prior to submission. See the RSPD SOPs for additional guidance on conducting research with vulnerable populations.
Population: Identify if your subjects will be Active Duty Military members, Civilian dependents, or both.
Does the Protocol Involve Active Subject Recruitment?: Most prospective protocols seek out subjects for participation, using recruitment materials such as flyers, announcements, or presentations. If a recruitment presentation is delivered to a group of potential subjects, an Ombudsman may need to be involved to monitor the interaction for possible coercion or undue influence. The inclusion of an Ombudsman is required for greater than minimal risk protocols, and optional for minimal risk protocols. For example, if a Commanding Officer is presenting his greater than minimal risk study to a platoon of service members, with the expectation that they will individually sign a consent form to agree to participation at the conclusion of the presentation, such an interaction would require the attendance of an Ombudsman. Conversely, if a patient presents in a clinic for treatment and the physician determines that the best course of action is to offer participation on a research protocol as their treatment plan, an Ombudsman would not be required for this interaction.
IND, IDE, HDE, or Single Patient Compassionate Use: If your project involves use of an experimental drug, device, biologic, or a humanitarian device conducted under the oversight of the FDA, enter the corresponding Investigational New Drug #, Investigational Device Exemption #, or the Humanitarian Device Exemption #. If you are requesting access to an unapproved treatment for single patient compassionate use, please contact the IRB office for guidance, particularly if the need to access the unapproved treatment is time sensitive.
Number of Subjects
Total: Identify the total number of subjects to be enrolled at this local site. A subject is considered enrolled on a study when they have signed consent, even if they screen fail out prior to randomization or intervention. Be certain to account for subject loss when identifying the total number to be enrolled. (You may need to enroll 30 subjects for 15 to complete the study). If medical records are to be queried, identify the total number of records to be examined, not the number of records expected to meet inclusion/exclusion criteria. (You may choose to query an entire database of 10 million records with the hope of identifying 300 that meet your selection criteria).
Control: Identify how many of the subjects to be enrolled will be controls.
Experimental:Identify how many of the subjects to be enrolled will be experimental.
Brief Abstract
Provide a brief overview of the project, describing the purpose, objectives, design, and site of the research in straightforward non-technical language. Limit your abstract to one page.
Protocol Approval Signature page
The Principal Investigator must sign, attesting that he/she has read and understood the NAVMEDCENTPTSINST related to the conduct of human subjects research.
The Department Head must sign, documenting that he/she believes the PI is qualified to conduct the research; that the Director has been made aware that this research will occur in the Department; and that accountability for and continuity of ongoing research will be maintained in the event that the PI detaches from the Command.
If the Department Head is an investigator on the study, then he/she may not approve as the Department Head, but the next person up the chain of command must be approached to obtain approval (the Director, for example).
Scientific Review is obtained by the IRB office. Once scientific review is complete, the study is assigned to an IRB for review.
IRB Chair/Vice Chair approval is obtained by the IRB office.
HRPO Review is obtained by the IRB office.Research conducted at extramural commands (NHCL, NHJX, NHPC, NMOTC, etc.) will have HRPO review performed by the HRPO Officer at their command.
Command approval is obtained by the IRB office. All agreements associated with a protocol must be finalized before an IRB-approved study may be presented to the CO for approval. No research activity may occur before CO approval is given. For research conducted at extramural commands (NHCL, NHJX, NHPC, NMOTC, etc.), approval by the local CO replaces approval by the NMCP CO.
Human Use Assurance, Informed Consent, and Privacy Act Statement
The PI and all AIs on a study must be identified by Rank, First Name, Last Name, Degree; contact number, and Department. Please note that Research Monitors are not expected to sign the HUA because their role as Research Monitor does not include authorization to obtain subject consent.
Role: Identify the investigator’s role for this project: PI, AI, Coordinator, etc.
Status: Identify the investigator’s status: Staff, Resident, Intern, Student, GS, Contractor, etc.
All listed personnel must sign in the space provided.
Please make an effort to obtain all signatures on a single hard copy for submitting as a PDF, rather than a single sheet for each signature.
Conflict of Interest Declaration
All members of the Research Team, including the Research Monitor, must sign or initial to indicate if they do or do not have a conflict of interest with the protocol. If a conflict is identified, a management plan must be submitted.
Support Statement
Identify any support activities critical to the conduct of your project that will be performed by patient care / hospital departments. Requested information about the Department Head and their signature must be obtained to document acceptance of the impact this project will have to the department.
Research Monitor
The Research Monitor must sign, documenting their understanding of the responsibilities they are undertaking and their willingness to serve in this capacity.
All fields must be completed.
Research Plan
Please see Guidance for IRB Research Plan Completion for assistance.
Appendices Check Boxes
Be certain to make a selection for B, C, and D.
Electronic Submission Checklist
Use this checklist to make certain that all necessary documents are being included in the submission package.
Request for Chart / Records Review
This appendix must be competed for records review protocols, and it details the chain of custody for data that travels from a database to the investigators.
Please explain where records originate from.
How are records identified for inclusion and who performs this identification?
Do the investigators receive records with identifiers or are identifiers are stripped from records prior to the release to the investigators?
Define the retrospective and/or prospective nature of the records to be examined.
If a link to the records will be maintained in the form of a Subject ID Key, which linking identifiers are included in the key (MR#, DOB, Name, DOD ID#, etc.)?
Describe how the confidentiality of the data (both paper and electronic) will be protected, and documents maintained. Indicate who has access to harvested data.
Request for Waiver of Authorization for the Use of PHI
Please see Guidance for Waiver Requests for assistance.
Request for Waiver of Consent, Waiver of Documentation of Consent, or Alteration of Consent
Please see Guidance for Waiver Requests for assistance.
Guidance for Application CompletionVersion 12 September 2017Page 1