New Protocol Submissions

Once you have concluded that your project is human subject research, you will need to determine if your research meets the requirement for review using the NHSR Submission Form or the New Protocol Submission Form.

Not-Human Subject Research

To determine if the research activities you are conducting meet the requirements for the following review type, Not-Human Subjects Research (NHSR) by using the NHSR Categories Guidance.

Some NHSR categories do not require IRB review and can be started without any submission. However, you will be responsible for making the right decision. If you are uncertain, the IRB suggests you submit an NHSR Submission Form. If the IRB determines that your project is NHSR, the IRB will provide you with an official letter indicating your project does not require review by the IRB.

For some NHSR projects the Campbell IRB requires you to submit the NHSR Submission Form. These include projects that use secondary public datasets and possibly instrument/questionnaire development, course-related activities, and research using health information for deceased individuals. The IRB also highly recommends you submit quality improvements/assessment or program evaluation projects to the IRB for an official determination.

New Protocol

All other types of research require the submission of a new protocol.

Please note that only the IRB is authorized to determine if research is exempt from IRB approval under the federal regulations. Exempt research is not the same as NHSR. Research can be determined as “exempt” if is not more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Research that may be exempt must be submitted as a regular IRB submission. The Campbell IRB applies the federal regulations only to human subject research protocols that are federally funded  are required to be reviewed under the federal regulations either by sponsors or the research activities are greater than minimal risk.

To reduce the regulatory burdens, on the IRB and investigators, Campbell has chosen to not apply all federal regulations to certain minimal risk research that is NOT federally funded or federally regulated research. These research projects will nonetheless be afforded equivalent protections under the Belmont Report and will provide protections commensurate with risk as determined by the IRB. These projects will be reviewed  by FLEX Review and approved as Registration Projects.  All Registration projects must be no more than minimal risk and meet specific requirements. Most research at Campbell University is approved under the Registration Projects by FLEX Review.

Steps to submit to the IRB

If you conclude your project requires review, you will need to prepare a protocol for submission.

An initial or new protocol submission will require that you:

1. Complete a New Protocol Submission Form
2. Identify your research team
3. Develop a Research Plan and other protocol materials
4. Submit required materials to the IRB using the Electronic New Protocol Submission Form.

Submission to the IRB requires that all aspects of the research is fully developed. This includes, but is not limited to, all materials that participants will interact with (e.g., training materials, flyers for recruitment, questionnaires etc.), research ethics training of all research personnel, and agreement of all sites were research is conducted (if outside of Campbell University). Please see Protocol Review Process Presentation for further information on the IRB review process.

Consider which type of review your project qualifies for: Registration by FLEX Review, Exempt Review, Expedited Review or Full Board Review. Worksheets can be found here to help you decide the best IRB review type and category your research may be reviewed under.

Information regarding each type of review cam also be found in the Guidance Library and in the IRB Investigator Manual. Note that the IRB makes the final decision on what category your research belongs in.

Some submission documents may be different for each of the categories. Be sure to use the most current available forms and templates with your submission.

You will need to identify your research team. All research personnel will need to complete the human subject research training requirement. The Human Subjects Research Training page provides detailed information regarding training requirements and instructions on completing training.

In addition, all individuals will need to complete the IRB Conflict of Interest (COI) Form to screen the research team for any potential conflicts of interest with the research. The completed IRB Investigator COI Disclosure Form will need to be included with a protocol submission only for the individuals who have identified a potential conflict as described in IRB SOP: Conflict of Interest (COI) in Human Subjects Research.

All individuals listed below will need to be included on the Research Personnel Form with role and training completion dates provided.

• Principal Investigator: The Principal Investigator (PI) for a human subjects protocol must be the individual most qualified to oversee the conduct of the human subject research and is ultimately responsible for the design, conduct, execution, and/or reporting of the human subject research. 
• Sub-Investigators, Students, Research Staff, Community Members: Should report to the Principal Investigator and complete the required training or equivalent, if applicable.

Protocol materials required for submission will depend on the type of research being conducted. Use the checklist at the end of the New Protocol Submission Form to identify the necessary protocol materials to include with your submission.

Below are the key materials with instructions about when to include these with your protocol submission.

• Research Plan. All good research has a plan. A Research Plan is a blueprint for the conduct of your research and provides details in narrative form. Develop a Research Plan using our IRB Research Plan Template. You may also review the IRB Presentation, Writing an Effective Protocol Plan: Overview. Note that compared to scientific research plans (e.g., grant applications),  the research plan required by the IRB involves additional information about consent, study procedures, risks and protection against risk. Please follow the guidance document.  A Research Plan is required for all submissions that do not qualify for NHSR determination.
• Recruitment Materials. Materials used to facilitate recruitment will need to be developed such as emails, letters, scripts, advertisements, and brochures. Detailed information regarding requirements for advertisements and recruiting can be found in the IRB Investigator Manual and on the website under Guidance Library & FAQ and Policy & Procedures. Submission of recruitment materials is required for all submissions that do not qualify for NHSR determination.
• Informed Consent and/or Assent Forms. Obtaining the informed consent and/or assent of potential participants is an ethically important consideration in the responsible conduct of research. Researchers will need to develop an informed consent and/or assent process and documentation of consent form. For expedited and full board research, informed consent will need to satisfy the required elements of informed consent, unless waived or altered by the IRB. Registration and Exempt Projects have more flexibility in the elements of informed consent. The IRB has developed informed consent templates which can be found in Forms & Consents. Detailed instructions regarding information on the consent process and documentation can be found in the IRB Investigator Manual and on the website under Guidance & FAQ and Policies & Procedures.
• Data Collection and Research Instruments. To conduct and facilitate the research, data collection and research instruments will need to be developed for use with participants. These include but are not limited to questionnaires, surveys, data collection forms, and interview guides/scripts. Data collection and research instruments will need to be included with all protocol submissions and should be in final format.
• Data Safety Monitoring Plan. A data and safety monitoring plan (DSMP) may be necessary to ensure the safety of research participants and to protect the validity and integrity of the research data. DSMPs are typically required for clinical trials and may be appropriate for other research. If a DSMP is required by the funding agency, consult the agency resources to ensure you meet program requirements (e.g., NIH division website). If conducting a clinical trial, also be sure to visit our Clinical Trials page for further information. If a DSMP is created, this needs to be included with the submission materials.
• Data Safety Monitoring Board/Committee (DSMB/DSMC). The Data and Safety Monitoring Board/Committee (DSMB/DSMC) may be appropriate when an independent group of experts is needed to advise the project investigators. DSMB/DSMC are typically required for clinical trials. The primary responsibilities of the DSMB/DSMC is to provide periodic review and evaluation of the research data for participant safety, research conduct and progress, and when appropriate, efficacy. The DSMB/DSMC makes recommendations concerning the continuation, modification, or termination of the project. If a DSMB/DSMC is required by the funding agency, consult the agency resources to ensure you meet program requirements (e.g., NIH division website). If a DSMB/DSMC is being used, provide the details of the committee’s scope, composition, and oversight functions with your application materials.
• Other Materials: Consult the submission checklist at the end of the new protocol submission form to identify any additional materials required for your submission. Refer to Forms & Consent for additional sample materials and templates. Review documents in the Guidance Library & FAQ and Policies & Procedures areas of the website for additional topical information that may be useful in developing your protocol.