Institutional Review Board

The Campbell University Human Research Protection Program’s (HRPP) primary mission is to protect the rights, welfare and privacy of all individuals participating in research conducted at Campbell University. The HRPP oversees and supports the Campbell University Institutional Review Board (IRB) which reviews all research projects involving human subjects for safety, compliance with regulations, scientific quality, and ethical standards. The HRPP provides guidance and resources for the Campbell University IRB, investigators, and project team members. Ongoing training for researchers and quality improvement activities are directed toward compliance with regulations and scientific integrity.

All potential research projects involving human participants must be reviewed by the IRB.

An investigator who intends to conduct research activities that might involve human subject research must submit an application to the Campbell University IRB Office for review and approval prior to beginning research activities.

For information on human subjects research, including instructions on applying for review and approval of research project involving human subjects, please see below.

Important News and Updates

EFFECTIVE 3/16/2020 – IMPORTANT INFORMATION: COVID 19 and Human Subjects Research

HRPP/IRB October 2020 Newsletter

Continue to browse the IRB website for updates and changes to research and documents.

Fall Term Meeting Schedule

October 29, 2020
November 19, 2020
– all submission requiring full board review are required to be submitted by 10/22/2020
December 17, 2020
 – all submissions requiring full board review are required to be submitted by 11/12/2020
Spring meeting dates have not been scheduled at this time.

Human Subjects Research Overview

Determine If Your Project Requires IRB Review

Investigators engaged in human subject research are required to obtain either a determination of Registration or Exempt determination or IRB approval before research activities begin.

To determine if your project requires IRB review, you will need to first determine that your project meets both the federal definitions of research and human subjects.

  1. Are you doing research?
  • Research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
  1. Does the research involve human subjects?
  • Human subject is “a living individual about whom an investigator (whether professional or student) conducting research:
  1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Use our Human Subjects Research Determination Worksheet and the IRB Guidance: Projects Not Meeting the Definition of Research to assist you in carefully considering whether your project meets the federal definitions discussed above. If after completing the worksheet and reading the guidance, you are unsure whether your project requires review contact the IRB Office.

If your study does meet the definition of human subject research, you will need to complete the New Protocol Submission Form, located on the IRB website, and submit to the IRB for review. Human subject research activities may not begin until determination or IRB approval is issued by the IRB.

Is Campbell University engaged in human subjects research?

The IRB will review research for which Campbell University is engaged.

“An institution is considered engaged in human subjects research when its employees or agents for the purpose of the research project obtain:

  1. Data about the subjects of the research through intervention or interaction with them;
  2. Identifiable private information about the subjects of the research; or
  3. The informed consent of human subjects for the research.

If you are conducting the human subject research as part of your affiliation with Campbell University (i.e., in you capacity as a faculty, student, staff, etc.), then Campbell University is engaged. For more information about engagement of research, see OHRP’s guidance on engagement of institutions in human subjects research. This guidance includes scenarios and examples of when an institution is or is not engage in human subjects research.

Projects determined to involve human subject research, must be review by the Institutional Review Board (IRB).  There are four types of human subjects review: FLEX for Registration Projects, Exempt, Expedited and Full Board.

There is one type of determination for Not Human Subjects Research (NHSR).

Upon receipt of a new protocol submission, the IRB will determine the appropriate level of review. At the time of subsequent submission of an amendment, continuing review (if required) or progress report, the project will be evaluated to determine if the overall project continues to qualify for the originally determine level of review.

Not Human Subjects Determination

Projects that do not fit the definition of research, do not actively involve human subjects, do not access private, identifiable human data, or are not purposed to support the marketing of an FDA-regulated drug, biologic, or device product. For detailed information please see Not Human Subjects Research Categories or the NHSR Protocol Submission Form.

FLEX Review for Registration Project

Research that qualifies as a Registration Project is no greater than minimal risk and all research activities fall into at least one of the 10 categories specified in the Registration Projects by FLEX Review HRPP policy or Registration Project Research Criteria and Categories. The activity must fit the description of the registration categories and meet all 8 criteria for registration projects. Under no circumstances will federally funded or regulated projects be reviewed by FLEX review.

The research activity must fit the description of the registration category, this may include activities that would otherwise qualify as Exempt, Exempt with Limited Review or Expedited if all 8 criteria for registrations projects were not met.

A registration project determination does not lessen an investigator’s ethical obligation to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct.

IRB oversight is not required for projects determined to be a registration project and research does not require submission for Continuing Review; however, the IRB does maintain institutional oversight for the research determined as a registration project. With a registration project determination, the IRB grants an approval period based on anticipated project dates listed in the protocol submission form. Investigators are required to submit to the IRB the following:

  • Amendments: Most changes to the research must be submitted to the IRB via an amendment to verify the project continues to qualify for exemption prior to implementing the changes. Review IRB SOP: Amendment to Approved IRB Protocol to identify what changes require review.
  • Reportable Events: Any occurrence of unanticipated problems including those involving risks to subjects or others, protocol deviation, subject complaints, etc. must be promptly reported to the IRB. Review IRB SOP: Requirements for Reporting to the IRB for detailed information.
  • Project Closure: Prior to a project reaching expiration for the approved project period you must request either an extension of the approval of the project period or to notify the IRB the project is no longer active. Review IRB SOP: Closure of IRB Approved Protocol for detailed information.
Exempt Review & Exempt with Limited Review

Research that is exempt is no greater than minimal risk and all research activities fall into at least one of the categories for exemption specified in the federal regulations. The activity must fit the description of the exempt category and may not include nonexempt research activities. Exempt does not always mean exempt for all the requirements of the federal regulations. Exempt research must be determined to satisfy specific criteria within each category for the research to eligible for exemption. For a list of exempt categories and criteria please see Exempt Research Categories.

An exempt determination does not lessen an investigator’s ethical obligation to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct.

IRB oversight is not required for projects determined to be exempt and research does not require submission for Continuing Review; however, the IRB does maintain institutional oversight for the research determined exempt. With an exemption determination, the IRB grants an approval period based on anticipated project dates listed in the protocol submission form. Investigators are required to submit to the IRB the following:

  • Amendments: Most changes to the research must be submitted to the IRB via an amendment to verify the project continues to qualify for exemption prior to implementing the changes. Review IRB SOP: Amendment to Approved IRB Protocol to identify what changes require review.
  • Reportable Events: Any occurrence of unanticipated problems including those involving risks to subjects or others, protocol deviation, subject complaints, etc. must be promptly reported to the IRB. Review IRB SOP: Requirements for Reporting to the IRB for detailed information.
  • Project Closure: Prior to a project reaching expiration for the approved project period you must request either an extension of the approval of the project period or to notify the IRB the project is no longer active. Review IRB SOP: Closure of IRB Approved Protocol for detailed information.
Expedited Review

Research that is expedited is no greater than minimal risk and all research activities fall into at least one of the categories for expedited review specified in the federal regulations. Under the Expedited review process, the protocol is reviewed by at least one designated IRB committee member. Expedited research must be determined to satisfy all conditions of the expedited category (categories) as well as all criteria for IRB approval defined within the federal regulations. For a list of expedited categories and criteria please see Expedited Research Categories.

 

Ongoing IRB oversight is generally not required of research qualifying for expedited review but may be justified by the reviewer based on the type of research being conducted.

Investigators are required to submit to the IRB the following:

  • Amendments: Most changes to the research must be submitted to the IRB via an amendment to verify the project continues to qualify for expedited review prior to implementing the changes. Review IRB SOP: Amendment to Approved IRB Protocol to identify what changes require review.
  • Expedited protocols which require the submission of a Continuing Review must submit the Continuing Review documentation at least 45-days in advance of the expiration date issued by the IRB.
  • Reportable Events: Any occurrence of unanticipated problems including those involving risks to subjects or others, protocol deviation, subject complaints, etc. must be promptly reported to the IRB. The IRB will determine if further action is necessary. Review IRB SOP: Requirements for Reporting to the IRB for detailed information.
  • Project Closure: Prior to a project reaching expiration for the approved project period you must notify the IRB the project is no longer active. Review IRB SOP: Closure of IRB Approved Protocol for detailed information.
Full Board Review

Research that does not qualify for any of the categories above or that is determined to involve greater than minimal risk to participants must undergo full IRB review. Full board review requires a project be considered by the fully convened IRB committee. Full board projects must be determined to satisfy all criteria for IRB approval defined within the federal regulations.

Ongoing IRB oversight is required for full board projects:

  • Any changes to previously approved research require a submission of an amendment for IRB review and approval prior to initiating changes. In some cases, minor changes to projects previously determined to require full board review may be reviewed by a designated member(s) of the IRB and do not require consideration by the full board.
  • Projects determined to require full board approval must submit a request for Continuing Review at least 45-days prior to the expiration dated issued by the IRB.
  • Reportable Events: Any occurrence of unanticipated problems including those involving risks to subjects or others, protocol deviation, subject complaints, etc. must be promptly reported to the IRB. The IRB will determine if further action is necessary. Review IRB SOP: Requirements for Reporting to the IRB for detailed information.
  • Project Closure: Prior to a project reaching expiration for the approved project period you must notify the IRB the project is no longer active. Review IRB SOP: Closure of IRB Approved Protocol for detailed information.

Review Process
Time Line

Protocol submission are processed for review in the order in which they are received, with funded protocols taking precedence. If you do not receive an IRB Submission Intake Notification email from us confirming receipt of your protocol submission within one week, please contact the IRB by email at irbadmin@campbell.edu or phone at (710) 893-7780. Your intake email will contain the assigned IRB protocol number. This number will not change during the life of the protocol and be sure to reference the protocol number on all correspondence with the IRB.

It is common for the IRB to request revisions to protocols as part of the review process. Your timely response to requests for revisions or additional information will help facilitate the review.

The time it takes from initial protocol submission to final determination/approval, depends on several factors including the completeness, quality of the submission and the IRB’s volume of protocol submissions. On average, review times are as follows:

New protocol determination or review:

  • NHSR: within 24 – 48 hours
  • Registration: one to three weeks
  • Exempt: one to three weeks
  • Expedited: two weeks to two months
  • Full: six weeks to six months
  • Amendment review: two to four weeks
  • Continuing review: submit 45 days prior to protocol expiration (approximately 6 weeks)

Research should consider that these are average review times. Some reviews will consider extra time, such as collaborative and multi-site research.

Please be sure to submit your protocol application well in advance of the anticipated start date for human subjects research activities in order to allow sufficient time to secure approval.

If you have questions, please contact the IRB Office.

If you human subjects research is funded or sponsored, the IRB Office must ensure the research activities described in the grant/funding proposal are consistent with the information in your protocol submission. In order to avoid delays in award set-up and access to funds, it is imperative that awards administered by the Office of Research & Sponsored Programs (ORSP) be formally associated with an approved human subjects protocol.

  • To associate funding during the initial review of the protocol, submit Funding and Sponsorship Form and the human subjects portion of the grant proposal with the initial review materials.
  • To associate funding with an existing protocol, submit a Funding and Sponsorship Form and the human subjects portion of the grant proposal along with the Amendment Submission Form materials. If the addition of funding alters previously approved human subjects research activities, the amendment submission must include revised protocol information and materials, as applicable. Any proposed changes to previously approved research must be reviewed and approved prior to conducting the research activities and before the award can be released.
  • If participant involvement in your sponsored research is yet to be defined, please contact the IRB Office for specific instructions.

If you have questions, please contact the IRB Office.

Preparing Protocol Submissions

Getting Started

First, you will need to determine that your project meets the definition of human subjects researcher and what type of determination or IRB approval is required. If you are unsure if your project requires review, use the Human Subject Research Determination Worksheet. If you conclude that your project is Not-Human Subjects Research (NHSR), please complete and submit to the IRB the NHSR Submission Form. The IRB will provide you with an official letter indicating your project does not require review by the IRB. Only the IRB is authorized to determine if research requires IRB determination or approval. 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.
New Protocol Submissions/Non-Human Subjects Research

First you will want to consider which type of review your project qualifies for: Registration by FLEX Review, Exempt Review, Expedited Review or Full Board Review. Information regarding each type of review is located in the IRB Investigator Manual. You may use Registration by FLEX Review or Exempt Review Worksheets to make a preliminary assessment of your project.  These worksheets are located on the IRB website. Additional information regarding review types can be found in the IRB Investigator Manual and on the IRB website. Use the checklist at the end of the New Protocol Submission Form to identify the necessary protocol materials to include with your submission.

Be sure to use the most current available forms and templates with your submission.

Identify Your Research Team

You will need to identify your research team. All research personnel will need to complete the human subject research training requirement. See the IRB SOP: Human Subject Research Protections Training Requirements for detailed information. 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. See IRB SOP: Requirements & Qualification to Serve as a Principal Investigator (PI) for detailed information.
  • Sub-Investigators, Students, Research Staff, Community Members: Should report to the Principal Investigator and complete the required training or equivalent, if applicable.
Developing Protocol Materials

Protocol materials required for submission will depend on the type of research being conducted. Below are the key materials with instructions about when to include these with your protocol submission.

  • Research Plan. All good research has 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 Research Plan Template and IRB Guidance: Research Plan. 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. See the IRB Investigator Manual or check the IRB SOP section of the IRB website for further detailed information. 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 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 SOP documents, guidance and informed consent templates which can be found in the IRB Investigator Manual and on the IRB website.
  • 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.
  • 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. 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 submission form to identify any additional materials required for your submission. See our Submissions and Forms section for additional sample materials and templates on the IRB website. See our Guidance and SOP sections on the IRB website for additional topical information that may be useful in developing your protocol.

If you have questions, please contact the IRB Office.

Amending an Existing Protocol

Changes to previously approved research generally require additional review by the IRB. If a change requires either an amendment review or resubmission as a new project, approval for the changes must be obtained prior to starting new research activities.

If you must make a change to an approved protocol to eliminate immediate potential hazards to participants, you may do so without prior approval. If you make a change to eliminate potential hazards, contact the IRB, as soon as possible and within no less than 5 business days after the change was implemented.

To determine what types of changes require submission prior to initiation, see IRB SOP: Amendment to Approved IRB Protocol. If an amendment submission is necessary, the following is requested:

  • Exempt or Registration Project (by FLEX review) – For projects previously determined to qualify for exempt or registration, investigators should first determine if the project appears to continue to qualify for exemption or registration by using the Exempt and Registration Project Worksheets found on the IRB website.
  • If the project continues to qualify for exemption or registration, an amendment should be prepared using the Amendment Submission Form and submit to the IRB.
  • If the project no longer appears to qualify for exemption or registration, a New Protocol Submission Form and applicable protocol materials will need to be prepared and submitted to the IRB for review.
  • Expedited and Full Review – Projects previously determined to require expedited or full review, must submit an Amendment Submission Form for any changes to previously approved research. The IRB must determine that all approval criteria specified in the federal regulation continue to be satisfied. If all criteria are satisfied, the IRB will issue an approval for the proposed changes.

Requests for amendments to previously determined/approved research must be reviewed separately from Continuing Review and Progress Report submissions.

For further information regarding changes to approved research please see the IRB Investigator Manual and the IRB SOP: Amendment to Approved IRB Protocol, located on the IRB website.

If you have further questions, please contact the IRB Office.

Continuing Review Submission & Progress Reporting for Human Subjects Research

Continued protocol review is required for human subjects research projects. At the time of initial review, a protocol is granted an approval period. The Principal Investigator (PI) is responsible for submitting and maintaining approval prior to continuing human subjects research activities beyond the expiration date. If human subject research activities have concluded, the PI must properly close the protocol as detailed in Project Closures.

To request continued approval and obtain continued approval prior to the expiration date, the PI must complete and submit a Continuing Review Submission Form or a Progress Report Submission Form to the IRB in a timely manner. The IRB requires continued review requests to be submitted at least 45 days prior to the protocol’s expiration date.

Continued approval must be requested as follows:

  • Exempt, Registration Project (by FLEX review) and Expedited (without continuing review requirement) – Protocols previously determined/approved by exempt, registration project by FLEX review and expedited without continuing review requirement, must submit a Progress Report Submission Form and a revised project end date will need to be provided. The IRB will review the protocol to verify the project’s progress and determine that the protocol continues to qualify for exemption or registration. A revised expiration date will be issued.
  • Expedited and Full Review – Projects previously determined to require expedited with continuing review or full review, must submit a Continuing Review Submission Form. The IRB must conduct a continuing review of the protocol annually, at minimum, and determine that all the approved criteria specified in the federal regulations continue to be satisfied. If approved, the IRB will issue continued approval with a new expiration date.

Requests for continuous reviews/progress reports must be reviewed separately from other proposed changes to previously approved research (i.e., amendments).

For more information on Continuing Reviews and Progress Reporting please see IRB Investigator Manual and the IRB SOP: Continuing Review and Progress Reporting of IRB Approved Protocol, located on the IRB website.

If you have further questions, please contact the IRB Office.

Closure Submission for Human Subjects Research

All IRB protocols reviewed and determined/approved by Registration Project by FLEX review, Exempt, Expedited and Full review must be closed once human subject research activities conclude and prior to the project’s expiration date.

Human subjects research activities are completed when the research team as completed:

  1. Obtaining data through intervention or interaction with subjects; and/or
  2. Obtaining/using identifiable private information about the subjects (i.e., data has been stripped of any identifiers and any code keys linking the data to the participants has been destroyed.

A Closure Submission Form needs to be submitted to request closure by the IRB. The IRB will conduct a review of the submission and verify the protocol is eligible for closure based on the status of reported activities. Notification of the determination will be provided to the investigator.

For additional information regarding Protocol Closure please see IRB Investigator Manual and the IRB SOP: Closure of IRB Approved Protocol, located on the IRB website.

Records

Research records must be maintained for at least three years after completion of the research and must be accessible for inspection or audit. Other regulation or requirements may apply to the retention of records, for a longer period of time, such as HIPAA or project sponsor requirements.

Documentation of IRB approval documents, the approved Research Plan, informed consent documents (without a link to data), and all source materials related to the conduct of the research should be maintained, unless the IRB has waived the requirement for informed consent or the requirement of documentation of informed consent.

If you have any questions, please contact the IRB Office.

Reportable Event Submission for Human Subjects Research

Use the Reportable Event Submission Form to report unanticipated problems or adverse events involving risks to participants or to others. If the event, problem or information meets the immediate reporting criteria, the Principal Investigator must submit the reportable event within 5 business days of becoming aware of the occurrence.

Researchers should contact the IRB Office immediately upon discovery of an unanticipated problem or event involving risks to subjects or others.

If the reportable event does not involve unanticipated problems or adverse events involving risks to participants or to others, the PI must submit the reportable even at the time of discovery or at the time of submission of a progress report, continuing review or protocol closure.

For additional information regarding Reportable Events please see IRB Investigator Manual and the IRB SOP: Requirements for Reporting to the IRB to, located on the IRB website.

If you have further questions, please contact the IRB Office.

Collaboration/Multi-Site Research

Campbell University researchers may engage in collaborative research with individuals and organizations outside of Campbell University. Often circumstances require agreements between collaborators to be in place prior to conducting research activities with human subjects. This page provided guidance on the most comment agreements used in collaborative/Multi-Site research.

IRB Authorization Agreements (IAA)

When more than one institution with an established FederalWide Assurance (FWA) and an established Institutional Review Board (IRB) collaborate in research, an agreement may be established to designate one IRB to serve as the IRB of record for the research. An investigator may purse and IRB Authorization Agreement (IAA) by completing and submitting an IRB Authorization Agreement (IAA) Request Form and supporting materials to the IRB Office.

Example:

  • A federally project that has been awarded to a Principal Investigator at an External Institution with its own IRB which has approved the project. A Campbell University investigator has been listed as a co-investigator and research activities will be conducted at Campbell University.

Individual Investigator Agreement (IIA)

When a non-Campbell University individual is engaged in the human subject research and their work is not performed as an agent of an institution with an established FederalWide Assurance (FWA), it may be necessary to establish an Individual Investigator Agreement (IIA). An investigator may purse and IRB Individual Investigator Agreement (IIA) by completing and submitting an IRB Individual Investigator Agreement (IIA) Request Form. This form needs to be included with the new protocol submission or an amendment submission, if an individual is being added to an existing protocol.

Example:

  • A Campbell University investigator would like to conduct research at a physical therapy clinic and the clinic is not affiliated with an institution with a FederalWide Assurance (FWA) and IRB and there are no Campbell University faculty on staff.

Letters of Support

When projects are conducted in whole or in part at sites external to Campbell University, project teams are requested to provide letters (or emails) of support from those sites. The purpose of a letter of support is to provide documentation to the CU IRB that the site is aware of the project activities that will be conducted at that site and it supports participation in the project.

For further details regarding letters of support please see IRB Guidance: Letters of Support from External Sites and IRB Guidance: Research Involving K-12 or Higher Education Schools.

Other Collaborations

Other agreements may be entered into as part of collaborative research such as Memos of Understanding (MOUs) and Data Use Agreements (DUAs). These agreements can include parameters for the conduct of research relevant to human subjects research and permission for use of data and/or biospecimens and may need to be considered as part of the IRB review. These may require consultation with Campbell University’s General Council.

For additional information regarding Collaborative Research  please see IRB Investigator Manual and the IRB SOP: Reliance Agreements for Multi-Site Projects and IRB SOP: Conducting Multi-site (sIRB) Research and Investigator Responsibilities. to, located on the IRB website.

If you have any questions, please contact the IRB Office.

If you have problems downloading or opening IRB documents, email irbadmin@campbell.edu to request forms.

Forms and Supporting Documents

To submit a protocol for a new project, to amend/modify an approved IRB project, for continuing review, or closure of a project, please complete the appropriate  submission form  and include the appropriate Submission Form as an attachment in the area provided on the appropriate Electronic Application Form.

Submission Forms
Submission Attachment Forms

When using IRB submission forms and other templates please save to your computer and then open the document in MS Word or Adobe Acrobat and return documents in their original format. Depending on your computer and software versions running your editing may not be saved properly if you open the document and immediately enter information and then try to save the document.  If you find you are having problems with saving an edited document, please contact the IRB office. Do not submit documents in any other form than which they were originally formatted. This will delay your submission (no Google pages documents, Word documents saved as Adobe documents, etc.)

Regulatory Information/Policies & Procedures

Federalwide Assurance Information

FWA#: FWA00008608

Campbell University

Institutional Official and Designated Signatory Official: Mark L. Hammond, Ph.D., Vice President for Academic Affairs & Provost:

Signatory Official: J. Bradley Creed, Ph.D., Chief Executive Officer

IRB Registration Information

IORG#: IORG0004771

Campbell U IRB#2

IRB Chair: Miranda van Tilburg, PhD.

IRB Contact: Shawn Leming, BA, CIP

IRB Roster 2019 – 2020

IRB Investigator Manual

IRB Investigator SOP Documents:

Advertisement and Recruitment

Conduct of Research

Informed Consent

IRB Submissions and Review

Multi-Site Research

Regulatory Compliance

Reporting to the IRB

Vulnerable Populations

Human Subjects Research (HSR) Training

The purpose of CU Human Subject Research Protections (HSRP) training is threefold:

  1. Responsible Conduct in Research – to assure a thorough and universal foundation in the ethical and legal principles guiding human participant research.
  2. Scientific Integrity – to enhance the awareness of and sensitivity to research integrity issues such as conflict of interest.
  3. Public Duty – to demonstrate to subjects, the community, and research sponsors that we have the training and expertise necessary to protect the rights and welfare of research subjects.

All individuals involved in the design, conduct, or analysis of human subjects research are required to be certified in completing human subjects research protections (HSRP) training via Collaborative IRB Training Initiative (CITI) Program or CIRTification Community Involvement in Research. Depending upon the type of human subject research, additional HSRP training may be required.

Additional training may be required for individuals when conducting research funded by certain federal agencies (e.g. Department of Defense, Department of Navy, and NIH). It is the Principal Investigator’s responsibilities to know and obtain the required training.

Training is valid for a three-year period, after which time the training must be refreshed. 

All members of the research team, including the faculty advisor, involved in the conduct of Human Subjects Research must complete training.

Users are expected to maintain their certification records individuals by printing out their completion reports or notifications.

Detailed information regarding program contents, registration and enrollment instructions for both training programs can be found in the IRB Investigator Manual or IRB SOP: Human Subject Research Training Requirements.

If you have questions, please contact the IRB Office.

Additional Resources

Contacts

Dr. Miranda van Tilburg, IRB Committee Chair
irbchair@campbell.edu

Shawn Leming, IRB Coordinator
irbadmin@campbell.edu