Institutional Review Board

The Institutional Review Board (IRB) of Campbell University is concerned with the ethical treatment of human when they are involved as participants in research. The committee’s primary responsibility is to protect the rights and welfare of human research participants.  All potential research 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.

Important Notes

  • The IRB Office will not be processing submissions or conducting reviews during the following  dates, December 20, 2019 – January 2, 2020 due to staff being on vacation. Please plan accordingly.
  • NEW: Full Committee Review Submissions – In order to assist researchers conducting more than minimal risk projects the IRB is now requiring investigators, as well as, Faculty Advisors to meet with the IRB Chair prior to submitting any protocol requiring Full Committee Review.
  • NEW: IRB SOP Documents can be found in the Policies and Procedurs Section Below.
  • Coming Soon: IRB Investigator Manual with detailed information for Investigators will be added to the Policies and Procedures Section below.
  • NEW Guidance Documents: be found in the Guidance and Information Section below.

Human Subjects Research Training  through the Campbell University account (not CUSOM) on CITI Programs website is mandatory for all faculty, mentors, students and staff conducting human research.  Please see the Training section blow.  All submissions will be placed “On Hold” until CITI training has been completed before submissions will be processed for intake and review.

All researchers planning on conducting International Research, please contact the IRB Office.  This type of research requires special procedures which require advanced planning and additional approvals may be required.

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

IRB Meetings

January 30, 2020 – All protocol submission must be submitted by 12/20/19.

February 20, 2020 – All protocol submissions must be submitted by 1/23/20.

March 19, 2020 – All protocol submissions must be submitted by 2/20/20.

April 30, 2020 – All protocol submissions must be submitted by 4/2/20.

May 21, 2020 – All protocol submissions must be submitted by 4/23/20.

There are no full committee meetings for the months of June, July & August 2020.

Is your project Research?

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.  Activities which meet this definition constitute research for purpose of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.  For example: some demonstration and service programs may include research activities.

Systematic Investigation:  A project which:

  • Attempts to answer research questions (e.g. attempts to prove a hypothesis).
  • Is methodologically driven, i.e. it collects data or information in an organized and consistent way.
  • Analyzes information quantitatively and/or qualitatively.
  • Draws conclusions from the results.

Generalizable Knowledge:  Knowledge which contributes to a theoretical framework of an established body of knowledge. Results are expected to reflect a larger population beyond the studied population, and are expected to be replicable in other settings.

The following activities are deemed not to be research:    

Scholarly and journalist activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.

Human Subjects

As determined by the Department of Health and Human Services (DHHS), federal regulation 45 CFR 46.102.

Means a living individual about whom an investigator (whether professional or student) conducting research obtains:

    • Information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
    • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, medical records or school grades). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Not Human Subject Research (NHSR)

Projects that do not fit the definition of research, do not actively involve human subjects, do not access private, identifiable human data, and are not purposed to support the marketing of an FDA-regulated drug, biologic, or device product.

The following are examples of activities that are generally considered not to be Human Research. If your activity is limited to one of the examples below, then it is likely not Human Research which would need to be reviewed by the IRB.  Note that publication is not a determining factor for whether an activity is Human Research.

  • Research Using Public or Non-Identifiable Private Information about Living Individuals: The activity is limited to analyzing data about living individuals:
  1. Where the data have been retrieved by the investigator from public, non-restricted data sets; or
  2. Where the private data have been provided to the investigator without any accompanying information by which the investigator could identify the individuals.

Note: that “de-identified data” according to HIPAA may be identifiable according to the DHHS definition of “Human Subjects” above. Please consult “Human Research Determination Worksheet” for clarification and contact the IRB Office with any questions regarding research with data.

  • Program Evaluation/Quality Assurance Review/Quality Improvement Project: The activity is limited to program evaluation, quality assurance, or quality improvement activities designed specifically to evaluate, assure, or improve performance within a department, classroom, or hospital setting. Note: The purpose of a QA study is to assure known quality. The purpose of Program Evaluation (PE) is to assess that a program is doing what it is intended to do. Generally QI is designed for the purpose of improving the quality of a service, a program, a process, etc. A QA, QI or PE study should present NO CHANGE in RISK to participants. These studies are mechanisms to assure that a service, a program or process functions optimally. Such projects are usually for internal auditing purposes only.  If you can answer “yes” to all of the following questions, the activity is most likely not human research:
  1. Will you simply monitor an existing process for which there will be no manipulation of the existing process?
  2. For biomedical or Social Behavioral QA or PE studies, will physicians or caregivers (parents, teachers, therapists, etc.) provide usual and customary care regardless of the conduct of the study?
  3. Does the study involve collection of data to which the investigator routinely has access as part of his or her responsibilities within the institution to monitor data associated with, for example: treatment, cost containment, performance, or compliance?

Note: an evaluation, assurance review, or improvement project designed specifically for a particular setting may yield useful information for similar entities, and may still not meet one of the definitions for Human Research.

  • Case Report: The project consists of a case report or series which describes an interesting treatment, presentation, or outcome. A critical component is that nothing was done to the patient(s) with prior “research” intent.
    Note: HIPAA or other state or local laws may still apply to this activity. Please consult the entity from which you received or accessed the information contained in the report for further guidance.
  • Course-Related Activity: The project is limited to one or more course-related activities designed specifically for educational or teaching purposes where data are collected from and about students as part of routine class exercises or assignments and otherwise do not meet either of the definitions of Human Research in Section 1.0.
    Note: some course-related activities, even those conducted by students, may yield information suggesting additional investigation or analysis. If an additional activity entails Human Research, then it must be submitted to the IRB Office for review.
  • Journalistic or Documentary Activity (including Oral History): The activity is limited to investigations or interviews (structured or open-ended) that focus on specific events (current or historical), views, etc. Such investigations or interviews may be reported or published in any medium, e.g., print newspaper, documentary video, online magazine.
  • Research Using Health Information from Deceased Individuals: This activity is limited to analyzing data (identifiable or not) about deceased individuals.
  • Note: deceased individuals cannot be Human Subjects according to DHHS, but they may be Human Subjects according to FDA. Please review the definitions above for clarification. Note also that HIPAA or other state or local laws may still apply to this activity. Please consult the entity from which you received or accessed the information contained in the report for further guidance.
  • Instrument/Questionnaire Development: This activity is limited to interacting with individuals in order to obtain feedback on the types of questions which could or should be used to develop an instrument or questionnaire. The focus is on the development and construction of a data collection tool and not on the individuals who are providing the feedback on the questions being developed. This will be true even when the feedback may be specifically sought from an identified group of people most likely to be affected by the topic of the instrument, survey or questionnaire. The instrument/questionnaire development process will apply to many aspects of reliability and validity testing of the instrument or questionnaire. Note that once the process gets to the level of testing discriminant, concurrent or predictive validity, the activity may need to be reclassified as human subject research.
  • Note: If the participant is asked to provide additional information unrelated to instrument/questionnaire construction, such as demographic information, that will be analyzed as part of a research study, the project may need to be submitted to the IRB for review.

To apply for review and approval of this type of research, please complete the CUIRB NHSR Protocol Submission Form in addition to the regular IRB application form located in the section “For Submitters.”

Please note: The CUIRB NHSR Submission Form does not replace submission of an IRB application to the Campbell University IRB.  Investigators who intend to conduct activities that might involve human subject research must submit a formal application to the Campbell University IRB Office for determination.

FLEX Review and Registration Projects

Certain types of minimal risk research projects may not require the application of all federal regulations for determination or approval by the IRB. These research projects will be afforded equivalent protections under the Belmont and will afford equivalent protections commensurate with risk as determined by the IRB.  Registration projects must be no greater than minimal risk and do not have or ever have had federal support or contractual obligations or restrictions that precluded eligibility with this policy.  Depending on the research the IRB may determine that an informed consent process may be required.  All submission which are not granted Registration status must receive expedited or full committee review. FLEX Review is completed by an IRB Office member. Please see, “HSR-030 HRPP Policy: Registration Projects and FLEX Review” in the Regulatory Information/Policies and Procedures section below.

            Examples of registration projects include: evaluation or comparison of “normal” educational techniques or instructional curriculum, conducting surveys, questionnaires, focus groups, or interviews, use of biospecimens that have been collected or will be collected solely for non-research purposes, taste and fool quality evaluations, blood draws via venipuncture, ginger, hell, or ear stick, prospective collection of biospecimens via non-invasive procedures, research involving materials that has been collected, or will be collected solely for non-research purposes, collection of images, video or audio recordings solely for research, psychosocial interventions, including benign behavioral intervention which may or may not involve deception.

Exempt Determinations and Limited IRB Review

Certain types of research may qualify for exemption according to federal regulations contained in 45 CFR 46.101(b)(1)-(8). Exempt studies include research that involves no more than minimal risk and meets criteria specified by federal regulations.  Depending on the research the IRB may determine that an informed consent process may be required.  All submissions which are not granted exempt approval status must receive expedited or full committee review.  Exempt review is completed by an IRB office member and the IRB Chair.

Examples of exempt projects include research involving “normal” education practices, anonymous education testing, surveys, interviews, use of existing data, public benefit of service programs, etc. providing information obtained is recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects. If information or biospecimens are recording by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, the IRB will conduct a limited IRB review to to ensure there are adequate provision to protect the privacy of subjects and to maintain the confidentiality of the data or biospecimens. 

Please refer to Exempt Category Decision Flowcharts, listed in Guidance Information.

Note: Exempt categories 7 & 8 of the Common Rule (45 CFR 46) require the use of a broad consent and the IRB is not accepting project submission of this type at this time. If you are interested in submitting a project requiring this type of review, please contact the IRB office.

 

Expedited

Federal rules permit expedited review and approval for certain kinds of research involving no more than minimal risk and for minor changes in approved research according to 45 CRF 46.110 and 45 CFR 46.111. Expedited review is completed by the IRB Chair or a designated IRB member.

Examples of expedited projects include research involving blood samples, focus groups, program evaluation and collection of data through noninvasive procedures that have minimal risks to subjects.

 

Full Committee

Research that involves great than minimal risk requires review and approval by a convened IRB Committee composed of physicians, scientists, non-scientists, and community members. Risks to research participants should be justified by the anticipated benefits to the subjects or society.  Full committee review is conducted at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas.

Examples of full committee review projects include:

  • Most research that involves children, prisoners, pregnant women, fetuses and other vulnerable populations;
  • Other projects that may involve great than minimal risk such as, sensitive questions or unusual interventions.

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

Information for Investigators

Researchers

If you do not know if your research project meets the criteria of human subjects research please use the Human Subjects Research (HSR) Determination Worksheet as guidance. If you are still unsure if your project meets the criteria of human subjects research complete the worksheet and email to the IRB office at irbadmin@campbell.edu for a determination.

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 electronic submission form listed below, and include the appropriate Submission Form as an attachment in the area provided on the appropriate Electronic Application Form.

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.)

If the proposal requires additional applicable forms, listed below, please attached the document(s) in the area provided on the appropriate Application Form.Use the Initial/New Protocol Electronic Application Form for:

Use the Amendment (AME) Electronic Application Form for:

Use the Closure Electronic Application Form for:

Use the Electronic Continuing Review Application Form for:

Use the Electronic Reportable Event Application Form for:

Use the Undergraduate Classroom Human Subjects Research Submission Form for student classroom research projects and have instructor submit to the IRB at irbadmin@Campbell.edu.

 

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. 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.

Investigator Agreement (required at time of Initial/New Submission or with Amendment to change PI)This must be submitted with initial/new protocol submission or whenever there is a change in Principal Investigator

Research Protocol or Plan This  should be submitted with initial/new protocol submission, amendment to approved protocol and continuing review of approved protocol. If project has a sponsor, this is usually the “Investigator Protocol” document and must be submitted.

Translator Declaration Form Required Document when Investigators submit a translated document(s) to the IRB for review.

Back Translator Declaration Form Required Document when Investigators submit a back-translated document(s) to the IRB for review.

Request for Alteration/Waiver of Consent Process This must be submitted when requesting waiver of the consent process for the entire project or alteration/removal of any the required elements of consent. This is not required for  Exempt, Category 4 research involving the secondary use of identifiable information or biospecimens. Please see 45 CFR 46.104(d) for clarification.

Request for HIPAA Alteration/Waiver of Authorization This must be requested when requesting waiver/alteration of HIPPA authorization to access PHI for screening or recruitment purposes or waiving HIPAA authorization for the entire project. This is may requiressubmission of Request of Alteration/Waiver of the Consent Process and a Request of Waiver of the Documentation of Consent (located in the submission form).

IRB Investigator Attestation for Ceded Projects Form This attestation should be completed by the investigator in the process of requesting a ceded review and/or in the establishment of a reliance agreement of IRB review.

IRB Reliance Request Form Use this form to request CU to serve as the IRB of record or to defer IRB oversight when a project may involve 2 or more institutions holding a FWA.

Letters of Support from External Sites This Letter of Support Template can be used for projects where research activities are occurring outside of CU at locations/organization which may not have a formal ethics review board or IRB.

Research Personnel Form Use this form to list project team members and human subjects research training certifications.

Data Use Agreement

Human Subjects Research (HSR) Determination Worksheet Use this form to determine if your research requires submission to the IRB for review as Human Subjects Research.

 

Please attach all recruitment materials, surveys, questionnaires, data collection sheets, consent and human subjects research training certification documents with your submission.

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#: IORG004771

Campbell U IRB#2

IRB Chair: Miranda van Tilburg, PhD.

IRB Contact: Shawn Leming, BA, CIP

IRB Roster 2019 – 2020

IRB Investigator Manual coming soon.

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

Principal Investigators, Faculty Advisors and other research staff conducting Human Research must complete the following training program:

Additional training may be required for individuals when conducting research funded by certain federal agencies (e.g. Department of Defense, Department of Navy, NIH).

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

All members of the research team involved in the conduct of Human Research must complete training. Members of the research team who have not completed human research protections training may not take part in aspects of the research than involve human participants or their identifying information.

How to register and create my CITI Program account and select my course.

  1. Go to https://about.citiprogram.org/en/homepage/ and click on the “Register” button located on the right-hand side of the page.
  2. Enter “Campbell University” as your organization and click on “Continue.”
  3. Enter your first and last name and email address and click on “Continue.”

*Please use your CU email address

  1. Choose a username and password for your CITI account following the instructions for each field; you must also select and answer a security question and click on “Continue.”
  2. Provide information regarding gender, ethnicity and race and click on “Continue.”
  3. Provide information regarding CE credits and completion of surveys and click on “Continue.”   CE credits are available for purchasing by the individual.
  4. Provide the required information for Campbell University as identified by the *.
  5. Select the appropriate CITI course, for the type of research you conduct and click on “Next.”

Note: If you have completed CITI training at another institution, you may be able to transfer those courses/modules by using the add/change your affiliated institution on the CITI website.

Please access the CITI Support Center for further instructions.

Completion of the CITI course

The total time is approximately 2 to 6 hours for the basic course. You may complete it at multiple sittings.  The certification program is web-based and be accessed from any computer via the internet.

When you have completed your course, please print or save a copy of your certificate and list of completed modules for your records. Please notify the IRB office when you have completed your training.

Courses Which Meet IRB Criteria

Required Training (select at least one group)

  • Group 1: Biomedical Investigators

    Biomedical involves all types of clinical research studies, including FDA-regulated research and those that involve drugs, biologics, devices or medical records (PHI or HIPAA regulated research).

  • Group 2 : Social & Behavior  Research Social/Behavioral Research (SBR) encompasses a wide variety of research including but not limited to: observational, survey research, epidemiological studies.

  • Group 4: Clinical Research Students or IRB Members This group combines Group 1 and Group 2 and is required for CPHS students and IRB Members. If your research is a combination of biomedical and SBR this is the Group to select. 

Additional Training (may be mandatory depending on type of research conducted)

  • Group 3: Data or Specimens Only Research

    The focus of this group is on research which involves research activities which are limited to secondary use of data and biospecimens.

  • Good Clinical Practice (GPC)

    This course is mandatory for NIH research personnel and for some CPHS Programs.

  • Health Information Privacy and Security (HIPS) for Clinical Research Students

    This course is mandatory for some CPHS students.

  • Responsible Conduct in Research (RCR)

    Responsible Conduct in Research is required for all CU students conducting research, CPHS students, Students working on a NSF research project, certain faculty and staff at CU. If your research is NIH funded this RCR training does not meet the requirement for RCR Training. Please select the appropriate course based on your role in research and/or if you are in the Engineering School.

Resources

Contacts

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

Shawn Leming, IRB Coordinator
irbadmin@campbell.edu