Institutional Review Board

The Institutional Review Board (IRB) of Campbell University is concerned with the ethical treatment of humans when they are involved as participants in research.  The committee’s primary responsibility is to protect the rights and welfare of human research participants by seeking to ensure that the principles of respect for persons, beneficence, and justice are adhered to in research connected to Campbell University.

An investigator intending to conduct research activities potentially involving human subject research must submit an application to the Campbell University IRB Office for review and approval prior to beginning research activities.

To access fillable forms, download the documents linked in the text below.

Updates:

Currently there are no protocol submissions requiring full committee approval on the agenda.  If you have a project that requires full committee approval prior to September 2019, please submit no later than 4/11/2019.

The website has been update to reflect the New Common Rule changes that have been implemented.

The “Proposal Narrative Form” has been retired and replaced with the “Initial Protocol Submission”. Please use this new form when submitting a new protocol for IRB review.

Effective 4/1/2019, the IRB will begin requiring all Principal Investigators and research staff listed on newly submitted protocols to have successfully completed Human Subject Research Training prior to protocol review and approval. Campbell University currently uses CITI Training for human subject research training. As of 2/22/19, a section on “Training” has been added to the CU IRB website with instructions on how to complete required training.  If you have an IRB protocol which was or will be approved prior to 4/1/2019, you will receive a letter from the IRB requesting training certification at a later date.

The IRB is requesting that any Principal Investigator conducting an IRB approved Expedited protocol, with an approval prior to 3/1/2018 to please submit a Continuing Review Submission or Closure Submission to remain compliant with regulations and institutional policy. Investigators have until 4/17/2019 to submit their CR or Closure.  If the IRB does not receive one of these submissions all expedited or full committee expired protocols will be administrative closed.

When using IRB submission forms and other templates please save the document 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.

A new form, titled, Reportable Event Submission Form, has been uploaded and is to be used by investigators when reporting events occurring on approved IRB protocols, that are required to be reviewed by the IRB.  Two new documents have been uploaded for use in projects that involve Non-English speaking or Limit-English speaking subjects.  They are the Translator Declaration Form and the Back-Translator Form.  All new documents can be found in the Information for Investigators sections under Applications & Supporting Documents.

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

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.

  • 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 Form” 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.

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 Is it Research? What IRB Level of Review and  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.

Please refer to Is it Research? What IRB Level of Review listed in Guidance Information.

 

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.

Information for Investigators

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.

If the proposal requires additional applicable forms, listed below, please attached the document(s) in the area provided on the appropriate Application Form.

Additional Possible Submission Forms

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

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
  • Group 2: Social & Behavior Research
  • Group 4: Clinical Research Students or IRB Members

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

  • Group 3: Data or Specimens Only Research
  • Good Clinical Practice (GPC)
  • Health Information Privacy and Security (HIPS) for Clinical Research Students
  • RCR for Clinical Research Students

Resources

Contact

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

Shawn Leming, IRB coordinator
irbadmin@campbell.edu