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 PDF forms, download the documents linked in the text below.
There is no scheduled IRB Committee Meeting for January.
The New Common Rule goes into effect January 19th, 2019. For more information regarding this and how it may impact your current IRB approved protocol or future protocol submission view the following document: Addendum to CU IRB SOPs.
Continue to visit the IRB website for updates and changes to research and documents.
If your research requires the use of an informed consent document, please contact the IRB office. These documents are not available on the website at this time.
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.
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:
- Data through intervention or interaction with the individual, or
- Identifiable private information.
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.
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.
- Public Use Data
Research using certain publicly available data sets does not constitute human subjects research because the data contained within these specific data sets do not meet the federal definition of “human subject.
To apply for review and determination of this type of research, please complete the Initial Application Form and the Proposal Narrative Form.
Investigators who intend to conduct activities that might involve human subject research must submit a formal application to the Campbell University IRB Office.
Certain types of research may qualify for exemption according to federal regulations contained in 45 CFR 46.101(b)(1)-(6). 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. A small number of protocol submissions meet criteria for this review type. 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. Please refer to Is It Research? What IRB Level of Review and Decision Tree 1 and 2, listed in Guidance Information.
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 and Decision Tree 1 and 2, listed in Guidance Information..
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, 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 Application Form.
- Initial Application Form
- Download Proposal Narrative Form
- Amendment (AME) Application Form
- Download Amendment (AME) Submission Form
- Closure Application Form
- Download Closure Submission Form
If the proposal requires additional applicable forms, listed below, please attached the document(s) in the area provided on the approraite Application Form.
Additional Possible Submission Forms
- Project Protocol Summary
- Download Data Use Agreement
- Download Request for Alteration Waiver of Consent Process
- Download Request for HIPAA Alteration Waiver of Individual Authorization
- Download Request for Waiver of Documentation of Consent
- Download Investigator Attestation for Ceded Projects
- Letters of Support from K-12 Principals & Teachers
Please attach all recruitment materials, surveys, questionnaires, data collection sheets, consent and human subjects research training certification documents with your submission.
At this time please contact the IRB Office for current approved informed consent templates for use. The documents are not available in pdf format.
IRB Guidance Documents
- List of 18 Protected Heath Identifiers
- Is it Research? /What IRB-Level of Review?
- Decision Tree #1: Does Your Project Require Application to the IRB?
- Decision Tree #2: Does Your Research Involve Secondary or Existing Data Require Review by the IRB?
- Letters of Support from External Sites
- Research Conducted in Schools (K-12)
- IRB SOP Document Updated 2018
- Addendum to CU IRB SOPs