IRB - Frequently Asked Questions
Issue 1: General Questions
What is an Institutional Review Board (IRB)?
Under federal law and regulations, an IRB is the official group that has been formally designated by an institution to review any research involving human subjects.
Harding's IRB is made up of eight members, appointed by the University president, and has the authority to approve, require modifications, or disapprove research.
What is the purpose of an IRB?
The purpose of the IRB is to assure, both in advance and periodically, that adequate steps are taken to protect the rights and welfare of humans participating as subjects in research.
The eight members of the IRB review research protocols and related materials (e.g., informed consent documents) to ensure protection of the rights and welfare of human subjects.
Is the purpose of the IRB review of informed consent to protect the institution or the subject?
The fundamental purpose of IRB review is to assure that the rights and welfare of human subjects are protected. A signed informed consent document is evidence that the document has been provided to a prospective subject and that the subject has agreed to participate in the research. IRB review of informed consent documents also ensures that the institution is in compliance with applicable regulations.
Issue 2: Required Training for Research
What kind of training is needed?
Human Research Protection Training - preferred course by Harding's IRB
Federal regulations require education in human subject protections for all investigators and key research personnel before research may be conducted. The Human Research Protection Training course site through OHRP provides research ethics instruction in various aspects of responsible conduct of research including human subjects protection, health information privacy and security, laboratory animal welfare, research misconduct, data management, authorship, peer review, conflict of interest, mentoring and collaborative science.
NOTE: If your research project qualifies for IRB Exempt approval, you do not have to complete the required education.
FACULTY/STAFF MEMBERS submitting an IRB application or involved in a research project, even in an advisory or mentoring capacity should also document valid training. If your funded research is from the National Institutes of Health (NIH) or National Science Foundation (NSF), you must complete the “Responsible Conduct of Research Course” appropriate to your field of study.
STUDENTS submitting an IRB application or involved in a research project must complete the CITI Basic course titled “Research Investigators (Students, faculty, staff)” or another valid research training certification.
Issue 3: Determining the need for project approval
How do I know whether my project requires approval by the (IRB)?
Use this two-part test to see if your project must be submitted to the IRB:
Part 1: How do I know if my proposal constitutes "research"?
Ask yourself the following questions:
a. Is there any possibility you will someday publish or present the results of your project in a scholarly forum?
b. Is your project part of your capstone, masters or doctoral project or an independent project? (e.g., research paper, pilot study, video documentary)
If you answered NO to both questions, you do not have to submit your proposal to the IRB. You may start your project.
If you answered YES to either question, your project is considered to be "research." Go to Part 2.
Part 2: How do I know if my project is considered to be "research on human subjects"?
Ask yourself the following questions:
Are you planning to obtain information from or about living individuals?
a. Will the study involve direct interaction with individuals? (surveys, focus groups, etc.)
b. Will the study gather data linked to personal identifiers?
c. Will you gather information that would ordinarily be private?
d. Will you gather tissue, blood, or any other physical matter?
e. Will you observe behavior in a context where the subjects would reasonably expect privacy (e.g., their homes)?
f. Will you be making and/or observing changes to an individual environment?
g. Will you be making and/or observing changes related to a bodily alteration? (e.g., drugs, food, etc.)
If you answered NO to (a), then it would be impossible for you to answer YES to any other question. You are free to start your project.
If you answered YES to (a) and to one or more of the other questions, your project is considered to include human subjects and you must submit a formal IRB application.
Summary: If your answer to either question in Part 1 was YES, and your answered YES to question (a) and at least one other question in Part 2, your project is considered to be "research on human subjects" and you must submit a formal IRB application.
What sorts of projects do not need IRB approval?
Projects that do not require IRB review includes anything that is NOT research. This includes but is not limited to: records reviews, data requests, or classroom surveys conducted by a teacher to inform his or her instruction (and not intended for presentation or research).
In general, a project or a study that involves data gathered from groups or individuals solely for internal, on-going campus use (e.g., coursework, course evaluation, program assessment or internal programming), and not presented or distributed to individuals outside of a classroom or shared with external sources, does not need to be reviewed by the IRB. If results of a project or a study are publicly disseminated in any way (e.g., conference presentation, publication) or will contribute to generalizable knowledge, then the study probably constitutes research and will require IRB review/approval. If no dissemination is planned at the time the data is gathered but the possibility of future dissemination exists, the researcher is advised to submit the project for IRB review/approval before initiating the (research) project. Typically, an exemption is the form to be filed with the IRB.
If a Harding University student project does not constitute research and is determined by the student and the faculty advisor to be outside of the IRB preview, in the spirit of ethical principles, you are expected to respect the individuals participating, to protect their privacy and to maintain the confidentiality of data by conducting the project with good ethical and responsible practices.
What if I am using information that is already available?
If you are doing research that is limited to secondary analysis of data, records, or specimens that are (1) publicly available, (2) de-identified, or (3) otherwise impossible to be linked to individual identities, it is possible that you may need IRB review. On occasion, a data-use agreement between the researcher and the data custodian may still be required to verify that the researcher will not have access to identifying codes. The IRB can consider a proposal viable for review only after data is "de-linked" from personal identifiers.
Can I seek retroactive approval for a project?
No. An IRB does not have the option of granting "retroactive" approval after research is completed. Researchers are strongly encouraged to submit their research proposals or consult with the IRB if there is uncertainty regarding the need for IRB review and approval.
Issue 4: Submitting a Proposal
How do I submit a proposal?
The forms required for submitting a proposal for review are available online at the Harding IRB website: www.harding.edu/irb.
How do I know whether to submit a request for an exemption, an expedited review, or a full review?
The type of review is determined by such issues as the nature of the protocol, the level of potential risk to human subjects, and the subject population. There are forms for each type of review, and all are available on the Harding IRB web site.
a. Request for Exemption: Research with very minimal risk to human subjects may be exempted from review and includes but is not limited to research on educational strategies, curricula, or management methods or observations done in educational or public settings. To obtain an exemption, the researcher must submit a Request for Exemption from IRB Review form that will be reviewed by the IRB administrator and/or other IRB members. This sort of review generally does not require a full board meeting and can normally be completed in 2-4 business days.
b. Request for Expedited Review: Only research involving no more than minimal risk to subjects may be considered for expedited review. Examples of projects that may qualify for expedited review includes but are not limited to some types of survey research.
To apply for an expedited review, the researcher must submit a Request for Expedited Review form that will be reviewed by the IRB administrator and/or other IRB members. This sort of review generally does not require a full board meeting and can normally be completed in 3-5 business days.
c. Full Board Review: Any study involving greater than minimal risk to human subjects requires a review by the full IRB at a regularly scheduled meeting. Examples of such studies include but is not limited to studies with minors, studies using vulnerable populations as subjects (e.g., developmentally or mentally disabled adults, prisoners, etc.), studies with the possibility of physical risk, and surveys with sensitive questions.
To apply for a full board review, the researcher must submit a Request for Research Review form that will be reviewed at a regularly scheduled meeting of the IRB.
Studies assigned to full board review are reviewed by members ahead of time, then discussed at the meeting. The committee then votes to approve or disapprove the study, and the researcher is notified of the decision.
If my proposal is reviewed by the expedited procedure, do the same requirements apply to my research as they would under a full board review?
Yes. In most cases, expedited reviews simply take less time to review since they are conducted in a rolling fashion (as soon as we receive your protocol and all submission requirements, it is reviewed). That is the only difference between expedited and full board review. All of the same rules and regulations for proposals that receive full board approval apply to research projects that have received IRB approval via the expedited procedure.
Issue 5: Review Timeline
How long does it take for an IRB application to be evaluated?
The IRB is committed to providing a through review, but also a timely turn-around.
The following timeline represents our goal:
- Request for Exemption: 2-4 business days
- Request for Expedited Review: 3-5 business days
- Request for Project Approval (full board review): Within 24 hours of the scheduled Board meeting.