The IRB recommends researchers unfamiliar with the IRB protocol submissions review this page prior to submitting their protocol for IRB review.
We highly recommend new investigators discuss their study with the IRB office before preparing any of the submission documents. Meeting with the IRB to discuss your research will enhance the clarity of your submission and reduce the amount of time required to complete the IRB review.
What is the purpose of the IRB?
The primary purpose of the IRB is to protect the rights and welfare of human participants of research studies. The IRB is governed by federal, state, and Campbell-specific regulations. No research involving human subjects can be conducted without proper determinations/approvals by the IRB.
The IRB submission is a lot of work and the approval process can be long. You may feel frustrated at times. We are here to help to make it as seamless as possible, however, the IRB cannot change federal, state, or institutional rules. If you do not want to comply, simply do not conduct human subjects research. Otherwise, give yourself plenty of time to get an IRB determination/approval.
What to expect when submitting to the IRB
Below is a step-by-step guidance of the life cycle of a typical IRB application. Please note that certain studies may require extra levels of review. These include –but are not limited to studies involving other institutions (including many of our residency and clinical rotation sites) and studies in other countries. In these cases, please contact the IRB before submitting any documents. Please see Protocol Review Process Presentation for detailed information on the IRB review process. The Campbell IRB also has a simplified submission and approval process for undergraduate research in the classroom. Please visit Student Research.
Criteria for IRB Approval
Human subjects research training will provide you with an introduction to the ethical requirements for conducting human subjects research. The Belmont report provides the basis of any ethical conduct of human subjects research based on three principles: Respect for Persons, Beneficence, and Justice. Anyone conducting human subjects research should be intimately familiar with these principles.
A common mistake made by new investigators is to overlook the social value and scientific validity of their research. Studies that are without value expose subjects to risk –even if minimal- and inconvenience without any corresponding prospect of benefit to science, society, or the participants. This breaches the ethical principle of Beneficence. For more information see Emanuel et al JAMA 2000. The Federal regulations (45 CFR 46) establish the following criteria for IRB approval of research. When developing your submission documents, pay extra attention to each of these 8 factors: In order to approve research covered by this policy, the IRB shall determine that all of the following requirements are satisfied.
In order to approve research the Campbell IRB shall determine that all of the following requirements are satisfied:
- Risks to subjects are minimized:
- By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and
- Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider the possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
- The selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involve a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by, §46.116.
- Informed consent will be appropriately documented or appropriately waived in accordance with §46.117.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- For purposes of conducting the limited IRB review required by §46.104(d)(7)), the IRB need not make the determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations:
- Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of §46.116(a)(1)-(4), (a)(6), and (d);
- Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with §46.117; and
- If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
How long does it take to get IRB a determination/approval?
Each project is different and hence it is hard to give a timeline from submission to IRB approval/determination. Some determinations can be given in 24-48 hours, other approvals may take up to several months. Contact the IRB for an estimate for your particular project. Most delays in approvals for projects are due to requested revisions taking a long time and/or the need to submit multiple revisions of a submission. In order to speed up the review process, please resubmit the requested revisions as soon as possible and address all concerns raised by the IRB.