Any activity involving humans as participants in research must gain approval or exemption from the IRB before the research may be undertaken. To determine whether your project constitutes human research that requires review, use the Office for Human Research Protections (OHRP) provided decision charts.
The IRB reviews proposals as they are submitted. The IRB strives to review proposals and make contact with the PI within 15 business days that the university is open. Note that review will likely take longer during the Christmas holiday and during the summer. This does not mean that you will have approval within this window. Incomplete or unclear applications may result in delay of your application approval.
- Research cannot commence before formal notification of approval from IRB.
- The IRB strives to review proposals and make contact with the principal investigator (PI) within 15 business days that the university is open. However, in times of high quantities of submissions and/or holidays, this is not always possible.
- Studies that are deemed to include more than minimal risk are reviewed at IRB meetings with a quorum of the full board, called by the IRB chair, and consequently can take longer for completion of the review.
Please note that turn-around time is dependent on the submission of a complete and accurate proposal as well as the PI’s responsiveness to the review requirements and requests. Poorly written proposals and delay in response from researchers are the largest source of delays and frustration for applicants.
General Review Procedures
In order to approve research, the IRB must determine that all of the following requirements are satisfied in accordance with HHS regulations at 45 CFR 46.111:
- Risks to subjects are minimized (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) 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 possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
- 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 and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, 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 45 CFR 46.116.
- Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 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.
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
When applicable, the IRB must determine that the additional protections of subpart B (Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research), subpart C (Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects), or subpart D (Additional Protections for Children Involved as Subjects in Research) of 45 CFR part 46 have been met. The IRB uses criteria 46.111 of the Federal Code to evaluate research and criteria 46.416 to evaluate Informed Consent forms.
Approval is typically granted for one year, but the IRB may require reports or reviews of the project at three, six, or nine months.
The primary investigator of the project will be notified of the Board's decision in writing. The investigator may be asked to file an amended application reflecting any recommended changes with the IRB by a stated deadline.
The Samford University administration may rescind an IRB research approval, but may not override an IRB research denial.
Review Procedures for New Research
Exemption from Review
Research that qualifies as exempt must receive formal exemption from the IRB. A request for exemption will be reviewed by the IRB chair or designee. If the chair or designee agrees to the request, a formal exemption will be provided.
If the investigator indicates on the IRB Application that the proposed project involves no risk to participants, and if the chair of the IRB agrees with that assessment, the chair will distribute copies of the plan of investigation to two board members. If the two members agree on approval of the project, no meeting will be held, and formal written IRB approval of the project for up to one year will be given.
IRB members may offer approval with the provision that minor procedural changes be made in the protocol. If the suggestions appear to the chair to be reasonable, and the chair conveys them to the investigator, and the investigator agrees to implement the suggestions, it will not be necessary to convene the board to discuss them. The investigator will be asked to file an amended application reflecting any recommended changes with the IRB by a stated deadline.
If at least one member of the IRB does not want to approve the project without a meeting, or if the chair believes that the suggestions offered by one or more IRB members should be discussed, then the chair shall schedule a meeting for a full review the project.
If the investigator indicates on the IRB Application that the proposed project involves putting the participants at risk or if the IRB chair disagrees with the investigator's assessment that the project involves no risk to participants, the chair will distribute copies of the plan of investigation to each IRB member. The chair will schedule a meeting to discuss the project. At the full IRB review meeting, at least four members of the board must vote. A majority of those voting must agree to one of the three following outcomes:
- IRB approval of project
- IRB rejection of project
- IRB approval of project with modifications
Review Procedure for Modification of Prior-Approved Research
If modifications are made to research procedures at any time during the IRB approval period (typically one year from approval date), a project modification form is required. Expedited review by the IRB chair or designated member is allowed if modifications do not change the initial risk assessment of a no-risk proposal. If the initial proposal was classified as “at risk,” modifications may be brought before full board review, at the discretion of the IRB chair. Approval of modifications does not change the original IRB approval expiration date indicated in the original IRB approval letter.
Review Procedure for Continuing Research
Federal guidelines mandate that the IRB assess risks, potential benefits, informed consent, and safeguards for human subjects both at the initial review and when researchers file a project renewal form. Initial approvals are good for up to one year. When conducting continuing review, the IRB needs to determine whether any new information has emerged, either from the research itself or from other sources that could alter the IRB’s previous determinations, particularly with respect to risk to subjects. In addition, any unanticipated problems involving risk to participants or others that occurred since the previous IRB review will also be relevant to the IRB’s decision about continued approval.
Expedited Review of Continuing Research
Expedited Review of Continuing Research can occur in two possible ways:
- Expedited review by IRB chair or designee
- If the initial study was minimal risk and no additional risks are identified and
- The research is permanently closed to the enrollment of new participants, participants have completed all research interventions, and the research is active only for long-term follow-up of participants, or
- Continuing research activities are limited to data analysis.
- Expedited review by two IRB members
- If the continuing research has only minimal-risk.
Full IRB Review of Continuing Research
If the initial procedures were more-than-minimal risk, new risk issues emerged over the year or the continuing research includes additional risk issues, the review will be made by a quorum of the IRB at a convened IRB meeting. The researcher may be invited to attend this meeting to address questions.