BSC IRB Review Procedures
BSC IRB Review Procedures
Before Submitting Your Review
To determine whether your project constitutes human research that requires review, refer to the information provided on the Do I need IRB Review? page.
ANY activity involving humans as participants in research MUST gain approval or exemption from the BSC IRB before the research may be undertaken.
In order to gain approval or exemption for their research, all investigators must also complete the CITI Training prior to their submission.
Timeframe for Review After Submission
The BSC IRB Committee reviews proposals in a tiered system.
- First, investigators must determine if their research qualifies for Exemption, Expedited, or Full review. For help in determining where your project falls, refer to question 6 on the Frequently Asked Questions page. Final determination of status must be confirmed by the IRB.
- Once your project's review level has been determined, please fill out the appropriate form:
- If this is your first submission to the BSC IRB, please submit CITI certification for all study personnel.
- Then submit your completed review forms to the IRB Administrator.
- You can expect to receive a review decision for each level of review as follows
- Exemption: Within five business days
- Expedited/Minimal Risk: Within two weeks
- Full/Greater than Minimal Risk: Within four weeks
- Once you have received numbered, signed approval from the BSC IRB, you may begin data collection.
- All non-exempt projects must complete annual renewal prior to one year after the date of initial approval or latest numbered, signed renewal. To file for renewal, please use the Request for IRB Review of Non-Exempt Research Involving Human Subjects form, with the "Renewal" box checked.
- If the investigators make any substantive changes to the protocol (including, but not limited to, informed consent, instruments and measures used, sample size and / or population), they must submit a Modification request using the Request for IRB Review of Non-Exempt Research Involving Human Subjects form, with the "Modification" box checked, prior to implementing those changes.
- Upon completion of a project, investigators must submit a Project Closure Form.
Please note that turn-around time is dependent on the submission of a complete and accurate proposal as well as the Principal Investigator's responsiveness to the review requirements and requests. Poorly written proposals are the largest source of delays and frustration for applicants. Incomplete proposals will be returned to the investigator without review.
Exempt IRB Review Procedure
The Office for Human Research Protections (OHRP) has provided decision charts to determine if a research project involving human subjects must be reviewed by an institutional research board. These charts are quite useful in determining whether to submit a Request for Exemption with the IRB.
A Request for IRB Review of Exempt Research Involving Human Subjects must be filed with the IRB if you are conducting research with human participants. An exemption approval from IRB is a safeguard that protects research participants, the investigators, and the institution.
Exemptions are not allowed for research with vulnerable populations. Vulnerable populations include: pregnant women, fetuses, prisoners, minors/children (<19 years), and persons with cognitive disabilities.
The following exempt conditions have been developed and described within the Federal Common Rule (45 CFR 46):
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special educational instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods (Chart 3).
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside of the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation (Chart 4).
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior that is not exempt under category (b) of this section; if: (i) the human participants are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter (Chart 4).
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or indirectly through identifiers linked to subjects (Chart 5). (NOTE: According to the Office of Human Rights Protection [OHRP], "to qualify for this exemption, the data, documents, records, or specimens must be in existence before the project begins. The principle behind this policy is that the rights of the individuals should be respected; subjects must consent to participation in research.")
- Research and demonstration projects that are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs (Chart 6).
- Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed, or (ii) if a food is consumed that contains a food ingredient at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection of the U.S. Department of Agriculture (Chart 7).
Non-Exempt IRB Review Procedure
The BSC 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.
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 BSC IRB by a stated deadline. Approved protocols will receive an approval number and signature.
If the investigator indicates on the Request for IRB Review of Non-Exempt Research Involving Human Subjects form that the proposed project involves no risk to participants, and if the chair of the BSC IRB agrees with that assessment, the chair will distribute copies of the plan of investigation to three board members. If the three members provide the chair a written notice of approval of the project, no meeting will be held, and the chair shall give formal written BSC IRB approval of the project for up to one year.
Board 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 BSC IRB by a stated deadline.
If at least one member of the board does not want to approve the project without a meeting, or if the chair believes that the suggestions offered by one or more board members should be discussed, then the chair shall schedule a meeting for a full review the project.
If the investigator indicates on the IRB Review of Non-Exempt Research Involving Human Subjects form that the proposed project involves putting the participants at risk or if the BSC 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 board member. The chair will schedule a meeting to discuss the project. At the full board 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:
- BSC IRB approval of project
- BSC IRB rejection of project
- BSC IRB approval of project with modifications
Modification of Prior-Approved Research
If modifications are made to research procedures at any time during the BSC IRB approval period (typically one year from approval date), a formal Modification is required using the IRB Review of Non-Exempt Research Involving Human Subjects form with "Modification" box checked. Expedited review by the BSC 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 BSC IRB chair. Approval of modifications does not change the original BSC IRB approval expiration date indicated in the original BSC IRB approval letter.
Annual Review Procedures
Federal guidelines mandate that the BSC IRB assesses risks, potential benefits, informed consent, and safeguards for human subjects both at the initial review and when researchers file for Annual Review and Renewal. Initial approvals are good for up to one year. When conducting continuing review, the BSC IRB needs to determine whether any new information has emerged, either from the research itself or from other sources that could alter the BSC 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 BSC IRB review will also be relevant to the BSC IRB's decision about continued approval.
Expedited Review of Continuing Research can occur in two possible ways:
- Expedited review by BSC 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 three Board members
- If the continuing research has only minimal-risk.
Full BSC 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 BSC IRB at a convened BSC IRB meeting. The researcher may be invited to attend this meeting to address questions.