A step-by-step guide for submitting an IRB protocol for human subjects research on BU’s Charles River Campus.<\/p>\n
Not all projects require IRB review and approval. Before getting started, determine if IRB approval is required<\/a>.<\/p>\n The Charles River Campus IRB requires all study personnel who are engaged in human subjects research to complete training in human subjects protection via the Collaborative Institutional Training Initiative (CITI) Program. The training includes an initial certification course and subsequent recertification every three years.<\/p>\n To begin your training, review the Required Human Subject Training<\/a> information page.<\/p>\n Projects that involve human subjects research may undergo one of three types of review:<\/p>\n The type of review depends on the risk level of the research and if the research falls into one of the expedited or exempt categories as defined by the federal regulations.<\/p>\n Exempt reviews are conducted by at least one experienced member of the IRB. Research may be exempt from the requirements if the activities are not greater than minimal risk and fall into one of the federal exemption categories listed in the policy below<\/span>. Research activities that generally cannot be exempt include research that involves prisoners, survey or interview procedures or observations of public behavior involving children except for research involving observation of public behavior when the investigator does not participate in the activities being observed, and FDA regulated research unless it quali\ufb01es under Category 6. Read the full policy on IRB review of “Exempt Research\u201d in our Policies and Procedures for Working with Human Subjects<\/a>.<\/span><\/p>\n Projects not eligible for an exempt review may be eligible for an expedited review. To qualify for review via expedited procedures, the research must not be greater than minimal risk and fall into at least one of the expedited categories defined by the federal regulations (see below).<\/p>\n Expedited review may not be used where identification of the subjects and\/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal risk. Expedited reviews are conducted by at least one experienced member of the IRB.<\/p>\n (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared\/approved for marketing and the medical device is being used in accordance with its cleared\/approved labeling.<\/div>\n<\/div>\n\n (b) from other adults and children 2, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.<\/div>\n<\/div>\n\n (b) where no subjects have been enrolled and no additional risks have been identified; or where the remaining research activities are limited to data analysis.<\/div>\n<\/div>\n\n Once the application is received by the IRB, the IRB will make the final determination on the type of review.<\/p>\n Research that is greater than minimal risk, requires a risk determination on a device or does not qualify for Exempt or Expedited review is handled at a convened IRB meeting. Convened IRB meetings are ordinarily held on the third Tuesday<\/a> of each month. New projects are placed on the agenda only after designated IRB reviewers determine the submission is ready; that readiness usually requires 2\u20133 rounds of review and revision. To allow adequate time, please submit studies that will require Full Board review at least three weeks before the target meeting date. If you have a specific deadline or time-sensitive need, contact the IRB as early as possible so we can advise on scheduling and help you meet your timeline.<\/p>\n Administratively, there are some differences:<\/p>\n <\/div>\n<\/div>\n\n There are several signatures required on the IRB application. The IRB does accept scans, photos, and email confirmations from signatories indicating their review and support of the application. Each IRB application indicates the signatures required for submission.<\/p>\n For Student Investigators: <\/strong>Your signature is required on the application, your faculty advisor must also sign the application and be listed as a co-investigator, some schools\/departments have an IRB pre-reviewer and IRB applications must first be reviewed by that individual before it may be submitted to the IRB. If your school does not have a designated pre-reviewer, you may submit the application without this signature.<\/p>\n For Faculty Investigators: <\/strong>Your signature is required on the application and your department chair must also sign the application. If you are the Department Chair, your Dean must sign the application.<\/p>\n Before you begin assembling study-related documents, review our Tips for Creating a Consent Document<\/a>. Additionally, if you plan to submit your data to the FDA and you are planning to use BU REDCap for any data collection, including e-consent, please review BU’s guidance on REDCap (Research Electronic Data Capture) Part 11 Process & Training<\/a>.<\/span><\/p>\n The IRB reviews most study-related documents. The following documents should be included with your submission, as applicable:<\/p>\n Student investigators should submit a copy of the thesis\/dissertation prospectus. If the prospectus is extremely lengthy, students may submit the introduction\/summary and the design\/methods section including: the research plan, specific aims, background and significance, preliminary study information, research design and methods, appendices that relate to the conduct of the research (survey instruments, data collection forms, etc.).<\/p>\n Prior to sending in your application, make sure that:<\/p>\n
\nStep 2: Complete the Required Human Subject Protection Training<\/h2>\n
\nStep 3: Determine Which Application to Submit<\/h2>\n
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Exempt Review<\/h3>\n
How to Apply<\/h4>\n\t
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Expedited Review<\/h3>\n
Expedited Categories<\/h4>\n
(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.<\/h4>
(2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:<\/h4>
(3) Prospective collection of biological specimens for research purposes by noninvasive means.<\/h4>
(4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared\/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)<\/h4>
(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).<\/h4>
(6) Collection of data from voice, video, digital, or image recordings made for research purposes.<\/h4>
(7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, humanfactors evaluation, or quality assurance methodologies.<\/h4>
\n<\/div>\n<\/div>\n\n(8) Continuing review of research previously approved by the convened IRB as follows:<\/h4>
(9) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories 2-8 do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.<\/h4>
<\/strong>How to Apply<\/h4>\n\t
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Full Board Review<\/h3>\n
How to Apply<\/h4>\n\t
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FAQ<\/h3>\n
What happens if you send in the wrong application?<\/h4>
What difference does it make if my research is considered exempt or non-exempt research?<\/h4>
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I am working with an outside investigator and only being sent a limited amount of information from them. Do I need to submit my own IRB application to the BU IRB?<\/h4>
Do classroom projects (e.g., those assigned by a professor for class credit\/grade, etc.) require IRB review?<\/h4>
\nStep 4: Obtain Appropriate Signatures & Approvals<\/h2>\n
\nStep 5: Assemble Study-Related Documents for IRB Review<\/h2>\n
All Investigators<\/h3>\n
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Student Investigators Only<\/h3>\n
\nStep 6: Email Application to the IRB<\/h2>\n
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