If you are on the medical campus please see Med Campus IRB website
On CRCCharles River Campus:
Not all projects require IRB review and approval. Before getting started, determine if IRB approval is required.
How to submit an IRB Protocol
What the IRB Needs in Order to Approve
According to the federal regulations, IRBs must determine that all the criteria (45 CFR 46.111) listed below have been met in order to grant approval. In addition, the IRB will ensure that all other applicable laws and institutional policies have been met before granting approval.
§46.111 Criteria for IRB Approval of Research
(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:
- 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 §46.116.
- Informed consent will be appropriately documented, in accordance with, and to the extent required by §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.
(b) 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.
Step 1: Complete the Required Human Subject Protection Training
Principal Investigators and their co-investigators/study staff are required to take a human subjects protection training.
To begin your training, review the Required Human Subject Training information page.
Step 2: Determine Which Application to Submit
Projects that involve human subjects research may undergo one of three types of review:
- Exempt Review
- Expedited Review
- Full Board Review
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.
Exempt reviews are conducted by at least one experienced member of the IRB. In order to qualify for review via exempt procedures, the research must not be greater than minimal risk and must fall into at least one of the exempt categories defined by federal regulations.
Minimal risk is defined by the federal regulations as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
Summary of Exempt Categories
The following exempt categories do not apply to research involving prisoners, fetuses, or pregnant women, but to all other research with human subjects:
- Education research
- Surveys, interviews, educational tests, public observations (that do not involve children)
- Studies of public officials
- Analysis of previously-collected, anonymous data
- Public benefit or service program
- Consumer acceptance, taste, and food quality studies
Elaboration of the Six Categorical Exemptions
Exemption #1 (45 CFR 46.101(b)(1))
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Exemption #2 (45 CFR 46.101(b)(2))*
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 the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
Exemption #3 (45 CFR 46.101(b)(3))
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if: (i) the human subjects 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.
Exemption #4 (45 CFR 46.101(b)(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 through identifiers linked to the subjects.
Exemption #5 (45 CFR 46.101(b)(5))
Research and demonstration projects which 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 or services 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.
Exemption #6 (45 CFR 46.101(b)(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 and for a use found to be safe, or agricultural chemical or environmental contaminant 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 Service of the U.S. Department of Agriculture.
* The only research activities involving children that may fall under this exemption are those involving educational tests or observation of public behavior where the investigators do not participate in the activity being observed.
What Research Does Not Qualify for Exempt Review?
- is greater than “minimal risk” (Federal regulations define “minimal risk” as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.)
- involves children or adolescents as subjects (less than 18 years of age)
- involves collecting identifiable information from subjects
- involves administration or use of drugs or devices
- involves prisoners as subjects
Expedited reviews are conducted by at least one experienced member of the IRB. In order 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.
The expedited review procedure 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.
Summary of Expedited Categories
- Clinical studies of drugs and medical devices only when certain conditions are met
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts
- Prospective collection of biological specimens for research purposes by noninvasive means
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
- Collection of data from voice, video, digital, or image recordings made for research purposes
- Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies
- Certain continuing reviews
Once the application is received by the IRB, the IRB will make the final determination on the type of review.
(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
- Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
- 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.
(2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
- from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
- 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.
(3) Prospective collection of biological specimens for research purposes by noninvasive means.
- hair and nail clippings in a nondisfiguring manner;
- deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
- permanent teeth if routine patient care indicates a need for extraction;
- excreta and external secretions (including sweat);
- uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
- placenta removed at delivery;
- amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
- supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
- mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
- sputum collected after saline mist nebulization.
(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.)
- physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy;
- weighing or testing sensory acuity;
- magnetic resonance imaging;
- electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
- moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
(NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
(6) Collection of data from voice, video, digital, or image recordings made for research purposes.
(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.
(NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.110 (b) (2) and (b)(3). This listing refers only to research that is not exempt.)
(8) Continuing review of research previously approved by the convened IRB as follows:
- where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term followup of subjects; or
- where no subjects have been enrolled and no additional risks have been identified; or
- where the remaining research activities are limited to data analysis.
(9) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (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.
Full Board Review
Research that is greater than minimal risk and/or does not qualify for exempt or expedited review, as defined by the categories, will be reviewed at the Full Board IRB meeting.
The Full Board IRB meets once a month. For more information regarding the Full Board IRB meeting dates and submission deadlines, please refer to: full board meeting dates.
What happens if you send in the wrong application?
The IRB may be able to obtain the necessary information from the application that was initially submitted. If additional information is needed, the IRB will let you know. In some cases, the IRB will ask that you complete the correct application for your study type.
What difference does it make if my research is considered Exempt or Non-Exempt research?
No matter how your human subjects research is classified, you are still obligated to conduct your research with the highest ethical standards.
Administratively, the biggest difference is that Exempt studies do not need to have annual re-approvals conducted. Studies that are classified as Expedited or Full Board are required to have annual re-reviews completed in order to remain active.
Additionally, the regulations are a little different for the kind of consent documentation that is required. See tips for creating a consent document for more information on requirements needed in the consent form.
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?
If the data you receive is stripped of any identifiers and you do not have access to the code or link to those identifiers, than you might not need to submit. Call our office to discuss your specific case.
Do classroom projects require IRB review?
No, classroom projects do not require IRB review.
As of August 1, 2012, the CRC IRB will no longer require that faculty submit “Classroom Protocols” to the IRB for review. These classroom activities are not considered to be human subjects research as there is no intent to develop or contribute to generalizable knowledge. These activities are being conducted for educational purposes only. The CRC IRB will consider these activities to be educational and not subject to IRB review when the following criteria are true:
- The classroom activity is not designed to develop or contribute to generalizable knowledge. The only purpose of the activity is to teach research methodology
- Activities are not considered to be generalizable because either:
- The results of the activity will not leave the classroom (e.g. the data/results will NOT be published or presented at meetings) OR
- The activity involves collecting data from or about a company, organization, or agency and the data/results will only be shared with that company, organization, or agency to be used internally for the purpose of quality assurance or quality improvement
- The activity is limited to surveys/questionnaires, interviews, observations of public behavior, conducting non-invasive biomechanical measurements (e.g. placing sensors on the skin), or standard educational exercises directly related to the class assignment for the official Boston University course.
It is the responsibility of the faculty member to determine if the assignment meets the criteria above. If the faculty member is unsure if the activity meets the criteria, he/she should contact the IRB office for consultation.
If the classroom activity does not meet the criteria listed above, contact the IRB office for consultation. Federal regulations require that research projects involving human subjects be reviewed by an Institutional Review Board (IRB). The IRB must approve the project prior to the start of any research activities. The IRB cannot provide approval or determinations for research that has already been conducted.
If you have any questions, please contact the IRB at 617-358-6115 or firstname.lastname@example.org.
Step 3: Obtain Appropriate Signatures & Approvals
There are several signatures required on the IRB application. The IRB does accept scanned versions of the signature page. If you do not have access to a scanner, you can mail a copy of the signature page to us at 25 Buick Street, Room 157. Be sure to include a cover sheet that indicates the study title and Principal Investigator.
For Student Investigators
- 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 the pre-reviewer. If your school does not have a designated pre-reviewer, you may submit the application without this signature.
Student investigators must first have their IRB application reviewed by their designated school or department pre-reviewer before submitting to the IRB.
Not all schools/departments have a designated pre-reviewer. If your school/department does not have a pre-reviewer, you may submit your IRB application without this signature.
Please note that all student applications must be signed by the Faculty Advisor.
Faculty advisors need to be listed as co-investigators on all student applications.
For Faculty Investigators
- Your signature is required on the application
- Your Department Chair must also sign the application. If you are the Department Chair, your Dean must sign the application.
Step 4: Assemble Study-Related Documents for IRB Review
The IRB reviews most study-related documents. The following documents should be included with your submission, as applicable:
- Consent/Assent forms or information sheet (submit as a Word document)
- Recruitment materials
- Participant diaries
- A text version of any website or audio/video advertisements
- Grant application
- A device description/manual
- FDA letters
- Drug label information/package insert, Investigator Brochure etc.
- Data and Safety Monitoring Board (DSMB) Charter
Student investigators: 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:
- Research Plan
- Specific Aims
- Background and Significance
- Preliminary Studies
- Research Design and Methods
- Human Subjects
- Appendices that relate to the conduct of the research (survey instruments, data collection forms, etc.)
If the project is federally funded and BU is the prime awardee, submit a full copy of the grant application. If BU receives a subcontract, submit relevant sections of the grant application and/or the scope of work.
Step 5: Email Application to the IRB Inbox
Prior to sending in your application, make sure that:
- You and your study staff/co-investigators have taken the required human subjects protection training
- You have completed the appropriate IRB application
- You have obtained all of the proper signatures
- You have assembled all study-related documents
After you complete the above steps, you may email your completed application and relevant documents to the IRB inbox at email@example.com.
Expedited and exempt submissions are reviewed on a rolling basis. If the study qualifies for Full Board review, it will be reviewed at the next Full Board meeting in accordance with the submission deadline dates.Back to Human Subjects