The NBER and our funders are committed to protecting the rights, welfare and privacy of human subjects.
Federal mandate (The Common Rule, 45 CFR pt. 46) and longstanding NBER policy require that the NBER IRB review and approve ALL research involving human subjects that is performed under the auspices of the NBER.
The U.S. Department of Health and Human Services and 15 other federal agencies issued a final rule to update regulations that safeguard individuals who participate in research. Most provisions in the new rule were effective January 21, 2019.
The new rule strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research. It also allows more flexibility in keeping with today's dynamic research environment.
Some categories of research are exempted from review by federal regulation. However, it is the NBER IRB’s responsibility to make a determination on a study’s exempt status, and so ALL projects involving human subjects at the NBER must be reviewed and either approved or ruled exempt by NBER IRB.
The NBER IRB approval must be obtained BEFORE any human subjects studies are begun. For research involving minimal risk, approval is granted for the life of the project unless there are personnel or protocol changes. The NBER IRB can require projects be renewed annually. For research involving more than minimal risk, renewal frequency will be determined by the IRB upon approval.
Submitting Research to the NBER
Submission to NBER's IRB is only necessary for NBER projects, i.e., those related to a grant that NBER is or will be administering and/or related to data stored on NBER servers. Required information that must be submitted can be found below.
The information can be emailed to the Research Compliance Manager at email@example.com. The IRB will notify you of approval or request additional information – this may require up to 4 weeks from the date of submission.
Click here for the Protocol Format. If you are simultaneously applying to the IRB at your home institution, you may submit their materials to NBER’s IRB for review and approval.
The NBER IRB recognizes that certain confidential or proprietary data sets do not meet the definition of human subjects research and may not need to be submitted to the IRB for review and approval. Please click here for additional information. Data Sets Not Requiring IRB Review
C.I.T.I. Training Course
The NBER requires all investigators involved in human subjects research to complete the NBER CITI Human Subjects/IRB Social & Behavioral Research - Basic/Refresher training course found at www.citiprogram.org. Instructions for using the site to access the course.
We expect investigators to renew their training at least every 5 years. Investigators or key personnel on subcontracts are subject to the human subjects training policy of the subcontract institution.
Due to the adoption of the Revised Common Rule and the substantial changes it implements, the NBER will require all investigators to renew their human subjects training in 2019.
You can print or download a Completion Report as evidence that you have completed the course. You do not need to submit this report to the NBER as the system automatically alerts the NBER that you finished the course. You may return to the course site in the future to obtain a copy of the completion report.
If you have completed similar CITI training at your home institution the NBER may accept it in lieu of the NBER course. Please submit the completion report for your course which includes a list of the completed modules to firstname.lastname@example.org.
After Review and Approval
How to submit for Annual Review
How to submit a Modification to a previously approved IRB submission
When a study is completed, withdrawn or discontinued the PI must send notice to the IRB. An email to email@example.com is sufficient.
Randomized Controlled Trials (RCTs)
If your research project involves an RCT, please register your project with the American Economic Association's RCT registry, if you have not done so already. Registration is encouraged before the trial starts, but remains possible even after it is completed. If you register your trial, please indicate that in the materials that you submit to the NBER IRB. In addition, if you distribute an NBER working paper based on this research project, please note your registration in the acknowledgement footnote with language like "This RCT was registered in the American Economic Association registry for randomized control trials under Trial number XXXX".
The NBER IRB
General Principles Compliance and Oversight
Background information on the role of human subjects research and on IRBs in general may be found at these locations: More on the Revised Common Rule
- Principles and Guidelines for the Protection of Human Subjects of Research
- Research must comply with Title 45 CFR Part 46
- Research must comply with HIPAA and the Privacy Rule
- Key Implications for Research under the Privacy Rule
- NIH Information You can learn more about human subjects issues from the NIH Office of Human Research Protections.
Department of Health and Human Services and Office of Human Research Protections Research Categories:
The IRB reviews and approves research under the categories specified by federal regulations: Exempt, Expedited, Limited Review, and Full IRB Research Review. Under each category there are numbers that correlate to the type of research that is being conducted.
Full Board For studies conducting research that is more than minimal risk and recruiting vulnerable populations
Expedited Review For research that is no more than minimal risk. 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.
Limited Review: Limited IRB review is a process that is required only for certain exemptions, and does not require an IRB to consider all of the IRB approval criteria in §46.111. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations, are met. Limited IRB review may be done via the expedited review mechanism, that is, by the Chair or an experienced IRB member designated by the Chair (although it can also be conducted by the full IRB). Continuing review is not required.
Categories for Expedited Review
- Clinical studies of (a) drugs for which an investigational new drug application 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), or (b) medical devices for which an investigational device exemption application is not required; or the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds (Note: amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than two time per week) or (b) from other adults and children, 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 ( Note: amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an eight week period and collection may not occur more frequently than two times per week).
- Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) Hair and nail clippings in a nondisfiguring manner; (b) Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) Permanent teeth if routine patient care indicates a need for extraction; (d) Excreta and external secretions (including sweat); and (e) 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; (f) Placenta removal at delivery; (g) Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) 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; (i) Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) Sputum collected after saline mist nebulization.
- 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.) Examples: (a) 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; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinoraphy, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight and health of the individual.
- 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).
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- 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, social behavior), or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
Exempt Review 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. Eight categories of research are considered exempt (previously six). Some "exempt" activities now require limited IRB review.
Categories for Exempt Review
Category 1: Research in Established or Commonly Accepted Educational Settings 45 CFR 46.104(d)(1):
This applies to research in established or commonly accepted educational settings that involves certain normal educational practices, such as research on instructional techniques already in use or classroom management. This category has been amended from the pre-2018 rule to include a condition that the research is not likely to have adverse impacts on students learning required educational content or assessment of educators who provide instruction (HHS 2017). The exemption may only be used for studies about normal educational practices.
Category 2: Educational Tests, Surveys, Interviews, Observations of Public Behavior 45 CFR 46.104(d)(2):
(1) Information obtained is not identifiable
(2) Disclosure outside of the research would not put subjects at risk of harm
(3) Information obtained can be identifiable but the IRB has done a limited IRB review in keeping with 46.111(a)(7), which relates to there being adequate provisions for protecting privacy and maintaining confidentiality
Final Rule revised this category to include visual or auditory recording as research methods. Surveys also cannot include collection of biospecimens or interventions, as those additional activities would disqualify the research from this category.
When the research is subject to Subpart D and includes children, Category 2 still does not allow surveys or interviews or the observer participating with children (public behavior observation without intervention is permitted).
Category 3: Benign Behavioral Interventions in Conjunction with the Collection of Information From Adult Subjects 45 CFR 46.104(d)(3):
Benign behavioral interventions are defined as “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing”
Applies to research involving benign behavioral interventions with adults who prospectively agree to the research, when the information collected is limited to verbal or written responses, including data entry or audiovisual recordings.
The information is recorded in an identifiable manner, even if sensitive, provided that an IRB determines through limited review that, when appropriate, there are adequate privacy and confidentiality protections in the study.
Research using deception is not eligible for exemption in this category unless the subjects prospectively agree that they will be unaware of or misled regarding the nature and purpose of the research. The new Exemption 3 applies to behavioral interventions only. It is not applicable to biomedical research. Additionally, it applies only to research with adults; it is not applicable to research with children.
Category 4: Secondary Research for Which Consent is Not Required 45 CFR 46.104(d)(4):
- Use of publicly available identifiable private information or identifiable biospecimens.
- Information recorded by the investigator in such a way that the identity of the subjects cannot be readily ascertained, and the investigator will neither contact the subjects nor re-identify subjects.
- Research use of identifiable health information when that use is regulated by HIPAA as health care operations, research, or public health activities and purposes as those terms are defined in HIPAA.
- Analysis of data on behalf of a federal agency or department – as opposed to an investigator-initiated analysis of federally supplied data – if the requirements of certain federal laws are met.
It is important to note that data do not need to be existing (“on the shelf”) at the time of the research study, as was previously required by the pre-2018 rule. The data can be collected prospectively and still be used for exempt research under Category 4 in the Final Rule.
Category 5: Research and Demonstration Projects that Are Conducted or Supported by a Federal Department or Agency 45 CFR 46.104(d)(5)
The category has been revised to: allow research supported by a federal agency (not just conducted) to qualify for this exemption; provide examples of the types of public benefit and service programs covered by the exemption; and clarify the federal components for which the exempt research is subject to approval (for example, delegated subordinate agencies).
Applies to research that is designed to study, evaluate, improve, or otherwise examine public benefit or public service programs, if the research is conducted by a federal department or agency.
There is also a new requirement for the federal entity conducting or sponsoring the research to publish a publicly available list of the projects that are covered by this exemption before the research begins. Category 6:Taste and food quality evaluation and consumer acceptance studies, if (a) wholesome foods without additives are consumed, or if (b) a food is consumed that contains a food ingredient at or below the level and for a use 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.
NEW Category 7: Storage or Maintenance for Secondary Use for Which Broad Consent is Required 45 CFR 46.104(d)(7), 46.111(a)(8), and 46.116(d):
This category is for the storage of identifiable biospecimens and identifiable private information, prior to secondary analysis. The storage and maintenance may be exempt if the IRB conducts a limited IRB review to determine that there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data, and if broad consent is obtained.
Secondary research refers to research with materials originally obtained for nonresearch purposes or for research other than the current research proposal. The exemption can only be used when there is broad consent from the subjects for the storage, maintenance, and secondary research use of their identifiable materials.
The use of exemption 7 in the revised Common Rule requires the IRB to conduct a limited review of specific requirements that pertain to the use of the exemption. The IRB is not asked to conduct a standard IRB review using all the criteria at 46.111. For Exemption 7, the IRB review is limited to the determinations described in 46.111(a)(8), which pertain to protections for privacy and confidentiality and broad consent.
NEW: Category 8: Secondary Research for Which Broad Consent is Required 45 CFR 46.104(d)(8), 111(a)(7) and 46.116(d):
Allows the secondary analysis of existing private identifiable data and identifiable biospecimens provided broad consent was secured and the documentation of consent was either secured or waived. The IRB must also conduct a limited IRB review to determine that there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data as noted in 46.111(a)(7), and that the use is within the scope of the broad consent.
Category 8 also requires that the investigator does not include returning individual research results to subjects as part of the study plan; however, the exemption does not prevent investigators from returning results if required by law.
Similar to Category 7, this category may be more widely used by biomedical researchers. However, social and behavioral researchers may also use identifiable private information for secondary analysis.
Helpful NBER research links: