IRB Member Resources Einstein IRB Members come from a diverse community of physicians, researchers, clinicians, nurses, pharmacists, physical therapists (among other members of the medical community), engineers, lawyers, and non-scientists. We rely on their combined expertise and hard work to ensure that we are engaging in the responsible conduct of research. The following are resources that are useful for understanding and conducting an IRB review. Common Types of IRB Submissions New Protocols: Initial review of research submissions Progress Report: yearly review required for full board projects Amendment: any change in risk, personnel, scope, procedures, etc. Reportable Event: adverse events and unanticipated problems involving risks to subjects or others, protocol deviations, or noncompliance Regulatory Levels of IRB Review The “Common Rule” (45 CFR 46) provides for three levels of review for human subjects research. They are exempt, expedited, and full board. Note: Not all research using human subjects requires IRB review. Studies that do not meet the regulatory definitions of human subject or research are relegated to a category the Einstein IRB calls Not Human Subjects Research (NHSR) Exempt Review Exempt research involves research with human subjects, but because of its nature and “minimal risk” it is “exempt” from the provisions of the Code of Federal Regulations. Exempt research projects must still be submitted to the IRB for initial review. Changes to exempt research must be submitted to the IRB for review and approval only if the project is amended in such a way that it no longer meets the exemption criteria, or if there is a change in PI. An IRB member or designated staff determines if a research project falls under one or more of the following eight exempt categories listed in the federal regulations (45 CFR 46.104): Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review of the privacy and confidentiality measures.1 Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met: The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review of the privacy and confidentiality measures. For the purpose of this provision, benign behavioral interventions are 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. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: The identifiable private information or identifiable biospecimens are publicly available; Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; Collection and analysis involving investigators use of identifiable health information when use is regulated by HIPAA “health care operations” or “research” or “public health activities and purposes”2; or Research information collected by or on behalf of federal government using government generated or collected information obtained for non-research activities. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Taste and food quality evaluation and consumer acceptance studies. Storage or maintenance of identifiable private information or identifiable biospecimens for secondary research for which broad consent is required.3 Secondary research involving use of identifiable private information or identifiable biospecimens for which broad consent was required.4 Expedited Review If the level of risk in a research project is considered to be no greater than minimal, and the research meets at least one of the expedited categories below, the IRB may review the project as expedited. Expedited review covers the same considerations as a full committee review. However, the project can be reviewed and approved by the IRB Chair or one Designated Reviewer, rather than the whole convened IRB committee. In reviewing research, expedited reviewers may exercise all of the authorities of the IRB, except the reviewer may not disapprove the research. In this case, the expedited reviewer must defer review to the full IRB committee. There are nine expedited categories listed in the federal regulations (45 CFR 46.110): The federally defined expedited categories are: 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 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. 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 , 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. 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); (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 removed 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, electroretinography, 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 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. This listing refers only to research that is not exempt.) 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, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. This listing refers only to research that is not exempt.) There are two additional categories, but they apply only to continuing review of research that has already been approved: 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 follow-up 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. 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 Studies that involve more than minimal risk require full board review at a convened meeting, at which a quorum of IRB members is present, including a community member. For the research to be approved, it must receive the approval of a majority of those members present. While federal regulations do not specifically list categories that would fall under full board review, below are certain criteria that may require full board review. Clinical procedures involving drugs, devices, or biologics; Studies using vulnerable populations; Drug, device, or biologics studies taking place internationally (particularly those countries with little or no provisions for protection of human subjects); Studies where information may be disclosed to researchers that could require mandatory legal reporting (e.g., child/elder abuse, drugs, etc.); Studies involving deception which raise the risk level; Studies where the IRB staff, chair, member, or designee, determines to be greater than minimal risk. Voting Options at Meetings Approved: The study meets the regulatory criteria for IRB approval as defined by 45 CFR 46.111 and/or 21 CFR 56.111. The application has secured approval, thus the investigator is not required to make changes to the protocol or IRB application. IRB approval is valid for one year, unless the committee designates a shorter period due to higher levels of risk. An approval letter is sent to the investigator. The consent documents (if any) are stamped with the IRB approval dates. The investigator may start enrolling subjects. Approved Pending: A study may be “approved pending” if only non-substantive changes are necessary to gain final approval. Examples of such minor non-substantive requested changes include: Confirmation of specific assumptions or understandings on the part of the IRB regarding how the research will be conducted (e.g., confirmation that the research excludes children); Submission of additional documentation (e.g., certificate of ethics training); Directed language changes to protocol or informed consent documents; or Directed changes to protocol or informed consent documents along with clearly stated parameters that the changes must satisfy. If a study is “approved pending,” the investigator’s response to the requests does not need to go back to the full board for approval. Rather, it can be done via “expedited” review. Deferred: A study may be deferred because of substantive changes requested by the committee, or other issues related to the criteria for approval. The investigator’s response to the requested changes will come back to the full board for review. Disapproved: A study may be disapproved if the magnitude and/or number of concerns, questions, and problems are such that an “approved pending” or “deferred” decision are inappropriate. In contrast to deferral, which implies that the study may be approvable pending substantive changes, disapproval of research should be reserved for when the board cannot reasonably imagine revising the study in such a way that the benefits outweigh the risks. Tabled: A study may be tabled if the IRB determines that it does not have enough information to vote on a study. Recuse: If an IRB member is listed in a study under IRB review or has any other conflict of interest, they may not participate in the initial or continuing review of the study (or an amendment) except to provide information requested by the IRB. The IRB member must leave the room (e.g. “recuse” themselves for the discussion and vote). The meeting minutes will reflect this. The chair requests IRB members with a conflict of interest to leave the room and not participate in the vote or discussion. Conflicts of interest include financial interest, active participation in the trial as principal investigator or co-investigator, or any other issue for which the member feels his or her vote could be potentially conflicted. Abstain: If an IRB member does not have a “conflict” but is unable to vote (e.g., left the room during discussion, does not comprehend the study or the issues) the member may “abstain” from voting. A vote to “abstain” will be included as part of the voting quorum. The meeting minutes will reflect this. Definition of Minimal Risk The probability and magnitude of harm or discomfort anticipated in the research that 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. IRB Member Placemat This Quick Reference Placemat is a convenient reference tool for IRB Members and is designed to be printed on 11 x 17 sized paper, double-sided for optimal reading. Download the full IRB Quick Reference Placemat 1 Note, categories 2-a and 2-b can only be applied to studies involving children if the PI plans only to observe and not interact with children. Category 2-c cannot be applied to any research involving children. 2 Note that Albert Einstein College of Medicine is not a HIPAA-covered entity. Therefore, the Einstein IRB does not make use of this category, since we cannot track when research data is or is not protected by HIPAA laws. 3 The Einstein IRB will not be implementing this category due to the impracticability of implementing “broad consent,” or an open-ended permission to use identifiable private information or biospecimens for unspecified future research. To implement broad consent, we would have to track all refusals, which would be a serious logistical challenge. 4 The Einstein IRB will not be implementing this category due to the logistical challenges of implementing broad consent.
