Activities Requiring IRB Review and Approval
Exempt vs. Expedited vs. Full Board
Activities Requiring IRB Review and Approval
To determine if the proposed activity requires review by the Drake IRB, answer the following three questions:
- Is the proposed activity research?
Research is a systematic investigation that includes research development, testing and evaluation and is intended to develop or contribute to general knowledge. If, according to this definition, the proposed activity is not research, then IRB review is not required. If the proposed activity is research, continue with the next question.
- Does it involve human subjects?
Research investigators must determine whether their proposed research will involve human subjects. Regulations define "human subject" as a living individual about whom an investigator (whether professional or student) conducting research obtains 1) data through intervention or interaction with the individual or 2) identifiable private information. If you determine that the research does not involve human subjects, then IRB review is not required. If you determine that the research does involve human subjects, IRB review is required. If it is not clear whether the research involves human subjects, seek assistance from the IRB Chair.
- Will it be authorized and conducted under the jurisdiction of Drake University?
All research involving human subjects regardless of the funding status or the source of any funding is under the jurisdiction of the University. In cooperative research projects involving one or more institutions in addition to Drake University, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with the individual IRB policies.
Exempt vs. Expedited vs. Full Board
Federal guidelines identify those research activities that are exempt and therefore do not require full IRB review. The following information on exempt categories is from 45CFR46.101(b).
Unless otherwise required by federal department or agency heads, research activities in which the only involvement of human subjects (excluding prisoners, fetuses, pregnant women or human in vitro fertilization) will be in one or more of the following categories are exempt:
- Research conducted in established or commonly accepted educational settings, involving normal education 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
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior UNLESS both of the following conditions hold:
- information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
- 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
Note: This exemption DOES NOT apply to minors, except for research involving public behavior when the investigators do not participate in the activities being observed.
- 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 above, if:
- the human subjects are elected or appointed public officials or candidates for public office; or
- Federal statute(s) require(s) without exception that the confidentially of the personally identifiable information will be maintained throughout the research and thereafter
- 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.
- Research and demonstration projects which are conducted by or subject to the approval of federal department or agency heads, and which are designed to study, evaluate or otherwise examine:
- public benefit or service programs
- procedures for obtaining benefits or services under these programs
- possible changes in or alternatives to these programs or procedures
- possible changes in methods or levels of payment for benefits or services under these programs
- Taste and food quality evaluation and consumer acceptance studies if:
- wholesome foods without additives are consumed, or
- a food is consumed that contains a food ingredient at or below the level and for a use found to be safe by the FDA or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
If you have any questions regarding the exempt categories defined above, please contact the IRB Chair for assistance.
The following information on expedited review categories is from the Federal Register (63 FR 60364-60367, November 9, 1998).
- Research activities that 1) present no more than minimal risk to human subjects and 2) involve only procedures listed in one or more of the following categories may be reviewed by the IRB through expedited review. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
- The categories listed herein apply regardless of the subject’s age, except as noted.
- 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 privacy and breach of confidentiality are no greater than minimal.
- The expedited review procedure may not be used for classified research involving human subjects.
Research Categories for Expedited Review
- 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 (21CFR312) is not required. Note: Research on marketed drugs that significantly increases risk or decreases the acceptability of risks associated with the use of the product is not eligible for expedited review.
- Research on medical devices for which 1) an investigational device exemption (21CFR812) is not required; or 2) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared approved labeling.
- Prospective collection of biological specimens for research purpose by noninvasive means. Examples include:
- 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;
- excretia and external secretions (including sweat);
- uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or was 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 techniques;
- mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washing;
- sputum collected after saline mist nebulization.
- Collection of data through noninvasive procedures (not nvolving 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 include:
- 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.
- Research involving materials (data, documents, records or specimens) that have been collected solely for nonresearch purposes (such as medical treatment or diagnosis). Note: Some research in this category may be exempt from the DHHS regulations for the protection of human subjects (See DIRB Section 5.2.1, #4). 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, identify, 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 DHHS regulations for the protection of human subjects (See DIRB Section 5.2.1, #2 and #3). This listing refers only to research that is not exempt.
If your project involves human subjects and does not qualify for exempt status or expedited review, full board review is required. If funding support is requested from the federal government and human subject research is involved, full board review is required. All expedited reviews that are not approved will be subject to full board for final determination. In addition, the IRB can request a full board review of any protocol that has been approved through the expedited review process.
Federal guidelines require that the investigator and colleagues provide evidence of human subjects research training for the purpose of protecting the human subjects involved . Prior to Drake IRB approval of an Expeited or Full-Board proposal the investigator and her/his colleagues must provide Drake IRB with proof of training completeion. As of Fall 2010 Drake accepts training from CITI Program, a research ethics training collaborative. You can access the website at this link: http://www.citiprogram.org
Individuals in the following categories must complete the Drake University Human Subject Research Education Program:
- The Drake University Institutional Official (Provost of the University)
- All IRB members
- Drake University faculty serving as Principal Investigators
- Any Drake project staff conducting the informed consent process
- All Drake project staff designated by the Principal Investigator
- Drake University faculty serving as teaching faculty to Drake students who are involved in exempt or non-exempt research projects
- Drake students who are conducting non-exempt research (i.e. research that is subject to either expedited review or full IRB review; See Section 5.2)
- Principal investigators from non-Drake facilities who do not have certification of education from another institution's IRB and who are conducting research with the consent of the Drake IRB or under the responsibility of the University and
- Project staff from non-Drake facilities who are conducting the consent process either within Drake or with the consent of the Drake IRB and who do not have certification of education from another institution's IRB
- Anyone serving as a Principal Investigator in a non-exempt submission
Mandatory education and certification must be completed before IRB approval of any new project, revisions or amendments to existing projects or renewals of existing projects. Training must be renewed every three years. Individuals are responsible for sending IRB a copy of their training certificate of completion to firstname.lastname@example.org
The following individuals are exempt from human subject's research education requirements:
- Research staff who perform standard of care procedures in connection with a protocol
- Research staff who analyze data, if the data do not contain identifying information (e.g. name, social security number)
Please contact the IRB with any questions or concerns