Types of IRB Review: Exempt, Expedited and Full
The information provided in the category descriptions below is based on the federal regulations and is meant to help you determine whether you should apply for exempt status determination. You may also want to review the exact wording of the federal regulations at 45 CFR 46.101(b) and 21 CFR 56.104.
An important aspect of applying for exempt status is that all of the research procedures must fall within one or more of the six categories. If you believe that your research project qualifies for exempt status, after reading over these general guidelines and the information about the six different categories of research that qualify for exemption, you may submit one of the exempt project applications. Otherwise, please complete an expedited application.
CATEGORIES OF RESEARCH THAT QUALIFY FOR EXEMPTION
Please Note: The Lipscomb IRB will not allow research to be exempt when any of the following apply:
- research involves prisoners;
- research involves techniques which expose participants to discomfort or harassment beyond levels encountered in daily life (i.e., greater than minimal risk);
- deception of research participants; and
- research that involves a test article regulated by the FDA unless the research meets the criteria for exemption described in 45 CFR 46.101(b)(6).
Category 1 – Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular or special educational instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Approval under this category requires that two criteria be met. Your research project must involve collecting data in established or commonly accepted educational settings, including but not limited to, schools and colleges. This could include other sites where the type of educational activity you are investigating regularly occurs; and
The research must involve only normal education practices. This exemption would not include research involving randomization of participants or research on experimental methods, unless these are considered normal education practices for the discipline.
Faculty in the Department of Education may be consulted for guidance on whether the research involves “normal educational practices.”
There are no age restrictions for participants and no restrictions on research methods in this category
Category 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 participants’ responses outside the research could reasonably place participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.
Age restrictions apply: Survey or interview procedures cannot involve children.
Observation of public behavior cannot involve children, if the investigator will interact with them.
Note that data collected under this category may be identifiable as long as questions are not of a sensitive nature. Likewise, sensitive data may be obtained, if data are recorded in a completely anonymous manner.
Focus groups are considered an interview procedure and will qualify for exemption under this category, as long as the issues discussed are not of a sensitive nature such that participants would be at risk, if a breach in confidentiality should occur. Likewise, data recorded by use of recording devices would qualify for exemption as long as the information collected is benign in nature.
Category 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 category 2, if: (i) the human participants 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.
This category can be confusing and actually applies to two very different criteria.
Item (i) of this category includes the research procedures previously identified in category 2 (i.e., use of educational tests, survey procedures, interview procedures, and observation of public behavior). However, this category differs from the previous one in the situations to which it applies. If the population targeted for the research activities is elected or appointed officials or candidates running for public office, the research qualifies for exempt review. The key difference between this category and category 2 is that public officials or candidates running for public office give up their right to confidentiality in lieu of the public’s “right to know.”
OHRP has provided guidance on what constitutes public officials. Public officials could include mayors, governors, school superintendent, school board members, police chief and others appointed by a state official. Public officials would not include public employees such as teachers or police officers.
The second part of this category (ii) addresses the use of educational tests, surveys, interviews, or observation of public behavior to collect data for specific federal programs conducted or supported by the Department of Justice or data collected for the Institute of Education Sciences which includes the National Center for Education Statistics of the United States Department of Education. These agencies have specific programs that create data bases which are then protected by law from ever being accessed by anyone other than those federal agencies. No officer or employee of the Federal Government, and no recipient of assistance under the provisions of this category is allowed to use or reveal any research or statistical information furnished under this category by any person and identifiable to any specific private person for any purpose other than the purpose for which it was obtained. Data collected for these programs will be immune from legal process and cannot, without the consent of the individual concerned, be admitted as evidence or used for any purpose in any action, suit or other judicial or administration proceeding.
The only circumstance in which an exemption application would be submitted to the IRB for consideration under part (ii) of this category would be if Lipscomb University was awarded a grant to conduct research involving specific programs of the Department of Justice or the National Center for Education Statistics.
Category 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.
Clarification of Existing Data
According to the Office for Human Research Protections (OHRP), to qualify for this exemption criterion, the data, documents, records, or specimens must be in existence at the time of IRB review. OHRP interprets the term “existing” to mean that all of the data, documents, records, or specimens to be used in the research are in existence prior to IRB review and were collected for purposes other than the proposed research. The principle behind this requirement is that the rights of individuals should be respected; participants should provide permission for their individually identifiable information to be used for research purposes. The investigator must clearly demonstrate that all of the data to be collected under this category are currently in existence at the time of IRB review and the source(s) from which data will be obtained.
Data, documents, etc. must be either available to the public (e.g., court records, telephone directory information) or the data must be stripped of any direct identifiers (e.g., names, addresses, telephone numbers, social security numbers) and any indirect identifiers (e.g., codes that can be used to link data to participants).
It is important that the IRB understands the investigators’ plans for recording the data. Temporarily recording a name or other identifiers that allow individual subjects to be identified will exclude this type of research activity from meeting the exempt 4 criteria.
Definition of Human Subject and Coded Private Information/Data or Coded Specimens
Exemption Category 4 is difficult to apply because in some cases the activities do not technically meet the category but still do not require expedited or full review because they do not meet the federal definition of “human subject” (i.e. identity of the subject is not readily ascertainable by the PI).
For example, if the research involves only coded private information/data or coded specimens, OHRP does not consider the research to involve human subjects as defined under the HHS Protection of Human Subjects Regulations (45 CFR Part 46.102(f)) if the following conditions are both met:
- the private information/data or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and
- the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example:
(a) the key to decipher the code is destroyed before the research begins;
(b) the investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased;
(c) there are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased
(d) there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.
Category 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.
This category is limited to very specific types of research or demonstration projects that are conducted by or subject to the approval of federal Department or Agency heads. The following criteria must be satisfied to invoke the exemption under this category:
- the program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act);
- the research or demonstration project must be conducted pursuant to specific federal statutory authority;
- there must be no statutory requirement that the project be reviewed by an Institutional Review Board (IRB);
- the project must not involve significant physical invasions or intrusions upon the privacy of participants; and
- the funding agency has authorized or concurs with the exemption.
Category 6 – Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or 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 & Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
This category addresses two different types of research activity.
1. First, if the taste test involves wholesome food without any additives it is then eligible for exemption. The IRB reviewer must make sure that the food product to be researched is “wholesome” (no additives).
An example of such a research project would be a taste-test conducted on different types of apples to determine consumer preference. The apples are those normally grown in different sections of the country, using normal agricultural practices, and do not involve the addition of food additives or chemicals. The subjects merely indicate which of the apples they prefer.
2. The second item (ii) is more difficult to understand. Research conducted on human subjects who consume plants or animals raised for food products may qualify for exempt review.
The Food and Drug Administration has determined levels of safety for various agricultural chemicals, referred to as GRAS (FDA generally recognized as safe) and GRAE (generally recognized as effective) additives which are fed to animals raised for food production. If these agricultural additives are given to animals at or below the levels found to be safe by FDA, the research can receive exempt review.
An example of such research would be taste-testing pork products where the swine have been fed corn and a chemical additive at a level designated below FDA guidelines that make the animal gain weight more quickly. The objective of the study is to determine whether the addition of the chemical changes the flavor of the pork.
There are also approved levels for environmental contaminants set forth by the Food and Drug Administration, the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA) that may affect the grass or grain consumed by grazing food animals such as chemicals sprayed on a field to combat chickweed. If the research involves taste-testing of food products that come from animals exposed to environmental contaminants and the investigator can show that the use of these contaminants was at or below those approved levels, the research can receive exempt review.
In all of these situations, the investigator should provide some documentation that the alterations, either chemical, environmental or agricultural, have been found to be safe by FDA, USDA, and/or EPA. 9
However, if there have been food and color additives incorporated into the food product and these additives are used in research with the intent to apply to FDA for marketing that additive, the research would not qualify for exemption. Even if the procedures are preliminary in nature, if the research would eventually lead to FDA approval for marketing the food or color additive, it would not qualify for exempt review. The additives are viewed as investigational by FDA and, therefore, do meet the exemption criteria.
This category applies to Food and Drug Administration (FDA) regulated research.
45 CFR 46
OHRP Policy & Guidance
University of Kentucky, Office of Research Integrity,
Issues to be Addressed When Conducting Exempt Review 8/19/09
An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the federal requirements. All of the authorities of the IRB may be exercised, except the reviewers may not disapprove the research, that being reserved for a full committee action. Expedited review is appropriate for research that involves no more than minimal risk or for review of minor changes to previously approved research projects and protocols. The research proposal and protocols must be submitted to the University IRB to determine that all of the following requirements are satisfied:
- risks to subjects are minimal;
- risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge;
- selection of subjects is equitable and non-coercive;
- informed consent will be sought from each prospective subject or the subject's legally authorized representative;
- informed consent will be appropriately documented;
- when appropriate, the research plan makes adequate provision for monitoring data collected to ensure safety of subjects; and
- when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
Below is a list of types of research with human subjects that may be eligible for an expedited review:
1. Collection of hair and nail clippings in a non-disfiguring manner.
2. Collection of excreta and external secretions.
3. Collection of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice.
4. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
5. Anonymous voice recordings made for research purposes, such as investigations of speech defects.
6. Moderate exercise by healthy volunteers age 18 to 60.
7. Study of existing data, documents, records, pathological specimens or diagnostic specimens.
8. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate the subject's behavior and the research will not involve stress to subjects.
9. Research involving manipulation of the subject's behavior which does not involve stress or risk.
Expedited review may also be appropriate for minor changes or requests for extensions in previously approved research during the period (one year or less) for which approval is authorized.
Proposed research studies involving human subjects that do not qualify for Exempt or Expedited level review must be reviewed by the IRB at a convened meeting (Full Board level review). Studies requiring Full Board review present more than minimal risk to subjects, and/or involve vulnerable populations, such as prisoners, institutionalized individuals, or persons with diminished capacity to consent (e.g., Alzheimer patients).
Full Board studies are reviewed on a first come, first served basis by the IRB at scheduled meetings. Common examples of research reviewed at the Full Board level at Lipscomb are studies that include:
- Maximal exercise (VO2 Max) by healthy volunteers,
- Institutionalized persons (e.g., prisoners, patients in long term care facilities)
- Protected populations (such as children, mentally retarded individuals, mentally ill individuals, patients with medical disorders) when placed at more than minimal risk,
- Persons who lack capacity to consent (e.g., persons with severe mental disabilities or developmental delays), or
- Deception as a part of the protocol,
- The administration of drugs or other substances to subjects where an IND/IDE are required,
- Subjects with life-threatening physical conditions,
- Activity that induces a significant level of psychological or physical stress,
- Sensitive topics that could put the subject at risk for legal or civil liability or invade a subject's privacy in regard to high-risk aspects of his/her behavior (e.g., illegal conduct, drug use, sexual behavior, alcohol use) when there is a possibility that the subject could be identified,
- Research involving waivers of any HIPAA regulations.