Do research studies go to the full board if they are greater than minimal?

Information regarding the types of reviews are guidelines. Special considerations such as the Health Insurance Portability and Accountability Act (HIPAA), Federal regulations, or other applicable law or local policies must be taken into consideration and included regarding IRB review. Items 1 – 4 refer to IRB applications for initial review.

Brief overview of review categories:

1. IRB review not required: The IRB may determine that the research proposal does not meet the qualifications for IRB review

2. Exempt review: An “exempt” IRB review is selected when the research falls into one of the six approved categories of exempt research (45 CFR 46.101 [b]) and is not applicable to research in a covered research category (e.g., FDA regulation – 21 CFR 50.20).  Often anonymous survey research with adults in a non protected class that is minimal risk (i.e. does not ask invasive/sensitive questions) is classified as exempt.

3. Expedited review: If the research does not meet the exempt review criteria, but involves no more than minimal risk, it typically classified as expedited.

4. Full review: Research that does not meet the criteria of the previous review categories (typically involves more than minimal risk) is classified as a full review. This means that a quorum (aka majority) of IRB committee members must meet, discuss, and have a majority vote on the research proposal.

5. Amendments or Modification Review: Any changes that affect the subjects in any way after initial IRB approval must be submitted to the IRB for review before the implementation of that change. This can include minor changes (i.e. changing the wording on a survey question), or major changes (i.e. changing a procedure). An exception is if an immediate change is needed to protect the safety of human subjects, in which case the IRB should be contacted as soon as possible.

6. Continuing review: The IRB must re-review studies at minimum of once every year. Continuing Review may not be required in the following circumstances:

• studies approved through an expedited mechanism
• studies approved by the full board once subject interaction is completed

DEFINITIONS:

Research: means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human subject: means 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.

Minimal Risk:  Minimal risk means that the probability and magnitude of harm or discomfort anticipated are not greater in and of themselves than those encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(i)).

Explanations & examples of review categories: 

1. IRB review not required. If the research application is determined to not meet the requirement of human subjects research, it is not required to be reviewed by the IRB. University policies and ethical guidelines regarding research are still applicable to the research project. The IRB chair, or their designee, will contact the researcher in writing with this decision. Typically this determination will take 5-7 business days, however, it may take longer if clarification from the researcher is needed.

2. EXEMPT review: Submissions that meet the criteria for exempt review are reviewed at minimum by the IRB chair or their designee. Typically turnaround time for IRB exempt review decisions is two weeks or less, however, it may take longer if clarification from the researcher is needed.

Exempt review criteria: An “exempt” IRB review is selected when the research falls into one of the six approved categories of exempt research (45 CFR 46.101 [b]) and is not applicable to research in a covered research category (e.g., FDA regulation – 21 CFR 50.20).

Exempt Category 1: 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.

Examples of research exempt under Category 1:

• A study evaluating the effectiveness of a commonly accepted science curriculum. For the study, researchers will observe classroom instruction and collect quizzes and class evaluations that are part of the curriculum and classroom practices.
• A study comparing two curricula that are currently being implemented in a school. Researchers will observe classrooms as well as interview instructors about their experiences implementing the instructional materials (but not about specific students).
• A study comparing driver’s education curricula offered by area driving schools. The researcher will observe classes and compare group driving test scores at the end of the courses.

Note: If the researcher is also the teacher/instructor and is part of the interaction with the participants it DOES NOT qualify under this exemption.

Exempt Category 2:

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:

(i) 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;

(ii) 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

(iii) 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 to make the determination required by §46.111(a)(7)*. 

*Not applied for use with children. 

**Can only be applied for use with children when the investigators do not participate in the activities being observed

Examples of research exempt under Category 2:

• A study involving an anonymous survey regarding workplace satisfaction at area firms.
• An observational study of pedestrians crossing a street; the researcher takes notes of what occurs, recording sex, race, and type of clothing of pedestrians, but does not interact with subjects.
• A study involving interviews with college seniors (age 18 and older) about their plans after graduation. The answers to questions asked would present no risks to subjects if divulged outside the research.
• A study involving focus groups with expectant mothers regarding their perceptions of parenting education.

Exempt Category 3:

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:

(A) 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;

(B) 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

(C) 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 to make the determination required by §46.111(a)(7).

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.

Examples of research exempt under Category 3:

Exempt Category 4: 

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:

(i) The identifiable private information or identifiable biospecimens are publicly available;

(ii) 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;

(iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or

(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Examples of research exempt under Category 4:

• A research study of treatment outcomes for a certain drug that involves the review of patient charts at a medical facility. The researcher records patient age, sex, diagnosis, and treatment outcome in such a way that the information cannot be linked back to the patient.
• A graduate student has access to coded data from a study previously conducted by her faculty advisor and records the information she needs for her research without the code, so that the data being analyzed for the research can in no way be traced back to individual subjects.

Exempt Category 5: 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. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

Note: Exemption Category 5 only applies to research on public benefit programs (such as Social Security) conducted by the federal government and therefore is rarely, if ever, applied to research at WLU. Research and demonstration projects in general (e.g., state or city funded public service programs) do not fit under this exempt category.

Exempt Category 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.

Examples of research exempt under Category 6:

• A taste-test on different varieties of a fruit to determine consumer preference, when the fruits do not have any additives and subjects are asked to indicate which fruit they prefer.
• A study that involves taste-testing of various beef products from cattle that have been given feed with a chemical additive. If the researcher can document that the amount of the additive was at or below the levels approved by the USDA, the research may qualify for an exemption.

3. EXPEDITED review: Submissions that meet the criteria for expedited review are reviewed by the IRB chair or their designee, and at least one other IRB member. Typically turnaround time for IRB decision is two weeks or less, however, it may take longer if clarification from the researcher is needed, or it is determined that a full review is warranted.

Expedited review criteria: An “expedited” IRB review is selected when the research does not meet the criteria for exempt status but involves no more than minimal risk to subjects OR is being reviewed strictly for minor changes to previously approved protocols in the research project.

Minimal risk means “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”

Expedited Category 1 – Clinical studies of drugs and medical devices only when (a) the research is on drugs for which an investigational new drug application (21 CFR 312) is not required or (b) the research is 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.

Expedited Category 2 – Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from (a) healthy, non-pregnant adults who weigh at least 110 pounds for whom (i) the amounts drawn do not exceed 550 ml in an 8 week period and (ii) collection does not occur more frequently than 2 times per week or (b) other adults and children, for whom, considering the age, weight, and health of the subjects, and the collection procedures, (i) the amount of blood to be collected does not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and (ii) collection does not occur more frequently than 2 times per week. (Note: Children are defined as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.”)

Expedited Category 3 – Prospective collection of biological specimens for research purposes by noninvasive means.

Expedited Category 4 – Collection of data through non-invasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. (Note: Where medical devices are employed, they must be cleared/approved for marketing.)

Expedited Category 5 – 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. (This listing refers only to research that is not exempt )

Expedited Category 6 – Collection of data from voice, video, digital, or image recordings made for research purposes.

*Expedited Category 7 – 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.

*According to the Federal regulations and Category 7, most survey research that is not otherwise exempt is eligible for expedited review. However, 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.” (63 FR 60364, November 9, 1998)

Expedited Category 8 (continuing review)

Continuing review of research previously approved by the convened IRB:
(a) where

1. the research is permanently closed to the enrollment of new subjects;
2. all subjects have completed all research-related interventions; and
3. the research remains active only for long-term follow-up of subjects; or

(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.

Expedited Category 9 (continuing review)

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.

4. Full review: Submissions that meet the criteria for full review are typically reviewed by a quorum (aka majority) of IRB members which must include at least one member whose primary concern is in a nonscientific area.

Full review criteria: A “full” IRB review is required when the research is defined as (a) a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (38 CFR 16.102d); (b) that involves human subjects (i.e., a living person about whom a researcher collects either identifiable private information OR data through an intervention or interaction); and (c) involves greater than minimal risk to those human subjects. A full review is required for any study that does not meet the requirements for an exempt or expedited review. In order to approve research, the IRB must determine that all of the requirements specified in 45 CFR 46.111 (and if applicable, 21 CFR 56.111) are satisfied.

5. Amendments or Modification Review: Changes that affect the subjects in any way cannot be made to approved studies, including informed consent documents, without prior IRB review and approval. An exception to this is any changes necessary to immediately protect subjects safety as noted in 21 CFR 56.108(a)(4) and 56.115(a)(1). The amendment or modification review may fall under a “full” or “expedited” category, depending on the magnitude of the change and the affect of the change on the risks/benefits ratio.

Amendment or Modification procedure: The Amendment or Modification form and information is accessible on the IRB website. This form is completed online by the P.I. and is forwarded to the IRB chair.  The IRB chair, or their designee, determines if the form has been appropriately completed and contacts the researcher regarding any necessary clarifications regarding the submission. The IRB chair, or their designee, then determines the appropriate level of IRB review. See above for descriptions of expedited and full reviews.

6. Continuing review: The IRB must re-review studies at minimum of once every year. The IRB may require review more frequently depending on the IRB’s assessment of the study’s risk/benefit ratio and provisions provided by federal guidance (i.e. final rule HHS 2018). The frequency of review is indicated in the IRB notification of decision document. The continuing review may be a full or expedited review.

Continuing review procedure: The Continuing review form and information is accessible on the IRB website. This form is completed online by the P.I. and is forwarded to the IRB chair.  The IRB chair, or their designee, determines if the form has been appropriately completed and contacts the researcher regarding any necessary clarifications regarding the submission. The IRB chair, or their designee, then determines the appropriate level of IRB review. See above for descriptions of expedited and full reviews.

What requires a full IRB review?

What is a greater than minimal risk study?

What studies are exempt from IRB review?

What are the 3 levels of IRB review?