Understanding the Three Types of IRB Review in Human Subjects Research | Lecture notes Decision Making

The Three Types of IRB Review

Within each level of IRB there may be three types of review.

Initial Review. This refers to a study being submitted and reviewed for the first time.

Continuing Review. This refers to a study being reviewed at the time of continuation,

sometimes referred to as a “renewal.” Continuing review frequency is determined

based upon level of review.

Amendment. This refers to a change, also referred to as a “modification” to the

current approved study. Amendments to currently approved research must be

approved by the IRB prior to implementation, except when necessary to eliminate

apparent immediate hazards to the human subjects. Depending upon the nature of

the amendment, the IRB may conduct an Expedited or Full Committee review.

Levels of Human Subjects Research Review

IRB must review all projects that meet the definition of research and that involve

human participants prior to any data collection to determine the appropriate level of

review, and, as appropriate, approve them. There are three major levels of human

subjects’ research review: Exempt, Expedited, and Full.

Exempt Review

Studies that receive an exemption determination from IRB are exempt from the

specific regulations and requirements in Title 45, Part 46 of the Code of Federal

Regulations. Please note, however, that they are still considered human subject

research.

If the proposed research involves no greater than minimal risk to participants and

involves any of the following, it may qualify for exempt status in accordance with the

revised Common Rule (effective January 21, 2019):

• Exemption 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.

• Exemption 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:

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The Three Types of IRB Review Within each level of IRB there may be three types of review. Initial Review. This refers to a study being submitted and reviewed for the first time. Continuing Review. This refers to a study being reviewed at the time of continuation, sometimes referred to as a “renewal.” Continuing review frequency is determined based upon level of review. Amendment. This refers to a change, also referred to as a “modification” to the current approved study. Amendments to currently approved research must be approved by the IRB prior to implementation, except when necessary to eliminate apparent immediate hazards to the human subjects. Depending upon the nature of the amendment, the IRB may conduct an Expedited or Full Committee review. Levels of Human Subjects Research Review IRB must review all projects that meet the definition of research and that involve human participants prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major levels of human subjects’ research review: Exempt, Expedited, and Full. Exempt Review Studies that receive an exemption determination from IRB are exempt from the specific regulations and requirements in Title 45, Part 46 of the Code of Federal Regulations. Please note, however, that they are still considered human subject research. If the proposed research involves no greater than minimal risk to participants and involves any of the following, it may qualify for exempt status in accordance with the revised Common Rule (effective January 21, 2019):

Exemption 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.
Exemption 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:

o 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. o 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 o 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 that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Exemption 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: o 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. o 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 o 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 that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
Exemption Category #4. Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: o The identifiable private information or identifiable biospecimens are publicly available. o 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;

o The investigator does not include returning individual research results to subjects as part of the study plan. [Refer to sections 45 CFR 46.104(d)(8), 111(a)(7) and 46.116(d) of the revised Common Rule] Expedited Review Studies that involve no more than minimal risk, but which do not meet any of the above criteria for exempt status may be eligible for Expedited Review. According to the CFR, “ minimal risk means that 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.” If the proposed research presents no more than minimal risk, does not involve any vulnerable populations (i.e., children, prisoners, individuals with impaired decision- making capacity, and/or economically or educationally disadvantaged persons), and involves any of the following, it may qualify for Expedited Review.

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.
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as for medical treatment or diagnosis).
Collection of data through noninvasive procedures routinely employed in clinical practice, excluding procedures involving X-rays or microwaves.
Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (b) research on medical devices for which (i) an investigational device exemption application (21CFR 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, or venipuncture as follows: (a) from healthy, non-pregnant adults who weigh at least 110 pounds; 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.
Prospective collection of biological specimens for research purposes by noninvasive means.

Minor changes to research previously approved by the Huston-Tillotson University IRB may also qualify for expedited review. Full Review If the proposed research does not qualify for Exempt or Expedited Review as defined above, it will be subject to a Full Review. In addition, if the proposed research involves any of the following, it will be subject to Full Review.
Children under the age of 18
Prisoners
Individuals with impaired decision-making capacity
Economically or educationally disadvantaged persons
Procedures that might cause physical harm.
Procedures that might cause significant psychological/emotional distress.
Collection of information about highly sensitive topics.
Collection of information about illegal behavior.
Collection of information that could seriously harm the participant legally, socially, financially etc. if other people could identify them. Protocols requiring Full Review are vetted by the entire IRB and discussed at a convened meeting. Please see our Timing of the IRB Process web page for submission deadlines and meeting dates for Full Review protocols. If you have questions about what type of review may be appropriate, contact the Chair of IRB at cmcervantes@htu.edu prior to submitting a proposal. IRB, however, makes all final determinations of what level of review is required.

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