According To Federal Regulations, Research Is Eligible For An Exemption If?
According to federal regulations, research is eligible for an exemption if it fits into one or more of eight specific categories. Exempt studies do not need ongoing IRB review and can be used for research with a low level of risk to subjects.
Use this decision tool to determine whether your research meets the criteria for an exemption.
Educational research is a systematic and scholarly approach to studying the learning process in schools or other educational settings. This research seeks to improve education by finding better ways to teach and learn different subjects. In addition, the goal is to find answers to questions about learner motivation, development, and classroom management hindering the learning process in a particular school or school district.
According to federal regulations, research is eligible for an exemption if it is conducted in established or commonly accepted educational settings and involves normal educational practices and techniques. This can include teaching methods, curricula, classroom management, and student interaction with teachers and classmates. It also includes research that compares the effectiveness of various instructional techniques or methods of instruction.
Suppose you conduct research in a classroom setting. In that case, you must comply with the DHHS requirements for consent and use a parental consent form for all students involved. You may also need a letter of support from the official in charge of the classroom, such as the principal or superintendent.
Research conducted in educational settings that meets the criteria for exemption requires an IRB review. The IRB will determine whether the research is exempt based on the specific procedures used and the content of the data collected. Suppose an IRB determines the research is not exempt. In that case, the project must undergo either expedited or full board review before beginning. The IRB will explain why the project is not exempt in a written response to your application.
Research With Instructional Methods Or Classroom / School Activities
According to federal regulations, research is eligible for an exemption if the research is conducted in a commonly accepted educational setting and the subjects are not at risk due to the methods used. Examples of educational settings include K-12 and college classrooms, training simulators, medical schools, Scouts meetings, professional development seminars, vocational programs, and sports fields.
For example, a student researcher is studying test anxiety in General Education Development (GED) learners and wants to conduct interviews and surveys of the students about their feelings about test-taking. As a result, he may not qualify for a Category 1 exemption. Still, he could be granted an Exempt 2 or 3 status based on the interview and survey measures he plans to use and whether the research will likely be considered “normal” educational practices.
Suppose this research is done in a school or other educational institution. In that case, the investigator should check with that school or institution and obtain permission to conduct the research before beginning the study. Researchers must also comply with all other state and federal laws that apply to their research, such as FERPA and PPRA.
In addition to the above, researchers must specify which methods they will use for collecting data (tests, surveys, and/or interviews) in their protocol and ensure that those methods are not invasive or deceptive. Moreover, they should explain why the chosen method is necessary and specify what will be collected.
TC IRB administrators determine whether each initial application qualifies for an exemption as part of their standard pre-review process (SOP Pre-Review). If an IRB administrator determines that a study is exempt, it is typically not required to undergo continuing reviews. However, suppose a change to the study impacts the exemption status of an existing protocol. In that case, the principal investigator must alert the IRB and gain approval before implementing that modification.
Research With Video Or Audio Recordings And/Or Photography
According to federal regulations, research is eligible for an exemption if recording the subject’s voice and/or image is conducted according to the procedures described in the informed consent process. These procedures include: obtaining consent to record or photograph, informing the subjects of their involvement in the research, and ensuring that the recordings/photographs are stored securely.
Using video or audio recording or photography for research is an important tool to gather data on a wide variety of topics and is often used in conjunction with other methods of collecting data, such as interviews and focus groups. However, researchers must consider the sensitivity of the content of the recorded or photographed information and choose the most appropriate methods for a particular study.
Understanding the different video and audio equipment available to researchers is also important. These equipment options can range from small camera-based devices to high-powered professional cameras. It is essential to choose the method and equipment that best serves a given research problem and determine the specific storage and handling needs of the recordings.
A researcher should clearly describe how the recorded or photographed information will be stored and accessed. This information should be included in the informed consent process for video, audio recording and any supplemental forms participants fill out.
In addition, the investigator must ensure that the research team has proper access to all video and audio recordings and ensure that these are accessed only per the informed consent process. It is also necessary to ensure that all audio/video recordings are stored securely and destroyed when the study is completed.
Research With Individuals With Disabilities
According to federal regulations, research is eligible for an exemption if it is conducted according to DHHS guidelines published in the Code of Federal Regulations (45 CFR 46). This exemption is granted when an investigator completes an Institutional Review Board for Protection of Human Subjects (IRB) application, and the IRB finds that the study is consistent with the principles outlined in this document.
The eligibility criteria for most protocols reviewed excluded participants who lacked such functional skills as self-care and the ability to read and write or who, in the research team’s view, would be unable to complete study procedures safely and/or confound study findings. Other exclusions included individuals with psychiatric problems, substance use issues, HIV or hepatitis, cognitive or intellectual impairments, and visual disability, as well as individuals with hearing, mobility, long-term care, and speech and communication disabilities.
While these eligibility criteria are generally considered reasonable and do not prohibit researchers from including individuals with disabilities, they can lead to barriers in research participation for people with intellectual disabilities, especially if the inclusion of these people is not carefully planned and implemented. This is especially true when a lack of knowledge about people with disabilities leads to inclusions that do not match their abilities or needs and when researchers do not understand how to include participants with disabilities in their research.
Including individuals with intellectual disabilities in health, research is essential to address a history of disparities and exclusions from participation. Individuals with intellectual disabilities are eager to engage in research. They can participate in research if offered appropriate opportunities and accommodations. However, a history of exclusion and significant barriers to participation in research for individuals with intellectual disabilities has created a need for recommendations and tools to facilitate inclusive practices in university health research.
Research With Prisoners
According to federal regulations, research is eligible for an exemption if it involves subjects who are inmates, including children detained in a juvenile facility. It is also exempt if the subject’s records or information are not identifiable. Disclosing this information would place subjects at risk.
The research must follow federal, state, and local laws and regulations. It must also be reviewed by OHRP requirements and 45 CFR 46 Subpart C.
Suppose a previously enrolled subject becomes a prisoner during the study. In that case, a request must be submitted to the convened IRB requesting permission for the prisoner-subject to continue the research. The IRB must re-review the proposal and determine whether to approve or reject the modification.
PIs should ensure that all procedures are clearly explained and appropriate for the research project. They should also ensure they comply with all other IRB policies involving prisoners.
It is important to understand that maintaining the privacy and confidentiality of prisoners’ information may be more difficult than for non-prisoner populations because correctional officers will have access to the research subjects during interview procedures. They may also be able to monitor communication by mail, phone, or social media.
Researchers should also discuss their research projects with the institution where they will be researching so that they are aware of any restrictions that may affect the participants. For example, some institutions may require that the prisoners be physically present during research interviews.
In addition, the PI should ensure that any changes to the research protocol are made in a way that is consistent with the protections outlined in Subpart C. They should also contact OHRP for guidance on their research involving prisoners and/or if they are unsure about any requirements.
Best Guide: According To Federal Regulations, Research Is Eligible For An Exemption If?
According to Federal Regulations, research is eligible for an exemption if it falls under certain categories and meets specific criteria. The Common Rule, which outlines the regulations governing human subjects research conducted or supported by the US federal government, provides specific guidance on what types of research may qualify for the exemption.
The Following Categories Of Research May Be Exempt From The Common Rule’s Regulations:
- Research conducted in established or commonly accepted educational settings involving normal educational practices, such as:
- Research on regular and special education instructional strategies
- Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods
- Research on the effectiveness of or the comparison among test, survey, or interview procedures
2. Research involving the use of educational tests, surveys, interviews, or observation of public behavior, unless:
- Information obtained is recorded so human subjects can be identified directly or through identifiers linked to the subjects.
- 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.
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 so that subjects cannot be identified directly or through identifiers linked to the subjects.
Research and demonstration projects that are conducted by or subject to the approval of department or agency heads and that are designed to study, evaluate, or otherwise examine:
- Public benefit or service programs
- Procedures for obtaining benefits or services under those programs
- Possible changes in or alternatives to those programs or procedures or in methods or levels of payment for benefits or services under those programs
Taste and food quality evaluation and consumer acceptance studies, if the food is consumed in moderation by human subjects and the testing does not expose the subjects to risk of illness or injury.
The Criteria For Exemption Include
- Minimal risk: The research must involve no more than minimal risk to subjects. Minimal risk is 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 routine physical or psychological examinations or tests.
- Anonymous or de-identified data: The research must use only anonymous or de-identified data, meaning there is no reasonable expectation that the identity of the subjects could be ascertained by the researcher or associated with the information.
- No sensitive populations: The research must not involve vulnerable populations such as children, prisoners, pregnant women, or mentally disabled persons.
Suppose a study meets the criteria for exemption. In that case, the investigator is not required to obtain informed consent from participants or submit the study for institutional review board (IRB) review. However, it is still important for the investigator to adhere to ethical principles, such as ensuring the confidentiality of data, obtaining voluntary participation, and minimizing risk to subjects.
Which example of research with prisoners would be allowable under regulations?
Which example of a study involving convicts would be permitted by the rules? examining the relationship between the age of first arrest and adult criminal history. The right response involves looking at the age at first arrest.
In which of the following studies would it not be appropriate to provide subjects with information?
Which of the following research would it NOT be appropriate to advise participants about the absence of certain components of consent: Your response: A study in which respondents were placed in study groups based on a physical trait that the research team deemed to be unpleasant or unflattering.
When must continue review of an approved and ongoing study posing more than minimal risk that was initially approved by convened IRB?
Ongoing review of an approved and continuing study that has been given initial approval by a convened IRB but poses higher risk than minimum risk: must take place within a year of the approval date.
Who determines what review category research falls into?
The appropriate category of review is determined for each submission that is received by the IRB. The IRB divides submissions into four categories: Excluded.
Can research with prisoners be exempt?
The inclusion of convicts in exempt research is prohibited by the Common Rule, with the exception of studies intended to incorporate a larger subject population that just so happens to include prisoners.
How is research defined by federal regulations?
Research is described by federal regulations as “a systematic examination, including development, testing, and evaluation, aiming to produce or add to generalizable knowledge.