Unless otherwise required by Health and Human Services or other federal department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from IRB review:.
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;. 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. 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:.
The research or demonstration project must be published on this list prior to commencing the research involving human subjects. Broad consent exempt categories D7 and D8 : Emory as an institution will not implement these categories at this time due to practicability issues. Modifications are only required for exempt studies when substantive changes are being made that could alter the original review determination. In limited IRB review, the IRB must determine that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of subject data.
Are there any new research activities that may now qualify for exemption under the revised common rule? Interventions must be brief in duration, harmless, not physically invasive, not likely to pose a significant lasting adverse impact, and not offensive or embarrassing.
Because medical interventions are not behavioral interventions, studies that plan to include medical tests or procedures would not be eligible for exemption under category 3. Does Exempt Research have an expiration date? However, for projects that qualify as exempt research where a limited IRB review was conducted, the IRB may determine that continuing review or an institutional progress report is required. If a progress report is required, the expiration date for the study will be set at the period required for the progress report [may be 1, 2 or 3 years from the date of approval].
For exempt research where a progress report is not required, the research will automatically be given a 3-year expiration date.
Thirty 30 days prior to the expiration date, an eIRB email reminder notification will be sent to the PI. If the PI does not request an extension, the research will automatically terminate 30 days after the expiration date. Contact us or find a patient care location. Privacy Statement. For instance, clear procedures should be in place for maintaining the educational activities of students who are not participating in the study in order to minimize interruption to the typical school day. Although students are generally obligated to participate in activity designed for the whole class, activities specifically implemented for the research need to be clearly explained and alternatives be provided for those choosing not to participate.
Appropriate alternatives should be provided for those who opt out, and must be described in the protocol as well as the consent documents. The risks and inconveniences should be assessed and clearly described in the protocol and consent process. For instance, in studies involving examination of classroom management techniques, will individual students be singled out for use of specific techniques? If so, what risks does that present to that child and to the other students e.
Describe how privacy and confidentiality of all participants e. For example, will study results be shared back with the school on an individual level or in aggregate? Will information about teacher performance be shared with school administration? What risks to participants are presented given how data will be both managed and shared? The participants should include those involved in the educational experience, and from or about whom data are being collected.
This will most likely include the teacher s , student s , and possibly the administrator s. Participants that are indirectly involved in the educational experience may be included in the study.
For example, if a child is significantly cognitively delayed, obtaining assent may not be appropriate, and the investigator must describe what steps will be taken to ensure that appropriate cues are taken from the child that may indicate an unwillingness to continue with study procedures. When researchers propose research activities that occur in public or private schools or other educational institutions other than colleges or universities , they must submit a letter of permission i.
Additionally, should that representative have a conflict of interest with the research, a different representative should grant the permission e. Some school districts have district-wide procedures for granting permission for research in schools, while others allow individual school principals to make decisions about research to take place in the schools they oversee.
It is advisable that researchers check with each school district in which they intend to conduct research in order to determine at what level they must obtain permission.
For more guidance on research site letters, please see the guidance on the Resources page. Research exempted as normal educational practice is often conducted in public school settings, which may demand that specific steps be followed in order to comply with additional state and federal laws.
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 Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: 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.
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