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Data Collection at Other Institutions

If data will be collected at institutions other than GSW (hospitals, schools, businesses, etc.), it is necessary to provide written documentation that the other institution approves of the research to be conducted. The other institution’s own IRB or research review panel must approve the study, and a copy of this approval must be attached to the GSW IRB application. If the other institution does not have its own IRB or review panel, then written approval should be obtained from an authorized official of that institution and submitted along with the GSW IRB application. If it is not possible to obtain the other institution’s written approval prior to submission of materials to the GSW IRB, then a statement of preliminary contacts with the appropriate officials should be attached to materials submitted for GSW IRB review. Approval from the other institution does not guarantee GSW IRB approval and vice versa. Furthermore, a project that receives GSW IRB approval but does not receive approval from the other institution cannot be conducted at that institution and vice versa.

Researchers from Multiple Institutions

If a project involves researchers from more than one institution, but data will only be collected at one institution, then a single review by one institution’s IRB may be sufficient to avoid redundancy of effort. However, this single review must be approved by the IRB chairs at all institutions involved. If the project will involve data collection at multiple institutions, then each institution must review and approve the proposed projects as described in the “Data Collection at Other Institutions” section.

Children as Research Subjects

Federal guidelines state that the definition of “child” depends on the specific statutes of the state where the research is to be conducted. For research conducted in Georgia, children are defined as individuals under 18 years of age. However, if the research involves subjects in other states or countries, the investigator must adhere to the laws of majority for those states or countries. The age of 18 cannot be assumed to be a universal age of majority.

Investigators are responsible for determining that potential subjects are old enough to participate in research without parental consent. College students and people in a workplace environment cannot be assumed to be adults simply on the basis of their status or position.

Research involving children as subjects requires not only assent (verbal or nonverbal agreement to participate) from the child, but also informed consent from parents or guardians. Under certain circumstances, the child’s assent can be waived. The sample consent forms and federal statutes contain more information about these situations and requirements.

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