Data Collection Outside of GSW

If data will be collected at sites or institutions external to GSW (e.g., hospitals, schools, businesses), it is necessary to provide written documentation that the other site or institution approves of the research to be conducted.  The other site or 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 site or institution does not have its own IRB or review panel, then written approval should be obtained from an authorized official of that site or institution and submitted along with the GSW IRB application.  If it is not possible to obtain the other site or institution’s written approval prior to submission of materials to the GSW IRB, then a statement of preliminary contacts with appropriate officials should be attached to materials submitted for GSW IRB review.  Approval from the external site or 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 site or institution cannot be conducted there and vice versa.

Researchers from Multiple Institutions

If a project involves researchers from more than one institution, then a single IRB approval is sufficient in most cases.  This single approval may come from a joint review, a review from the IRB of one of the institutions involved, or other arrangements.  However, there are several nuances of this policy that warrant attention:

• This approval must be made available to the IRBs of all institutions involved before starting data collection.  
• Each institution is responsible for safeguarding the rights and welfare of human subjects and complying with federal and local policy, whether or not their IRB was the one that reviewed and approved the research.
• The lead institution’s IRB is typically the one that provides IRB approval. However, any external department or agency supporting or conducting the research has the authority to designate which institution’s IRB conducts this review.  
• If data are collected at institutions both within and outside of the United States, then the single approval only covers that portion of the research that is conducted within the United States.  Separate approval must be obtained from IRBs or ethics review boards of institutions in other countries.  
• Certain types of cooperative research may require review from more than one IRB.  For example, tribal law passed by the official governing body of an American Indian or Alaska Native tribe may dictate that approval from more than one institution’s IRB be solicited.  Similarly, in the case of federally funded research, the funding department or agency may determine that the use of a single IRB is not appropriate for the research in question; if so, then separate approvals from each participating institution must be obtained.

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.