This study and all of its materials and consent documents were approved prior to the initiation of data collection by the Army Research Laboratory Institutional Review Board ARLL 15-090).
The Biomedical Institutional Review Board at the University of North Carolina Chapel Hill and the U.S. EPA approved the study protocol, recruitment materials, and consent forms.
Of these adults, many lack the minimum skills necessary for comprehending patient education materials, informed consent forms, medication labels, and other health care-related materials [ 6].
All study screening materials, informed consent, demographic forms, protocol and other study documents were submitted and approved by the Copernicus Group Institutional Revew Board (IRB), an independent IRB (approval granted on May 10th 2007).
The researchers reported that they used the stakeholder input to refine their proposals, revise recruitment materials, modify consent forms, and add or increase participant compensation.
Information materials and consent forms as well as research staff's contact information are given or sent to the legal guardians with request for reply.
The Biomedical Institutional Review Board at the University of North Carolina at Chapel Hill and the U.S. Environmental Protection Agency approved the study protocol, recruitment materials, and consent forms.
Since the tumor pieces used in this study were regarded as post-operative waste materials, verbal consent was recorded by the surgeon during the preoperative examination.
Specific input was sought for the study design and ethical implications, patient recruitment and involvement, and development and use of study materials including consent forms and information leaflets.
