Will study enrollment be limited to specific ages or ethnic or social group(s)? If so, describe age ranges and ethnic or social groups:
WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
It is important to include persons of all ages in research to determine whether the intervention or therapy being studied affects various age groups differently. There are additional protections in the Federal regulations and/or guidance governing research involving certain age groups (e.g., children, elderly) often considered to be vulnerable.
INVESTIGATOR HELP:
Treatments applied to children are often based upon testing done only in adults, and scientifically evaluated treatments are less available to children due to barriers to their inclusion in research studies. Because of this, the NIH adopted a new policy in March, 1998 regarding the inclusion of children as participants in research involving human subjects. The goal of the policy was to increase the participation in research so that adequate data will be developed to support the treatment modalities for disorders and conditions that affect adults and may affect children. The NIH policy states, “that children (i.e., individuals under the age of 21) must be included in all human subjects research conducted or supported by the NIH unless there are specific scientific or ethical reasons not to include them. The inclusion of children as subjects in research must be in compliance with all applicable subparts of 45 CFR 46, as well as with other pertinent federal laws and regulations. Therefore, proposals for research involving human subjects must include a description of plans for including children. If children are to be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.
On the other end of the spectrum, it is equally as important to include the aging or elderly as participants in research. The OHRP IRB Guidebook states, “As the American population ages, research on the aging process and conditions and diseases that disproportionately affect the elderly has become increasingly important. There is no age at which perspective subjects should become ineligible to participate in research. Most older people are neither cognitively impaired nor live in institutional settings. Nevertheless, investigators may tend to avoid elderly subjects because it is hard to recruit them to participate in research that interrupts their daily routine, is uncomfortable or inconvenient, or is not designed to provide direct benefit to them. Also, conducting research with older patients may be more difficult and costly, and they also drop out of studies at a higher rate than do younger subjects, so that investigators may need to recruit more subjects initially to account for this possibility. Despite these difficulties, the inclusion of older persons in research enterprise is important. Together, researchers and IRBs should enable older persons to share in the benefits and burdens of research.
IRB POLICIES AND PROCEDURES:
IRB Policy 6.3 - Special Categories of Research: Children
It is the policy of the DOH IRB to review, approve and provide guidance on the special ethical and regulatory considerations when children are involved in human subjects research under 45 CFR 46, Subpart D, "Additional DHHS Protections for Children."
FEDERAL REGULATIONS/GUIDANCE:
Title 45 CFR 46
45 CFR 46.111(a)(3)
Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
Special Consideration for Research with Children