Consider the following scenario: As a faculty mentor, you have been asked to supervise an undergraduate student research project. The student proposes a study to examine whether physical and mental health knowledge, attitudes and behavior are related to the content presented in the class. To conduct this study, the student proposes a survey that will require high school students in a health class to respond to questions about their own physical and mental health. Does this research qualify for exemption from the full IRB review process and approval requirement under current federal regulations?
Regardless of the exemption status of this project, invoking the review process not only provides the supervising faculty member with a source for objective feedback, but also affords students valuable and oftentimes required research experience. From a regulatory perspective, supervision of school-based research requires careful considerations. Therefore, faculty mentors need to be cognizant of federal regulations and local policies to effectively mentor students in navigating the sometimes daunting regulatory process.
In the above example, not only will the student need to proceed through university IRB procedures, the project might also need to be approved by an IRB in the local school system. In general, depending on the source of funding--and the specifics of the institution's federal assurance--faculty are required to be conversant, at the minimum, with the Common Rule (Title 45 Code of Federal Regulations Part 46 [45 CFR 46], Subpart A) and, if their research involves children, 45 CFR 46 Subpart D, as well.
Under these regulations, the research described in the above scenario would be exempted from the requirements of the policy, as permitted at 45 CFR 46.101(b) (1), "Research conducted in established or commonly accepted educational settings...on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods." Thus, researchers have typically been able to conduct studies of efficacy of instruction through self-report surveys without IRB oversight (after the initial determination of exempt status by the IRB), and without having to meet the requirement for obtaining parental permission.
The No Child Left Behind Act of 2001 included amendments to the Protection of Pupil Rights Amendments (PPRA), which has broad implications for school-based survey research. In the past, PPRA requirements applied solely to certain surveys that were funded, in whole or in part, by the U.S. Department of Education. The more recent amendments to PPRA extend coverage to all institutions that receive any funds from the Department of Education.
Thus, all public elementary and secondary schools are now subject to the PPRA requirements. These new regulations specifically require schools to obtain permission from parents for any survey of minors that includes one of the following categories of protected information: political affiliations of student or student's parent; mental or psychological problems of student or student's family; sexual behavior or attitudes; illegal, antisocial, self-incriminating or demeaning behavior; critical appraisals of others with whom students have close family relationships; legally recognized privileged or analogous relationships; religious practices, affiliations or beliefs of student or student's parent; and income.
It also requires schools to provide advance notice and offer parents an opportunity to keep their children out of any survey that includes such information. Furthermore, parents, upon request, should be able to inspect a survey before it is administered.
It is clear that all surveys designed to solicit protected information from students, independent of the curriculum, will need to adhere to the additional PPRA regulations, yet interpretation of regulations relative to exempt studies remains unclear. If the survey measures efficacy of curriculum, can a researcher administer the survey without parental notification and permission? Specific applications of these regulations must be clarified by the Department of Education. In the meantime, IRBs and local school systems will need to apply criteria consistent with local standards.
Despite the importance of parental permission, it can be difficult to contact and inform parents, impeding surveying of large groups. Although some student researchers may be daunted by the permission requirement, it is important to remember that the first adage of conducting ethical research is to protect the rights and welfare of research participants. These additional protections not only provide added assurance of protection from misuse of sensitive information, but also protect their rights. Moreover, empirically sound advances in the understanding of human behavior depend on the public's willingness to participate in research studies, which in turn depends on human research participants' sustained trust in the scientific enterprise.
Sangeeta Panicker, PhD, APA's director for research ethics, contributed to this column.
Additional school research resources:
APA Science Directorate office of Research Ethics: www.apa.org/science/research.html
Office for Human Research Protections: http://ohrp.osophs.dhhs.gov/polasur.htm
Office of Research Integrity: www.ori.dhhs.gov
U.S. Department of Education: www.ed.gov/offices/OII/fpco/hot_topics.html
Sales, B.D., & Folkman, S. (2000). Ethics in research with human participants. American Psychological Association: Washington, DC.