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| PPRA Summary | Common Rule Waiver Requirement |
| Provisions of the PPRA | Additional Resources |
To jump to a topic, click your choice below:
| PPRA Summary | Common Rule Waiver Requirement |
| Provisions of the PPRA | Additional Resources |
The No Child Left Behind Act of 2001 (Public Law 107-110) amended the Protection of Pupil Rights Amendment (PPRA), which concerns surveys of students, in two ways:
First, it added an eighth category to the categories of protected information in surveys of minors that were already covered by PPRA.
Second, it gave parents new rights with regard to the surveying of minor students, the collection, disclosure, or use of information from students for marketing purposes, and certain non-emergency medical examinations.
PPRA, as amended, has two sets of requirements for surveys:
PPRA lists eight categories of protected information for survey responses:
PPRA has implications for IRBs in applying the Common Rule criteria for waiving informed consent (in section 116(d) of the Common Rule). Specifically, the second IRB criterion, "research does not adversely affect the rights and welfare of subjects," is impacted because of the "rights" that PPRA gives parents.
If the answer is yes to the three questions, PPRA affords parents the right to provide active consent.
Under the circumstances, it would be difficult for an IRB to determine that the "rights and welfare" criterion for waiving informed consent entirely could be met; therefore, prior written parental consent would be required, even if the IRB determined that some of the basic elements of informed consent specified in section 116(a) could be waived as inappropriate to the activity.
[The U.S. Department of Education has not yet written regulations providing guidance about some of the key terms in the current law. For example, the Department has not taken a position about whether the word "required" should be interpreted to mean that surveys that are clearly voluntary are exempt from PPRA requirements. Also, the law does not directly address the question of whether anonymous surveys are exempt from PPRA because anonymous surveys do not provide individually identifiable information about students or their families. Until the Department issues revised regulations implementing PPRA, IRBs need to use their judgment in complying with the first set of requirements.]
[Note: In this set of requirements, there is no language about students being "required" to respond to the survey, so here the issue of voluntariness appears to be moot].
If the answer is yes to both questions, PPRA affords parents the right to inspect the surveys before they are administered or distributed and to opt the student out of the surveys.
For IRBs, these requirements suggest that local schools have the discretion to set up their own individual policies for non-U.S. Department of Education protected information surveys. For example, local schools can choose whether to have an active written consent policy or some other policy, such as passive consent.
IRBs will have to decide how they will handle these requirements in those protocols where the investigators are requesting passive consent. For example, an IRB might require that if an investigator asks for passive consent procedures, they must also document that the procedures are consistent with the policy of the local school(s) to be included in the research sample. The IRB can then use that information in determining if the "rights and welfare" criterion for waiving informed consent has been met.
Subsection (a) of the legislation was not changed.
Subsection (b) added an additional category, Number 7, and made minor changes to the existing seven categories. This provision applies to surveys funded in whole or in part by any program administered by the U. S. Department of Education (DoED).
PPRA provides:
*Prior consent means:
Subsections (a) and (b) of PPRA generally apply when a survey is funded, at least in part, by any program administered by the Secretary of Education.
The new provisions (contained in subsection c) apply (as does FERPA) to educational agencies or institutions that receive funds from any program of the Department of Education. Thus, public elementary and secondary schools are subject to the new provisions of PPRA. Schools are required to develop and adopt policies, in conjunction with parents, regarding the following:
Local educational agencies (LEAs) must “directly” notify parents of these policies and, at a minimum, provide the notice at least annually. In the notification, the LEA shall offer an opportunity for parents to opt out of (remove their child) from participation in the administration of any third-party (non-Department of Education-funded) survey containing one or more of the above-described eight items of information.
UK Guidance for Researchers/IRB Members