Rebecca D. Armstrong

Purdue policy and our assurance with the federal government requires that all research involving human subjects be reviewed and approved by the Committee on the Use of Human Subjects in Research—known also as the Institutional Review Board (IRB)—prior to initiation of the research project. To ensure that research funded by the Department of Health and Human Services (DHHS) has been approved by IRB, the Vice Provost for Research’s Office of Research Administration must certify that each approved protocol (approved plan of work) corresponds to the research activities proposed in the corresponding grant proposal.

Beginning September 1, 2003, Principal Investigators submitting new or renewal protocols for IRB review will be required to provide a copy of any pending or awarded proposal submitted to a DHHS agency that would or does fund the research described in the protocol, if they have not provided a copy previously. Investigators should include the grant proposal as supplemental material with any new application or return a copy with the surveillance form for protocol renewals. This will permit an assessment of whether the approved protocol and proposal are consistent in scope. This requirement also covers any proposed or funded research that may be conducted as a sub-contract; for any mini-grants that are part of a larger DHHS agency funded project; and/or, human subjects research conducted as part of a training grant. The main DHHS agency currently funding research at Purdue is the National Institutes of Health (NIH).

And finally, we would like to welcome TWO new IRB Associate Chairs – Darlene Sedlock, Associate Professor, HLKS and Bruce Craig, Associate Professor, Statistics.  They will assist and support your IRB Chair, Professor Rick Mattes in the execution of his duties.  We appreciate their dedication and service to the IRB.

Rebecca D. Armstrong

The No Child Left Behind Act of 2001 amended the Protection of Pupil Rights Amendment (PPRA) and gave parents more rights with regard to the collection of information from minors.  The amendments identify particular categories of protected information:

1.      political affiliations of student or the student’s parents;

2.      mental or psychological problems of student or student’s family;

3.      sexual behavior or attitudes;

4.      illegal, anti-social, self-incriminating or demeaning behavior;

5.      critical appraisals of others with whom students have close family relationships;

6.      legally recognized privileged or analogous relationships;

7.      religious practices, affiliations or beliefs of student or student’s parent; and,

8.      income.

Investigators—who study the above topics and utilize survey research methodology in schools—now need to be aware of the requirements allowing for parents to be able to review surveys and “opt out” (remove child from participation) if the investigator wants to obtain “protected information” from the child in the course of his/her research data collection. Furthermore, a student (minor) cannot be required to participate in any personal analysis, an evaluation or survey that is not directly related to academic instruction which attempts to obtain information categorized as protected information.  This is consistent with federal regulations governing human subjects research that routinely require the assent of the child and consent of the parent, prior to research data being collected from a minor.

These amendments apply to a) “protected information” survey research funded in whole or part by the Department of Education; or to b) “protected information” survey research that is disseminated at educational institutions that receive funding from any Department of Education program.  In other words, virtually all public elementary and secondary schools as well as some private schools are affected.  Under provision a) above, parents are given the right to consent before the students are required to submit to a “protected information” survey, making it impossible for researchers to request a waiver of consent from the IRB in their protocols.  Active parental consent is required. 

In response to the second scenario b) above, schools are required to develop and adopt policies, in conjunction with parents, that address—among other things—the right of the parent to inspect a survey before it is administered; procedures to protect student privacy; and, the right of parents to inspect any instructional material used as part of an educational curriculum.  Local educational agencies (LEAs) have the responsibility of directly notifying parents of the policies and parents must be given the opportunity to remove their child from participating in non U.S. Department of Education protected information survey research.

What’s the practical implication of these amendments?  LEAs may have a variety of policies on how to handle the parental consent issues and investigators should be aware of what these policies are so that the policy and procedure can be described in the recruitment and informed consent sections of any human subjects research application involving children, schools and protected information.  In addition, if an investigator feels that a waiver of parental consent is critical to the research design, the IRB may ask for documentation to ensure that the request is consistent with participant’s school policy to ensure that the “rights and welfare” criterion for waiving parental consent has been met.

Additional guidance on the No Child Left Behind Act of 2001 and PPRA can be found at: http://www.ed.gov/offices/OII/fpco/hot_topics.html

Rebecca D. Armstrong

If an Investigator’s human subjects research application was not reviewed under 45 CFR 46 Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects—specifically section 45 CFR 46.305 and a research subject enrolled in a study becomes a prisoner, the investigator must immediately notify the IRB.  Until all the requirements of subpart C have been satisfied in the protocol, all research interactions and interventions with subjects who become prisoners must cease.  Under special circumstances, the PI must be able to document and substantiate to the IRB Chair any assertion that it is in the subject’s best interest to continue in the study while a prisoner until such time as the requirements of subpart C are met.  If you have this situation occur, where a research participant suddenly becomes a prisoner or under the jurisdiction of the courts and your protocol was not reviewed and approved for this special protected research participant type, you must immediately notify the IRB Chair (irb@purdue.edu or 765/494-5942).