8
Mar2017

In February, PRIM&R hosted Research with Children and Adolescents in Elementary and Secondary Schools, a webinar presented by Shannon Sewards, MA, CIP, and Julie Slayton, PhD, JD. This webinar provided strategies for IRB administrators and staff who work closely with research in public school settings to determine IRB review and risk levels for protocols, understand and implement best practices for research in the classroom, and support and guide investigators on regulatory and logistical matters.

After the webinar, speakers answered some attendee questions that time didn’t permit us to answer live. We’re pleased to share those answers with the readers of Ampersand.

Is there any way for students whose parents have not consented (not opted in, or not responded) to be part of a control group?
Shannon Sewards (SS): Yes, children whose parents have not responded could be part of a control group as long as specific regulatory criteria are met. If this process is being used in a situation involving children, such as in this example, the IRB would need to evaluate whether parental permission could be waived under 45 CFR 46.408(c) or 45 CFR 46.116(c) or (d). As this example also mentioned a “control group”, it is important to remember that a criterion for the waiver is that the research is not greater than minimal risk. If the research is greater than minimal risk, then the “opt-out” process could not be used for the research.

Can you expand on how a researcher can mitigate undue influence issues when the researcher is the child's teacher? What best practices can you provide?
SS: It is recommended that the teacher not engage in this role. The following points are important to convey to children and parents when the teacher is also the researcher.  

  • There must be a line between teacher and researcher: the teacher will be wearing two hats and the outcome of research may be different than education.
  • Stress voluntariness: the student does not have to participate.
  • There must be no negative consequences: not participating will in no way affect grades.
  • It is research: the outcome may be positive or negative and the research may not benefit the student.

For the Protection of Pupil Rights Amendment (PPRA), does the IRB have to ask the PI for documentation that  s/he has talked to the school about the school’s or district’s policy for sharing survey instruments with parents/guardians?
Julie Slayton (JS): PPRA does not impose any requirements on the IRB or on the researcher to document that the PI has talked with the school about the school’s or district’s policy for sharing survey instruments with parents/guardians. Instead, PPRA simply indicates that parents/guardians must be provided with access to the instruments that contain questions intended to elicit sensitive information that falls under the act. Having said that, best practice for the PI is to document that  s/he has spoken with someone at the school or district and that  s/he is following district protocol. It is also best practice for the IRB to document that it has asked the PI to ensure that  s/he is following district protocol with respect to making the instrument(s) available. The only action the IRB may not take is it may not direct the PI to make the instrument(s) available in a way that is contradictory to district policy.

During the webinar, you presented a case study about a school district that has chronically low attendance and low parent involvement. Previous initiatives to increase attendance have failed. A local researcher, Professor Jones, has promising data for a new research program to increase attendance. He obtains approval from the school district to implement the program and he sends a mailer to each parent that contains a link to his website and his phone contact information. The study has a dedicated school liaison and there have been several school announcements about the program. In order for students to not participate, parents must opt out. In this scenario, is passive consent ever acceptable? Should a Certificate of Confidentiality (CoC) always be obtained?
SS: “Passive consent”, also known as an “opt-out” procedure, is a term used to describe situations in which there has not been an affirmative “yes” to participate in research. The Office of Human Research Protections (OHRP) has deemed this process to be acceptable as long as the criteria for a waiver of informed consent can be justified. If this process is being used in a situation involving children, such as in this example, the IRB would need to evaluate whether parental permission could be waived under 45 CFR 46.408(c) or 45 CFR 46.116(c) or (d). OHRP also has indicated that “even though not required by the regulations, an IRB may require that parents be given the opportunity to refuse permission even when the IRB has waived the regulatory requirement to obtain parental permission.”

For this particular situation, the IRB determined (in addition to the criteria for a waiver of informed consent) that the opt-out procedure was permissible for a number of reasons: 1) low involvement of parents (without the opt-out procedure, many children would lose out on the potential benefit that the research may provide); 2) permission was obtained from the school district for the research as well as the opt-out procedure; and 3) the researcher was to report all parent complaints that pertained to the use of the opt-out procedure. Additionally, the researcher included many modes of communication to inform parents that the research was taking place and provided various methods by which the parents could express their decision whether or not to continue to participate.

Pertaining to the obtaining of a CoC for this example, a CoC was not pursued as the National Institutes of Health limits CoCs to “sensitive, health-related research.” The above scenario did not collect sensitive information and was not health-related. An additional reason is that if a CoC was needed, then the research would most likely not meet the threshold of minimal risk research and therefore the waiver of informed consent criterion of “no greater than minimal risk” would not be met, the waiver could not be granted, and the opt-out procedure would not be possible.

I'm affiliated with a mental health provider that has been providing mental health services within school settings. They've now received a federal grant to add a research component (school-based only services versus school and home-based services). There is a university-based evaluator involved to analyze the data, which will be de-identified. Now that we've moved into the “research” realm, what additional requirements does this mental health agency have? For example, does the non-intervention group (school-based only) also need to provide consent for this research activity (versus consent only for existing service component)?
SS: The important aspect here is to determine which services provided by the mental health provider are considered “standard practice” and which are “research”. From the information that has been provided, there are two comparison groups: 1) school-based only services and 2) school- and home-based services. Although the school-based only services are considered standard practice, in order to make this comparison, data from these individuals will need to be obtained and analyzed. If the data that will be used from the school-based only group is non-identifiable to the research team, then these data would not meet the threshold of a human subject and consent would not be required. However, if the data are identifiable, then one must consider if obtaining informed consent is possible and if not, whether a waiver of informed consent is justified. 

Above the basics of the regulations, the mental health provider should consider the overall ethical aspects of the use of these mental health data and the possible intervention that will take place.  Another consideration is whether HIPAA regulations are applicable. A best-case scenario would be for the provider to introduce the research study to those that receive services indicating that if one should participate, they may be randomized to one of two conditions (school-based only services [standard practice] or school and home-based services [experimental condition]). Consent would be obtained from all individuals taking part in the research. 

Of course, there are many different research designs that could be used for the above comparison. However, what is of most importance is for the provider to clearly indicate what is research and what is not and to ensure not only that those who wish to take part are informed, but that they also have the choice to participate or not. 

As this question also involved the use of a university-based evaluator, one must determine what their role is in this research study. As it appears that this individual is not affiliated with the mental health provider, there would potentially be two institutions involved – the mental health provider and the university to which the evaluator is associated. When this type of situation occurs, one must consider the activities of each and whether those activities “engage” the respective institution. From what has been described, if the evaluator is only receiving non-identifiable data and this is their only involvement, then the evaluator would not be “engaged” in the research and their institution would not be required to have IRB oversight for these activities; however, the mental health provider would be required to have IRB oversight of the entire research study. For more information on engagement, please see OHRP’s guidance on this topic.

Any study procedure that results in a subject complaint should be re-evaluated. Are there risks that were not initially considered by the IRB? What is the risk? Does this complaint appear to be an exception? Are there additional safeguards that are needed?
SS: When a research study receives initial approval by the IRB, they are granting the approval on the basis of the information presented in the protocol, the knowledge of similar research and the risks that were shown, and the knowledge and expertise of the individual(s) that is reviewing the submission. Only when a research study begins does one have the opportunity to truly evaluate the risk. After the initial approval, it is the responsibility of the researcher and their research team to monitor all study procedures. If a problem arises, the researcher is required to notify the IRB and the IRB is required to re-evaluate the event. Some questions that they might consider: What is the nature of the complaint? Is it an isolated event? Or, are many of the subjects having the same complaint? Are there any factors that lead to the complaint (environment, other event)? Was the complaint anticipated? Did the researcher include a mitigation plan in the initial submission? What are some steps that need to be taken to address the complaint? Were the ethical and regulatory concerns that might pertain to the complaint addressed in the initial submission?

What regulations apply if a researcher is obtaining de-identified student achievement data from school records?
JS: The Family Education Rights and Protections Act (FERPA) applies to any information that is a part of a student’s education record. Therefore, FERPA still applies when it comes to de-identified student achievement data. FERPA does have an exception in the regulations that provides for the release of de-identified student achievement data. As a result, parent/guardian or eligible student consent is not required for a district to release de-identified student achievement data. On the other hand, a PI may not share any data, de-identified or otherwise, that has been obtained from students’ education records.

PRIM&R would like to thank our speakers for sharing their expertise!

The recording of this webinar is available for individuals to purchase in PRIM&R’s online store. If you would like to purchase the webinar for group viewing, please download the order form (PDF) and send it to registration@primr.org.

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