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OVPRI Human Subject Research Protection Blog

The VCU Human Research Protection Program is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

The VCU Human Research Protection Program presents IRB Mythbusters — a periodic newsletter clarifying common misconceptions about conducting human research and the IRB! 

In this issue, “myths” surrounding research with children are addressed. View the attachment to see the newsletter, or read through the same content below. Access previous editions of IRB Mythbusters by visiting the “mythbusters” tag on our blog.

MYTH #1:

When my research involves collecting data from mothers and their infants, I only need to count the number of dyads included when estimating sample size

FACT: When a research study involves collecting data/specimens from both mothers and their infants, then both mothers and infants are considered subjects of the research, and therefore both subjects must be counted in the total population size. For example, if the research plans to enroll 20 mother and infant dyads, then the estimated sample size would be 40 subjects, rather than 20.

TIP: Carefully consider the definition of “human subject” and use that definition to help you determine how many subjects are to be included in your research. “Human subject” is defined as “a living individual about whom an investigator either (1) obtains information/biospecimens through interaction or intervention; and/or (2) obtains, uses, studies, analyzes or generates identifiable, private information/biospecimens.” Any individual who meets this definition must be counted towards the overall sample size in the IRB submission.

Consider a project that proposes to collect saliva samples from both infants and their mothers to investigate stress hormones in both mothers and infants following birth. In this case, both the mother and the infant are subjects, because the investigator is collecting samples through interaction from both the mother and the infant. In this case, both mothers and infants need to be accounted for individually in the overall sample size.

On the other hand, if a study proposes to only collect saliva samples from infants, and collects no samples or data from mothers, then only the infants need to be counted towards the total sample size, since mothers are not subjects of the research project. 

MYTH #2: 

If I am using DocuSign to collect signatures from adults in my study, I can also use DocuSign to collect signatures from children as part of the assent process

FACT: DocuSign is allowable for adult signatures only. For studies including children where assent is required, DocuSign may not be used to collect signatures from child participants. While DocuSign may be used to collect parental permission signatures, other arrangements must be made for assent. In general, most eConsent platforms (including DocuSign and REDCap eConsent) are not allowable for child signatures. 

TIP: The regulations provide a lot of flexibility when it comes to how assent is obtained and documented. While using a written assent form and collecting signatures from child participants is considered standard practice for research involving children, the regulations do not strictly require assent to be documented in the same way that adult consent is documented. If you are using an electronic consent process for adults, you should consider the best way to obtain and document assent in the context of your study. If obtaining a written assent signature is not practicable or feasible in your study, you may consider alternative methods. Assent may be obtained verbally, or assent information may be delivered electronically using a survey platform, and a radio button or checkbox may be used for children to indicate their assent. If you are considering electronic consent for adults in your study that involves children, you are encouraged to request a consultation prior to submitting your IRB application, to discuss with IRB staff the best method of obtaining assent for your study.

MYTH #3:

Once a child has stopped actively participating in my study, I don’t need to re-consent them when they turn 18

FACT: Consent must be obtained from children who “age up” to the age of majority (18 years old in Virginia), so long as they continue to meet the definition of “human subject.” This means that even if the active intervention portion of a study is over, if you continue to use the now-adult subject’s identifiable, private information, then you must consider consent implications for the now-adult subject.

TIP:  Issues of consent must be addressed for child subjects who reach the age of majority while they continue to meet the definition of “human subject.” Remember that “human subject” is defined as “a living individual about whom an investigator either (1) obtains information/biospecimens through interaction or intervention; and/or (2) obtains, uses, studies, analyzes or generates identifiable, private information/biospecimens.”

This means that, even if an active intervention is over, if an investigator continues to “use, study, analyze or generate” identifiable, private information about a former child subject, our principle of Respect for Persons compels researchers to address issues of consent for the now-adult subject. The VCU HRPP has issued a video on this topic, accessible under the “informed consent” accordion of the HRPP’s policies and guidance page.

In general, there are three options for researchers when their subjects reach the age of majority while still meeting the definition of “human subject.” 

  1. Obtain consent from the now-adult subject to continue to utilize their data in your study. This consent process would need to be approved by the IRB, and would include a consent form that contains all required and applicable additional elements of consent. If such a consent process was not included in the original IRB application, an amendment must be submitted to gain approval for a consent form and process for this purpose.
  2. Anonymize the now-adult subject’s data by stripping all identifiable information from the research database for that subject. This obviates the need for consent from the now-adult subject, because anonymizing the data means that the individual no longer meets the definition of “human subject.”
  3. Request a waiver of consent for subjects who reach the age of majority while they continue to meet the definition of “human subject.” This option is the least likely to be used, as such a waiver is only justifiable if obtaining consent is not practicable or feasible. Typically, such a waiver is only used for studies that are longitudinal in nature, when child subjects were enrolled as very young children, and it is no longer practicable or feasible to track down the now-adult subjects for consent.

Ultimately, it is important for researchers who work with children to consider whether it is likely or possible for child subjects to reach the age of majority while still meeting the definition of “human subject,” and plan ahead for how to address issues of consent for those subjects. This is an image of the IRB Mythbusters Newsletter. It includes two Halloween-themed images, and an image of a smiling woman wearing sunglasses and holding a drinking glass. The caption to that picture says “Meet the IRB! Allison Keeler is beginning anew in her role as a Panel Administrator for the VCU IRB. She has a professional background in clinical research trials and nursing prior to joining the full board administrative team. Allison would like to say cheers to all who are enjoying this Virginia fall weather and to turning over a new leaf!” The rest of the newsletter contains the same myths and facts as the blog post. [View Image]Categories IRB Education and Training
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