Adolescents as Doubly Vulnerable Research Subjects

Research subjects are judged to be vulnerable if they cannot give informed consent for themselves or if they belong to groups especially subject to coercion or manipulation (Kopelman 2003). Adolescents are typically vulnerable on both counts. First, because adolescents are minors, investigators and institutional review board (IRB) members must follow federal rules specifying additional protections for minors. Older adolescents verge on adult maturity, both developmentally and legally, and many possess the capacity to decide if they wish to participate in research. Nonetheless, they usually cannot be enrolled in studies with more than a minor risk of harm unless the studies are designed to benefit them directly or to study diseases or conditions they have. Parental permission and subject assent is typically needed to enroll minors in research studies (U.S. 45 CFR 46d).

Potential subjects might also be vulnerable because they are likely to be coerced or manipulated into enrolling. "Assent" from minors or "consent" from legally competent adults is coerced or manipulated when it is not freely given or when they would otherwise refuse to be a subject in a study but for fear, ignorance, pressure, or undue temptation (Kopelman 2004). Students are often cited as potentially vulnerable to such pressure, as are institutionalized persons, prisoners, members of the military, hospital staff, laboratory assistants, and pharmaceutical personnel (Council for International Organizations of Medical Science 2002).

The double vulnerability of adolescent subjects is well illustrated by a controversy over the SATURN (Student Athlete Testing Using Random Notification) study. SATURN was designed to study the effects of mandatory, random drug testing among high school students by comparing high schools with mandatory drug testing and those without such testing (Goldberg et al. 2003; Office for Human Research Protections 2002; 2003). At the beginning and end of the school year, subjects at the control schools complete anonymous questionnaires and student athletes at the experimental schools complete confidential questionnaires. Student athletes at the experimental schools must participate in random testing for drugs or alcohol by urine samples collected by same-sex observers. If tests are positive, parents and the school are notified, mandatory counseling begins, and students must sit out some sports events.

Adil E. Shamoo and Jonathan D. Moreno (2004) conclude that SATURN violated well-established research policy regarding

1. informed consent: SATURN's consent form and procedures were flawed, and students and parents were pressured into participating as a precondition of being in sports programs;
2. confidentiality and privacy: SATURN pressured randomly selected student athletes to give urine samples and then returned positive findings to parents and the school; and
3. just selection of research subjects: SATURN singled out student athletes for special burdens.

Merely Evaluating School Policy or Research-Driven Mandatory Testing?

In assessing some of these charges, a pivotal issue is whether SATURN is just an independent research evaluation of existing school programs or whether SATURN's protocol drives the nature of the participating high schools' mandatory testing programs. SATURN investigators maintain that they were just observers who undertook the important task of evaluating the mushrooming high school policies on mandatory testing (Chiodo, Goldberg, and Moe 2004). Such a claim, however, seemed implausible to the U.S. Department of Health and Human Services (DHHS). Three months before the pilot study was published in January 2003, the Office for Human Research Protection (OHRP) at DHHS suspended SATURN (OHRP 2002) for consent and other violations, writing:

OHPR finds that mandatory drug testing of student athletes is an integral part of the design of the SATURN research protocol. OHRP finds that the principal investigator designed a research study in which the goals of the mandatory testing of student athletes and the scientific aims of the study are so closely woven as to be indistinguishable.

OHRP's justification for this claim includes the randomized study design, the investigators' influence of school drug-testing policies, the financial arrangements, and the manner of the collection and evaluation of drug sample tests.

In April 2003, OHRP continued...