Step 4

Children (anyone under 18 years of age) can participate as research subjects only if the research meets certain standards, defined in the federal regulations [45 CFR 46(d)]. Specifically, the research may not be greater than minimal risk unless it provides a direct benefit to the child.

Written parental/guardian permission is required for studies involving children. Once parental/guardian permission has been obtained, the agreement or assent of the child is required. This requires the researcher to explain the study in child-friendly language using an Child Oral Assent Script. While the parents/guardians must provide legal consent for the child to participate in research, the child must always assent to his/her own participation; assent being an active affirmation of a desire to participate.

Research with children will be reviewed by the full HPRB at a convened meeting.

IMPORTANT NOTE:

The HPRB requires criminal background checks for all investigators who will have unsupervised direct contact with minors.

Many research sites already have this requirement in place (e.g., public schools, hospitals) and make provisions for having background checks completed.

If needed, PLU can help investigators obtain a background check through Washington State Patrol (for those who have lived in Washington State for the last 5 years). The cost is $12 and there are a couple of forms that need to be completed and submitted. There are alternative routes for those who have lived out of state in the past 5 years.

To initiate a background check through PLU, please contact:

Susan J. Liden
Director, Risk Management and Insurance
Pacific Lutheran University

lidensj@plu.edu
(253) 535-7116

An incarcerated person is defined by federal regulations as any individual involuntarily confined or detained in a penal institution. This definition includes individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, as well as individuals being held prior to arraignment, trial or sentencing. Research involving incarcerated persons must have as its goal either a direct benefit to the individual subject or seek an understanding of issues and conditions specific to incarcerated persons.

Research with incarcerated persons will be reviewed by the full HPRB at a convened meeting.  See HPRB meeting schedule here.

Students recruited as participants in faculty- or staff-initiated research, and employees recruited for research initiated by PLU faculty, staff or students, require special considerations for engaging them in research. You should pay particular attention to the circumstances surrounding the research and whether the students/employees may feel pressured to participate in research because of their relationship with the investigator.

Where possible, faculty/staff/administrators recruiting students or employees in research should ensure that:

• They do not have access to information about whether students or employees participated.
• Participants know that they may choose not to participate in the research and that the decision will not affect their grade/class standing or employment.
• Students have an equal alternative to participation, which should be comparable in terms of effort, time commitment and credit given.

Research with students and employees may be expedited or exempted from continuing HPRB review if it is minimal risk and falls into one the regulatory defined categories.

Research on pregnant women, fetuses, and neonates may not include invasive procedures unless it provides a direct benefit to the mother and only exposes the fetus to minimal risk.

Survey and interview based research involving pregnant women may be expedited or exempted from continuing HPRB review as long as the research satisfies one of the expedited/exempt criteria. However, research involving physical interventions should be reviewed by the full HPRB at a convened meeting.  See HPRB meeting schedule here.

Decisionally-impaired individuals are those who have a diminished capacity for decision-making and who may be unable to fully understand the risks of research. Research may involve decisionally-impaired individuals only if it offers a direct benefit to the individual participant or to the participant’s class or condition. If the participants are not capable of giving consent for themselves, it must be obtained from their legal guardians. In that case oral assent from the subject must be obtained.

Research involving decisionally-impaired individuals may be expedited if it is minimal risk and falls into one of the regulatory defined categories. Research with decisionally impaired individuals will not be exempted unless it is strictly observational in nature.

Institutionalized individuals, such as those at mental health institutions require special consideration. Written permission for the conduct of the research at the institution must be obtained from the appropriate officials at that institution. In addition, if the participants are not capable of giving consent for themselves, written consent must be obtained from their legal guardians (see Parent/Guardian Consent template). In that case oral assent from the subject must also be obtained.

Research with institutionalized individuals may be expedited or exempted from continuing HPRB review if it is minimal risk and falls into one the regulatory defined categories.