CITI Exam Info, Modules 7-9

Informed Consent in Prison Research

Prisoners must be told that participation in the research will have no effect on their parole.

Exempt Status of Prison Research

Research conducted in prisons may not be exempt under 45 CFR 46.101(b). OHRP strongly discourages expedited too.

The definition of minimal risk for children

Same as the definition for adults.

(FERPA)

The Family Educational Rights and Privacy Act, sometimes referred to as the Buckley Amendment, gives parents certain rights over the content of their children's educational records.

Minimal risk

Means that the probability and magnitude of harm or discomfort are not greater in and of themselves than those ordinarily encountered in the daily life or during the performance of routine physical or psychological examinations or tests.

According to Subpart D, exemptions may not be used for any of the following activities when children are the research subjects:

1) Research involving interviews 2) Research involving surveys 3) Observation in which the researcher participates in the activities observed

REQUIRED COMPOSITION OF THE IRB in prison research

A majority of the IRB members must have no association with the prison(s) involved, apart from their membership on the IRB. At least one member of the IRB must be a prisoner or a prisoner representative with appropriate background and experience to serve in that capacity. If a research project is being reviewed by more than one IRB, only one IRB must satisfy this requirement. Suitable board members would include former prisoners, prison chaplains, prison psychologists, prison social workers, other prison service providers, prisoners' rights advocates, and other individuals who are qualified.

Collaborate with prison staff when?

An essential step in preventing problems entails establishing a collaborative relationship with correctional department staff while still in the research design stage.

Prisoner

Any individual involuntarily confined or detained in a penal institution (Included in this definition are individuals in hospitals or alcohol and drug treatment facilities, who are under court order. Individuals in work-release and house arrest programs also qualify as prisoners. Individuals on parole are not considered prisoners. The definition applies to both minors and adults.)

Gaining access into federal prisons for research

Approval by an IRB is frequently not sufficient to get a researcher inside a state prison. The superintendent has the final authority to allow a researcher access to prisoners.

WHEN ENROLLED SUBJECTS BECOME PRISONERS

If a human subject involved in ongoing research becomes a prisoner during the course of the study, the researcher must notify the IRB promptly. All research activities with the now incarcerated prisoner/subject must be suspended immediately. The only exception is when it is in the best interests of the subject to remain in the study.

When do regulations in public schools apply?

If research in a private school is directly funded by the Department of Education, PPRA applies. A private school that does not receive any federal funding is not subject to the provisions of FERPA or PPRA.

(PPRA)

The Protection of Pupil Rights Amendment, amended by the "No Child Left Behind Act" of 2001, is designed to provide parental control over the content of surveys, instructional materials, analyses, and evaluations of minor students. Two levels of control are provided based upon how the research is funded.

Who has the responsibility to decide whether child assent is required and whether assent must be documented?

The federal regulations give IRBs the responsibility to decide

child assent process

no regulations about the content. absence of dissent does not mean assent