Glossary

This is a list of useful definitions of terms relevant to Research on Human Subjects

Broad consent

Agreement by a legal adult that their private, identifiable data or biospecimens may be stored and used for future research projects.

Consent Form

A Consent Form is used by any researcher who intends to work with human subjects in order to seek legally effective "informed consent from each prospective subject or the subject's legally authorized representative." Under federal regulations, this is a mandate, not an optional matter, because informed consent is "one of the primary ethical requirements underpinning research with human subjects," reflecting the principle of respect for persons.

Missing or inadequate Consent Forms are the most common reason for delays in the processing of IRB application.

Cooperative (multi-site) Research

Cooperative research projects are those projects covered by this policy which involve more than one institution. When Carleton community members conduct research subject to IRB review at multiple institutions in the United States, one IRB must be designated as the IRB of record." If the Carleton IRB is not the "IRB of record," the chair of the Carleton IRB must receive in writing a statement from the reviewing IRB affirming its responsibility for approving and ensuring compliance with the federal regulations. This agreement must be received before the research at Carleton may begin.Research at schools, camps, and other institutions without IRBs may be reviewed by the Carleton IRB, but must also be approved by the principal, director, or other appropriate administrator.

DHHS

The Federal Department of Health & Human Services

Exculpatory language

Language in a consent form that asks the subject to waive (or appear to waive)  legal rights or asks the subject to release the investigator, any funding organization, or Carleton College from liability for negligence. When used, the subject is "signing away" rights. Exculpatory language cannot be included in consent forms, or other human-subjects research documentation.

Formal Application

A Formal Application to the IRB is a federal requirement for faculty, students, and staff who plan do do Research on Human Subjects. It consists of an IRB application form, a Consent Form, and a list of questions if the subjects will be interviewed.

Informed Consent

Agreement by a legal adult to participate in research after being provided with all the information that reasonable person would want to have to make an informed decisions.

IRB Application Form

The IRB application is a form used by the IRB Committee at Carleton to approve Research on Human Subjects as required by the federal government

Legal Adult

In Minnesota, a legal adult is a person at least 18 years of age.

Minimal Risk

Minimal risk means that "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." [45 CFR 46.102(i)]

Minimal risk means that the subjects' responses, if linked to identifying information, would not reasonably be expected to place the subjects "at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, or reputation, or be stigmatizing." [63 FR 60364-60367, November 9, 1998]

OHRP

Office for Human Research Protections

Primary Reviewer

The member of the IRB Committee who is the first one to read the IRB application after submission.

Research

According to the Code of Federal Regulations, research means "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." [45 CFR 46.102(d)]

The federal Common Rule specifically excludes certain types of investigations from the definition of "research": oral history, journalism, biography, literary criticism, legal research, and historical scholarship that focuses directly on the specific individuals about whom the information is collected.

These kinds of investigations are not subject to IRB review.

Research Supervisor

The Research Supervisor is a member of the faculty whose role is to sign IRB applications in the case where a student is the investigators - e.g., comps advisor, directed-reading supervisor, etc. Note that this faculty member is not necessarily the student's academic advisor. The supervisor needs to be the individual overseeing the student research project.

"Vulnerable Public"

Children, prisoners, mentally disabled person, or economically or educationally disadvantaged persons.