Office of Human Research Ethics SOP 2200: U.S. Department of Justice Supported Research

Title

Office of Human Research Ethics SOP 2200: U.S. Department of Justice Supported Research

1. Purpose

The purpose of this SOP is to establish written requirements to ensure compliance with U.S. Department of Justice requirements regarding human subjects research. This SOP specifies requirements for research supported by the National Institute of Justice (NIJ) and/or conducted within the Bureau of Prisons (BOP). General requirements for conducting DOJ-regulated research are set forth at 28 CFR 46. Research conducted within the Bureau of Prisons is subject to additional requirements set forth in 28 CFR 512.

2. Responsibility

The UNC-Chapel Hill IRB and researchers conducting human subjects research supported by the Department of Justice are responsible for ensuring compliance with this SOP.

3. Definitions

Certification means the official notification by the institution to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:

1. Data through intervention or interaction with the individual, or
2. Identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.

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.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Research For purposes of research conducted within the Bureau of Prisons only, implementation of Bureau of Prisons programmatic or operational initiatives made through pilot projects is not considered to be research.

4. Procedures Related Requirements

4.1 NIJ-Supported Research

UNC-Chapel Hill researchers receiving support from the NIJ to conduct human subjects research are required to comply with Department of Justice regulations at 28 CFR 46.The Department of Justice is not a signatory to the 2018 Revised Common Rule.As such, note that all NIJ/BOP non-exempt research will require a continuing review.

UNC-Chapel Hill researchers are responsible for communicating with their NIJ Program Officer to ensure that all NIJ requirements are met prior to starting an IRB-approved study.  NIJ requirements include:

• Privacy Certificate: All projects are required to have a privacy certificate approved by the NIJ human subjects protection officer.
• Child Abuse Reporting: Under a privacy certificate, researchers and research staff do not have to report child abuse unless the participant signs another consent document to allow child abuse reporting.
• Employee Confidentiality Statements: All researchers and research staff are required to sign employee confidentiality statements, which are maintained by the responsible researcher.
• Confidentiality Statement in the Consent Form: The confidentiality statement in the consent document must state that confidentiality can only be broken if the participant reports immediate harm to participants or others.
• De-identified Data Sent to the National Archive: A copy of all data must be de-identified and sent to the National Archive of Criminal Justice Data, including copies of the informed consent document, data collection instruments, surveys, or other relevant research materials.

4.2 Research Conducted within the Bureau of Prisons

UNC-Chapel Hill researchers conducting research within the Bureau of Prisons (BOP) are required to comply with Bureau of Prisons regulations at 28 CFR 512.

UNC-Chapel Hill researchers are responsible for communicating with the BOP to ensure that all requirements are met prior to starting an IRB-approved study.  BOP requirements include:

• In all research projects, the rights, health, and human dignity of individuals involved must be respected.
• The project must have an adequate research design and contribute to the advancement of knowledge about corrections.
• The project must not involve medical experimentation, cosmetic research, or pharmaceutical testing.
• The project must minimize risk to subjects; risks to subjects must be reasonable in relation to anticipated benefits. The selection of subjects within any one institution must be equitable. When applicable, informed consent must be sought and documented (see 28 CFR 512.15 and 512.16).
• Incentives may not be offered to help persuade inmate subjects to participate. However, soft drinks and snacks to be consumed at the test setting may be offered. Reasonable accommodations such as nominal monetary recompense for time and effort may be offered to non-confined research subjects who are both:
  • No longer in Bureau of Prisons custody, and
  • Participating in authorized research being conducted by Bureau employees or contractors.
• The researcher must have academic preparation or experience in the area of study of the proposed research.
• The researcher must assume responsibility for actions of any person engaged to participate in the research project as an associate, assistant, or subcontractor to the researcher.
• Except as noted in the informed consent statement to the subject, the researcher must not provide research information which identifies a subject to any person without that subject's prior written consent to release the information. For example, research information identifiable to a particular individual cannot be admitted as evidence or used for any purpose in any action, suit or other judicial, administrative, or legislative proceeding without the written consent of the individual to whom the data pertains.
• The researcher must adhere to applicable provisions of the Privacy Act of 1974 and regulations pursuant to this Act.
• The research design must be compatible with both the operation of prison facilities and protection of human subjects. The researcher must observe the rules of the institution or office in which the research is conducted.
• Any researcher who is a non-employee of the Bureau of Prisons must sign a statement in which the researcher agrees to adhere to the provisions of 28 CFR 512.
• A non-employee of the Bureau of Prisons may receive records in a form not individually identifiable when advance adequate written assurance that the record will be used solely as a statistical research or reporting record is provided to the agency.
• Except for computerized data records maintained at an official Department of Justice site, records which contain non-disclosable information directly traceable to a specific person may not be stored in, or introduced into, an electronic retrieval system.
• If the researcher is conducting a study of special interest to the Office of Research and Evaluation (ORE), but the study is not a joint project involving ORE, the researcher may be asked to provide ORE with the computerized research data, not identifiable to individual subjects, accompanied by detailed documentation. These arrangements must be negotiated prior to the beginning of the data collection phase of the project.
• The researcher must submit planned methodological changes in a research project to the IRB for approval and may be required to revise study procedures in accordance with the new methodology.

Contact Information

Policy Contact

Office of Human Research Ethics
CB 7097
720 Martin Luther King Jr. Blvd.
Bldg # 385, Second Floor
Chapel Hill, NC 27599

Ph: 919-966-3113
Fax: 919-966-787