Northwestern University – Institutional Review Board Office

Supplement for Department of Justice (DoJ) ResearchConducted

within the Federal Bureau of Prisons (BOP)

Please use this form only when:

  • The study is under the purview of the Department of Justice (DoJ) and the research is conducted within the Federal Bureau of Prisons (BOP)
  • For more information:

DOJ Regulations 28CFR46:

BOP Website:

BOP Regulations 28CFR512:

1. Principal Investigator Name:

2. Project Title:

3. IRB Study Number:STU

4. This form is an attachment to a new study or existing study (select one)

Instructions:

  • Handwritten or incomplete forms will not be accepted
  • Complete all applicable sections of this form and do not leave any blanks unless directed otherwise.
  • Within eIRB, upload a copy of the completed form in the protocol section of the study application.
  1. Pilot Project – Complete the question in this section only if you are submitting a pilot study to the IRB.

Yes N/A - Is the project conducted within the Bureau of Prisons and intended to implement a Bureau programmatic or operation initiative made through a pilot project?

If “yes”, the pilot project is not considered research by the BOP and is not subject to BOP regulations set forth at 28CFR512. The remainder of this form does not need to be completed.

B. Research ProjectRequirements

Check if “yes” or indicate the question is not applicable. Provide a response for all items listed below.

  1. Yes N/A - The investigator and research staff are aware of and have educated themselves about the specific requirements of Department of Justice (DoJ) research with the Federal Bureau of Prisons (BOP)
  2. Yes N/A - The project does not involve medical experimentation, cosmetic research or pharmaceutical testing
  3. Yes N/A - The research design is compatible with both the operation of prison facilities and protection of human subjects
  4. Yes N/A - The investigator will observe the rules of the institution or office in which the research is conducted
  5. Yes N/A – Investigators, who are BOP employees, have signed a statement agreeing to adhere to the requirements of 28 CFR 512
  6. Yes N/A - All research proposals will be reviewed by the BOP IRB
  7. Yes N/A - The project has an adequate design and will contribute to the advancement of knowledge about corrections
  1. Principal Investigator Responsibilities and Requirements:

Check if “yes” or indicate the question is not applicable. Provide a response for all items listed below.

  1. Yes N/A – The investigator has academic preparation or experience in the area of study of the proposed research
  2. Yes N/A – The investigator will assume responsibility for actions of any person engaged to participate in the research project as an associate, assistant, or subcontractor to the researcher
  3. Yes N/A – At least once a year, the investigator will provide the Chief, Office of Research and Evaluation, with a report on the progress of the research
  4. Yes N/A – At least 12 working days before any report of findings is to be released, the investigator will distribute one copy of the report to each of the following
  5. the chairperson of the BOP IRB
  6. the regional director
  7. the warden of each institution that provided data or assistance
  1. Yes N/A – The investigator will include an abstract in the report of findings
  2. Yes N/A – If any publication of results, the investigator shall acknowledge the BOP’s participation in the research project
  3. Yes N/A –The investigator will expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the BOP
  4. Yes N/A – Prior to submitting for publication the results of a research project conducted under this subpart, the investigator shall provide two copies of the material, for informational purposes only, to the Chief, Office of Research and Evaluation, Ventral Office, BOP.
  1. Research Protocol Requirements:

Check if “yes” or indicate the question is not applicable. Provide a response for all items listed below.

  1. Yes N/A – The IRB protocol includes a summary statement which includes

a.Name of PI and co-investigator and their affiliations

b.Study title

c.Purpose of the study

d.Location of the study

e.Methods to be employed

f.Anticipated results

g.Duration of the study

h.Number of subjects (staff or inmates) required and amount of time required of each population

i.Indication of risk or discomfort involved as a result of participation

  1. Yes N/A The IRB protocol includes a comprehensive statement which includes
  1. Review or related literature
  2. Detailed description of the research method
  3. Significance of anticipated results and their contribution to the advancement of knowledge
  4. Specific resources required from the Bureau of Prisons
  5. Description of all possible risks, discomforts and benefits to individual or a class of subjects and a discussion of the likelihood that risks and discomforts will actually occur
  6. Description of steps taken to minimize risks described in “e”
  7. Description of physical or administrative procedures to be followed to

i.ensure the security of individually identifiable data that are being collected for the study

ii.Destroy research records or remove individual identifiers from those records when the research has been completed

  1. Description of any anticipated effects of the research study on organizational programs and operations
  2. Relevant research materials, such as vitae, endorsements, questionnaires and interview schedules are included in the proposal
  1. Yes N/A The IRB protocol includes a statement that the investigator comply with additional assurances and certifications required by federal regulations at 28 CFR 46.103.

E. Equitable Selection of Research Subjects Requirements:

Check if “yes” or indicate the question is not applicable. Provide a response for all items listed below.

  1. Yes N/A – The project minimizes risks to subjects; the risks to subjects are reasonable in relation to anticipated benefits.
  2. Yes N/A - The selection of subjects within any one organization is equitable
  3. Yes N/A - Incentives will not be offered to help persuade inmate subjects to participate (although soft drinks and snacks to be consumed at the test setting may be offered).
  4. Yes N/A - Reasonable accommodations such as nominal monetary recompense for time and effort willbe offered to non-confined research subjects who are no longer in BOP custody and participating in authorized research being conducted by BOP employees or contractors
  1. Informed Consent Requirements

Check if “yes” or indicate the question is not applicable. Provide a response for all items listed below.

  1. Yes N/A –Confirm that the required consent form elements listed below are contained in the consent document submitted with the eIRB application:
  1. Identification of the principal investigator(s);
  2. Objectives of the research project;
  3. Procedures to be followed in the conduct of research;
  4. Purpose of each procedure;
  5. Anticipated uses of the results of the research;
  6. A statement of benefits reasonably to be expected;
  7. A declaration concerning discomfort and risk, including a description of anticipated discomfort and risk;
  8. A statement that participation is completely voluntary and that the participant may withdraw consent and end participation in the project at any time without penalty or prejudice (the inmate will be returned to regular assignment or activity by staff as soon as practicable);
  9. A statement regarding the confidentiality of the research information and exceptions to any guarantees of confidentiality required by federal or state law. For example, a researcher may not guarantee confidentiality when the subject indicates an intent to commit future criminal conduct or harm himself/herself or someone else, or, if the subject is an inmate, indicates an intent to leave the facility without authorization.
  10. A statement that participation in the research project will have no effect on the inmate participant's release date or parole eligibility;
  11. An offer to answer questions about the research project; and
  12. Appropriate additional information as needed to describe adequately the nature and risks of the research.
  1. Yes N/A This study includes researchers who areemployees of the Bureau. As such, the informed consent form includes a statement declaring the authority under which the research is conducted.
  1. Yes N/A This study includes researchers who are employees of the Bureau. As such, in addition to presenting the statement of informed consent to the subject, the researchers shall also obtain the subject's signature on the statement of informed consent, when:

1. The subject's activity requires something other than response to a questionnaire or interview; or

2. The Chief, ORE, determines the research project or data-collection instrument is of a sensitive nature.

  1. Yes N/A This study includes researchers who are non-employees of the Bureau. As such, in addition to presenting the statement of informed consent to the subject, the researchers shall also obtain the subject's signature on the statement of informed consent prior to initiating the research activity.
  2. Yes N/A This study includes researchers who are non-employees of the Bureau. They plan to present the statement of informed consent to the subject, but will not obtain the signature of the subject. The researchers can demonstrate that the only link to the subject's identity is the signed statement of informed consent or that there is significantly more risk to the subject if the statement is signed. The signed statement will be uploaded with the protocol in the eIRB application to be reviewed by the IRB.

Confidentiality Requirements:

Check if “yes” or indicate the question is not applicable. Provide a response for all items listed below.

Yes N/A - A non-employee of the BOP will receive records in a form not individually identifiable, and advance adequate written assurance that the record will be used solely as a statistical research or reporting record has been provided to the agency

Yes N/A – Except as noted in the consent statement to the subject, the investigator will not provide research information that 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.

Yes N/A – Except for computerized data, records maintained at an official Department of Justice site, records that contain non-disclosable information directly traceable to a specific person will not be stored in, or introduced to, an electronic retrieval system.

Yes N/A – 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. Researcher may be asked to provide ORE with the computerized research data, not identifiable to individual participants, accompanied by detailed documentation. These arrangements will be negotiated prior to the beginning of the data collection phase of the project

Version date: 04/05/2012Page 1 of 5