BOP Program Statement 6031.06 § 41

Inmates in custody of the Bureau will not be used as subjects for any non-therapeutic medical or

pharmaceutical experimentation or study.

This does not preclude the use of approved clinical trials that may be warranted for a specific

inmate’s diagnosis or treatment, when recommended by a subspecialist (e.g., oncologist), the

CD, and approved by the Medical Director.

Clinical trials can be the last option an inmate has in receiving treatment for a serious condition.

Clinical trials are designed by a team of professionals, including clinical investigators,

biostatisticians, and regulatory experts who ensure compliance with ethical standards and

regulatory requirements. When the Medical Director approves an inmate’s participation in a

clinical trial, the inmate must give written informed consent, and the clinical trial must be

registered by the National Institutes of Health database and conducted according to the standards

for the protection of human subjects. If there are questions about the legitimacy of a clinical trial,

contact the Medical Director’s office and the Bureau’s Research Review Board. Refer to the

Program Statement Research for additional information.

Research regarding disease prevalence, response to accepted therapeutic interventions, etc., may

be performed if the protocols meet the requirements of the Program Statement Research.

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REFERENCES

Program Statements

Autopsies

Compassionate Release/Reduction in Sentence: Procedures for Implementation of 18 U.S.C. §§

3582 and 4205(g)

Dental Services

Employee Development Manual

Escapes/Deaths Notifications

Female Offender Manual

Food Service Manual

Health Care Credential and Privileging Program

Healthcare Utilization Management

Health Information Management

Health Services Administration

Health Services Quality Improvement

Infection Prevention and Control

Inmate Copayment Program

Inmate Furloughs

Inmate Personal Property

Ion Spectrometry Device Program

Management of Inmates With Disabilities

Medical Designations and Referral Services for Federal Prisoners

Narcotic Identification, Inmate Urine and Alcohol Surveillance and Testing Program

Occupational Safety

Pharmacy Services

Pretrial Inmates

Psychiatric Evaluation and Treatment

Psychology Services Manual

Research

Searches of Housing Units, Inmates, and Inmate Work Areas

Sexually Abusive Behavior Prevention and Intervention Program

Suicide Prevention Program

Treatment and Care of Inmates With Mental Illness

Use of Force, Application of Restraints, and Firearms

Visiting Regulations

Whole Body Imaging

Bureau Forms

BP-A0358 Medical Treatment Refusal

BP-A0408 Acknowledgment of Inmate, Part 3 & 4

BP-A0621 Authorization for Release of Medical Records

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BP-A0770 Medical/Surgical and Psychiatric Referral Request

Other Forms

OF-522 Medical Record – Request for Administration of Anesthesia and for

Performance of Operations and Other Procedures

OSHA Form 300 Log of Work-Related Injuries and Illnesses

ACA Standards

Performance-Based Standards and Expected Practices for Adult Correctional Institutions (5th

Edition): 5-ACI-5C-11M, 5-ACI-6A-01M, 5-ACI-6A-03, 5-ACI-6A-04, 5-ACI-6A-05, 5-ACI-

6A-06, 5-ACI-6A-07,5-ACI-6A-08M, 5-ACI-6A-09, 5-ACI-6A-10M, 5-ACI-6A-12M, 5-ACI-

6A-18M, 5-ACI-6A-19, 5-ACI-6A-19-1, 5-ACI-6A-21M, 5-ACI-6A-22M, 5-ACI-6A-25M, 5-

ACI-6A-27, 5-ACI-6A-31M, 5-ACI-6A-37, 5-ACI-6A-40, 5-ACI-6A-42, 5-ACI-6B-01M, 5-

ACI-6B-02M, 5-ACI-6B-03M, 5-ACI-6B-08M, 5-ACI-6C-04M, 5-ACI-6C-05, 5-ACI-4A-01M,

5-AC-6C-08M, 5-ACI-6C-09M, 5-ACI-6D-04, 5-ACI-2A-03

Performance-Based Standards and Expected Practices for Adult Local Detention Facilities (5th

Edition): 5-ALDF-2E-02, 5-ALDF-4A-13M, 5-ALDF-4C-01M, 5-ALDF-4C-03, 5-ALDF-4C-

04, 5-ALDF-4C-05, 5-ALDF-4C-06, 5-ALDF-4C-08M, 5-ALDF-4C-09, 5-ALDF-4C-13M, 5-

ALDF-4C-19M, 5-ALDF-4C-20, 5-ALDF-4C-21, 5-ALDF-4C-23M, 5-ALDF-4C-24M, 5-

ALDF-4C-25M, 5-ALDF-4C-26, 5-ALDF-4C-27M, 5-ADLF-4C-28M, 5-ALDF-4C-33, 5-

ALDF-4C-34, 5-ALDF-4C-36, 5-ALDF-4D-01M, 5-ALDF-4D-02M, 5-ALDF-4D-03M, 5-

ALDF-4D-15M, 5-ALDF-4D-16, 5-ALDF-4D-17M, 5-ALDF-4D-18M

Standards for Administration of Correctional Agencies, 2nd Edition: 2-CO-1F-14, 2-CO-4E-01

Records Retention Requirements

Requirements and retention guidance for records and information applicable to this program are

available in the Records and Information Disposition Schedule (RIDS) on the Bureau’s intranet

site.

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