Subpart C Additional DHHS Protections Pertaining to Biomedical and


	º46.301 Applicability.
46.301(a) To all DHHS supported research on prisoners	(a) The regulations in this subpart are applicable to all biomedical and behavioral research conducted or supported by the Department of Health and Human Services involving prisoners as subjects.
46.301(b) State and local laws also apply	(b) Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth herein will authorize research involving prisoners as subjects, to the extent such research is limited or barred by applicable State or local law.
46.301(c) Other subparts of this rule also apply	(c) The requirements of this subpart are in addition to those imposed under the other subparts of this part.

	º46.302 Purpose.
46.302 Purpose	Inasmuch as prisoners may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it is the purpose of this subpart to provide additional safeguards for the protection of prisoners involved in activities to which this subpart is applicable.

	º46.303 Definitions.
	As used in this subpart:
46.303(a) Secretary	(a) "Secretary" means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has been delegated.
46.303(b) DHHS	(b) "DHHS" means the Department of Health and Human Services.
46.303(c) Prisoner	(c) "Prisoner" means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
46.303(d) Minimal Risk	(d) "Minimal risk" is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

	º46.304 Composition of Institutional Review Boards where prisoners are involved.
46.304 Additional IRB membership requirements when prisoners are involved in covered research:	In addition to satisfying the requirements in º46.107 of this part, an Institutional Review Board, carrying out responsibilities under this part with respect to research covered by this subpart, shall also meet the following specific requirements:
46.304(a) Majority of IRB must have no association with the prison(s) involved	(a) A majority of the Board (exclusive of prisoner members) shall have no association with the prison(s) involved, apart from their membership on the Board.
46.304(b) At least one member must be a prisoner or prisoner advocate	(b) At least one member of the Board shall be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity, except that where a particular research project is reviewed by more than one Board only one Board need satisfy this requirement.

	º46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
46.305(a) As additional duties, the IRB may only approve covered research if it finds that:	(a) In addition to all other responsibilities prescribed for Institutional Review Boards under this part, the Board shall review research covered by this subpart and approve such research only if it finds that:
46.305(a)(1) Research falls in a permissible category	(1) the research under review represents one of the categories of research permissible under º46.306(a)(2);
46.305(a)(2) Advantages of participation are not great enough to be coercive	(2) any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired;
46.305(a)(3) Risks would be acceptable to nonprisoner volunteers	(3) the risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers;
46.305(a)(4) Subject selection is equitable	(4) procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the Board justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project;
46.305(a)(5) Understandable information will be given to subjects	(5) the information is presented in language which is understandable to the subject population;
46.305(a)(6) Participation will have no effect on parole & subject understands this	(6) adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole; and
46.305(a)(7) Follow up care will be provided as needed	(7) where the Board finds there may be a need for follow‑up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact.
46.305(b) The IRB will carry out other duties assigned by the Secretary	(b) The Board shall carry out such other duties as may be assigned by the Secretary.
46.305(c) Institution will certify to the Secretary that these duties have been fulfilled	(c) The institution shall certify to the Secretary, in such form and manner as the Secretary may require, that the duties of the Board under this section have been fulfilled.

	º46.306 Permitted research involving prisoners.
46.306(a) Covered research may involve prisoners only if:	(a) Biomedical or behavioral research conducted or supported by DHHS may involve prisoners as subjects only if:
46.306(a)(1) The institution has certified to the Secretary that the IRB has fulfilled its duties	(1) the institution responsible for the conduct of the research has certified to the Secretary that the Institutional Review Board has approved the research under º46.305 of this subpart; and
46.306(a)(2) The Secretary judges the research to be one of the following:	(2) in the judgment of the Secretary the proposed research involves solely the following:
46.306(a)(2)(A) Minimal risk study of incarceration and criminal behavior	(A) study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
46.306(a)(2)(B) Minimal risk study of prisons or prisoners	(B) study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
46.306(a)(2)(C) Research on conditions affecting prisoners as a class. Secretary must publish notice in Federal Register before study begins	(C) research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults) provided that the study may proceed only after the Secretary has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his intent to approve such research; or
46.306(a)(2)(D) Research which has the likelihood of helping the subject. Secretary must publish notice in Federal Register before study begins	(D) research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well‑being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary has consulted with appropriate experts, including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of the intent to approve such research.
46.306(b) No other types of research supported by DHHS may involve prisoners	(b) Except as provided in paragraph (a) of this section, biomedical or behavioral research conducted or supported by DHHS shall not involve prisoners as subjects