IRBs

A number of protections for human subjects involved in research are specified in the Common Rule. IRBs are required to review and approve any nonexempt research that involves human subjects, with its membership specified, functions defined, and review processes outlined.⁶ The Common Rule also includes criteria for IRB approval of research and identifies certain categories of research that can be approved on an expedited basis.⁷ It also specifies that, when “some or all of the subjects are likely to be vulnerable to coercion or undue influence,” the IRB must find that “additional safeguards have been included to protect the rights and welfare of those subjects.”⁸ IRBs are empowered to suspend or terminate research that has been approved and are required to maintain records that document all IRB activities.⁹

In some cases, IRB review of individual research projects can be expedited if the project involves no more than minimal risk and fits certain categories (e.g., collection of small amounts of blood, analysis of existing materials) or involves minor changes to a previously approved research project. Minimal risk for the Common Rule is defined as:

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.¹⁰

Under expedited procedures that bypass the full IRB process, the IRB chair or one or more experienced IRB members who is designated by the chair can review and approve the research. Although regulations do not preclude the use of expedited review for research involving prisoners, the OHRP recommends that such research be reviewed by the full committee.

Informed Consent

Informed consent processes are also defined in the Common Rule. The basic disclosure requirements for obtaining informed consent are (1) a description of the study and its purposes; (2) identification of any foreseeable risks or discomforts to the participant; (3) a description of any benefits that could be expected; (4) disclosure of alternative treatments that may also be beneficial; (5) a description of how confidentiality of records will be maintained; (6) for treatment involving more than minimal risk, an explanation of the potential consequences resulting from participation in the research; (7) contact information for answering questions; and (8) a statement that the individual’s participation in the research must be voluntary, that refusal to participate will not result in a penalty or loss of benefits to which the individual is otherwise entitled, and that the individual may withdraw at any time.¹¹ Additional information may also be required, depending on the specific nature of the research.¹² The investigator must document that the person agreed to participate in the research project by obtaining the individual’s signature or the signature of an authorized representative.¹³

Institutional Assurances

Generally, the Common Rule requires that the departments or agencies applying the Common Rule obtain some form of written assurance from all research institutions engaging in covered research that the research complies with the regulations.¹⁴ If a research organization frequently conducts research supported by one of the signatory federal agencies, it may apply for a federal-wide assurance (FWA), a special kind of assurance process administered by the DHHS. The research organization seeking an FWA certifies that (1) all research will be performed in accordance with the ethical principles in the Belmont Report and (2) for any research that the organization conducts for which it receives any federal funds,¹⁵ certain procedures will be followed that ensure compliance with the Common Rule and any other applicable subparts the organization chooses to sign on to.

In lieu of requiring its own form of written assurance, a department or agency other than DHHS may accept the FWA.¹⁶ In that case, once the FWA is approved by the DHHS, it allows individual research proposals to be approved by the organization and its local IRB rather than by the individual federal department or agency that is funding the research, and any reports required are made both to the department or agency and the OHRP.¹⁷ Note that most organizations that conduct federally funded re search hold an FWA.

Key Definitions Within Subpart C

Subpart C defines a prisoner as any person who is “involuntarily confined or detained in a penal institution” as a result of violating a criminal or civil statute, a person who is committed to other facilities as an alternative to criminal prosecution or incarceration, or someone who is detained pending arraignment, trial, or sentencing.¹⁸ Research with this population must present no more than minimal risk. Here, that is defined as:

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.¹⁹

Subpart C identifies four categories of research that are permitted with prisoners.

1. 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;
2. 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;
3. 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 the intent to approve such research; or
4. Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subjects. 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.²⁰

There has been confusion among researchers and correctional departments regarding the exact meaning of the categories stated previously and the specific circumstances in which they should be applied (See later discussion on the Subpart C Subcommittee of Secretary’s Advisory Committee on Human Research Protections [SACHRP] on page 81). In October 2002, the secretary of the DHHS published a notification in the Federal Register proposing to waive certain provisions of Subpart C to epidemiological research involving prisoners that involved no more than minimal risk and no more than inconvenience to potential subjects.²¹ The regulations, which became final in June 2003, allow for epidemiological research on specific diseases that describes the prevalence or incidence of the disease by identifying all cases, including prisoner cases, or studies of potential risk factor associations for these diseases in which prisoners were included in the population of interest but were not the sole study group.²²

Implementation of an epidemiological research project involving prisoners requires that an IRB must approve the research, document that one of the two conditions described previously has been met, and determine that the research involves minimal risk and no more than inconvenience to the prisoner-subjects.²³

Additional Requirements for IRBs

When research is proposed that involves prisoners, IRBs must approve each individual project. IRBs for prisoner research are not only required to meet the conditions of the Common Rule (outlined previously) but also must have among its membership a prisoner or prisoner representative.

Further, the IRB must find that the research proposal meets both the Common Rule requirements as well as additional requirements specific to the prisoner setting. These additional requirements are as follows:

• the research is within one of the four permissible categories of research for prisoners;
• benefits that accrue as a result of the prisoner’s participation should not be so great in comparison to what is available in the correctional environment that the ability to provide informed consent is impaired;
• risks are commensurate with those that would be accepted by nonprisoner volunteers;
• selection procedures are fair and not subject to arbitrary intervention by either prison authorities or other prisoners;
• the consent form is written in language that is easily understood by the prisoner;
• the person’s participation in the research project will not be a consideration in parole or probation decisions; and
• adequate provisions are made for follow-up care, should it be needed, once the research study ends.²⁴

OHRP Certification

Once the IRB has found that the research meets the criteria described previously and approves the study, OHRP certification must be obtained for research in Categories i through iv and for epidemiological waivers as well (Table 3-1). If the OHRP certifies that the category is appropriate and that the criteria have been met, the research is approved. This certification step adds an average of 3–4 weeks to the review process.

TABLE 3-1

Approximate OHRP Prisoner Certifications January 2000– October 12, 2005.

Definition of Prisoner

The subcommittee recommended that a modified Subpart A analysis apply when a subject who is enrolled in a study may not be fully within the definition of prisoner for the duration of the study. First, the subcommittee affirmed that the interpretation of the term prisoner should remain defined by the words of the regulation and not be expanded to include other individuals whose liberty is restricted, such as those in community correctional facilities or on probation or parole. Although these individuals deserve heightened protection, the subcommittee recommended that the DHHS rely on Subpart A’s protections for individuals “vulnerable to coercion or undue influence” without including them as prisoners under Subpart C. Likewise, when an individual is incarcerated after enrolling in a study, the concerns about coercion and undue influence are not as great, and it may be difficult to modify the research protocol to comply with Subpart C. Therefore, the subcommittee suggested that Subpart A’s general requirement of heightened protection instead apply. The subcommittee recommended that an IRB should review a researcher’s request to continue the research when an individual subsequently becomes incarcerated, taking into account the new conditions of incarceration but without fully engaging in a new Subpart C approval process.

Prisoner IRB Representative

The subcommittee discussed a variety of problems with identifying a representative who would be skilled and knowledgeable enough to be effective but not so unlike the rest of the IRB as to be marginalized. The subcommittee recommended that the OHRP should assist IRBs in searching for an appropriate prisoner representative, which might include family members of prisoners, former prisoners (especially people in recovery from substance addiction who have also had experience as prisoners), and service providers who assist in the correctional process. The OHRP should provide functional criteria that might help IRBs (and investigators, who are also responsible for the composition of an IRB that will properly evaluate ethical issues) identify persons who can be an effective voice for prisoners within the IRB. With respect to multisite studies, the subcommittee recommended that, although Subpart C only requires one prisoner representative on a central IRB for multisite research, the IRB must nevertheless consider the individual circumstances of each prison site, which can vary widely. With respect to expedited review, the subcommittee recommended that, if expedited review of a protocol is required, a prisoner representative be one of the reviewers.

Defining Minimal Risk and Benefit to Participant

The subcommittee considered two issues regarding the distinction between using other healthy prisoners as the ethical baseline as opposed to other healthy persons generally. First, the subcommittee affirmed that the different definition of minimal risk in the Subpart C regulations compared with Subpart A regulations was appropriate. The Subpart C regulations specify that the determination of minimal risk must be in comparison to the ordinary experience of a healthy person, interpreted as meaning a healthy person outside the prison environment. The subcommittee cautioned that the greater situational risk in the prison setting should not influence the baseline for the IRB’s decision; rather, the minimal risk should be compared with the risk to a healthy person in a safe environment. The OHRP should provide guidance, using examples, of how the minimal risk might be viewed in different protocols.

At the same time, the subcommittee viewed the current OHRP interpretation of when a protocol does not provide a benefit to the participant as overly restrictive. The OHRP’s position is that using standard of care as a control arm does not provide any benefit to the participant and thus re quires secretarial review and expert panel consideration. The subcommittee’s view is that, because the participant receives the standard of care and does ultimately benefit from the results of the research, even if not immediately, such a control arm should not require heightened review. The subcommittee recommended that only when the control group is placebo only (and thus deviating from the standard of care) should the protocol be considered to include an arm not benefiting from the research.

The subcommittee also pointed out the problems with the jurisdiction of Subpart C. Because it has been adopted by so few agencies, it has limited application to federally funded research. In addition, it does not automatically apply to institutions that have signed an FWA unless they specifically request that it be part of their obligation. Because of these two enormous gaps in coverage, most research involving prisoners does not fall under the special protections of Subpart C.

Recommendations for Further Consideration by the IOM

In addition to its recommendations on these issues, the subcommittee noted with approval that the IOM had been charged with studying the human research protections for prisoners. The subcommittee recommended the IOM committee’s consideration of:

• the need for a requirement that research only be conducted in prisons providing standard of care to the general population (and how best to get such services in place);
• the interpretation of the requirement that follow-up care be provided when the prisoner has been released from confinement; and
• the limited jurisdiction of Subpart C (i.e., to DHHS-supported research only).

Confidentiality

The BOP research program statement specifically provides that personal identifiable information may not be released without the subject’s prior written consent and, in particular, may not be admitted as evidence or used for any other purpose in any judicial, administrative, or legislative proceeding. At the same time, as part of the process of informed consent, the subject must be told that confidentiality may not be guaranteed as to information that the subject intends to commit a crime, harm him- or herself or someone else, or leave a facility in which he or she is incarcerated.

The concern for confidentiality of records also places specific limits on the researcher. Records that contain information that may be traced to an individual generally must not be placed on any electronic retrieval system. Additionally, nonemployee researchers can only have access to BOP records if the information does not identify the individual and will only be used “as a statistical research or reporting record,” unless the information is available under the Freedom of Information Act.

Informed Consent

BOP policies relating to informed and voluntary consent appear to have been tailored to their assessment of the requirements of the prison setting. First, the disclosures that are required for informed consent are modified slightly from the Common Rule requirements. In some cases, the disclosure is required to be more specific. For instance, where the Common Rule requires disclosure of “which procedures are experimental,” the BOP regulations require a somewhat more specific disclosure of “the purpose of each procedure” and further require “identification of the principal investigator(s),” which is not specifically required by the Common Rule. As noted previously, the program statement regarding confidentiality contains an exception for when an inmate threatens to harm him- or herself or others, or to leave the facility. Certain other information that is required under the Common Rule’s informed consent disclosure requirement, such as alternative treatments and information regarding treatment for research-related injury, is not expressly required to be disclosed under the BOP program statement on research,³⁹ perhaps because such disclosures are less relevant in a setting in which medical treatment is controlled by the institution. Nevertheless, the BOP program statement allows the possibility that other information might be required “as needed to describe adequately the nature and risks of the research.”

More striking on the issue of informed (and voluntary) consent is the BOP program statement’s treatment of incentives for participating in research. Where Subpart C provides a standard against which to measure incentives—that incentives should not be “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”⁴⁰— BOP policy simply forbids any incentives for research subjects in BOP custody. However, “soft drinks and snacks to be consumed at the test setting may be offered,” and steps may be taken to avoid prisoners being put at a disadvantage (e.g., because of work schedule) by participating in the research.

Review of Research Protocols

Review under the BOP research program statement reflects further BOP control over the research protocol and review process. The review is conducted at three levels. First, an application meeting the detailed informational requirements set forth in the policy is submitted to the warden, who convenes a local research review board (LRRB).⁴¹ The LRRB not only reviews the proposal for compliance with the research policy but also consults with prison operational staff and evaluates the research protocol’s compliance with prison policies. The warden takes the LRRB review, formulates recommendations, and forwards the application to the regional director, who then sends the application to a central IRB, called the Bureau Research Review Board (BRRB). After BRRB review and recommendations, the chief of the Office of Research and Evaluation (ORE), who chairs the BRRB, sends the proposal to the director of the BOP, who has the final authority to approve or disapprove all research proposals. Finally, the warden has the opportunity to review the project in its final form, consult with the LRRB, and request reconsideration if necessary. Furthermore, each research project is reviewed on an annual basis, and the director has the authority to terminate a project at any time if it violates the policy or “may prove detrimental to the inmate population.”

Perhaps in recognition of the difficulty of convening a fully qualified local IRB, and because the LRRB’s decision is always reviewed by the BRRB, membership requirements for LRRBs are not as strict as in Subpart C and, in fact, need not necessarily meet the requirements of an IRB as set out in Subpart A. As a general rule, the LRRB “is encouraged, but not required” to meet the membership requirements set forth in the Common Rule. However, the program statement specifies that the LRRB must have the chief psychologist at the prison as the chairperson, and representatives of departments that will be involved with the project must serve as consultants to the LRRB. When the facility allows more than one research project per year, it is “specially encouraged” to require membership, including a prisoner’s representative, that would comply with DHHS’s Subpart C.

The BRRB is necessarily an IRB and, as described by the research policy requirements, meets Subpart C requirements. The BRRB is composed of the chief of the ORE, who serves as the chair; at least four other members; and one alternate, who serves in the event of a conflict of interest of a member. A majority cannot be BOP employees, and the membership must include an individual with legal expertise (usually someone from the BOP general counsel’s office) and “a representative for inmates whom the Director determines is able to identify with inmate concerns and evaluate objectively a research proposal’s impact on, and relevance to, inmates and to the correctional process” (who is generally a prison chaplain). The implementation guidelines further specify that the members shall have varying backgrounds, genders, and racial/cultural makeup, shall not be associated with the conduct of the research, and shall include at least one scientist and one nonscientist. Thus, the research program statement’s description of the BRRB meets Subpart C requirements and also sets out a few additional requirements not contained in Subpart C.

Overall, the BOP guidelines are a useful tool for comparison with Subpart C because they govern all research involving prisoners in federal custody, whether or not it is funded by the DOJ (or DHHS). Moreover, they reflect the BOP’s decisions regarding which aspects of Subpart C are not feasible or are unnecessary and which aspects are inadequate, because they either do not provide enough protection for subjects in the prison environment or are not specific enough about what is required.

The Constitution of the United States

The congressional spending power derives from the federal Constitution, Article I, Section 8, clause 1, which provides in pertinent part:

Section 8. The Congress shall have power to lay and collect taxes, duties, imposts and excises, to pay the debts and provide for the common defense and general welfare of the United States; but all duties, imposts and excises shall be uniform throughout the United States….

The Scope of the Congressional Spending Power

For generations, the “spending power” has provided the legal basis for legislation touching upon myriad subjects. The court has long recognized the broad authority conferred under the spending clause. “[W]hen money is spent to promote the general welfare, the concept of welfare or the opposite is shaped by Congress….” Helvering v. Davis, 301 U.S. 619 (1937).

South Dakota v. Dole, 483 U.S. 203 (1987), remains the primary precedent for the authority of Congress to pass spending clause legislation. In that case, the Supreme Court upheld a federal statute that reduced federal highway funding to states with a minimum drinking age below 21. The court found that the legislation was sufficiently related to the federal interest in promoting safe highway travel and concluded that the statute did not exceed Congress’s spending power under the U.S. Constitution, Article I, Section 8, clause 1, Id. at 208–209. The Supreme Court affirmed the broad scope of the spending power, though it acknowledged that congressional authority is limited in the following ways:⁵⁰

The first of these limitations is derived from the language of the Constitution itself: the exercise of the spending power must be in pursuit of “the general welfare.” In considering whether a particular expenditure is intended to serve general public purposes, courts should defer substantially to the judgment of Congress. Second, we have required that if Congress desires to condition the States’ receipt of federal funds, it “must do so unambiguously…., enabl[ing] the States to exercise their choice knowingly, cognizant of the consequences of their participation.” Third, our cases have suggested (without significant elaboration) that conditions on federal grants might be illegitimate if they are unrelated “to the federal interest in particular national projects or programs.” Finally, we have noted that other constitutional provisions may provide an independent bar to the conditional grant of federal funds.

South Dakota v. Dole, 483 U.S. 203, 207–208 (citations and footnote omitted). Considering the legislation at issue—limiting the drinking age—was considered sufficiently related not only to the general welfare and to the states’ receipt of federal highway funds, these “limitations” are evidently not exceedingly rigorous. In sum, it is clear that Congress has well established and broad authority to condition federal funding upon acceptance of specified conditions that, in a general sense, pertain to the purpose of the legislation.⁵¹

The spending power is a familiar basis for congressional action. There are numerous examples of legislation—for example, Title VI of the Civil Rights Act, Title IX of the Education Amendments, § 504 of the Rehabilitation Act, and The Religious Land Use and Institutionalized Persons Act of 2000, 42 U.S.C. § 2000cc, et seq. (2000)—all of which contain conditions based on the spending clause power. One particularly pertinent example of spending power legislation is the Prison Rape Elimination Act of 2003 [PREA] (42 U.S.C. § 15601, et. seq.). Section 15605 (d) of PREA provides in pertinent part:

(d) Applications.

(1) In general. To request a grant under this section, the chief executive of a State shall submit an application to the Attorney General at such time, in such manner, and accompanied by such information as the Attorney General may require.

(2) Contents. Each application required by paragraph (1) shall—

(A) include the certification of the chief executive that the State receiving such grant—

(i) has adopted all national prison rape standards that, as of the date on which the application was submitted, have been promulgated under this Act [42 U.S.C. § 15601, et seq.] …

This legislation conditions the release of federal funds upon fairly demanding and relatively intrusive terms, but because of the conditional nature of spending power legislation, it likely would withstand a legal challenge under principles articulated by the U.S. Supreme Court.⁵²

Spending power legislation could easily be used to require compliance with the DHHS regulations in state as well as federal institutions. Every state receives federal assistance for corrections (U.S. Census Bureau, 2006), and that assistance is itself based, at least in part, on Spending Clause legislation.⁵³ Hence, if Congress were so inclined, it could enact legislation (or amend the existing legislation) to require the state agency’s adoption of a regulatory scheme governing the involvement of prisoners in research as a condition for receiving the federal funds. There are many rationales that would likely be sufficient justification for such legislation. For example, the federal government’s interest in “set[ting] uniform national standards in regulating health and safety,” as articulated in Gonzales v. Oregon, 126 S. Ct. 904, 923 (2006), and in particular, in ensuring reliable results from health sciences research, would be sufficient. This assisted suicide case addressed Congress’s more limited authority to directly impose requirements, but the interest articulated by the Court would be sufficient to impose conditional requirements. Additionally, the PREA was based in part on the federal government’s interest both in ensuring states do not violate prisoners’ federal civil and constitutional rights by their deliberate indifference to the problem of prison rape, and its interest in ensuring the “effectiveness and efficiency” of federally funded research and grant programs relating to health care and other prisoner-related research, which (Congress stated) were compromised (directly and indirectly) by state officials’ failure to monitor and address the problem of prison rape.⁵⁴ Clearly these rationales would also support legislation requiring states to impose (at a minimum) the ethical limitations on research required by the DHHS as a condition of receiving the same federal funding.

The regulations could only be imposed in this manner if the states did in fact accept the federal funding. However, because the federal government only seeks to require the states to establish the same ethical regulations as those promulgated by the DHHS, and not to spend money on any new programs, the committee is confident that the states would choose simply to enact the DHHS regulations rather than foregoing substantial federal monies to avoid compliance.