Oversight Responsibilities Research Articles

Board Oversight of Patient Care Quality in Large Nonprofit Health Systems

In hospitals and health systems, ensuring that organizational standards for patient care quality are adopted and that processes for monitoring and improving clinical services are in place are among governing boards' most important duties. A recent study examined board oversight of patient care quality in 14 of the country's 15 largest private nonprofit health systems. The findings show that 13 of the 14 boards have standing committees with oversight responsibility for patient quality and safety within their system; 11 of the 14 system boards formally adopt systemwide quality measures and standards; and all 14 regularly receive written reports on systemwide and hospital performance. In recent months, most of these boards had adopted action plans directed at improving their system's performance with respect to patient care quality.

The Protectors and the Protected: What Regulators and Researchers Can Learn from IRB Members and Subjects

Clinical research is increasingly conducted in settings that include private physicians' offices, clinics, community hospitals, local institutes, and independent research centers. The migration of such research into this new, non-academic environment has brought new cadres of researchers into the clinical research enterprise and also broadened the pool of potential research participants. Regulatory approaches for protecting human subjects who participate in research have also evolved. Some institutions retain their own Institutional Review Boards (IRBs), but Independent IRBs, community hospital IRBs and community-based IRBs also fulfill oversight responsibilities. This article sheds light on this evolving world by discussing the findings gleaned from two studies: a study of the decision making processes used by members who serve on different kinds of IRBs and a study of the decision making processes employed by research participants. The article then discusses how the key findings may inform proposed revisions to the Common Rule.

Managing Risk, Ensuring Privacy and Preventing Fraud - Risk Management in a Computerized Accounting System

There are many forms of risk management in our professional world which from an integral part of Practice management. Many corporations today consider market risk, credit risk, operational risk, legal risk and other business risks. Operational risks include fraud and security breach. Information is stored and retrieved by a personal identifier such as name, Social Security Number (SSN), fingerprint or other unique symbol. Since computer technology has made it possible to store, retrieve and manipulate data quickly and efficiently, additional safeguards are needed to ensure that personal data contained in IT systems are protected from unauthorized and illegal use. Computer professional have the oversight responsibility for information privacy because they have the most extensive knowledge of their organization’s systems and programs and an intimate understanding of the data. Thus, the competence of these professionals in ensuring sound practice of information privacy is of great importance to both researchers and practitioners. The role of auditing in improving the performance of the organization implicitly leads to more responsibilities of the auditors in identifying and finding fraud. Consequently, the audit has become a critical active element in managing fraud phenomena which bring about negative effects on the fulfillment of the objectives of the served entities. This paper addresses the challenges in managing risks with special focus on two risks faces in the computerized financial world – Preventing Fraud and Ensuring Privacy.

The role of the audit committee in resolving auditor‐client disagreements: a Malaysian study

PurposeThis paper aims to report the findings of semi‐structured interviews with management, external auditors and audit committee members in Malaysia concerning the role of the audit committee in resolving auditor‐client disagreements.Design/methodology/approachAn exploratory case study method was applied in seven publicly listed companies in Malaysia. In each company interviews were conducted with an audit committee chair/member, the finance manager/CFO and the external auditor.FindingsThe study finds that, when the issue is very material, the audit committee plays a mediating role as a third‐party intermediary who provides assistance to resolve the dispute. The authority of the committee to act as a mediator comes from its oversight responsibilities, its understanding and awareness of possible issues and the members' accounting and business expertise. Mediation techniques used include controlling the agenda, gathering information, advising and solving problems. With two exceptions, the interviews indicate that the audit committee does not take sides when helping to resolve a dispute. The outcome from the mediation process is generally a compromise solution.Research limitations/implicationsThe study is based on 21 interviews undertaken in Malaysia. Hence, the findings may not be generalizable to other cultures and jurisdictions. Further, while a number of mediation techniques used by audit committees are identified, the paper does not examine in‐depth the mediation processes used in resolving disagreements.Originality/valueThe study extends the auditor‐client negotiation literature by examining whether the audit committee plays a mediating role to help resolve disagreements. The findings demonstrate that audit committee effectiveness can extend beyond a pure oversight role to more active involvement in resolving contentious accounting issues.

Three models, one goal: Assessing financial vulnerability in New Zealand amateur sports clubs

Financial vulnerability is a critical issue for nonprofit sports clubs due to clubs’ increasing costs and impediments to generating sufficient income. The first objective of this study is to derive a conceptual understanding of financial vulnerability for sports clubs by assessing three financial vulnerability models, two of which have previously been applied in the nonprofit sector generally. Two models are based on revenue patterns and expenditure, and the third is based on movements in Net Assets over four years. A second objective is to identify determinants of financial vulnerability within amateur sports clubs, focusing specifically on golf and football.The data to test these models were derived from the financial reports of 227 amateur sports clubs in New Zealand (98 football and 129 golf clubs). Each of the three models results in different predictive variables and has different explanatory strengths. For example, football clubs that were financially vulnerable under Model 1: Program Expenditure had declining revenues from members and trading, as well as high administration costs. Conversely, declining reserves are predictive in financially vulnerable golf clubs using Model 2: Net Assets. Model 3: Net Earnings was generalizable to both football and golf clubs. The explanatory variables were different between these sports, due to their different asset base and propensity to employ paid staff. The common variables those with oversight responsibilities should monitor against financial vulnerability are: an undue reliance on external, rather than member-based revenue, increasing debt, and excessive expenditure. Further research could extend this model to other sports and other jurisdictions.

Enhancing Nonprofit Governance Through Better Information Flow to Directors

ABSTRACT.Improved governance is necessary if nonprofits are to meet their social missions. In this regard, one major issue is the influence that nonprofit chief executives have on providing information to nonprofit boards that are largely comprised of volunteers. To counterbalance the ability of a nonprofit's chief executive officer to control information reaching the board of directors, we recommend that a nonprofit board consider requiring leaders of the organization's various functions to provide operational reports directly to the board on at least an annual basis. Additionally, we recommend that a board discuss these reports directly with management members, preferably without the participation of the CEO. Implementing such a protocol should strengthen the board's ability to make based on information from sources in addition to that of the CEO, improve the directors' ability to independently evaluate members of the management team, and increase the directors' understanding of the nonprofit's activities and performance.Keywords: nonprofit, governance, information flow, director, management1. IntroductionNonprofit boards tend to suffer from various corporate governance problems that have led some observers to propose that: Effective governance by the board of a nonprofit organization is a rare and unnatural act (Taylor et al. 1996, p. 36). The difficulties of achieving effective governance for nonprofits arise from the interaction of several factors. Directors may be appointed for reasons other than their governance expertise or business experience per se. The nonprofit itself may really want the directors it appoints for fund raising, their contacts, or to enhance the reputation of the nonprofit (Bowen 1994). Because most nonprofit directors are volunteers, the links normally found in the corporate sector between director accountability and compensation are nonexistent. When they are serving as unpaid volunteers, nonprofit directors generally face little personal risk for their (Bishop 2008). Accordingly, individual nonprofit directors may simply disengage from nonprofit boards, particularly when they are denied adequate strategic information about the organization or are relegated to nonstrategic operational issues by the nonprofit's executive officer (Chait and Taylor 1989). Such a mindset is reinforced by [t]he fact that individual trustees are rarely identified with troubled nonprofits, even in highly publicized situations ... (Bowen 1994, p. 41).In addition to the traditional challenges of bringing a strategy into focus, establishing organization policy, selecting leadership, and dealing with operational results and finances, nonprofit boards face the challenge of integrating nonprofit directors from varied business and non-business backgrounds into a cohesive team that understands and is focused on the mission of the nonprofit (Bowen 1994). Nonprofit boards, which tend to be large, need to avoid the temptation to rely on a small executive committee to assume the powers of the entire board to make decisions, with the entire board serving only as a forum for reporting the executive committee's decisions (McFarlan 1999, p. 74). Failure to do so is an abdication of the directors' oversight responsibility as this responsibility requires each director to use his judgment to make informed decisions.Members of nonprofit boards need to understand the essential differences between nonprofit and for-profit organizations. In particular, nonprofit directors need to appreciate the fundamental importance of the nonfinancial mission and evaluation of the nonprofit's programs to meet that mission, the nature of raising funds for nonprofits, and often, the challenges faced by large boards trying to make long-term (Epstein and McFarlan 2011). Nonprofit directors from the business world may fail to appreciate that non-financial results are more important than the financial results of a nonprofit. …

Beyond Contracts: Governing Structures in Non-Equity Alliances

Non-equity alliances are often portrayed in the literature as purely contractual collaborative agreements. This paper questions the notion that contractual safeguards and incentives alone provide the formal governance mechanisms that undergird non-equity alliances. We argue and show that partners craft elaborate committee structures that serve as administrative interfaces for collaborative agreements. These committee structures have well-defined authority relationships and oversight responsibilities and exhibit several key characteristics of hierarchy. We demonstrate that monitoring needs arising from moral hazard and knowledge misappropriation risk, as well as coordination needs arising from increased partner interdependence, are key determinants of such administrative mechanisms in the governance of non-equity alliances.

The new model of governance and risk management for financial institutions

The paper proposes a new model of governance and risk management consisting of four components: (i) board risk oversight responsibilities, (ii) a board level risk committee, (iii) an executive risk committee and (iv) an individual with responsibility for overall risk management. Some companies are subject to the Dodd–Frank Act and are forming a stand-alone risk committee; other companies still have the option of adopting these best practices. The paper contends that the new model promotes greater risk disclosure, the audit committee should complement the risk management committee, the board level risk committee should have an independent member with extensive risk management experience, the board should develop a clear risk position, management should form an executive risk committee, have a chief risk officer, create an internal risk intelligence function and, if these are done, institutions will enjoy higher stock prices.

The role of auditors in the financial crisis: an African perspective

This paper investigated the role of auditors in the financial crisis from an African perspective. Desk research approach scanning through various documents that include; reports and accounts from the internet, published journal articles, national and international newspapers was used. Assessment of the auditors’ role was premised on quality of financial reporting and auditors’ oversight responsibility on one hand, and effectiveness of internal control to safeguard company assets on the other. Results indicated that it is not in all cases that auditors acted professionally or/and ethically thus accentuating the financial crises which culminate in shareholders’ wealth destruction. To reduce this unacceptable behaviour, it is recommended that more emphasis should be placed on the practice of business ethics, and more rigorous enforcement of legal standards by the government and the courts.

Changing water governance in Ghana through decentralisation

There is a great deal of diversity in the form water governance takes in the provision of water services at the district level in Ghana. Two central government agencies, the GWCL and CWSA have oversight responsibility. The decentralisation framework has had some influence on the approach used by CWSA, which was established in the heat of the reforms; and no influence on the GWCL, which was established long before the current wave of decentralisation reforms started. While the CWSA approach seeks a central role for local government in service delivery and thereby provides mainly policy and funding roles to local governments, the GWCL operates in a deconcentrated manner having almost no institutional links with local government. By operating under GWCL, Tamale for example, does not enjoy the benefits that decentralisation and pluralism bring, unlike Savelugu-Nanton, which has significantly increased coverage and reliability of services in recent years.

Influencing public health without authority

This paper analyzes the present processes, products and needs of post-graduate public health education for the health programming, implementation and oversight responsibilities at field level and suggests some solutions for the institutes to adopt or adapt for improving the quality of their scholars. Large number of institutions has cropped up in India in the recent years to meet the growing demand of public health specialists/practitioners in various national health projects, international development partners, national and international NGOs. Throwing open MPH courses to multi-disciplinary graduate's is a new phenomenon in India and may be a two edged sword. On one hand it is advantageous to produce multi-faceted Public health postgraduates to meet the multi tasking required, on the other hand getting all of them to a common basic understanding, demystifying technical teaching and churning out products that are acceptable to the traditional health system. These Institutions can and must influence public health in the country through producing professionals of MPH/ MD degree with right attitude and skill-mix. Engaging learners in experimentation, experience sharing projects, stepping into health professionals' roles and similar activities lead to development of relatively clear and permanent neural traces in the brain. The MPH institutes may not have all efficient faculties, for which they should try to achieve this by inviting veterans in public health and professionals from corporate health industry for interface with students on a regular basis. The corporate and public health stalwarts have the capacities to transmit the winning skills and knowledge and also inspire them to adopt or adapt in order to achieve the desired goals.

Intelligent design: How to model gambler risk assessment by using loyalty tracking data

The ability to analyse player data collected from customer loyalty programs, smart cards, and on-line systems by risk for problem gambling has the potential to change the gaming industry and how it operates. Gambling providers are coming under increasing pressure to make use of player tracking data to identify and subsequently help at-risk and/or problem gamblers. Although the prospect of successful identification and intervention is vastly improved by the use of such a system, there are still legitimate concerns surrounding how to implement and evaluate the use of player data for these purposes. To inform ongoing debate, this paper will provide an overview of lessons learned through the authors' work in creating gambler risk assessment models by using loyalty data. This paper has particular relevance for social policy, regulatory oversight, and corporate social responsibility applications.

Public Art, Porn and Censorship on a Catholic Campus

Public Art, Porn and Censorship on a Catholic Campus

Assets or liabilities? Custodian risk in the new paradigm

The Alternative Investment Fund Management Directive was passed by the European Parliament in July 2011 and will become law by the end of 2013. The European Securities and Markets Authority issued its Level 2 Implementation Measures Consultation Paper recently to provide detailed clarification around more difficult concepts. Designed to regulate hedge and private equity funds, it encompasses any non-UCITS fund (bar some exceptions). At its heart is the need for every fund sold into Europe after 2018 to appoint a depositary (similar to, but not the same as, a UK trustee) which will bear fiduciary responsibility. This is a new phenomenon to alternatives and no-one yet has a clear idea of how it will operate or what the cost will be. What is known is the depositary will carry an obligation to investors to replace assets held in a securities account that are lost, with a legal onus to prove that it took every possible course of action to avoid loss if it wishes to avoid liability. The deep-pockets principle springs to mind. This, together with other onerous oversight responsibilities, is a long way from industry practice. The paper explores the potential impact of a depositary liability too strict for industry participants.

Professor Natan Goldblum and the Combined Vaccination Program in Gaza

Blum et al. in November 2010 described the pioneering work of Natan Goldblum, a great Israeli virologist and innovator in polio immunization.1 Another important facet of his work was as a key contributor to development of the combined or sequential oral polio vaccine (OPV) and inactivated polio vaccine (IPV) programs used in the West Bank and Gaza since the late 1970s. Goldblum and Joseph Melnick from Baylor University were asked to consult in 1978 with the Israel Ministry of Health and the Gaza and West Bank public health services. During this time, I was the Coordinator for Health in the West Bank and Gaza for the Israeli Ministry of Health (from 1978-1994), with oversight responsibility for health in the West Bank and Gaza including immunization policy and other aspects of health services and training of Palestinian health providers. At that time, we faced continuing polio epidemics, mostly in Gaza where sanitary conditions were poor, despite high levels of OPV coverage. As an outcome of the discussions with Goldblum and Melnick, a new approach they recommended was jointly agreed to by the Israeli and Palestinian health officials. This accord expanded the routine immunization program from four doses of OPV by adding three doses of IPV given in a mixed sequence during the first year of life. This method was later dubbed the Gaza system. Coverage was soon greater than 85%, and catch-up campaigns were conducted for persons aged up to 18 years. Polio disappeared during the next two years and was effectively eradicated from these previously endemic areas.2 During the 1980s, Israel maintained an OPV-only policy, but with a trial IPV program in 2 districts of the country. In 1988, an outbreak of paralytic poliomyelitis occurred mainly among adolescents and young adults in one of these trial districts where the IPV-only policy was in effect (15 cases and one death). As a result of this episode, Israel adopted the Gaza system, and total eradication of polio was rapidly achieved.3,4 After eradication of polio in Gaza, the West Bank, and subsequently in Israel, the Gaza system was adopted and continues in other parts of the Middle East. A combined or sequential OPV and IPV program is an important policy option for polio control.5,6 In light of challenges in countries in which the virus is still endemic (Nigeria, India, Afghanistan, and Pakistan), with recent spread to other countries, the combination of OPV and IPV should again be considered for the end stage of polio eradication in remaining high-risk areas.7,8

The influence of the informal social learning environment on information privacy policy compliance efficacy and intention

Throughout the world, sensitive personal information is now protected by regulatory requirements that have translated into significant new compliance oversight responsibilities for IT managers who have a legal mandate to ensure that individual employees are adequately prepared and motivated to observe policies and procedures designed to ensure compliance. This research project investigates the antecedents of information privacy policy compliance efficacy by individuals. Using Health Insurance Portability and Accountability Act compliance within the healthcare industry as a practical proxy for general organizational privacy policy compliance, the results of this survey of 234 healthcare professionals indicate that certain social conditions within the organizational setting (referred to as external cues and comprising situational support, verbal persuasion, and vicarious experience) contribute to an informal learning process. This process is distinct from the formal compliance training procedures and is shown to influence employee perceptions of efficacy to engage in compliance activities, which contributes to behavioural intention to comply with information privacy policies. Implications for managers and researchers are discussed.

THE IMPORTANCE OF COMMITTEE ASSIGNMENT: HEALTH CARE INDUSTRY POLITICAL ACTION COMMITTEE CONTRIBUTIONS AND THE HOUSE OF REPRESENTATIVES

I. INTRODUCTION The Congressional Budget Office estimates that total spending on health care will increase from 16% of gross domestic product (GDP) in 2007 to 25% in 2025 even as almost 15% of Americans lack health insurance. The debate surrounding health care financing and access has been around for almost 75 years since the Social Security Act was passed in 1935, but the issue of health care reform received more attention as rising health care costs and limited access to health care services became a campaign issue and later a failed domestic policy objective during the Clinton administration. The current system of health care is not sustainable. Reform of the health care system will create winners and losers, particularly among consumers, taxpayers, and members of the health care industry. Unlike the average consumer and taxpayer, however, members of the health care industry may have the ability to influence the outcomes of health care legislation through political action committee contributions. This paper explores the relationship between House committee membership and campaign contributions from political action (PACs) representing specific sectors of the health care industry over three election cycles, 1997-1998, 1999-2000, and 2001-2002. Although there have been a few papers dealing with PAC contributions from the American Medical Association (AMA) and voting on particular pieces of legislation affecting the health industry and one paper dealing with PAC contributions from sectors of the health industry and voting on medical liability legislation, the role of committee membership and PAC contributions has not been examined with respect to the health industry. Economic theory suggests that individual have more power than the entire Congress over their areas of jurisdiction. Individual legislators, recognizing the power of committees, seek legislative assignments that benefit their constituents' interest and the congressperson's own chance of reelection. Bennett and Loucks (1994, 1996, 2008) provide evidence that committee membership is one of the most important determinants of PAC contributions from different sectors of the financial services industry to members of the House of Representatives. In this paper, we extend that analysis to the health industry. In particular, we examine the relationship between PAC contributions from four sectors of the health industry to individual legislators over the 1998-2002 election cycles using a sample selection model. We expect to find that membership on that have significant oversight responsibilities for the health care industry, the Appropriations Committee, the Committee on Energy and Commerce, the Veterans' Affairs Committee, and the Committee on Ways and Means, is positively and significantly related to contributions from PACs representing different sectors of the health care industry. We expect that committee membership matters to health industry PACs, and health industry PACs will contribute disproportionately to those legislators who sit on committee with oversight responsibilities for the health care industry. II. LITERATURE REVIEW As discussed in Weingast and Moran (1983) and Weingast and Marshall (1988), individual have more power than the entire Congress over their areas of jurisdiction. As noted by Grier and Munger (1991, p. 25), committees in Congress, and particularly in the House of Representatives, possess disproportionate power over the policy areas in their respective jurisdictions, have the right to hold hearings, and recommend budget allocations for the bureaus in their district. Committee members determine the nature and content of any legislation that reaches the floor and have the power to prevent legislation from ever reaching the floor. Krozner and Stratmann (2000) also note that the relationship between PACs and congressional standing committee members may be particularly strong because the committee structure gives PACs the ability to build long-term relationships with members of because of the near permanent nature of standing and the ability of legislators to keep their committee assignments for as long as they are in the House (p. …

Imagined promises versus real challenges to public performance management

PurposeThis paper aims to alert and to sensitize managers and those charged with oversight responsibility about the possible follies of relying too much on performance measurement as a management toolDesign/methodology/approachThe study is based on review and analysis of published documents and data.FindingsCurrent pressure to increase transparency and accountability, on the one hand, and complementary burdens to demonstrate the efficiency and effectiveness, on the other, in order to justify future allocation of resources make the use of performance measurement very attractive. However, these forces are not enough to ensure proper use and prevention of certain pathologies.Social implicationsFailing to understand the possible follies of over‐relaying on performance measurements may be dysfunctional when it comes to service of the public's best interest.Originality/valueThe value of this paper has to do with its double goal. First, the education of potential users of performance measurement about its potential weaknesses. Second, the prevention of overuse of performance measurements, as a staff function and overhead cost at the expense of line operations.

The People’s Right: Reimagining the Right to Counsel

This Article re-imagines the Sixth Amendment’s right to counsel, which has been treated exclusively as an individual right enforceable through the Due Process Clause, as a collective right of the People. Building on the writings of Anthony Amsterdam and Akhil Amar, this Article argues that there are vital structural protections inherent in the right to counsel that go well beyond an individual’s due process rights. In particular, the Founders of the Constitution, above all else, contemplated a robust system of checks and balances when executive power was exercised. Perhaps the paradigmatic example of the exercise of such power is the arrest and prosecution of an individual. In the world inhabited by the Founders, the primary means by which executive power was to be checked was through the jury system.In the modern crush of criminal justice, however, juries play a statistically insignificant checking power function. In the overwhelming majority of cases prosecuted in state court, defendants are not provided with an attorney who has the capacity to undertake any kind of meaningful investigation into the facts and circumstances of their cases.Courts need to rely on a vital ally when performing their oversight responsibilities. They depend (we depend) on a robust indigent defense system which routinely investigates the underlying facts and circumstances of individual cases as the only truly meaningful check on executive power.In our adversary justice system, judges are constrained from performing more than a very modest investigation into cases. Instead, if investigations are to take place, they will be done by defense counsel or no one outside of the executive branch. Challenges to inadequate indigent defense systems have invariably been brought as Sixth Amendment claims. For the most part, these challenges have failed. Challenges brought on separation of powers claims, however, would have to be considered in entirely new terms. Simply stated, it would assert that those responsible for the failure to provide sufficient funds for an adequate defender system (usually the legislative but sometimes the executive branch as well) have improperly intruded into core judicial branch responsibilities, denying courts the opportunity to perform their essential functions. This shift from an individual’s to society’s loss would change the focus of the inquiry in dramatic ways and would provide courts with the legitimacy to do something that, paradoxically, they are currently denied because of an opposite understanding of the court’s proper place in our system of separation of powers. Specifically, current wisdom has it that courts act beyond their proper authority when they order legislatures to spend more money than they are willing on indigent defense. Because choices concerning the expenditure of public money are properly allocated to the legislative branch, the reasoning goes, such judicial orders would constitute an improper intrusion by the courts into the legislature’s prerogatives.This Article advances the obverse claim. Separation of powers, which has long been a shield preventing courts from overseeing indigent defense systems, is now a sword by which courts are authorized to decide for themselves whether indigent defense systems are adequate to allow courts to do their duty. If courts find they are not, they would be constitutionally empowered to fix the problem by insisting that more money is made available for indigent defense.An indigent defender system is widely understood as necessary to protect and enforce the rights of its clients. But taken as a whole, the indigent system becomes something much bigger. If the individual defense attorney may be seen as a private attorney general enforcing the rights of his or her client, the collective defense system should be seen as the investigative arm of the judiciary providing meaningful oversight on executive power. Without a robust indigent defense system, one with the capacity to investigate cases on a regular basis, the executive branch ends up with a license to act which would have been unthinkable to the Framers of the Constitution who worked so carefully to ensure that executive power would be checked on a regular basis.

Exploring the Obligation to Inform: Disclosing the Purpose and Benefits of Research in an Increasingly Commercial Research Environment

This article draws on a subset of data from an empirical study supported by the National Science Foundation. The study explored how institutional review boards (IRBs) fulfill their obligations to oversee research that involves human subjects. The subset of data is used to discuss two themes that shed light on how IRBs approach issues that may have a bearing on protection of human subjects but that are not well covered by federal regulatory guidance. The authors conducted 40 semistructured, key informant interviews, over a 1-year period, with members of various types of IRBs, including independent, academic/university, hospital, medical school, and community/tribal IRBs. Among the 40 participants, there were 16 chairs (president, administrator) and 24 members, and 17 males and 23 females; most had served as IRB members for more than 5 years. The data from this study indicate that fulfillment of the IRBs’ oversight responsibilities may be undermined by a lack of regulatory guidance as to how much information should be disclosed to the IRB and to research participants about: (a) the purpose of a study including commercial purposes and (b) researcher/institutional compensation. The data suggest that without adequate regulatory guidance, IRBs may be meeting the letter but not the spirit of the federal regulations. The lack of regulatory guidance with respect to these two issues limits the extent to which IRBs can assess the adequacy of the consent process, the effectiveness of the IRB in performing oversight responsibilities, and optimal protection of human subjects.