THE REGULATION OF HUMAN GENOMICS RESEARCH

THE REGULATION OF HUMAN GENOMICS RESEARCH

INTRODUCTION

A key event in the regulation of medical research was the Nuremberg Trials that were held after World War II, which found Nazi physicians and researchers guilty of atrocities carried out in the name of medical research. Since then, research ethics committees and oversight mechanisms for medical research on human beings have become the accepted norm in most countries. The regulation of genomic research, like other subsets of medical research, is subject to the same regulatory controls that apply to medical research in general. Therefore, the focus of this chapter will be on the regulation of medical research on human beings (excluding the approval of medicines and medical devices) in order to discuss the ways in which these more general requirements apply to genomic research. This chapter will also make reference to some of the specialist bodies that have been established as expert advisory bodies for genomics.

I will compare the regulatory systems in the United Kingdom and the United States in order to provide a general overview, while at the same time illustrating some of the significant differences that exist between them. These countries have quite different ways of regulating medical research on human beings. For example, the United Kingdom is increasingly influenced by European law and is subject to increasing harmonization across Europe, whereas the United States has its own unique regulatory regime. In order to elucidate these differences, this chapter will compare the legal framework between the two jurisdictions, the institutions that have been established to oversee medical research on human beings, and the powers that they have. By highlighting the differences between two well-established legal systems in the Western world, it is hoped that this review may assist readers in other countries where the issues of the regulation of human genomics research are also actively debated and considered.

THE LEGAL FRAMEWORK FOR MEDICAL  RESEARCH

THE CONSTITUTIONAL STRUCTURE

In order to understand the legal framework for medical research, it is important to understand the role of law and its origins in each jurisdiction. The legal frameworks in the United Kingdom and the United States have been developed through different processes. In the United Kingdom, there is a national Parliament that makes law for the whole country. As a member of the European Community, the United Kingdom is also subject to European law. Regulations are directly applicable in all European Union member states, but EU directives need to be implemented by the member state in order to have effect. The Westminster Parliament is obliged to implement directives that are passed by the European Parliament into U.K. law. Failure to do so will result in legal proceedings against the United Kingdom in the Court of Justice of the European Union. However, each of the member states has its own “margin of appreciation” in the way that it implements and interprets European Directives, and this has led to discrepancies in the legislation of each member state. The United Kingdom can also sign Conventions of the European Council, but this is entirely voluntary. The most significant legal instrument regarding medical research in terms of the European  Community is the Convention on Human Rights and Biomedicine (1997). However, the United Kingdom has yet to sign this, due to the provisions that relate to stem cell research.

In contrast, the U.S. Congress (consisting of the House of Representatives and the Senate) is the highest law-making body in the United States. There is no obligation to sign or ratify the law of another authority, such as the United Nations or an international treaty, unless this has been a decision of the American Congress. The United States is a federal system, which means that the Congress and the 50 state legislatures have different Constitutional powers. For medical research there is federal legislation, but the states also have considerable powers to legislate. The lack of a national health service has also resulted in differences and anomalies in the provision of  healthcare in different parts of the United States.

THE ROLE OF STATUTE

The United States has specially drafted federal legislation that covers the regulation of medical research, which applies across the United States. In 1991, the Department of Health and Human Services issued the “Common Rule.”1 The philosophical underpinnings of the Common Rule come from the Belmont Report—Ethical Principles and Guidelines for the Protection of Human Subjects. The Common Rule has a very narrow ambit, as it only applies to medical research that is conducted by a federal department or agency or is federally funded. Research that comes under this scope must be reviewed and approved by an institutional review board (IRB) that  operates in accordance with the requirements of this policy.

However, under the Common Rule, the following research does not require IRB approval:

1.   Research conducted in established or commonly accepted educational settings, involving normal educational practices;

2.   Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless an individual can be identified or the information provided by the individual will incriminate or be detrimental to him or her;

3.   Research involving the use of educational tests as long as the human subjects are elected or appointed public officials or candidates for public office; or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter;

4.   Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects;

5.   Research and demonstration projects which are conducted by or subject to the approval of department or agency heads;

6.   Taste and food quality evaluation and consumer acceptance studies.2

There have been significant advances in scientific research since the Common Rule was developed, and it is no longer seen to be as effective and comprehensive as it could be. Therefore, in July 2011, the U.S.  Department of Health and Human Services announced a proposal to improve the rules protecting human research subjects.3 The suggested amendments would make considerable changes to the Common Rule. They propose to amend seven aspects of the current framework, as follows:4

1.   Refining the existing risk-based regulatory framework;

2.   Establishing a single IRB review of record for domestic sites in multiple locations;

3.   Improving consent forms and the consent process;

4.   Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data;

5.   Establishing an improved system for managing data on unanticipated problems and adverse events;

6.   Extending all federal regulatory protections to include all research at a U.S. institution that is wholly or even partly federally funded for research on human subjects; and

7.   Harmonization of regulations and related agency guidance.

One of the consequences of these changes would be the amendment of the exemption categories listed above. For instance, category 4 would be expanded to include “all secondary research use of identifiable data and biospecimens that have been collected for purposes other than the currently proposed research, provided that specified new consent requirements are satisfied.”5 The aim of the proposals is to place less emphasis on the need to de-identify data, and to counteract the related loss of privacy by  establishing a general rule that the participant must consent in writing to the use of their biospecimens in research. Whilst the initial public consultation period for these proposals has closed, it is likely to undergo further amendment before becoming federal law.

There are numerous pieces of legislation that give power to supervisory bodies to act, or that have direct or indirect implications for research. Some examples are the Bayh-Doyle Act 1980,6 which has had an effect on research, as it imposes a legal obligation on researchers who receive government funding to protect their intellectual property in order to allow the commercialization of their results.7 The Health Information Patient Privacy Act (HIPPA) was introduced across the United States in 2003 to provide uniform privacy protection for patients across the country, and it has also had a significant impact on research practice. The HIPAA Regulations require that a patient must authorize the use of their records for medical research purposes. This can be waived, however, by an IRB or a privacy board. Alternatively, researchers can obtain access to medical records from a covered entity (such as a hospital) without IRB or patient authorization, in two situations:8

1.   In preparing a research protocol (provided access to medical records is required in order to do so, and no protected medical information is removed from the site); and

2.   When performing research relating solely to those who have already died.

However, there are various other pieces of legislation that have relevance for medical research.9

In contrast, the U.K. regulatory system for medical research on human beings does not have one piece of legislation that provides a framework for the governance of all medical research.10 Animal research, on the other hand, is governed by the Animal (Scientific Procedures) Act 1986, which has its origins in a nineteenth-century piece of legislation.11 Providing a statutory framework for an activity not only gives a mandate from a democratically elected body, it also provides the opportunity to allocate powers of enforcement and accountability. Instead of a comprehensive piece of legislation, the law that applies to medical research on human beings in the United Kingdom is a complex patchwork of legislation, regulations, common law principles, guidelines, and codes of practice.12 At the level of statute, there are many general pieces of legislation that have clauses that refer to medical research. There are other statutes that relate directly to either medical research, the use of personal information, or the use of human tissue. These are the Data Protection Act (1998), the Human Rights Act (1998), the Mental Capacity Act (2005), the Human Tissue Act (2004), the National Health Service Act (2006), the Freedom of Information Act (2000), the Human Fertilisation and Embryology Act (1990 and 2008), the Access to Health Records Act (1990), the Health and Social Care Act (2001), the Computer Misuse Act (1990), and the Electronic Communications Act (2000).

Alongside these are regulations that also have a bearing on medical research, and are approved by the Secretary of State for Health. The most significant of these is the Medicines for Human Use (Clinical Trials) Regulations 2004. These regulations apply to clinical trials, and are the only instrument in the United Kingdom that details the requirements for informed consent of medical research. These requirements are derived from the Declaration of Helsinki. The other important features of these regulations are the sections that relate to research ethics procedures and standards. These regulations are a direct implementation of the European Community Clinical Trials Directive 2001/20/EC.13 This is an example of the increasing influence that the law of the European Community has on its member states.

This European influence on medical research will greatly increase if the proposed European Data Protection Regulation is passed in its current form. The Regulation specifically includes “genetic data” (Article 4[10]), and attempts to amend the current restrictions on scientific research that arose from the current Data Protection Directive. It proposes implementing strict requirements as to consent, in that it must be freely given, informed, specific and explicit (Article 4[8]). The Regulation could result in a greater degree of harmonization between member states, but there will still be a considerable margin for appreciation. It is unlikely that it will be in force before 2014.

THE ROLE OF GUIDELINES

There are also several key guidelines that apply to all employees in the National Health Service (NHS). These are written by the Department of Health and the National Institute for Health and Clinical Excellence (NICE); an independent organization that is responsible for providing national guidance relating to health care. As there is a comprehensive health system (though this is constantly being reorganized), most medical professionals in the  United  Kingdom  are  currently  employed  by  the  NHS.  However, the passing of the Health and Social Care Act in 2012 means that the commissioning of healthcare provision will be carried out by general medical practitioners, which has opened up the possibility for greater provision of NHS services by private companies, with fewer medical professionals being employed by the NHS. This will also have an effect on medical research. Whilst the NHS is currently one of the key access points for research participants and patients, not all medical research is carried out by this body. A great deal of research is also carried out in universities and through the commercial sector. There are guidelines written by professional bodies such as the General Medical Council (the statutory body responsible for the registration and accreditation of doctors), the British Medical Association, and the Royal Colleges. Also, major funding bodies such as the Medical Research Council, Cancer Research U.K., and the British Heart Foundation write guidelines or notes for practice. If a case is litigated, the courts will take into account professional guidelines, particularly those issued by the General Medical Council, as a basis for determining whether the appropriate standard of care has been followed. In the United States, there are similar bodies that write guidelines for medical research, but these are not binding on researchers. This differs from guidance issued by the National Institute of Health and other nationally funded bodies, which must be followed.

THE ROLE OF THE COURTS

Whilst the courts in England and Wales are prepared to consider guidelines when assessing the evidence relating to the standard of care, the court will make the final decision on what is the appropriate standard. In the vast majority of cases, the court will accept the medical standard of a body such as the General Medical Council, unless “it is not capable of logical analysis.”14 The decisions of the courts have an effect on the way that medical research is conducted in the United Kingdom, even though many of the decisions are based on cases relating to medical treatment involving negligence. There has only been one case concerning negligence in medical research, and that was the Creutzfeldt-Jakob Disease Litigation, Plaintiffs v. United Kingdom Medical Research Council and another case.15 It is worth quoting from the judgement, as, while the courts acknowledge that they should err on the side of caution in finding negligence, they are also prepared to impose a high standard  of  care  on  researchers,  using  the  same  legal  standards  that  are applied in all negligence cases.

The courts must be very cautious in condemning a clinical trial or therapeutic programme. Too ready a labeling of an act or omission as negligent by the courts could stultify progress in medical and scientific research and render eminent experts reluctant to serve on committees voluntarily. However, during the clinical trial of a new drug or form of treatment, and especially when the clinical trial is becoming a general therapeutic programme, all reasonably practicable steps should be taken to minimise dangers and side-effects. To discharge this duty, constant alert and inquiring evaluation of the trial or programme is required. I do not accept that a government department or a quasi-governmental agency such as the MRC [Medical Research Council] can discharge this duty by a lower standard of care than a commercial pharmaceutical company. . . . In my judgement, the same duty with the same standard of care is owed to all patients who are the subjects of clinical trials or new therapeutic programmes, whether the responsibility of a pharmaceutical company, government department or other agency.16

The courts in England and Wales also have a key role in determining the requirements for valid consent. The chosen criteria primarily stem from the common law doctrine of negligence and the medical professional’s duty to warn. In contrast to the United States, Canada, and Australia, the test in the United Kingdom has been based on what a doctor would consider necessary to tell a patient, rather than what a reasonable patient would expect  to know.17 However the House of Lords’ decision in Chester v. Afshar18 suggests that the courts may be moving more to a position where the information that must be given to the patient should be based on what a reasonable patient would want to know.

The courts in the United States have also been very influential in directing the standards that should be applied to medical research. As in the United Kingdom, the courts pass judgement on the gray areas in the law, and have established the requirements on issues such as consent, duty to warn, privacy, and anti-discrimination. Examples of important U.S. decisions are Washington University v. William J. Catalona19 on the ownership of biological samples collected for research purposes, and the cases on genetic testing, such as Pate v. Threlkel,20 Safer v. Pack,21 and Molloy  v.  Meier.22 But the courts are not responsible for establishing a legal framework for research, as their rulings are dependent upon the cases that come before them, and are an incremental extension of existing principles rather than a complete overhaul of a particular area. Therefore, the courts can explain and develop certain areas of law for guidance for researchers, but it is not their role to develop completely new legal frameworks, which is the responsibility of the state and federal governments that have the democratic mandate to do so.

REGULATORY BODIES AND THEIR  POWERS

THE SITUATION IN THE UNITED STATES

The U.S. Department of Health and Human Services funds two key organizations for the regulation of medical research on human beings. These are the Office for Human Research Protections (OHRP) and the National Institutes of Health (NIH). The NIH is responsible for research in general, whereas the OHRP has more responsibility for compliance and accountability in research. Both of these institutions focus on federally funded research, though their activities and guidelines have an effect on other bodies that carry out medical research in the United States.

The NIH is the primary federal agency in the United States for conducting and supporting medical research. The organization has its own research centers, which are leaders in their respective fields, but it also funds other research and provides guidance and information to researchers. The NIH Office of Biotechnology Activities (OBA) is responsible for  writing guidance, providing advice, monitoring scientific progress, and maintaining a register of research activities. There are many expert advisory committees that develop guidance and feed back findings to the OBA and the NIH director, including the Recombinant DNA Advisory Committee (RAC). Researchers at institutions receiving NIH funding for research involving recombinant DNA must comply with the NIH guidelines. These have become a “universal standard for safe scientific practice in this area of research and are followed voluntarily by many companies and other institutions not otherwise subject to their requirements.”23

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and well- being of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.24

In order to fulfill all of these functions, they organize conferences, develop resource materials, and hold quality-improvement consultations. As a part of its accountability strategy, OHRP has a system of assurances where research institutions both in the United States and abroad have formal agreements to comply with the OHRP regulations relating to research on humans. It also runs an accreditation scheme for researchers in order to improve the ethos of research practice within an organization.

The OHRP is also responsible for maintaining a register of institutional review boards (IRBs) or independent ethics committees (IECs). These must approve federally funded research on human subjects or research that comes under the Common Rule before it begins. The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991. It was then codified in separate regulations by 15 Federal departments and agencies and so applies to all publicly-funded research carried out in the USA.25 The OHRP is responsible for investigating any allegations of non- compliance with the Common Rule and has the power to take  action to protect human research subjects. The initial approach is to ask the institution to investigate; then OHRP may conduct further investigations through on-site evaluations. The OHRP has the power to make recommendations about further training, education, and procedures. In extreme circumstances, it has the power to suspend research programs if they are proving to be unsafe, such as in the case of the death of Jesse Gelsinger in a gene-therapy trial.26 These powers of inspection and investigation ensure that human subjects are protected throughout the research process.

As well as these key institutions, there are also numerous organizations that have responsibility for the regulation of medical research on human beings: for example, the Environmental Protection Agency, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration, the   Federal   Trade   Commission,   and   the   Securities and Exchange Commission.

As in the United Kingdom, it is the IRBs that are responsible for the approval of research projects and dealing with the applications. The IRBs evaluate proposed research activities, making sure that the design of each study is consistent with sound scientific principles and ethical norms, such as obtaining informed consent. Applications can be rejected if they do not meet the criteria, which will prevent the research from taking place. The IRBs also have authority to seek a yearly review of the research. If the research involves vulnerable participants, reviews may be carried out more frequently. In addition, IRBs have the authority to “suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects.”27

THE SITUATION IN THE UNITED  KINGDOM

Before 2011, there was no one body that was responsible for oversight of the whole research process in the United Kingdom. This has since changed, with the establishment of the Health Research Authority (HRA), whose purpose is to protect and promote the interests of patients and the public in health research.28 The National Research Ethics Service (NRES) now comes under the aegis of the HRA and is responsible for providing guidance and the system of accreditation for research ethics committees (RECs). NRES does not have any formal compliance or inspection powers, though it is required to audit RECs in the United Kingdom on a regular basis. In the United Kingdom, there are in excess of 30 bodies that write guidelines that have relevance for medical research. The result is that there a lot of activity at the front end of research, in the form of guidance and the approval of medical research by research ethics committees, but little supervision after it has been approved and is underway. The HRA may go some way towards changing this situation and providing a more cohesive approach to the regulation of medical research in the United Kingdom.

There are five other bodies in the United Kingdom that have powers of enforcement and supervision. These are the General Medical Council, the Information Commissioner, the Human Tissue Authority, the Human Fertilisation and Embryology Authority, and the National Health Service. The Human Tissue Authority is also responsible for licensing collections of biological samples, although there are numerous exemptions for research collections. The Information Commissioner’s Office (ICO) has a light touch when it comes to implementing the regulation, as it does not have a system of regular inspection or oversight. However, the ICO has recently been given powers to impose fines of up to £500,000 for breaches of the Data Protection Act, which has greatly increased the effectiveness of the ICO to enforce compliance with the Act. The Human Fertilisation and  Embryology Authority has several powers of inspection and enforcement for ensuring compliance, but its scope is restricted to gametic materials and embryos.29 The National Health Service as an employer also has  professional supervisory procedures in place, such as requiring Caldicott Guardians to be appointed to ensure that ethical practices are followed. “A Caldicott Guardian is a senior person responsible for protecting the confidentiality of a patient and service-user information and enabling appropriate information- sharing.”30 Under Health Service Circular: HSC 1999/012, each NHS organisation that has access to patient records is required to have a Caldicott Guardian.

Research Ethics Committees are the main decision-makers in determining if, and how, medical research should proceed in the United Kingdom. All biomedical research projects must undergo both ethical review and technical scientific appraisal before any research begins. Only research covered by  the U.K. clinical trials regulations31 and the Human Tissue Act of 2004 must be submitted to research ethics committees for approval; researchers in other areas are under no such obligation. Research Ethics Committees have no power to inspect research projects once they have commenced, so that approval has become a hurdle that just needs to be passed. This is in contrast to the powers of the IRBs in the United States.

Research Ethics Committees in the United Kingdom are concerned primarily with research that involves NHS patients, premises, staff, or tissue samples. If research does not fall within this ambit, “this does not mean the project team can pursue their work unrestrained. It would be highly unusual if the study did not fall within the remit of at least one (and possibly several) other regulatory bodies.”32 Whether research falls within the remit of the Research Ethics Committees or not, there will inevitably be further documents to be completed by the researcher in order to carry out their research. These are likely to include university registration documents and hospital approval forms, amongst others.

CONCLUSION

New developments in the regulation of medical research have come about largely in response to public scandals. For instance, in the United Kingdom, the unlawful collection and storage of human tissue and organs at Alder Hey and Bristol resulted in the Human Tissue Act of 2004. These changes have led to a “layering” effect of oversight mechanisms and an increase in the number of requirements for research to be approved, which in turn has led to frustration for researchers. As Shaw and her colleagues state:

In the UK the rapid growth of systems and procedures for research management and governance has generated confusion and resentment in the research community. They bemoan the rising burden of paperwork, the curtailment of research freedom, expensive delays caused by lengthy application procedures, inconsistent decisions, and in some cases, the halting of entire research programmes by allegedly heavy handed but misinformed ethics committees.33

The establishment of the HRA is intended to address this situation by having one body that is responsible for medical research regulation.

In the United States, scandals have also led to changes in the regulatory system for medical research. For example, the Tuskegee Syphilis Study led to the enactment of the National Research Act of 1974 and the formation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. More recently, the financial conflicts of interest in the early 1990s have led to monographs providing guidance by the Association of American Medical Colleges and the Association of Academic Health Centers.34

However, the essential difference between the United States and the United Kingdom is that there is a clear legislative basis for the regulation of research in the United States. Federal legislation provides a framework that gives clarity and certainty as to how, and on what basis, medical research should proceed. The changes to the Common Rule proposed by the Department of Health and Human Services would retain this basic framework, but in a modernized and more streamlined form. The bodies that are involved in the supervision of research, such as the IRB and the OHRP, have considerable powers and legal authority to enforce their decisions. They are therefore able to  take  action  when  research  projects  are  failing  to  meet  the required standards. But the weakness of the American system is that it does not have universal application to both public and private sectors where research is carried out.

The purpose of this chapter has been to give an overview of the legal framework for medical research in the United Kingdom and the United States, the bodies that are responsible for overseeing research in each nation, and to illustrate the different powers that they exercise. In the space available, I have only been able to give a board overview of the current regulatory frameworks for medical research in the two jurisdictions, which are in a constant state of change. It is evident that there are differences between the two systems, which reflect the societal concerns and the historical contexts of medical research in which they have been developed. Both systems have to be understood and complied with if researchers in each jurisdiction wish to collaborate. There is scope for further comparison and review of the two jurisdictions in order to make an assessment of the best procedures for medical research on human beings, as well as the implications that this may have for global genomic research.

ACKNOWLEDGEMENTS

My thanks go to Heather Griffin for her assistance in updating this chapter in light of considerable changes to the regulation of research in the United Kingdom and the United States since the previous edition of this volume. This research was funded by the Wellcome Trust (096599/2/11/Z; WT091310).

REFERENCES

1.   U.S. Department of Health and Human Services. 45 CFR 46. Fed Regist 1991;56: 28012.

2.   U.S. Department of Health and Human Services. 45 CFR 46. Fed Regist 1991;56: 28012.

3.   Office for Human Research Protections website: http://www.hhs.gov/ohrp/ Accessed Dec. 12, 2012.

4.    Federal Register Vol. 76, No. 143, July 26, 2011, p44512.

5.    Federal Register Vol. 76, No. 143, July 26, 2011, p44512. 6. Pub L No. 96-517, 35 USC (1980).

7.    Although the Supreme Court’s decision in Stanford University v. Roche Molecular Systems et al. (09-1159) Feb. 28, 2011, may have curtailed the effects of this legislation.

8.    George, A.J. 2002. Medical privacy and medical research—judging the new federal regulations. New England Journal of Medicine, Vol. 346, No. 3: 216–220.

9.     Library of Congress website, http://thomas.loc.gov/. Accessed Jan. 23, 2013.

10.   The devolution of powers to the Scottish and Northern Ireland Parliaments means that legally the concept of the United Kingdom is becoming increasingly complex. Over time, the law in these countries will start to deviate from that of England and Wales.

11.    The Cruelty to Animals Act of 1876.

12.    Kaye, J., et. al. Governing Biobanks—Understanding the Interplay Between Law and Practice (Hart Publishing:Oxford 2012).

13.    L 121/34, Official Journal of the European Communities, 1.5.2001.

14.    Bolitho v. City and Hackney Health Authority [1998] AC 232. 5. (2000) 54 BMLR 8 (QB).

15.    Creutzfeldt-Jakob Disease Litigation, Plaintiffs v. United Kingdom Medical Research Council and another QB 54 BMLR 8.

16.   Sidaway v. Bethlem Royal Hospital Governors [1985] AC 871 (HL). 8. (2004) UKHL 41.

17.    Case No. 4:03 cv 01065 SNL. http://prostatecure.wustl.edu/. Accessed April 28, 2006. Appealed in 2007; 490 F.3d 667.

18.    661 So 2d. 278 (Florida 1995).

19.    677 A. 2d 1188, 683 A 2d 1163 (New Jersey 1996).

20.    Nos. C9-02-1821, C9-02-1837 (Minnesota 2004).

21.    Recombinant DNA Advisory Committee (RAC) website, http://oba.od.nih.gov/rdna_rac/rac_about.html. Accessed Dec. 11, 2012.

22.    Office of Human Research Protections website, http://www.hhs.gov/ohrp/about/facts/index.html Accessed Dec. 11, 2012.

23.   http://www.hhs.gov/ohrp/humansubjects/commonrule/

24.   George, A.J.T., et al., 2002. Research governance at the crossroads. Nature Medicine Vol. 8, No. 2: 99.

25.    U.S. Department of Health and Human Services. 45 CFR 46. Fed Regist 1991;56: 28012. Para 46.113.

26.   HRA website: http://www.hra.nhs.uk/about-us/. Accessed Jan. 23, 2013.

27.   Human Fertilisation and Embryology Act, 1990 (HFEA).

28.   http://systems.hscic.gov.uk/data/ods/searchtools/caldicott/index_html

29.   SI 2004/1031 (Medicines for Human Use [Clinical Trials] Regulations).

30.   Shaw, S. et al. 2005. Research governance: where did it come from, what does it mean? Journal of the Royal Society of Medicine, Vol. 98: 496, 498.

31.   Shaw, S. et al. 2005. Research governance: where did it come from, what does it mean? Journal of the Royal Society of Medicine, Vol. 98: 496.

32.   Korn, D. 2000. Conflicts of interest in biomedical research. Journal of the American Medical Association. Vol. 284, no. 17, 2234.

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