IPPCR 2018: Legal Issues in Clinical Research

Summary

Carrie Kennedy, a senior attorney with the HHS Office of the General Counsel, discusses legal issues in clinical research, focusing on informed consent, the evolution of advanced directives, and surrogate decision-making. She also addresses children's research, confidentiality, privacy, authorship rights, and legal liability for federal and nonfederal researchers. The talk outlines the legal framework, including the Common Rule and the Belmont Report's ethical principles, and provides insights into consent processes, advanced directives, and the handling of medical records and privacy under the Privacy Act and HIPAA.

Takeaways

• 📜 Informed consent is a foundational principle in both medical care and research, ensuring patients understand procedures, treatments, and associated risks.
• 🏛️ The legal framework for clinical research in the U.S. is based on the Constitution, followed by laws passed by Congress, executive orders, regulations, and federal policies.
• 📚 The HHS regulations at 45 CFR 46, particularly the Common Rule in Subpart A, govern research involving human subjects, and are implemented by the Office for Human Research Protections (OHRP).
• 🔍 Informed consent requires clear communication about the nature of the research, duration, purpose, risks, benefits, and the voluntary nature of participation.
• 👶 Special considerations are required for research involving children, including obtaining assent from the child and consent from parents or legal guardians.
• 📝 Medical records and research records at NIH are distinct, with strict rules on accuracy, timeliness, and confidentiality, guided by the Privacy Act and other regulations.
• 🛡️ The Privacy Act and HIPAA govern the disclosure of personal information, ensuring patient privacy and outlining circumstances under which information can be shared without explicit consent.
• 🖋️ Authorship in research publications should reflect significant contributions to the study, with specific policies guiding the assignment of authorship.
• ⚖️ The Federal Tort Claims Act (FTCA) provides immunity to federal employees from personal liability for negligence claims arising from their official duties, with the government assuming responsibility.
• 🏥 Advanced directives and surrogate decision-making are crucial for patients who cannot make their own medical decisions, with specific legal frameworks guiding these processes.

Q & A

What is the role of Carrie Kennedy as a senior attorney with the HHS?

Carrie Kennedy serves as a senior attorney with the HHS, Office of the General Counsel, specifically with the NIH branch. Her role involves advising the National Institutes of Health on legal issues, particularly in the areas of human subjects research and the clinical center, which is the NIH research hospital.

What are the objectives of the lecture presented by Carrie Kennedy?

The objectives of the lecture are to discuss the history and elements of informed consent for clinical and research care, summarize the evolution of advanced directives and surrogate decision-making, address research-specific issues regarding children, and examine legal issues related to medical records, confidentiality, privacy, authorship rights, and legal liability for federal and nonfederal clinical researchers at the NIH clinical center.

Can you explain the legal framework in the United States as presented by Carrie Kennedy?

The legal framework in the United States is structured with the Constitution at the highest level, followed by laws or acts passed by Congress which are codified in the United States Code (USC). Below that are executive orders by the president, regulations passed by federal agencies as authorized by law, and finally, federal policies.

What is the significance of 45 CFR 46 in the context of the lecture?

45 CFR 46 refers to the Code of Federal Regulations specific to the Department of Health and Human Services (HHS). It contains the HHS regulations governing the protection of human subjects in research. Part A of these regulations is often called the Common Rule, which is followed by 15 other agencies and is crucial for the discussion on informed consent and human subjects research.

What is the Belmonte Report and its relevance to human subjects research?

The Belmonte Report was formed in 1978 by the first bio-ethics commission in the United States. It identified three fundamental ethical principles for human subjects research: respect for persons, beneficence, and justice. These principles have significantly influenced the development of regulations and ethical considerations in research involving human subjects.

How does the revised Common Rule affect informed consent?

The revised Common Rule, effective January 2019, includes changes to informed consent aimed at increasing autonomy and understanding of individual subjects. It introduces requirements such as presenting key information first, providing sufficient detail to inform subjects' decisions, and including additional elements like the use of identifiable private information for future research, potential commercial profit, and the return of clinically relevant information.

What is the concept of 'broad consent' as introduced in the revised Common Rule?

Broad consent is an option introduced in the revised Common Rule that allows for the collection of identifiable private information or bio-specimens with the consent of the subject for storage, maintenance, and use in future research. The purpose of future use can be stated broadly or narrowly, providing flexibility for institutions and researchers.

What are the legal considerations for obtaining informed consent in research?

In research, informed consent must be voluntary, and the disclosure must include relevant information that is comprehensible to the participant. The consent process involves explaining the research purpose, duration, procedures, risks, benefits, and the participant's right to withdraw at any time without penalty.

Who can provide consent for a child participating in research?

For children participating in research, consent is generally sought from both parents or legal guardians. However, Institutional Review Boards (IRBs) can approve consent from only one parent for lower-risk research. In certain circumstances, such as foster care, the legal authority to consent may lie with a court or Child Protective Services.

What is the difference between a guardian and a legally authorized representative in the context of research?

A guardian is appointed by a court to make decisions for an individual who is deemed incapable. A legally authorized representative, as defined in the HHS and FDA regulations, is a person or entity authorized under law to consent on behalf of a subject for their participation in research. This can include parents, legal guardians, or entities like child protective services or the court.

How does the concept of 'assent' apply to children in research?

Assent is the process of obtaining affirmative agreement from children who are not of legal age to provide formal consent. While children cannot legally consent to participate in research, they can be asked to assent, indicating their willingness to participate after being provided with appropriate information about the study.

What are the legal implications of the Federal Tort Claims Act (FTCA) for NIH employees?

The Federal Tort Claims Act (FTCA) allows the U.S. government to be sued in certain circumstances, providing an exclusive remedy for those with complaints against the government and its employees. Under FTCA, the government provides immunity to employees from claims of negligence related to their scope of employment. If a claim is filed and results in damages, the government, rather than the individual employee, would be responsible for the payout.

What is the role of the Institutional Review Board (IRB) in the context of research?

The Institutional Review Board (IRB) is a group tasked with overseeing and ensuring that the protocol submitted to them and approved meets the regulatory requirements for the protection of human subjects. They review research proposals to ensure that they adhere to ethical principles and regulations, including informed consent and the protection of privacy and confidentiality.

How does the Privacy Act impact the handling of medical records at the NIH Clinical Center?

The Privacy Act prohibits the disclosure of records that can be retrieved by an individual's name or identifying number to third parties without the written consent of the individual, unless one of the 12 disclosure exceptions in the Act applies. This means that medical records at the NIH Clinical Center are generally not disclosed without patient consent, and any disclosure must be limited and follow strict guidelines.

What are the considerations for authorship and data rights in research publications?

Authorship is generally based on significant contributions to the conceptualization, design, execution, and/or interpretation of the study. Data rights for research conducted within the NIH intramural program are typically the property of the federal government, with protections for both researchers and the government. For extramural research, where NIH funds outside institutions, data rights may vary and are subject to specific agreements.

How does the Health Insurance Portability and Accountability Act (HIPAA) apply to research and clinical care?

HIPAA applies to covered entities and requires that individuals give authorization for the use or disclosure of Protected Health Information (PHI). While NIH itself is not a covered entity, many collaborators and partners may be subject to HIPAA. HIPAA aims to balance the need for information exchange for clinical and research purposes with the protection of patient privacy.

Outlines

00:00

👩‍⚖️ Introduction to Legal Issues in Clinical Research

Carrie Kennedy, a senior attorney at the NIH branch of the HHS Office of General Counsel, introduces herself and outlines the objectives of the session, including discussing informed consent, advanced directives, research involving children, and legal liability for federal employees. She provides a basic legal framework in the U.S., highlighting the hierarchy from the Constitution to federal policies.

05:03

📜 Historical Context and Ethical Principles

Carrie provides a brief history of human subject regulations, starting with HHS's regulations in the 1970s and the Belmont Report in 1978, which established ethical principles for human subjects research. She explains FDA's separate regulations and similarities with HHS's Common Rule. Changes to the Common Rule effective January 2019 aim to enhance informed consent and protect individual autonomy and understanding.

10:04

🔄 Informed Consent and Its Evolution

Carrie discusses the evolution of informed consent, initially viewed through the lens of battery claims in law. She describes landmark cases that shaped the concept, leading to the reasonable patient standard for informed consent. The process includes comprehensive disclosure of relevant information and ensuring consent is voluntary and understandable.

15:07

👥 Legal Standards for Informed Consent

Focusing on the process and standards of obtaining informed consent, Carrie emphasizes that it is not merely about signing a form but ensuring the patient's understanding. She details who can obtain and provide consent, stressing institutional policies and the need for effective communication and deep understanding of the research or clinical procedure.

20:10

🧑‍⚖️ Guardianship and Advanced Directives

Carrie explains the role of legally authorized representatives and the necessity of advanced directives in research. She outlines the types of surrogate consent, including legally appointed guardians, living wills, and durable power of attorney for healthcare, and discusses state laws affecting guardians' consent capabilities.

25:14

📝 Advanced Directives: Living Wills and Durable Power of Attorney

Delving deeper into advanced directives, Carrie differentiates between living wills and durable power of attorney for healthcare. She highlights the flexibility and durability of power of attorney, noting state-specific variations and relevant court cases that influenced the legal landscape around advanced directives.

30:14

👶 Consent for Research Involving Children

Carrie addresses the participation of children in research, defining a child under research regulations and the requirement for parental or guardian consent. She discusses exceptions, the role of foster care, and the mature minor exception, ensuring legal authority for consent in clinical settings.

35:17

📂 Medical Records and Documentation

Carrie outlines the importance of accurate and timely medical records for continuous patient care and research. She explains the distinction between medical and research records at NIH, emphasizing confidentiality and the role of the Privacy Act in protecting patient information.

40:17

🔒 Privacy Act and Confidentiality

Detailing the Privacy Act, Carrie explains its provisions for protecting individual records, exceptions for disclosure, and applicability to U.S. citizens and lawful aliens. She contrasts it with the Freedom of Information Act (FOIA) and highlights the need for privacy coordinators to ensure compliance with both acts.

45:20

🔐 HIPAA and Protected Health Information

Carrie introduces HIPAA, its relevance to NIH researchers, and the concept of Protected Health Information (PHI). She explains HIPAA's balance between information exchange and patient privacy, its application to decedent information, and the role of authorizations and waivers in research.

50:21

✍️ Authorship and Data Rights

Discussing authorship in research publications, Carrie emphasizes policy-driven standards for significant contributions. She explains NIH's stance on data rights, differentiating between intramural and extramural research, and the ownership of data and inventions.

55:24

⚖️ Legal Liability and Malpractice

Carrie concludes with an overview of legal liability and malpractice protections under the Federal Tort Claims Act (FTCA). She explains how the FTCA provides immunity to federal employees, the process for filing claims, and the requirement for non-federal healthcare professionals to maintain professional liability insurance.

Keywords

💡Informed Consent

Informed consent is a fundamental principle in medical ethics and research, requiring that participants in clinical trials or patients undergoing treatment are given comprehensive information about the procedures involved, their risks, benefits, and alternatives. This ensures that the individual can make a voluntary and informed decision about their participation. In the context of the video, informed consent is discussed in relation to both clinical care and research, emphasizing the legal and ethical obligations to ensure that subjects fully understand what they are agreeing to. The script mentions the evolution of informed consent and the changes made to increase autonomy and understanding of participants.

💡Human Subjects Research

Human subjects research refers to any systematic investigation that involves human beings as research subjects. This can include clinical trials, behavioral studies, and any research that collects data from or about individuals. The video discusses the legal issues surrounding this type of research, particularly the ethical principles outlined in the Belmont Report and the regulations set forth by the HHS and FDA to protect the rights and welfare of participants. The script also touches on the history of human subjects regulations and the importance of informed consent in this context.

💡Clinical Center

The clinical center mentioned in the video refers to the NIH research hospital, which is a specialized medical facility that conducts clinical research. Clinical centers play a crucial role in translating scientific discoveries into medical practice by providing a controlled environment for patient care and research. The script discusses the legal issues related to medical records, confidentiality, and privacy in the context of a clinical center, highlighting the importance of protecting patient information and maintaining ethical standards in research.

💡45 CFR 46

45 CFR 46 refers to Title 45 of the Code of Federal Regulations, Part 46, which contains the U.S. Department of Health and Human Services regulations for the protection of human subjects in research. This set of regulations is commonly known as the 'Common Rule' and is followed by numerous federal departments and agencies. The video script discusses the significance of 45 CFR 46 in governing the conduct of research involving human subjects and the revisions made to the rule to enhance the protection of participants.

💡IRB (Institutional Review Board)

An Institutional Review Board, or IRB, is a committee that reviews, approves, and monitors biomedical and behavioral research involving humans. The IRB ensures that the research is conducted ethically and that the rights and welfare of the participants are protected. The script explains the role of IRBs in overseeing research protocols and ensuring compliance with regulations such as 45 CFR 46, as well as the changes to the Common Rule that affect IRB operations.

💡OHRP (Office for Human Research Protections)

The Office for Human Research Protections, or OHRP, is an office under the U.S. Department of Health and Human Services that provides leadership in the protection of human subjects involved in research. OHRP oversees the implementation of the HHS regulations and provides guidance on ethical issues in research. The video script describes OHRP as the regulatory body responsible for the oversight of 45 CFR 46 for HHS, emphasizing its role in ensuring compliance and protection of human subjects.

💡Intermural Research

Intermural research refers to research conducted within an institution, in this case, the NIH. It involves staff researchers and clinicians working at NIH or NIH-approved sites to perform research on behalf of the NIH. The script differentiates intermural research from extramural research, which involves grantees receiving NIH funding to conduct research at external institutions or academic centers.

💡Advanced Directives

Advanced directives are legal documents that allow individuals to make their healthcare preferences known in advance, typically in situations where they may be unable to communicate their wishes directly. These can include living wills, which specify life-prolonging treatments the individual does not want, and durable powers of attorney for healthcare, which appoint a proxy to make medical decisions. The video discusses the importance of advanced directives in the context of surrogate decision-making, especially when the individual is unable to provide informed consent.

💡Privacy Act

The Privacy Act is a U.S. federal law enacted in 1974 that establishes a code of fair information practices that governs the collection, maintenance, use, and dissemination of personally identifiable information by federal agencies. The script discusses the Privacy Act in the context of medical records disclosure, emphasizing its role in protecting the privacy of individuals and regulating how personal information can be shared by government agencies like the NIH.

💡FOIA (Freedom of Information Act)

The Freedom of Information Act, or FOIA, is a federal law that grants individuals the right to access records from federal agencies. Enacted in 1966 and expanded in 1974, FOIA is designed to promote transparency and accountability in government. The video script mentions FOIA in the context of record requests, explaining that while it provides access to information, it also includes exemptions that allow the government to withhold certain information to protect privacy and other interests.

💡HIPAA (Health Insurance Portability and Accountability Act)

HIPAA is a federal law that was enacted in 1996 to protect the privacy and security of individuals' health information. It establishes national standards for the transmission of certain health information and requires covered entities to obtain authorization for the use or disclosure of protected health information. The script notes that while NIH itself is not a covered entity under HIPAA, the law is relevant to NIH researchers who collaborate with or receive data from covered entities.

💡Legal Liability and Malpractice

Legal liability and malpractice refer to the legal responsibilities and potential claims of negligence or misconduct that healthcare professionals or researchers may face in their professional activities. The script discusses the protections provided by the Federal Tort Claims Act (FTCA) to federal employees, which includes clinical researchers and clinicians at the NIH, and how it affects the process of filing claims and seeking compensation for malpractice or negligence.

Highlights

Carrie Kennedy introduces herself as a senior attorney with the HHS Office of the General Counsel, specializing in human subjects research and the clinical center.

The lecture will cover legal issues in clinical research, including informed consent, advanced directives, and research involving children.

The US legal framework is outlined, starting with the Constitution and followed by laws, executive orders, regulations, and federal policies.

45 CFR 46 is the central focus, detailing HHS regulations on human subject research, including the Common Rule applicable to 15 other agencies.

OHRP and OHSRP are explained as the oversight authorities for 45 CFR 46, distinguishing their roles within HHS and NIH respectively.

The Belmonte Report's three fundamental ethical principles for human subjects research are discussed: respect for persons, beneficence, and justice.

FDA has its own regulations on human subjects protections, separate from HHS, under 21 CFR 50 and 56.

The revised Common Rule of 2018 introduces changes to informed consent to increase autonomy and understanding of research participants.

Key elements of informed consent under 45 CFR 46.116 are detailed, including new requirements for future use of identifiable information.

Broad consent is introduced as an option under the revised Common Rule, allowing for future use of identifiable bio-specimens and information.

The concept of informed consent is rooted in common law and developed through significant court cases like Schloendorff v. Society of New York Hospital.

The Nuremberg Code and its influence on the development of ethical standards for human subject research are discussed.

The process of obtaining informed consent is emphasized as an ongoing process beyond just signing a form.

The roles of guardians, advanced directives, and surrogate decision-makers are explained in the context of research with incapacitated adults.

Legally authorized representatives in research are defined and distinguished from other legal roles.

The importance of state laws in determining the authority of guardians and surrogates to consent to research is highlighted.

The Patient Self-Determination Act is discussed, emphasizing the rights of patients to execute advanced directives.

The hierarchy of surrogate decision-makers and the conditions under which substituted consent can be given are outlined.

The participation of children in research is discussed, including the legal authority to consent and the assent of the child.

The distinction between medical records and research records at the NIH Clinical Center is explained, along with their purposes.

The Privacy Act of 1974 is detailed, including its protections for individuals' records and the conditions for disclosure.

The Health Insurance Portability and Accountability Act (HIPAA) and its relevance to NIH researchers are discussed, despite NIH not being a covered entity.

Authorship in research publications is discussed, emphasizing the NIH policy requiring significant contributions for authorship designation.

Data rights for intramural and extramural research at NIH are explained, highlighting the differences in ownership and protections.

Legal liability and malpractice are discussed in the context of clinical researchers and clinicians at NIH, including the protections under the Federal Tort Claims Act (FTCA).

Transcripts

>> Carrie Kennedy: Hi there, thank you for joining me.

My name is Carrie Kennedy,

I'm a senior attorney with the HHS

Office of the General Counsel; I'm with the NIH branch,

the National Institutes of Health branch,

so we advise, in particular, the National Institutes of Health.

My particular backgrounds in the areas

in which I advise include human subjects research

and the clinical center,

which is the NIH research hospital.

And today, we'll be talking about

just some of the legal issues that occur in clinical research.

So, the objectives today, as you can see from the slides,

are we're going to discuss the history and elements of informed

consent for both clinical and research care,

summarize the evolution in types of advanced directive

and other surrogate decision making,

and discuss research specifically regarding children.

We'll examine issues related to medical records

and documentation,

protection of confidentiality and privacy.

We'll discuss, in some part, authorship rights

to research data and protections of legal liability

for federal employees and nonfederal clinical researchers

in particular at NIH clinical center.

We won't be going into a whole lot of detail

about technology transfer issues,

because I understand you have another lecture

on that particular topic.

So, before we get into the crux of this side

with the resources and the legal background, for those people --

I know there's a lot of people signed up for this course

who are international and not located in the United States.

So, to give them just a basic background,

in the United States,

we get the most deference to the constitution.

After that becomes --

so, the constitution's the highest level.

Next would be laws or acts passed by congress,

and those get codified in something called

the United States Code or the USC.

Typically below that, you can have an executive order

by the president,

which is a directive to do something,

followed by regulations.

Regulations are substantive rules

passed by federal agencies as authorized by law.

So, as authorized by a United States Code

or an act passed by congress.

The agency can take that authority

and make its own regulations,

and move forward and implement those regulations

and oversee those who are subject to the regulations.

And then below regulations are federal policy.

So, that's kind of the legal framework

of what we'll be talking about today,

just to give you that background.

So, as you can see in this slide,

a large focus of our discussion will be on 45 CFR 46.

CFR is Code of Federal Regulations;

that's where agencies publish their regulations

to make them official.

The HHS regulations are at 45 CFR 46.

So, 45 is an HHS specific CFR,

and you can see there are five subparts to the HHS regulations.

Part A of the HHS regulations is often called the Common Rule.

That's because 15 other agencies have the same exact regulation.

It will be found in a different part of the CFR,

but it's the same--

[audio echoes] Sorry, we have a little echo here.

Okay, the echo's gone [laughs].

Anyway, and so they might not have,

and typically do not have sections B-E like HHS does,

but Part A is the uniform for those 15 agencies.

It's easier for implementation when we're talking about

how to regulate research involving human subjects.

There's also three other agencies and departments

in the United States that follow what we call the Common Rule

as a matter of practice,

but they have not actually formalized it in a regulation.

The group that has the oversight authority

for 45 CFR 46 for HHS, they're called OHRP,

or the Office for Human Research Protections.

They are an HHS operating division,

similar to how NIH is an HHS operation division.

NIH has an office that oversees how NIH implements 45 CFR 46.

And this is a policy group,

and that's for those of you who are at the NIH,

or work at the Clinical Center,

or in different institutes or centers.

ICs at NIH, that office is OHSRP.

So, I know sometimes the wording confuses people,

but those are different offices in their house

and different operating divisions of HHS.

Again, OHRP is the regulatory group,

OHSRP is an NIH policy group

that oversees the implementation and compliance at NIH

for the intermural program. The intermural program--

I know this is a lot of background,

just trying to make sure we're all on the same page--

the intermural program at NIH

are those staff researchers and clinicians who work at NIH

or NIH approved sites to perform research on behalf of NIH.

It's different than what we would call

our NIH extramural researchers,

and those are usually our grantees

who NIH gives money to fund research,

let's say at an institution or an academic center.

So, a little bit of history as you probably heard

in some of your earlier lectures,

but just in case you haven't:

HHS actually came out with its first set

of human subject regulations in the 1970s;

and in 1978, the first, essentially,

bio-ethics commission in the United States

formed the Belmonte Report.

And that identified three-- well, it considered fundamental,

ethical principles for human subjects research,

respect for persons, beneficence, and justice.

And you'll see on the slide here,

that FDA has its own human subjects regulations.

That's somewhat of an anomaly because FDA is part of HHS,

but FDA is, in itself, is its own regulatory entity,

and so it has its own rules, which it oversees.

21 CFR 50-- the 21s of the CFRs are also HHS, just so you know--

21 CFR 50 are the FDA regulations

on human subjects protections,

and 56 regards the IRB, or Institutional Review Board.

IRBs are the groups that are tasked to oversee

and assure that the protocol submitted to them and approved,

as required by the regulations, meet the regulations.

So, parts 50 and 56 really are very similar

to 45 CFR 46, subpart A.

Parts 312 for the FDA regard investigational

new drug applications, so if you are testing,

part of your research question involves a drug,

and 812 regards investigational device exemptions.

So, to further discuss some additional resources

and backgrounds related to the Common Rule 45 CFR 46,

we can talk about some of the changes

made to the rule that will become effective very soon.

These changes began in their implementation in 2011,

and were culminated in the final rules publication in 2017.

The rule that is going to be effective in January 2019,

we refer to most often as the 2018 requirements,

or the revised common rule. And, although I don't have time

to discuss all of the provisions of the revised common rule,

I thought that the most relevant ones for this discussion

would be those related to informed consent.

And informed consent provisions in both the current rule

and in the revised rule are found at 45 CFR 46.116.

The changes to the common rule for informed consent

were really made to increase and foster autonomy

of the individual subject, as well as to increase

the subjects understanding of what he or she was agreeing

to when participating in research,

and to try to decrease what might be seen

as unhelpful boiler plate found in consent forms.

There are some changes to how informed consent

is presented to a subject.

An example would be that key information

must be presented first,

and must be presented in sufficient detail

to foster the subjects understanding of why he

or she may or may not want to participate in research.

Further, while the existing elements of 116

have not changed,

there are additional elements in the revised common rule

that I will touch on some of the points of examples.

And some of these might not be new in concept,

and might already be implemented at many institutions

through policy or practice,

but now they are being required through the regulation.

For example, one is that,

for research that involves identifiable private information

or identifiable bio-specimens, a statement about the use

of that identifiable private information

or bio-specimens for future research.

Another element of informed consent

under the advised common rule

will be that a subject must receive notice

about potential commercial profit that the institution

might benefit from as related to the research,

and that might include whether or not that individual gains

in any of that commercial profit.

As a third example, the informed consent provisions will discuss

when clinically relevant information

will or might be returned

to subjects that are enrolled in the research,

and also whether the research will

or might include whole genome sequencing.

Another element that will be addressed

explicitly in the regulations of the revised common rule

regards broad consent.

In the current framework, if you are doing research in today,

let's say, and your research involves identifiable

private information or identifiable bio-specimens,

and then five years down the road,

a different researcher wants to use

that identifiable private information

or identifiable bio-specimens for his or her own research,

that person has a few options

in terms of how to satisfy the common rule for preceding.

One would be to de-identify the information or specimens

and proceed

because they are outside of the scope of the common rule,

but if they wanted to use identifiable information

for whatever reason,

they could try to go back and find

and then consent each individual

to then use their identifiable information

for this newer study a few years down the line,

or seek an IRB waiver for informed consent

for the secondary research.

The revised common rule has a fourth option--

it's not a requirement, it's an option--

and the fourth option adds flexibility,

and so if an institution anticipates

that data or information they're collecting now

might be useful in the future,

and identifiable form for another study,

they can obtain an informed consent for broad future use.

And what that looks like is some of the provisions are similar

to what you would have for the current use of informed consent

and others that would be slightly different,

and that's all covered in the rule at 116d

in the revised rule.

But, effectively, you're obtaining informed

consent from the subject for storage maintenance

and use of future identifiable bio-specimens

and identifiable information.

And the future use purpose can be stated

as very narrow or very broad

as deemed appropriate by the institution

and the IRB at the institution.

So, now for informed consent.

So, now we know that informed consent

is essentially the bedrock principle

of medical care and research care.

It was developed, in part, the idea of informed consent,

through common law, which is precedence set by court cases

and judicial decisions as opposed to law

that was passed by legislatures

at either the state or the national level.

The law began, in terms of informed consent,

looking at it as a issue of a battery claim.

So, in the law for battery, you have to prove physical

touching regardless of harm without consent.

And one of the first cases known for considering these types

of informed consent issues, but as a battery concept

was the one I have on this slide before you.

In that one, the plaintiff claims

that he had agreed to an exploratory exam

related to some stomach fibroid tumors,

and during that exam the surgeon went ahead

and actually removed the tumors, which the patient, or plaintiff,

then said caused some additional distress and surgeries.

And so, that was the case where the court

considered the additional action by the provider

that wasn't known to the patient in advance

or agreed to by the patient in advance to be a trespass.

And a very famous Supreme Court Justice declared,

in his opinion regarding this case,

"every human being of adult years and sound mind has a right

to determine what shall be done with his own body."

So, that was in 1914,

and then I think the idea of informed

consent further developed by various intellectual bodies,

and some of them I've listed on this next slide.

The Nuremberg Code, as you might be familiar with,

was developed after the World War II

and it developed standards for physicians and scientist

who conducted biomedical experiments

on concentration camp prisoners.

And this code became the prototype for many other codes

intended to assure that research involving human subjects

would be carried out in an ethical manner.

And this was relied upon in the HHS Belmonte Report

that I referred to that

eventually led to the HHS regulations.

So, in this slide, you can see that the ideas of informed

consent

were then further solidified generally within the courts,

and the courts reframed the issue

as a negligence or malpractice action,

as opposed to an action of battery,

which we saw in the early 1900s.

Negligence, you have to prove that there's a duty owed,

the duty is breached, damages result,

and that the damage is actually caused by the breach.

In the case on the screen now,

this was the first case to actually use the term

"informed consent,"

and this was a case where somebody, a 55 year old,

had circulatory problems and underwent some surgery,

and it resulted in lower paralysis.

And the court determined

that there was a lack of informed consent,

and that the duty to disclose--

there was a duty to disclose certain risks

and obtain informed consent before performing procedures,

and that the patient should have been informed of these details,

again, in advance, including dangers.

The standard used in this case,

and which has been adopted and is still the standard today

is the reasonable patient standard,

which means, what would a reasonable patient

in those circumstances want to know?

This is as opposed to a reasonable physician standard.

So, it's a more patient-centric standard

that we use in the concept of whether informed consent

was satisfied.

So now let's move on to the process of talking

about obtaining informed consent.

Oh, and I'm sorry, I should have mentioned before I started,

or as I started, if any of you here with me have a question,

feel free to either interrupt by,

if you can, going to the microphone and asking question.

I also have breaks for questions throughout the lecture.

So, the informed consent process.

Today, courts generally focus on the quality of the consent.

It's not a legally effective consent

unless the patient understands the procedure,

and the treatment, and the risks.

The legal standard is the same, essentially, for research.

So, in research and in medical terms,

the consent needs to be voluntary,

it can't be against somebody's will.

The disclosure has to include relevant information,

it has to be comprehensible to the person,

either verbally or if it's a document in writing.

If it's in writing, it also has to be the appropriate language

and reading level, generally.

Again, the regulatory requirements are very similar

to what you would see in the medical context

for informed consent. There are some additional ones,

such as at 45 CFR 46, which we talked about earlier.

Subpart 116 has additional requirements

for informed consent.

So, one of those is, you have to be clear

and say what you're doing right now as the participant,

you say that's the participant

in your conversations and documents,

is "you're participating in research."

So it's clear it's not necessarily medical care,

but research.

That's you try to explain, to the best of your ability,

the duration of the research, the purpose of the research,

what if any will be experimental as part of the research,

that you're participation is voluntary

and you can withdraw at any time without loss of any benefits.

And the counterpart of the consent requirements

under the FDA regs is 21 CFR 50.25,

in case you are curious.

So, what must be disclosed?

So, in the informed consent process you generally diagnose

the following information on this slide.

You don't have to diagnose every possible risk,

again it's the reasonable patient standard,

it's based on the situation,

and a lot of degree to the clinician's judgement.

And often people ask how much information?

There's often concerns about what do we say

in the consent form,

we're concerned about the length,

again every risk, how much science.

For the research consents, how much must be explained?

And, again, it's about the digression

and understanding your patient population,

what they need to know to give you

legally effective informed consent.

Again, it's not every possible risk,

but it has to be a reasonable standard.

And I think we all probably know

this if we thought hard about it,

but informed consent is a process,

it's not simply just signing a form.

Sometimes we might feel like that,

when you go in for, let's say a medical procedure,

but it starts at the very beginning of the discussion.

It continues through, perhaps, execution of a written document,

and it can continue beyond that.

This slide explains who can obtain informed consent.

It's generally up to the institutional policy

of who can obtain it.

It has to be somebody who's not only effective communicator,

but has an in depth understanding

of the research procedure,

or if it's a clinical issue, the clinical procedure.

And then the other question

is on the counterpoint of obtaining it,

you can actually provide the consent.

A competent adult can provide informed consent.

In the United States, we as a legal matter assume

that once somebody has turned 18 they are competent

to make their own legal decisions.

If the adult is not competent, or if it's a child,

it would be the person's legally authorized representative.

Now, the term legally authorized representative

in the research context has a specific definition.

And it's defined in both the HHS regs

and the FDA regs as "another person,

such as a parent or a legal guardian,

or entity such as child protective services

or the court, who is authorized under law

to consent on behalf of the perspective subject

for the subjects participation in research,

and it's largely a matter of state law."

So now let's continue to discuss this concept

of legally authorized representatives,

and why it's necessary and useful.

So, like I said, competent adults--

we assume when somebody turns 18

that they will be able to make their own legal decisions.

If somebody's a competent adult,

they can consent to participation

in research or clinical care, or refuse.

If somebody lacks, as an adult, capacity to consent,

you can provide emergency clinical care.

If you're a clinician, you can provide emergency clinical care

if you can't obtain consent,

either from the patient or the surrogate.

However, research is another story.

Generally, it's not appropriate to initiate research

without obtaining legally effective consent,

from either the patient or their representative.

Which is why advanced directives in surrogates

are particularly useful in the research context.

So now let's get into the types of surrogate

or substitute consents.

There's three types with some subdivisions,

as you can see on this slide.

The first one we'll talk about are legally appointed guardians,

then we can talk about advanced directives.

And those, there's generally two types:

living wills or durable power of attorney for healthcare.

And the third type we'll talk about is substituted consent.

A guardian-- again, in the US if you're over 18,

there's the assumption that you're competent.

If a adult [sic] loses capacity,

or has never had capacity by the time they turned 18,

because of a developmental delay, let's say,

one can petition the court for guardianship.

This-- there's a whole legal process

that the court goes through. There's fact findings,

usually there's an attorney representing the person

who is being questioned in terms of their capacity.

And then the court makes a decision

about whether or not that person,

which we call, in the legal world,

"the ward" if it's deemed that they don't have capacity,

is able to make certain legal decisions on their own or not.

If a guardian is appointed-- so, let's say a guardian

is appointed for healthcare decision making,

the guardian, not the ward, consents in the future

and is the one who can give legally effective consent.

States have different laws about what a guardian can

and cannot consent to. For instance, some states,

I'd say maybe even many states have laws restricting guardians

from enrolling wards in medical or biomedical research,

or clinical research.

And that comes from legislative action by the state

in order to protect the ward.

And you can imagine where those types of laws

might have arisen out of.

If a guardian is a guardian of a state that has such a law,

at the clinical center what we do,

we accept guardians from 50 states where federally--

we have federal exclusive jurisdiction,

so we're not subject to state law per se by law,

but when it comes to guardians we follow the law of the state

where the guardian was appointed.

And so if the guardian doesn't have legal authority

to consent to research on behalf of the ward,

the guardian essentially would need to petition the court

for the additional authority to do so.

Okay, so let's move on to advanced directives.

As you can see, these are the two advanced directives

that I discussed-- that I referenced before.

A living will is very specific to the factual situations,

it discusses lifesaving measures that you would or wouldn't want,

such as a feeding tube, antibiotics,

and also for the types of usually very broad conditions

like persistent vegetative states.

And, as opposed to a durable power of attorney

for healthcare,

that is appointing a proxy decision maker.

It's appointing somebody and giving them flexibility

to make determinations based on a condition or situation

that may occur in the future.

The flexibility allows for a wide variety

of factual decisions

that you might not be able to anticipate,

as well as changes in technology, research,

and medicine that you might not be able to anticipate

through a living will.

And the word durable is added, and it has a specific meaning.

It means that the power of attorney

somebody is assigned lasts beyond their capacity.

So, if you assign a power of attorney,

depending on the state law,

but often times you have to specify that it's durable,

otherwise that power of attorney

is really only considered to have authority

when you are still competent. And if you lose competence,

they might not necessarily still have the authority

to make decisions for you.

And, again, that is a variable state by state.

And I mentioned-- I'm sorry.

In the prior slide, I didn't mention,

but it's written about a living

will that it usually relates to terminal conditions.

And the term terminal also varies state by state,

as decided by a legislature, sometimes court cases.

It generally means a condition from which

there can be no recovery, including death.

And, increasingly, states have been adding PVS

because it has been relevant.

And the way it's been relevant is in the courts,

and we might all remember some of these cases

that I've given as examples on this next slide:

the Quinlan, Cruzan, and Schiavo cases.

I'm happy to talk in detail about these cases

with anybody if they want,

but the general takeaway is that, generally, courts

and states favor the preservation of life

unless there's clear written statements by the person

before they've lost capacity to speak for themselves,

or the appointment of a proxy by that person.

For instance, in Quinlan, that was a 1979 case,

and it's known as a right to die case,

and the person was not terminally ill,

but was in a persistent vegetative state,

and it wasn't quite known what her wishes were.

And so, the state, it argued,

had an interest against anybody terminating life.

And the courts found that the state's interests weakens

as the individuals rights to privacy grows,

and the degree of bodily invasion increases,

and the prognosis dims.

The Cruzan case, which is also on this slide,

regards a woman who was 25 years old

and was in an accident and became,

also, in a persistent vegetative state,

and she had had a conversation with her friend

about her wishes. And the issue was about

what level of evidentiary standard the state

could require a family to prove

in order to remove life-sustaining support.

And the standard the state wanted to use was clear

and convincing evidence, which has a whole legal term

and lots of legal precedent behind it that I won't go into.

This case went to the Supreme Court,

and the Court ultimately stated that

that was an acceptable standard, that's a high standard,

but it was acceptable given the circumstances.

And it was remanded to this state court

for ultimate decision,

and what happened was the state withdrew its claim

and essentially ceded to the family

to make the decision that the family felt

was in the preference of Mrs. Cruzan.

And this, the takeaway, I guess of the legal summary

and kind of the crux of that case

was that the states interest in preserving life

was challenged by the family's constitutional ability

to refuse care, which is a 14th amendment due process.

They were due their due process prior to taking a liberty,

and the liberty here was the right to refuse treatment.

And so the courts were balancing the liberty interest

versus the state's interest.

And in the Schiavo case, that one really I mentioned

because it highlights what advanced directive

in living wills can do to prevent the, I guess,

unknowns in future, unanticipated circumstances.

In that case, Mrs. Schiavo had a cardiac arrest and a coma,

and was in PVS.

There was a feeding tube inserted,

and her husband wanted it removed,

and her parents petitioned against removal.

And this became a very controversial public issue.

But congress commented on it,

President Bush at the time commented on it,

there were 14 appeals in the courts of Florida,

five appeals to the federals,

four denials by the Supreme Court of the United States

simply about this one case alone.

And, again, it demonstrates the legal issues

when you have incapacitated adults

and you don't have a living will

or an advanced directive to understand

what they would have wanted.

And the last point I'll make on this slide

regards the Patient Self-Determination Act,

and that essentially requires that hospitals

who accept Medicare and Medicaid

funding to inform patients about their rights

to execute advanced directives,

and it's really a floor in terms of rights,

not a ceiling.

It prevents the hospitals from discriminating patients

who make advanced directives,

and it's intended to protect autonomy and self-determination.

So, we've talked about guardians,

and we've talked about advanced directives,

now we're going to move on and talk about surrogates.

Surrogates, the power of a surrogate varies

from state to state.

Some allow surrogates to make decisions only when it's known,

but the patient's wishes are. Some states, like Maryland,

allow the surrogate to make a decision

in the best interest of the patient.

The forms also vary state by state,

generally have to be voluntarily executed,

written, signed, and witnessed by two unrelated people.

For medical providers out there, you may be interested to know

that usually there's no criminal or civil liability

if medical providers, including researchers,

file an advanced directive in good faith

pursuant to reasonable medical standard.

And so, this puts a notice on medical practitioners to know

whether an advanced directive exists,

so that they can follow it.

And at the clinical center, again,

we are not subject to any particular state law,

but the clinical center accepts durable power of attorneys

and advanced directives from outside states or countries,

if patients bring them with them.

And we also allow patients to execute ones that we have here,

which actually specifically talks

about research participation.

And, as you'll see in the last bullet point on this slide,

some research protocols, as a condition of participation,

required the patient to have an advanced directive

because it's anticipated that the patient

will lose cognitive abilities, such as in an Alzheimer's study.

So, now let's talk about what happens

when somebody is a patient without a guardian,

without a durable power of attorney,

without a living will,

and then they become mentally incapacitated.

So, if they've expressed their wishes previously,

and certainly if they're documented

in the medical record,

clinicians can follow those wishes.

Without them, then there are certain ways for state law,

in particular, to authorize individuals

to give substituted consent for furnishing,

but not withdrawing care.

Unsubstituted consents, there's a hierarchy.

So, if a spouse or domestic partner exists--

and the example I have shown you is the clinical center policy,

which mirrors the Maryland law.

A spouse or domestic partner, and they can be on the same law

because that, as a legal matter, you can't have both.

You can only have one or the other.

So first is that, and then you can see the down--

the hierarchy.

If somebody higher on the hierarchy exists,

they're the ones to make the decision.

And, do you have any questions for me

before we move on to the next section?

Okay.

So, now we're going to talk about children

and their participation in research.

A child is a person who hasn't reached legal age to consent.

So, a child, as defined by the research regulations,

is a person who has not reached the legal age

to consent to the research, treatments,

or procedure under the applicable law

under the jurisdiction in which the research is to be conducted.

Different states have different laws,

typically child [sic] is somebody under 18.

Sometimes different clinical settings

that the age might be younger, such as obtaining sexual care,

healthcare, provision, and other circumstances.

At the clinical center, the definition of child is,

"anybody who is under 18 and not themselves married or a parent."

So, under the research regulations,

a child doesn't have the legal authority to consent,

but they can be asked to assent.

Generally, the permission is sought

from both parents of the child,

or in their absence it would be a legal guardian.

There are exceptions in the IRB,

again the Institutional Review Board

who looks at protocols before they're implemented,

can approve the consent of only one parent

as being sufficient in certain, usually lower risk research.

And something for clinicians to perform research related--

if you have a child who is in foster care,

you have to give extra scrutiny to the law of the state,

because you need to assure that the person

who has physical custody of the child

actually has the legal authority

to consent to their participation in research.

For instance, a foster parent

might not actually have that legal authority.

You might need to get it from a court

or the Child Protective Services of the state.

And, I should say,

when the permission of both parents is required

for consent under 45 CFR 46, there is a provision that,

if one parent is unavailable or deceased,

then both parents do not need to consent.

So, in the situation where you're dealing with children,

and the parent or legal guardian isn't available.

So, for emergency medical care

can be provided without consent [sic].

If a parent or legal guardian refuses to provide

their permission for research, their choice governs.

If they fail to provide consent for clinical care,

it depends on what the situation is, right?

If the benefits of the care outweigh the risks,

sometimes the state will step in,

or the hospital can seek a court order,

and in fact the parents' rights are essentially abrogated

and the court will speak on behalf of the child.

Sometimes, and in pretty rare exceptions,

I would say, you can have a mature minor exception.

And that is when a minor, who's usually closer to 18 years old,

but an older child can go through a court process

and petition the court to be deemed an adult

for the purposes of making their own legal decisions.

And the court usually tries to assure that this minor,

person under 18, understands the consequences

and permanency of their medical decisions.

And sometimes, this comes up in the case.

One example could be Jehovah's Witnesses and a child

understanding the implications of not receiving, for example,

a blood transfusion

that might be critically necessary to their health.

And for children who are participating in research

at NIH, care providers and researchers

need to be sure that they know who has the legal authority

to consent for the particular child,

and ideally in advance of the child's arrival.

There's, in very, very rare circumstances,

the clinical center, at least,

will allow a temporary decision maker

in place of the parent to attend for the child

for their research visit to the clinical center.

And there's a lot of balances to be had in this situation,

such as how risky the trial is,

what clinical care might need to be provided,

what the child's current medical or future medical state may be,

and why the parent can't attend.

Convenience isn't usually accepted

as a sufficient rational,

but let's say you're in your ninth month of pregnancy

and a single parent,

and you can't get on the plane to accompany your child,

that might be deemed a sufficient reason.

At the clinical center,

when a temporary decision maker is invoked,

it is the parent assigning somebody

to make a decision for the child on the parent's behalf,

but the way the clinical center operates

is that we still call the parent

and have the parent consent by phone as much as possible,

and direct the person who's here at the clinical center

so that the parent still understands

and has some sort of oversight facility.

So, that wraps up our discussion about children in research.

And so now we can go on to talking about medical records.

So, basically, medical records should contain diagnostic

and clinically relevant information.

It needs to be accurate, and it needs to be timely.

If somebody looks back on it,

it needs to give a full picture of what has happened:

discussions, lab results, the like.

In the clinical center, medical records,

just like at other institutions,

are maintained to provide continuous history of treatment,

and they also provide a database for clinical research

conducted within the hospital at the clinical center.

Again, they document care to patients,

and they plan and evaluate the patient's treatment through them

and sometimes a support justification

of somebody's involvement in the protocol.

Of course, medical records at the clinical center,

and elsewhere, facilitate communication

and support adequate discharge planning.

And failure to document properly

may lead to inappropriate treatment

and possible patient harm.

Now, at the clinical center at NIH,

medical records are distinct from research records,

and that might not be true in outside,

let's say, academic or other types of institutions,

such as industry.

At NIH, the research records contain data

about the individual as relevant to the research study.

So, the clinical medical record

might be more voluminous than the research record,

if the research record doesn't need all of the information

that's collected in a clinical care setting.

The research record serves to track, monitor,

and evaluate the clinical, epidemiologic,

and biometric research activities.

Generally, medical records can rarely be disclosed

without the patient or their surrogate's consent.

And if patients do consent to release their records,

they can consent to release only certain types of records,

or to only certain providers.

At the NIH, there's policies about record releases,

if you have any questions, we have, at the clinical center,

the medical administrative seers, or MAS.

There's also the medical record handbook.

And at the National Institutes of Health, as a federal agency,

we are subject to the Privacy Act,

which I'll talk about later,

which in part discusses medical records disclosure

and disclosure of Privacy Act records.

Now the Privacy Act.

So, the Privacy Act prohibits disclosure of the records

as defined on the slide that I've given you.

It's basically record under the control of an agency

from which information is retrieved by the name

or identifying number of the individual.

So, generally the Privacy Act, which was passed in 1974,

prohibits disclosure of records to third parties

without the written consent of the individual

to whom the record pertained,

unless one of the 12 disclosure exceptions

enumerated in the Act would apply,

and the permissible release without consent is limited,

and rarely would include identifiable information.

Some examples of when it might be released

without written consent would be fore law enforcement purposes,

or health and safety for emergent care.

So, for instances, again just a hypothetical,

if somebody landed in an ER

and the last thing they said before they passed out is,

"I just came from NIH clinical center

and I'm on this medication,"

and then they pass out and the hospital needs to know

what medication the person was on,

depending on the facts of the circumstances,

that might be an urgent medical circumstance

in which we would give very limited information

for the patient care.

And then there's other rules about how we would do that

and how we would notify the patient after the fact.

But, again, it's pretty rare.

The Privacy Act notably applies to US citizens

and lawful aliens,

it doesn't apply to corporations.

Privacy Act rights end at death, they don't extend beyond death.

The Privacy Act was enacted to balance the government's

need to maintain and collect information about individual,

with the right of the individual to be protected

against unwarranted invasion of their privacy

stemming from the federal collection maintenance, use,

and disclosure about this information.

Individuals under the Privacy Act

are entitled to their Privacy Act record

with some exceptions, of course.

Notably, one would be law enforcement.

And individuals are entitled to correction of the record.

And, related to the Privacy Act,

one can bring suit in court for Privacy Act breaches.

And this is an area in which the United States government,

which normally by law cannot be sued,

it has waived its ability,

its sovereign immunity as it's known,

and will allow itself to be sued

in this type of instance or violation,

in particular circumstances of the Privacy Act.

Notices of any systems of records,

so records collections, for instance,

need to be published in the federal register,

and the notices cite the legal authority for collecting

and storing the records. It discussed about--

the individuals about whom records will be collected,

so for example, the clinical records here

at the NIH clinical center would regard patients

who are seen at the clinical center for research.

The publication in the federal register

also informs what type of information will be collected,

and how it will be used.

And the public is considered unnoticed

once it's published in the federal register.

Violations of the Privacy Act can lead to both criminal

and civil prosecution-- or penalties, I'm sorry.

So, one of the exceptions I mentioned about the Privacy Act,

in which you can release information

without explicit consent of the individual

about whom the record pertains is a routine use.

And routine use is when published

in the federal register allow,

again, the release in certain situations,

so the law defines routine use as,

"the use of a record for a purpose

which is compatible for the purpose

for which it was collected." At the clinical center,

a routine use for the clinical center medical records

is responding to congressional inquiries,

allowing social work departments to reach out to local agencies

to aid in the transition of the patient

or the family back home,

or get other services that they need

if there's a referring physician

that's taking over care after discharge,

and other medical organizations or consultants

that are connected to the treatment of the patient.

Research records, again a different record system

than our medical records. They also have routine uses.

Sometimes-- and some of the routine

uses I've listed on the screen

just to give you a flavor of what they are.

So, you might have also heard of FOIA,

which is the Freedom of Information Act,

and this was passed in 1974 after the Watergate scandal.

And so, the idea of FOIA is that it provides individuals

with the right to access records

in the possession of the federal government.

The government, however, can withhold information

pursuant to nine exemptions and three exclusions in the act.

Medical records typically fall within an unwarranted invasion

of personal privacy,

which is in exemption number six.

And that protection under FOIA may continue after the death

of an individual for the benefit for the privacy of the family.

And, let's see. The FOIA--

as compared to the Privacy Act, FOIA

is applicable to people or a corporation, so it's broader.

For those of you at the National Institutes of Health,

if you ever have questions regarding a record release,

we have Privacy Act experts called Privacy Coordinators

for each institute and center.

We also have FOIA coordinators for each institute and center.

And when a request for records is made,

it might be specifically in a Privacy Act aspect

or a FOIA aspect,

but if it's not, or if it's both,

you do need to evaluate both standards

before releasing information

to assure you're not releasing information improperly,

or to the wrong person or entity.

So, HIPAA.

HIPAA is the Health Insurance Portability

and Accountability Act,

and it has a privacy rule that was passed,

I think four years after.

And it applies, by law, to covered entities.

NIH is not a covered entity.

NIH does not bill for its transactions,

and so, by virtue of that, in short,

it is not a covered entity.

HIPAA is relevant to NIH researchers

because many of our collaborators or partners

may be subject to HIPAA.

Generally, HIPAA also requires

that an individual give authorization for use

or disclosure for certain information PHI,

which is Protected Health Information.

That's a term of art under HIPAA.

And again, it's attempt to strike a balance

between information exchange as necessary for either clinical

or research purposes, and the patients' privacy.

This slide gives you a flavor of ways in which PHI, again

Protected Health Information, can be released under HIPAA.

Under HIPAA, decedent information

is continued to be protected by the law.

Again, that's slightly different than the Privacy Act.

In application, though, under the Privacy Act,

the clinical center extends the Privacy Act protections

for the benefit of the privacy of the family,

even if it specifically ends with the death

of that particular patient, we can extend it, in essence,

to protect the privacy of the family.

And going back to HIPAA,

authorizations for waver of consent

to sharing can be granted

by the Institutional Review Board or Privacy Board,

which is a term of art that relates mostly to HIPAA.

And switching gears to one of our,

I guess our second to last topic tonight,

sometimes folks have questions about authorship,

and who is seen to be an author on a research publication.

Generally, this is a policy matter.

There's no specific legal requirements,

but there are professional standards,

and NIH itself has policies

that require the designation of authorship be based

on significant contribution to the conceptualization,

design, execution, and/or interpretation of the study.

Otherwise, contributions can be handled

by a mere acknowledgment.

As for data rights, data that is developed

by those at the clinical center--

again our intramural research program--

those at institutes or centers at NIH

are generally the property of the federal government.

When research is supported in the intramural program,

there are protections that apply to the inventions

of both the researchers and the government.

However, an extramural research--

again, the grants concept

where NIH is funding outside institutions

to perform specific tasks with little--

I guess I would say where the government

doesn't anticipate substantial programmatic involvement

during the performance of that task,

the data rights will vary.

And finally, our last topic: legal liability and malpractice.

So, it's been said, and I tend to agree

that clinical researchers and clinicians at the NIH

are subject to fewer actions for negligence or malpractice

than is common in some other institutions.

The type of claims most commonly filed involve

mistakes of treatment or diagnosis,

or defects of informed consent.

So, the Federal Towards Claim Act,

you may have heard of it if you're an NIH employee,

the legal citations at the bottom of the page.

Again, I mentioned before,

the sovereign immunity doctrine in the United States.

Generally, the United States can't be sued as a party

unless it agrees, by law, to be sued.

And, under the FTCA,

the government is allowing itself to be sued.

And so, what happens is that,

under the Federal Towards Claim Act, or FTCA,

the FTCA becomes the exclusive remedy

for somebody who has a complaint

against the government and its employees.

Generally, the FTCA provides immunity to employees

from claims of negligence

relating to contact that in in their scope of employment.

What would happen is, if somebody is sued

in their official capacity relating to negligence actions

related to the scope of the employment,

the government would substitute itself for the individual.

So, the person would no longer have personal liability.

And if damages were found to be necessary paid out,

it wouldn't come from per se your personal pocket book,

it would be from the government. It's a way, essentially, to--

that the government self-insures itself.

And when FTCA matters come up,

FTCA requires that a claim be filed.

You can't go straight to court and file litigation.

The claim can either be disallowed,

and then the person could file suit,

or the claim could be allowed and it might be settled.

And often times-- always, I should say,

those claims are reviewed by the HHS office,

the general counsel.

And depending on the stage of the claim

and if it has become litigation

of also the Department of Justice,

who defends federal agencies in court.

But the HHS offices general counsel

provides support to the department of justice

in those situations.

And I should note--

oh, I'm sorry, it's on the slide--

that healthcare professionals, for example,

at the clinical center who are not federal employees

are required to be insured,

to maintain professional liability insurance

for the reason of the fact that the FTCA covers employees.

And that is all I have for you today

that I was planning on discussing.

If anybody has any questions, I'd be happy to answer them.

All right, thank you, have a good night.