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26 posts from September 2011

September 30, 2011

CME Coalition: Congressional Briefing on HIV and CME

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As part of its mission to raise awareness about the importance of continuing medical education (CME), the CME Coalition held its second policy briefing earlier this week. The second program, entitled “Continuing Medical Education:  A Focus on HIV Breakthroughs,” included experts in the fields of CME and HIV treatment, including

  • Dr. Jonathan Sackier, Visiting Professor, University of Virginia
  • Dr. John Bartlett, Professor and Chief of the Division of Infectious Diseases at Johns Hopkins; Internationally renowned authority on infectious diseases and recipient of the prestigious 2005 Maxwell Finland Award for scientific achievement from the National Foundation for Infectious Diseases; and
  • Dr. Alan Wasserman, The Eugene Meyer Professor of Medicine and the Chairman of the Department of Medicine at The GWU School of Medicine and Health Sciences; Chairman of the Board of Trustees and President of The George Washington University Medical Faculty Associates.

The first meeting, we noted earlier, focused on CME and breast cancer.   Dr. Sackier gave similar presentations both days.

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Dr. Bartlett – HIV

Dr. Bartlett began his presentation by showing the audience a brief history of HIV from 1980 through the present.  He walked the audience through the various stages and decades of research, discovery and medical progress.  After discussing the political landscape and coverage of HIV over the years, Dr. Bartlett showed various pieces of evidence demonstrating how drugs and treatments reduced the number of AIDS cases for children under the age of thirteen.

In fact, because of the breakthroughs and treatments discovered by the pharmaceutical industry, the diagnosis rate of AIDS in children under 13 went from just under 900 in 1992 to under 70 in 2005.

Dr. Bartlett then dove into some of the data he works on at Johns Hopkins University and discussed some of the findings and lessons he has learned through his years of experience and breakthroughs.

Importantly he noted the changes in the average duration of life after AIDS diagnosis in a 25 year old man.  He noted that in 1995, the age of death was 28 years, and that treatments only added an additional 3 years.

However, because of the advances in AIDS treatment, he noted that between 2000-2005, the age of death was 64 years, giving men 47 added years. 

Last, but not least, Dr. Bartlett gave an overview of how complex treating HIV is and how complicated caring for patients with HIV can be.  He noted how the Department of Health and Human Services (HHS) has guidelines of 106 pages, with new additions annually.

Moreover, he recognized how there have been major challenges in HIV care. For example, there are 25 drugs, in 6 classes, and these drugs have:

  • Adverse drug reactions
  • Drug interactions
  • Resistance
  • Co-morbidities
  • And the cost can be $16,600 per year.

Ultimately, based on these complexities, Dr. Bartlett recognized the significant importance of have continuing medical education to educate doctors about HIV treatments, the breakthroughs and the challenges, and most importantly, to keep up with the new drugs and clinical data.    It was clear that with help from industry there would be no way that HIV physicians would be able to keep up with these guidelines.

No other medical problem so directly affects the poor in America as HIV, the incidence rates in poorer areas are staggering.   The need to educate healthcare workers on this disease is vitally important to identifying those with the virus who are not treated.

He noted that we are near a time when HIV can be eradicated either trough prevention or a eventual vaccine.  Because the virus does not spread from treated patients the incidence should be going down if everyone with the virus was treated.

Additionally, Dr. Bartlett shared an important story.  He noted how, because he writes the US guidelines on HIV, he is no longer permitted to do work with industry.  While we agree in principle that such a restriction is reasonable and logical, there are nevertheless broader problems with physician-industry collaboration that Dr. Bartlett recognized.

Dr. Bartlett values the relationships he had with industry.   At one time, he sat on advisory boards for two major pharmaceutical firms.  At these meetings, he would have discussions with the best of the best in HIV.  They would debate issues and learn from each other.  He would learn the future of science coming from these companies. 

Since the rules banning his participation, he attempted to stay on these boards in a volunteer role or where the money he would have earned, is given to a charity on his behalf.  The company’s legal departments would not permit him to participate.  So he has for several years not been exposed to that part of science at the loss to patients and a loss to the guidelines he works on.  This is just one example of how overregulation and strict guidelines hurt patient care and benefit no one.

Dr. Wasserman – Acute Myocardial Infarction (MI)

Dr. Wasserman opened with a description of the CME program at George Washington University Medical Center with 50 grand rounds attended by 200 practicing physicians each week.  His access to experts from outside the immediate area has been seriously diminished because he can no longer ask companies to help support his programs. 

Similar to Dr. Bartlett’s presentation, Dr. Wasserman began by tracing the history of Heart Attack treatment back to 1912, when James B. Herrick, MD, published an essay on coronary thrombosis in the Journal of the American Medical Association (JAMA), nothing that, “clinical features of sudden obstruction of the coronary arteries.”

Moving along, he traced the kinds of treatment that took place for heart attacks between 1950-1985, noting things such as:

  • Bed rest
  • Oxygen
  • Sedation
  • Quiet room
  • Prophylactic lidocaine
  • Soft diet
  • Stool softener
  • Morphine

Then, he began to trace the steps of the advances in treating Acute MI, noting the improvement in flow restoration and overall reduction in hospital (21-day) mortality.  His presentation was very focused on presenting clear data and evidence, which has shown improvement in mortality in treating Acute MI over the years, largely because of the devices, medicines and technology industry, has provided to clinicians.

Dr. Wasserman noted that for twenty years he spent many days/months educating physicians around the country on the importance of timely treatment of patients with heart attacks.  Every minute a patient waits for treatment to clear the clot in the coronary arteries translates to loss of heart muscle and heart function.  If it were not for the collaboration that he had with industry in supporting the CME courses around the use of thrombolytic therapy lives would have been lost. 

Changing the medical system to adopt treatments that save lives, yet pose risks took tremendous effort.  Dr. Wasserman wondered, if given the changes in rules around CME and the diminished commercial support of CME, would the uptake of new revolutionary therapies like as reperfusion still take place at the same rate as before.


There was a question around the billions in fines that pharmaceutical and device companies have paid for off label marketing.  The response from Dr. Sackier was that companies have not paid fines but rather had settlements with no one admitting guilt.  It is Dr. Sackier’s opinion that if there is malfeasance it should be dealt with, including prosecution.  But the vast majority of those working in the pharmaceutical and device industry are honorable people who devote their lives to bringing on new medications that save lives.  They should not be shamed because of one or two bad apples.  The same holds true for congress, though there have been bad members of congress, the vast majority of the members of congress are honorable and this does not justify banning congressman from participating in public events.

"Implicit in the staffer's question, however, was a failure to acknowledge the very real "chilling effect" that is suppressing industry support of CME that can be directly attributable to government implication of widespread taint.  Dr. Wasserman responded that "the pendulum has swung too far" in favor of onerous reporting requirements and disproportionate media attention, and that it was having the effect of keeping experts like himself from even engaging in the practice of CME, to the ultimate detriment of patients."


After the two days of policy briefings hosted by the CME Coalition, it is clear what direction the CME community and CME stakeholders must go.  We must push harder for public funding by Congress and from federal health agencies.  CME providers need the proper recognition for their important role in the health care system, and collaboration with industry must be encouraged and applauded, not criticized and shamed.

CME providers must emphasize and publicize the good work we do, the quality outcomes we produce, and the tremendous efforts we all take in ensuring that our CME and educational programs are of the highest quality and integrity.  Moreover, we must emphasize and explicitly point out our commitment to transparency and reducing any kind of appearance of potential bias, and our dedication and full-fledged allegiance to following the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support.

As we get closer and closer to realizing some of the major pieces of the Affordable Care Act, and Congress and the federal health agencies begin to implement new programs, CME will be critical to reach the true promise of health care reform.

We cannot just expect our healthcare workers to be more efficient, more cost effective, more collaborative, without additional training and education.  We can’t expect our health professionals to work as teams, in interdisciplinary environments, and communicate together, over the internet, using electronic health records and health information technology (HIT) without CME and additional medical training. 

Accountable Care Organizations, medical loss ratio, the Partnership for Patients, reduced medical errors, reduced readmissions, reduction of hospital acquired infections, and numerous other objectives that will SAVE LIVES, cannot just up rules.

We need education. We need to educate our doctors in practice now, the next generation of our medical students, and the health care system as a whole.  The health problems we will continue to see in the next decades will only continue to grow exponentially with an aging population and a growing epidemic of chronic diseases such as diabetes, obesity, and heart disease.  We can eliminate HIV either through treatment or prevention.  Either way there will be a strong need for education.

Now is the time to support CME.  We as Americans should not be focused on who is supporting the education because the proper firewalls are in place to ensure quality, integrity and independence.  We as Americans should be focused on educating our doctors, before it’s too late. 

September 29, 2011

CME Coalition Congressional Briefing on Breast Cancer and CME

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For a typical physician who will practice medicine for 30 to 40 years over the course of his or her career, assessments, treatments and procedures learned in medical school and residency quickly become outdated with advances in medicine and technology.  To facilitate the continued integration of new advances into patient care, the medical community follows a system of continuing medical education (CME). 

Certified continuing medical education (CME) is defined as education that is planned, implemented, and evaluated in accordance with the Accreditation Council for Continuing Medical Education (ACCME) nationally mandated accreditation policies for all accredited CME providers. 

CME is recognized as an essential part of continued professional development for physicians and a key resource in ensuring both the quality and effectiveness of health care delivery.  CME is so important for health care quality and patient access that many states mandate CME as part of physician licensing requirements.

CME takes many forms, including live and Internet-based course instruction, lecture series, and publications.  Hundreds of organizations participate in providing CME opportunities, and several hundred thousand physician and non-physician participants engage in multiple accredited CME activities each year. Accredited CME providers are committed to the integrity of information that is provided to physicians as part of certified CME activities and have taken critical steps over the past several years to increase transparency, strengthen accreditation guidelines, and monitor and enforce policies.

Moreover, CME plays a vital role in the delivery of innovative health care to American patients.  The rapid pace of scientific discovery and innovation increases the need for CME as a means of communicating advances to medical practitioners and patients.  

Today, much of this education is underwritten by life sciences companies that recognize the value in broadening awareness of disease states, standards of care and new therapies.  However, the percentage of industry funded CME is decreasing each year, which will have a tremendous impact on training and patient outcomes.  Despite the existence of rigorous standards that ensure that all certified CME curricula be evidence-based and free of bias, there still remains a misinformed perception that CME can be tainted by industry support.

Consequently, a new group, the CME Coalition, formed to address these issues.  The mission of the CME Coalition is to:

  1. Educate federal policy makers on issues related to the provision of CME,
  2. Monitor state policy initiatives that could adversely impact CME, and
  3. Advocate for sensible federal and state policies to advance its practice. The CME Coalition will fulfill this mission by developing, managing, and implementing a government affairs and public relations strategy to further the interests of CME on Capitol Hill, with the Administration and among the states.

Meeting its mission, the CME Coalition recently held its first of two informational policy briefings on Capitol Hill.  The meeting, which took place in the House of Representatives Rayburn Building included:

  • Dr. Jonathan Sackier, Professor of Surgery, University of Virginia
  • Dr. Charles M. Balch, MD, FACS, Professor of Surgery, Division of Surgical Oncology, Dept of Surgery, University of Texas Southwestern Medical Center; and
  • Dr. Dana Simpler, Family Doctor & Internist, Mercy Medical Center, Baltimore

The second meeting took place on the Senate side and discussed CME issues and HIV.


Dr. Sackier, a surgeon with over 120 peer-reviewed articles, authorship in 7 textbooks on surgery, and the inventor of various surgical equipment and medical devices, noted how he came to America from the United Kingdom because he did not like what was going on there with regard to physician-industry collaboration. 

Dr. Sackier gave a brief introduction about CME and the issues the CME community face as well as the broader healthcare climate.  Sackier also pointed out the present atmosphere surrounding CME, particularly CME with industry support.  He asserted that there has been a significant overreaction by people about industry supported CME that has demonized good people who are seeking to educate their peers and improve patient outcomes, all of which reduce health care costs.

He also noted how CME is not alone in its attack, and that day-to-day interactions and good promotional practices are being criticized as well as payments for true innovation and collaboration between physicians and industry for clinical research, education, and consulting.

Dr. Sackier also took issue with the fact that critics of industry believe there is an “inherent conflict of interest” when any support from industry in any kind of educational program is present.  However, he recognized that highly trained physicians and medical professionals are aware of commercial support, disclose their potential conflicts of interest, and always have the patient’s best interest in mind.

He also recognized how physicians and researchers who work with industry developing and researching new drugs and devices are the best people to educate because they have the most hands on experience and knowledge.  He asked the audience, “Would you rather have a surgeon who learned how to perform your surgery from a journal article or from a surgeon who invented and mastered the particular procedure or equipment used in the surgery?”

Dr. Sackier also noted why CME is crucial and how industry support is critical to achieving better patient outcomes. Factors that make CME and industry support crucial include the fact that:

  • The scope and volume of medical literature is immense and complex
  • Doctors time is the commodity in shortest supply
  • Funding allows broader educational possibilities (i.e. national, local meetings)

He noted how CME costs thousands of dollars for individual physicians, many of whom do not attend events they and their patients would benefit from because of financial concerns.  He closed by noting that with an aging population facing continued chronic and severe diseases, CME will be crucial for doctors to learn about this population to better treat them.

Breast Cancer and CME

Dr. Balch told the audience that he strongly believes in the CME and medical education process because the content is evidence-based.  He has vast experience in academia, professional medical organizations, and as a CME participant and faculty.  He noted how, before giving any CME talk:

  • Needs assessments are compiled by a CME accredited organization in collaboration with experts
  • The Program Committee determines subject matter and speakers INDEPENDENT of any funding source
  • Speakers must disclose all sources of commercial funding relevant to subject material; conflicts must be declared and/or resolved; and
  • Speaker slides are reviewed to ensure lack of bias, appropriate disclosures, and scientific integrity

Consequently, Dr. Balch tailored the rest of his presentation to show the audience what a very brief and not so “scientific” CME program would look like. 

Dr. Balch began his discussion about breast cancer, and noted how 1 in 8 women will develop breast cancer in their lifetime and how there are over 250,000 new patients every year, making breast cancer a major public health issue. 

Over 40,000 deaths each year come from breast cancer, which is 15% of all cancer death in women; second after lung cancer.  And while rapid advances in breast cancer have led to over 2.5 million of breast cancer survivors in US, these survivors are still at risk for relapse.

Moreover, although fewer patients are dying from breast cancer, the treatments are complex and expensive, which demand continuing education, particularly because the management of breast cancer is multidisciplinary and there are over 100 kinds of sequences to treat breast cancer.  For example, the John Hopkins Multidisciplinary Breast Cancer Team consists of almost ten (10) different doctors.

As a result, Dr. Balch recognized how treating breast cancer is very much individualized and personalized.  He recognized how available prognostic/predictive tools can now identify patients who benefit from specific treatments and can eliminate patients who either do not need the therapy or will not benefit from it.  Thus, treatment plans have the right combination and sequence, at the right time, matched with biological /biomarkers and quality of life issues.  But doctors need CME to learn this.

Dr. Balch noted how there has been dramatic changes in cancer management, including:

  • Exponential growth in knowledge about oncology management
  • Frequent use of preoperative & postoperative chemotherapy & radiation therapy
  • New technical advances in the operating rooms, i.e. surgical devices, CT scans, ultrasound
  • Complete response rates with hormones and drugs at 50%; expansion to surgery for late stage cancer
  • Expansion of surgical intervention for prevention of cancer in high risk people
  • Targeted, non-toxic drugs (increasingly by oral agents)

He noted that once, breast cancer used to be a death sentence and now, it is becoming a chronic disease, with death rates declining by 30%.  Consequently, with all these advances and FDA approved drugs, Dr. Balch asked, “how do we deploy them in the right combination to patients?”

While there are hundreds of combinations and sequences of beneficial treatments, physicians need to learn about them.  Physicians from multiple specialties and practice locations must keep current on new advances based on evidence from clinical trials.

That is where CME comes in, Dr. Balch said.  He noted how the CME guidelines provide a rigorous process to ensure appropriate content of medical education to practicing physicians.  However, because industry support is declining, coupled with recent scrutiny by a small minority in academia and the press, the availability of CME courses is diminishing, especially in smaller centers, rural populations, and inner cities.

Ultimately, Dr. Balch said that moving forward, the CME and medical community need to ensure that we do not demonize CME and support from industry because there are significant processes in place to ensure high quality CME and reduce any potential for bias.

Primary Care and Internal Medicine

Dr. Simpler, who works closely with CME providers, also emphasized the importance of CME and industry support and collaboration. She said, “CME is how doctors keep up with medical advances,” and alternatives are not adequate.

For example, she noted that while journal articles are good, they are just limited to a specific subject area.  Additionally, she noted that textbooks and online information may be good as well, but the information is to research only a particular patient problem, and does not translate to improved practice or competency. 

As a result, she maintained that CME lectures are the best because this is where experts present the old and new information, making sense of the science data and offer guidelines for practicing physicians.

For example, Dr. Simpler noted how several years ago, she attended a CME event, which exposed the risky use of hormone replacement therapy.  Because of her attendance at the program, she was able to take her patients off hormones years ahead of others, which saved the lives of numerous patients from suffering heart attacks or other complications. She recognized that in this instance, CME not only saved lives, but also saved dollars to the health care system.

Another area she said doctors need education in is ACOG Pap Smear guidelines.  The 2009 consensus was that less frequent pap smears was appropriate, every 2-3 years instead of every year.  However, only 16% of gynecologists follow this guideline, demonstrating an area where more CME would be very beneficial and cost saving.

Finally, she noted how the U.S. Preventive Services Task Force (USPSTF) has recommendations based on hard science, however they are not particularly well followed.   

Moreover, she emphasized the fact that even though the government issues recommendations and guidelines, they provide no funding for continuing medical education to implement them.


Advances in medical science during the past 20 years have rapidly outpaced the ability of academic centers, hospitals, societies, journals, and medical education companies to fully educate physicians and other healthcare professionals.  The gap between clinical research and practice continues to widen. 

To motivate practitioners to change practice and improve medical care for patients, an expansion of the numbers and types of educational offerings will be required.  Despite the pressing need, public funding for certified CME has remained flat during the past two decades; private sources of support increased until 2008, but have continued to decline despite the growing healthcare need. 

CME providers support transparency regarding all sources of their funding, but curtailing commercial support for CME through unnecessary restrictions, burdensome reporting requirements or outright bans would dramatically diminish access to education, and negatively impact patient care.

FDA Guidance on Informed Consent

The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) released last month a new guidance, entitled: “Guidance on Exculpatory Language in Informed Consent.” 

The guidance applies to non-exempt human subject research conducted or supported by the Department of Health and Human Services (HHS) and is intended for clinical investigators, institutional review boards, and funding agencies that may be responsible for review or oversight of human subject research conducted or supported by HHS. 

The guidance also applies to human subject research regulated by FDA and is intended for clinical investigators, sponsors, and institutional review boards conducting or reviewing such research. 

The document provides guidance on the regulatory prohibition on the inclusion of exculpatory language in informed consent. The document includes examples of language that OHRP and FDA consider acceptable as well as examples of language that the agencies would consider exculpatory. 

When finalized, this document will supersede OHRP’s November 15, 1996, guidance entitled, “‘Exculpatory Language’ in Informed Consent” and question number 52 in FDA’s January 1998 guidance entitled, “Institutional Review Boards Frequently Asked Questions – Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.” 


Section 46.116 of 45 CFR and section 50.20 of 21 CFR state: “No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.” 

Thus, for particular language in a consent document to be impermissible under this provision, not only must the language involve a waiver, release, or the appearance of a waiver or release, but it must also be “exculpatory.” 

OHRP and FDA consider exculpatory language to be language, which has the general effect of freeing or appearing to free an individual or an entity from malpractice, negligence, blame, fault, or guilt. Therefore, a waiver in an informed consent document of any legal right a subject may have may be permissible so long as that waiver does not have the general effect of freeing or appearing to free an individual or an entity from responsibility for malpractice or negligence, or from blame, fault, or guilt (i.e., the waiver is not exculpatory). 

For example, if an informed consent document contains language by which a subject waives his or her right to be compensated for injuries arising from participation in the research, such language would meet the definition of exculpatory language because it has the general effect of freeing or appearing to free the investigator, sponsor, and/or the research institution from malpractice, negligence, blame, fault, or guilt. For that reason, such language would violate 45 CFR 46.116 and 21 CFR 50.20. 

On the other hand, a subject’s waiver of any rights he or she may have with respect to a biospecimen obtained by investigators for research purposes would not be exculpatory because it does not have the effect of freeing the investigator, sponsor, institution, or others involved in the research from malpractice, negligence, blame, fault, or guilt. Accordingly, including such waiver language in an informed consent document would be permissible under 45 CFR 46.116 and 21 CFR 50.20. 

OHRP and FDA understand it has long been common practice of investigators and sponsors not to compensate research subjects who agree to provide biospecimens for research purposes even if those biospecimens are later used for commercial purposes. Moreover, OHRP and FDA are not aware of any federal or state laws or policies that suggest that research subjects would have any legal right to such compensation if they voluntarily signed an informed consent form which clearly stated that they would not be paid or otherwise compensated for providing their biospecimens. 

Given these circumstances, OHRP and FDA have concluded that language in an informed consent form is not exculpatory if it informs subjects that, by agreeing to allow the use of their biospecimens for research purposes, they are giving up any legal right to be compensated for the use of the biospecimens. In other words, such releases or waivers of rights to biospecimens would be permissible when the waiver does not have the effect of freeing the investigator, sponsor, institution or others involved in the research from malpractice, negligence, blame, fault, or guilt. 

Such language may be considered an acceptable way to accurately inform subjects that they will not be receiving any financial compensation, now or in the future, for the use of those biospecimens. Such language may, therefore, be appropriately included in an informed consent form without violating 45 CFR 46.116 or 21 CFR 50.20.3 

In an effort to help the research community understand what may or may not constitute exculpatory language in violation of 45 CFR 46.116 and 21 CFR 50.20, FDA/OHRP provided the following examples below:


Examples of Acceptable Language                  

Although future research that uses your samples may lead to the development of new products, you will not receive any payments for these new products. 

By agreeing to this use, you are giving up all claims to any money obtained by the researchers from commercial or other use of these specimens. 

I voluntarily and freely donate any and all blood, urine, and tissue samples to the [name of research institution] and hereby relinquish all property rights, title, and interest I may have in those samples.                 

By consenting to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples collected during this research. 

Although the results of research, including your donated materials, may be patentable or have commercial value, you will have no legal or financial interest in any commercial development resulting from the research. 

Tissue obtained from you in this research may be used to establish a cell line that could be patented and licensed. No financial compensation will be provided to you should this occur. 

By consenting to participate, you authorize the use of your bodily fluids and tissue samples for the research described above. 

Because of hospital policy, the hospital is not able to offer financial compensation should you be injured as a result of participating in this research. However, you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research, including the hospital. 

Because of hospital policy, the hospital makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research. Medical services will be offered at the usual charge. However, you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research, including the hospital. 

In the event that you suffer a research-related injury, your medical expenses will be your responsibility or that of your third-party payer, although you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research. 

FDA/OHRP said that the above examples are permissible under 45 CFR 46.116 and 21 CFR 50.20 because in each example, the waiver or release does not have the general effect of freeing or appearing to free an individual or an entity from malpractice, negligence, blame, fault, or guilt.

Examples of Exculpatory Language  

The examples below would be in violation of 45 CFR 46.116 and 21 CFR 50.20 because in each example, the waiver or release has the general effect of freeing or appearing to free an individual or an entity from malpractice, negligence, blame, fault, or guilt.                 

I waive any possibility of compensation, including any right to sue, for injuries that I may receive as a result of participation in this research. 

If you suffer a research-related injury, neither the institution nor the investigator can assume financial responsibility or liability for the expenses of treatment for such injury. 

In the event that you suffer a research-related injury, your medical expenses will be your responsibility or that of your third-party payer.


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