Dr. Christopher Hartnick kindly provided the following explanation:

 

We are investigating the child’s immune response to HPV by looking at the RNA sequence of the child’s papilloma tissue as well as looking at their B Cell counts in their blood (as a measure of their immune system’s response) and have fairly strong pilot data that suggests we can predict disease severity as a function of immune response.  If this holds up, then we would look at ways of augmenting the child’s own immune response to fight infection.

 

In other words, our aim is to developing an immune model to understand JRRP and how and why one child is affected while another’s immune system wards off such infection.  By looking at the papilloma tissue and a blood sample, we are beginning to understand how the immune system works to fight off JRRP and HPV infection and clues that may lead either to an immunization or immune therapy.  We are actively looking for 20 more children to complete the study we are collaborating on with Novartis and , if the initial results remain promising, the next step is to work towards the therapy and/ or the vaccine.

 

Children would need to come to Massachusetts Eye and Ear Infirmary for one surgical debulking and a blood sample but then could resume their care with their local providers.  If anyone has any questions at all, please email me at Christopher_hartnick@meei.harvard.edu for more information.

 

See below for an “Informed Consent” form with more details:

Text Box: SUBJECT ID:

MASSACHUSETTS EYE AND EAR

RESEARCH CONSENT FORM

 

 

 


PROTOCOL TITLE: Use of Reprogrammed Cells to Identify Potential Therapies for Juvenile Recurrent Respiratory Papillomatosis

 

HSC PROTOCOL #: 14-145H

 

PRINCIPAL INVESTIGATOR: Christopher Hartnick, MD

 


        

Throughout the consent form, “you” always refers to the person who takes part in the study.

 

WHY IS THIS RESEARCH STUDY BEING CONDUCTED?

 

We are asking you to take part in this clinical research study because you have a benign tumor involving your airway called recurrent respiratory papillomatosis.  This research study is being conducted to help us gain new understanding about respiratory papillomas.

We would like to find new ways to choose the best treatment for each patient’s airway papilloma.  This research study is a step towards that goal. We are evaluating new tests to perform on the tumor cells that might help us predict how well the papilloma will respond to each of the current therapies available. 

We expect to enroll 25 patients at Mass. Eye and Ear (MEE) and Mass. General Hospital (MGH) to participate in this research study over 3 years.

Your doctor is also the person responsible for this research study.  Please be aware that he/she is interested in both your clinical care and the conduct of this research study.  You have the right to discuss this study with another person who is not part of the research team before making a decision about whether or not to participate.

 

WHO IS CONDUCTING THIS RESEARCH STUDY, AND WHERE IS IT BEING CONDUCTED?

 

This research study is being conducted through the Department of Pediatric Otolaryngology at MEE and the Department of Thoracic Surgery at MGH. 

 

WHAT WILL HAPPEN IN THIS RESEARCH STUDY?

 

Source of tumor tissue:As part of your standard care, papilloma is removed to open the airway on a regular basis.  This tissue would normally be discarded.  Additionally, as part of your standard care a piece of papilloma is removed and examined by pathology on approximately a yearly basis.  The pathologist does not usually need all of the tumor that is removed, and left-over tissue would normally be discarded. 

If you choose to participate in this research study, we ask your permission to:

 

1)    Keep the leftover tissue that would normally be discarded so we can do additional research tests;

 

2)    Use some of the preserved pathology tissues;

 

3)    Use medical information related to the diagnosis and treatment of your tumor and your response to treatment.  If you have received or will receive care related to your tumor from clinicians at other institutions, we will ask you to sign a separate authorization to allow us to get this information and your preserved pathology tissues from those clinicians and institutions, for use in this research study.  The type of treatment you receive will not be directly affected by the results of this study.

 

4)    Take a small (<5mm) sample of the tissue from the back of your throat (pharynx) to be used for a negative tissue comparison.

 

5)    During your surgery, an intravenous (IV) line will be placed.  During that time, a small amount of blood will be drawn from the IV for research.  There will be no extra needle stick.

 

What we may do with your blood and your preserved or leftover tissue:

 

 

·      Analyze proteins and nucleic acids (DNA and RNA) in the preserved or leftover tissue for changes from normal that might be related to how tumors respond to therapy.

 

 

·      Develop models to test tumor and immune cell reaction: Immune cells from your leftover tissues will be purified and cultured. Immune functions of these cells will be tested under multiple experimental conditions. This will allow us to study how these immune cells react to tumor cells and tumor antigens. Results of the study may help development of immunotherapy against these tumors.

 

·      Develop tumor models: cells from your leftover tissue will be grown in the laboratory or grown as tumors in mice (tumor xenografts).  

 

·      Use of your stored samples and clinical information for research: Investigators on this study can request samples to use for research about cancer as described earlier in this consent form. Samples will be sent to the United States and shared with outside non-profit academic investigators as well as for-profit pharmaceutical investigators or commercial entities with whom we collaborate. These entities will perform tests at both genetic and protein level as well as drug response tests. The information will provide guidance to develop improved therapies and diagnostic tests.

 

·      Culture normal epithelial cells in vitro and test immune cell reaction against these normal cells

 

·      Use the normal cells as a control for a drug screen

 

How long will I be in the research study?

There is no additional time required outside of your normally scheduled surgery or visit. We will collect information from your medical records for about 3 years after you enter the study.

 

WHAT ARE THE RISKS AND POSSIBLE DISCOMFORTS FROM BEING IN THIS RESEARCH STUDY?

 

The main risk of allowing us to store and use your samples and certain limited health information for research is a potential loss of privacy.  We will protect your privacy by labeling your samples and information only with a code, and keeping the key to the code securely, physically locked or in a password-protected computer database. 

We cannot predict how genetic information will be used in the future. There are many safeguards in place to protect your information while it is used for research.

Genetic information that results from this study does not have medical or treatment importance at this time.  However, there is a risk that information about taking part in a genetic study may influence insurance companies and/or employers regarding your health.  To further safeguard your privacy, genetic information obtained in this study will not be placed in your medical record. 

Taking part in a genetic study may also have a negative impact on family or other relationships.  If you do not share information about taking part in this study, you will reduce this risk.

Because your genetic information is unique to you, there is a very small chance that someone could potentially trace it back to you. The risk of this happening is very small, but may grow in the future. Researchers given permission to use this information will always have a duty to protect your privacy and to keep your information confidential.

Federal rules provide safeguards for privacy, security and authorized access. We will not give information that identifies you to anyone without permission. This study takes many steps to protect the privacy of the people who take part. There is a Federal law called the Genetic Information Nondiscrimination Act (GINA). In general, this law makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on genetic information. However, it does not protect you against discrimination by companies that sell life insurance, disability insurance or long-term care insurance.

The pharyngeal negative control tissue biopsy has a small risk of bleeding, pain, or infection.

If a blood sample is taken, there are very few physical risks. Possible side effects from drawing blood sample include mild pain, bleeding, bruising, and infection at the site of the needle insertion. In most cases, the patient is asleep during IV insertion, limiting pain, however, in rare circumstances of more significant respiratory distress the IV may be placed while the patient is awake, thus mild pain will remain a potential side effect.

 

WHAT ARE THE POSSIBLE BENEFITS FROM BEING IN THIS RESEARCH STUDY?

 

You will not directly benefit from participating in this research study. However, the study is designed to advance our knowledge and is expected to help future respiratory papillomatosis patients.

 

WHAT ALTERNATIVE TREATMENTS OR PROCEDURES ARE AVAILABLE FOR MY CONDITION?

 

Your clinical care will be the same and you will be treated by your regular clinicians whether or not you choose to take part in this research study.

 

IF YOU DO NOT WANT TO TAKE PART IN THIS RESEARCH STUDY, WHAT ARE THE OTHER CHOICES?

 

Your clinical care will be the same and you will be treated by your regular clinicians whether or not you choose to take part in this research study.  Your participation in this research study is entirely voluntary, and you may withdraw from the study even after signing this consent.  The quality of the healthcare you receive, the payment for your health care, and your health care benefits will not be affected if you decide not to participate or withdraw from the study.

If you change your mind later and do not want us to collect, use or share your health information, you need to send a letter to the investigator listed on this consent form.  The letter needs to say that you have changed your mind and do not want the investigator to collect, use and share your health information.  In this case, we may continue to use and share the information we have already collected about you, but we won’t collect any further information about you for the research study.

You have the right to choose not to sign this form. If you decide not to sign this form, you cannot participate in this research study.

You can ask us in writing to destroy your tissue specimens collected for this research study, and all other materials that came from them. We will do so, with the following exception: We will be unable to destroy specimens that have already been used.  Any materials that have already been reported in a manuscript submitted for publication in the biomedical literature or in preparation for a patent application cannot be destroyed.

WILL I BE PAID TO TAKE PART IN THIS RESEARCH STUDY?

You will not be paid for taking part in this research study.

WHAT WILL I HAVE TO PAY FOR IF I TAKE PART IN THIS RESEARCH STUDY?

 

 

You will not incur any additional cost as a result of your taking part in this research study, or any costs for the research tests we will perform on your blood or tissue. You will still be responsible for any co-pays required by your insurance company for standard treatment.

 

CONTACT INFORMATION IF YOU HAVE QUESTIONS OR CONCERNS ABOUT THIS STUDY

 

You are free to ask any questions you have about the study or about your rights and treatment as a research subject.  Further information about any aspect of this study is available now or at any time during the course of the study from the principal investigator, Dr. Christopher Hartnick, at (617) 523-7900. 

Additionally, you may contact the Office of Research and Academic Affairs, at (617) 573-3446, if you have any questions or concerns about your rights and treatment as a research subject.

 

IF I TAKE PART IN THIS RESEARCH STUDY, HOW WILL YOU PROTECT MY PRIVACY?

 

Information derived from this study may be used for research purposes that may include publication and teaching.  However, information used for publication and teaching will not disclose your identity.

As required by the federal Health Insurance Portability and Accountability Act (HIPAA), the Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates, Inc. (together referred to as “we” or “Mass. Eye and Ear”) will take reasonable measures to safeguard the confidentiality of information that identifies you and relates to your past, present, and future physical and mental health, and conditions (protected health information or PHI) collected, used and shared as part of this research.

What is the purpose of collecting, using and sharing of your protected health information?

 

We are asking you to take part in the research study described in this research consent form.  We need to be able to collect, use and share your protected health information in order for you to participate in this research study.

What protected health information about you will be collected, used and shared with others during this research study?

 

For you to be in this research study, we need your permission to collect, use and share health information that identifies you, (your “protected health information” or “PHI”) which may include one or more of the following:

 

 

 

 

Who will use or share protected health information about me?

 

We may use and share your protected health information with:

 

 

 

 

 

For how long will protected health information about you be collected, used or shared with others?

 

If you sign this form, we will collect, use and share your health information until the end of this research study, which may be after your direct participation in the research project ends.

Your samples will be destroyed after conclusion of this research project, which we estimate will be approximately 3 years after you enroll.  The information we gleen from your tissues and review of your response to treatments, however, may be useful for future studies.  We can only use the health information collected for this research study again if an institutional review board such as the MEEI Human Studies Committee gives us permission.  This Committee may ask us to talk to you again before using or sharing the health information collected for this research study for other research purposes.  However, if we meet certain requirements established by law, the Committee may also let us use and share your health information collected for this research study for additional research without talking to you again.

Health information collected as part of the research study that is also kept in your medical record for treatment and billing purposes will be maintained, used and disclosed in accordance with the policies and procedures of MEEI, and laws and regulations applicable to medical records.  As a patient of MEEI, and not as part of this research study, you will receive a copy of the MEEI Notice of Privacy Practices which explains how MEEI may use and disclose health information kept in your medical record.

 

YOUR PRIVACY RIGHTS:

 

You have the right to choose not to sign this form. If you decide not to sign this form, you cannot participate in this research study.

You can ask us in writing to destroy your tissue specimens collected for this research study, and all other materials that came from them.

WHAT HAPPENS IF I AM INJURED AS RESULT OF TAKING PART IN THIS RESEARCH STUDY?

 

We will offer you the care needed to treat any injury that directly results from taking part in this research study. We reserve the right to bill your insurance company or other third parties, if appropriate, for the care you get for the injury. We will try to have these costs paid for, but you may be responsible for some of them. For example, if the care is billed to your insurer, you will be responsible for payment of any deductibles and co-payments required by your insurer.

Injuries sometimes happen in research even when no one is at fault. There are no plans to pay you or give you other compensation for the injury aside from what was described above. However, you are not giving up any of your legal rights by signing this form.

If you think you have been injured or have experienced a medical problem as a result of taking part in this research study, tell the researcher in charge of the study as soon as possible. The researcher's name and phone number are listed on this consent form.

 


 

CONSENT

 

The purpose and procedures of this research project with its possible risks and benefits have been fully and adequately explained to me, and I understand them.  By signing below, I give permission for my participation in this study and for use of the associated protected health information for this research study as described above. I have been given a signed copy of this form to keep.

 

 

___________________________________________________ DATE: _________________________

Signature of Adult Subject (18 + years)

 

 

TIME: ____________________

 

 

 

____________________________________________________

Name of Person Obtaining Consent

 

 

____________________________________________________ DATE: _________________________

Signature of Person Obtaining Consent

 

TIME: _____________________

 

CHILD ASSENT

 

 

____________________________________________________ DATE: _________________________

Parent/Court-appointed Guardian

 

 

TIME: _____________________

 

 

Print Name: ________________________________________   Relationship: __________________

 

 

____________________________________________________

Name of Adolescent (ages 14-17)

 

 

____________________________________________________ DATE: _________________________

Signature of Adolescent (ages 14-17)

 

 

TIME: _____________________

 

 

WITNESS STATEMENT & SIGNATURE

 

Required ONLY IF (check which one applies):

 

             Consent document needs to be read to subject or legal representative, or

             Communication impairments limit the subject’s ability to clearly express consent, or

             Other reason: please specify _____________________________________________

 

I confirm that the information in this consent form was accurately explained to, and understood by the subject, parent and/or legally authorized representative as required, and that informed consent was given freely.

 

________________________________             __________________________________________
 Date    (MM/DD/YEAR)                           Signature of Witness       

 

 

TIME: _________________________