CONSENT FORM

INTRODUCTION
You are being asked to participate in a research study. Before you decide to be part of this research study, you will need to understand the risks and benefits so that you can make an informed decision. This is known as an informed consent. This consent form provides information about the research study. You will be asked to read this consent form and talk with the staff at the collection center about anything you do not understand. If you decide to participate in this study, you will be asked to sign and date this consent form. You will be given a copy of this signed and dated consent form.

PURPOSE/BACKGROUND
You are being asked to donate a sample of your tissues and/or biological fluids so that ProMedDx may share your tissues and fluids with researchers throughout the United States and the world to be used in medical research for creating new tests for earlier diagnosis and/or better management for treating cancers and other diseases. These researchers need access to tissue and/or fluids from healthy donors as well as those from donors diagnosed with different illnesses or diseases so that they can do their studies.

If you agree to volunteer for this study, you may be asked to donate, for research, samples of your blood, urine, saliva, or other bodily secretions and/or left over tissues not needed for diagnosis that would be thrown away. If you agree, arrangements will be made for you to donate one or more of these types of samples. Donating your samples may require up to 30 to 45 minutes of your time. In some cases you may be asked to fast (no solid foods) for a certain amount of time before the collection. If tissue samples are collected, these samples will come from procedures already scheduled, and no surgical procedure will be performed on you for the specific purpose of obtaining the tissue samples unless you give your separate permission. ProMedDx may store your samples for future research studies. In addition, your samples may be provided to for-profit medical companies because many advances in healthcare research come from their use of these types of research samples. In some instances, you may be asked to obtain and provide information from your medical records about your medical history and medical treatments, which will make your donated samples even more useful to medical researchers.

Samples obtained from you will never be used for treatment of other individuals. Additionally, these samples will not be used in your primary care.

We hope to enroll 10,000 individuals by December 31, 2021.

PROCEDURE
If you are asked and agree to donate blood: You may have blood collected from a vein in your arm or hand with a needle attached to blood collection tube or bag. Alternatively, a fingerstick with a sterile lancet may be performed and your blood collected by placing one end of a capillary tube against the drop of blood on your finger created by the lancet. You will be told in advance of signing this consent form how much blood you are being asked to donate and how often. If you are asked to donate blood more than once, you will be asked to sign a consent form prior to each donation. Depending on the amount of blood that is collected during your donation, the actual amount of time to collect your blood may take as little as one minute for small amounts or up to 20 minutes for large amounts. Whether you agree to donate one-time or more than once, ProMedDx will track the amount of blood you donate so that the total amount collected does not exceed 500 mLs (one pint) within an 8 week period if you are a healthy donor weighing at least 110 pounds or 100 mLs (approximately 6 ½ tablespoons) within an 8 week period if you are pregnant or are a patient with a health condition.

For some but not all studies, a portion of your blood sample may be sent out for testing. The testing performed will be based on specific requests by the medical researchers. The sample may be tested for the detection of the following transmissible diseases: Hepatitis B surface antigen, Hepatitis B core antibody, Hepatitis A antibodies, Human Immunodeficiency Virus (HIV) antibody, Human Lymphotrophic Virus (HTLV) type IIII antibody, Hepatitis C Virus antibody, and Syphilis. If these specific tests will be performed on your sample you will be told in advance of signing this consent form and if you agree to donate, you will be notified of ANY positive or abnormal test results. You will be referred to your primary care physician for confirmatory testing and follow-up. Your test results will be maintained in strictest confidence, consistent with state and federal laws. You may ask for your tests results and a description of what they mean for your health, at any time. Positive test results for any of these infectious diseases will be reported to the Massachusetts Department of Public Health.

If you are asked and agree to donate a sample collected with a swab: You may be asked to self-collect a sample using one or more sterile swabs that will be provided to you for the collection.

  • If you are asked and agree to self-collect a saliva sample, you will rub the swab(s) against the inside of your cheek several times to collect the sample.
  • If you are asked and agree to self-collect a nasal mucus sample, you will insert the tip of the swab into your nostril(s) and rotate several times against the nasal wall.
  • If you are asked and agree to self-collect a vaginal mucus sample, you will insert the swab into your vagina about 2 inches and gently rotate the swab slowly for 10‐30 seconds.
  • If you are asked and agree to self-collect a rectal mucus/fecal sample, you will insert the swab into your anal canal about 1 inch and gently rotate the swab slowly for 10‐30 seconds.

After collecting the sample, you will then place the swab(s) in a collection container provided.

If you are asked and agree to donate saliva, urine or stool samples: Collection containers will be provided to you for catching excreted saliva (up to 2 mLs), urine (up to 500 mLs) or stool samples during self-collection.

If you are asked and agree to donate tissue samples: If tissue samples are obtained during your routine procedure (for example, if a biopsy is taken for diagnostic purposes), any left-over tissue that is not needed for diagnosis and would otherwise be thrown away would instead be provided to ProMedDx to be used for research. Surgical procedures will not be performed on you for the specific purpose of obtaining your samples and may only be obtained during medical procedures that are part of your healthcare management by your physician.
General procedures: In some cases, you may be asked to fast (no solid foods) for a certain number of hours before the sample collection. We will advise you in advance if you will need to fast. You will be provided with instructions to perform self-collections.

RISKS
If you are asked and agree to donate blood, some pain or bruising, fainting spell, or very rarely, an infection may occur when blood is drawn. If tissue samples are obtained for research, they will come from left-over tissue obtained from procedures that are already scheduled for you to undergo and for which you will sign another consent form provided by your healthcare provider, which will inform you of the procedures and any risks associated with the associated procedure. The study procedures as described pose no special risks to pregnant woman, unborn fetuses, or patients undergoing medical care.

WHAT IS EXPERIMENTAL
The following are being performed for the purposes of this study (are experimental) and are not considered standard care: Collecting samples of your blood and/or other biofluids to be used to support various areas of medical research.

BENEFITS
There will be no benefit or any financial gain to you from the use of this sample. You will not be given the results of any tests done on your blood unless specifically indicated on the last page of this form.

ALTERNATIVES TO PARTICIPATION
This study is not being done for your health or well being and your alternative is not to participate.

COMPENSATION
You will be reimbursed exclusively for your travel and/or time for participation in the study. Compensation may vary for each collection type depending on the nature and duration of the collection but will range from $10 (minimum) up to $100 (maximum). You will be told before you sign this informed consent form what you will receive for compensation. In the event that you choose to stop your participation in the collection before the collection is completed or if unanticipated problems occur and your collection cannot be completed, you will receive a prorated amount based on the compensation amount indicated for the collection. No funds have been set aside for additional compensation. Your donated samples will be stored and used later for research and development, and you will not have any rights to or interest in products which may come from this donation.

COSTS
There is no cost to you for donating the sample.

INJURY STATEMENT FOR MEDICAL CENTER AND CLINIC
No funds have been set aside if you require medical treatment as a result of injury arising from your participation in this study. The financial responsibility for such care will be yours.

CONFIDENTIALITY
If you agree to donate your samples, the following information will be sent to the researcher along with your sample:

  • A coded identification number that will be linked to your name
  • Age
  • Gender
  • Race/Ethnicity
  • Information you’ve provided about any of your existing health conditions or diseases
  • Results for any testing performed

You will be identified only by the coded number. This number will be randomly assigned by ProMedDx, LLC and will not include any personal identifiers such as name, initials, date of birth, or social security number. This code can be linked to your name only by ProMedDx, LLC personnel and will not be given to the researchers who receive your sample. Therefore, the researchers will not be able to link the information sent to them to you. Your name and personal information will be kept indefinitely at ProMedDx, LLC.
The following individuals may review your study records: authorized employees of ProMedDx, LLC, employees of the FDA or other authorized state or federal agencies, and representatives of New England Institutional Review Board. These individuals may photocopy information and take it for their files. Absolute confidentiality cannot be guaranteed.

Both the information that identifies you and the de-identified information will be kept indefinitely and there is no way of telling when and if it will be destroyed. The information sent to the researcher will be kept on paper and possibly in a database. The information that identifies you will not be sent to the researcher, but will be kept in your records at ProMedDx, LLC.

The information collected during this study will be processed to meet the purpose of the research study using the sample. The results of this research may be used for seeking approval from regulatory authorities for diagnostic tests. It may also be presented at meetings or in publications. However, your identity will not be disclosed in those presentations.

RESEARCH SUBJECT’S RIGHTS
Your sample donation is voluntary. Your refusal to participate will not affect your treatment or medical care in any way. You are free to withdraw your sample from this study for as long as the sample remains at ProMedDx, LLC. Once the sample has been sent to medical researchers it will not be able to be retrieved or destroyed. New information will not be gathered, but information already gathered will be used. ProMedDx, LLC will keep your records indefinitely. Your request to withdraw your sample must be received by ProMedDx in writing.
If you are a ProMedDx employee and choose to volunteer, this research study is not a part of your ProMedDx duties as an employee, and refusing to donate your sample(s) will not affect your continued employment or your relationship with individuals who may have an interest in this study. You will not be offered or receive any special job-related consideration if you take part in this research. Additionally, you must participate in this study on your own time; not during regular working hours.

OTHER REASONS FOR WITHDRAWAL
The Investigator may withdraw you from the study if the study is terminated by ProMedDx, the FDA or Institutional Review Board, or for administrative reasons.

QUESTIONS AND CONCERNS
If you have any questions about the purpose of this study or in the event a research-related injury occurs, you can call (508) 285-7877 and speak with Dr. Lyle or you can contact the Clinical Affairs department at ProMedDx, LLC at (508) 285-7877. If you have any questions about your rights as a participant, you may call the New England Independent Review Board (NEIRB) at 1-800-232-9570.

VOLUNTEER’S STATEMENT:
I have been given a chance to ask questions about this research study. These questions have been answered to my satisfaction.
I may contact Dr. Lyle or the Clinical Affairs department at ProMedDx, LLC if I have any more questions about taking part in this study.

I understand that my participation in this research project is voluntary. I know that I may quit the study at any time without harming my future medical care or losing any benefits to which I might be entitled. I also understand that the investigator in charge of this study may decide at any time that I should no longer participate in this study.

If I have any questions about my rights as a research subject in this study I may contact:
New England Independent Review Board
Telephone: 1-800-232-9570