Research Consent/Authorization

Continuing Participation by Subjects Previously Enrolled by

Parents, Legally Authorized Representative or Research Proxy

Addendum - For Follow-up Only

Protocol Title:

Principal Investigator:

Sponsor:

You have been participating in the above titled research study for which your parents / legally authorized representative / research proxy signed a consent form. Now that you are able to act on your own behalf, we are asking for your consent to remain in the study for follow-up only.

All of the elements of informed consent in the attached consent document signed by your parents/legally authorized representative/ research proxy remain the same. All the procedures listed in the original consent form have been completed with the exception of follow-up.

By signing this form you agree to have your research study follow-up continue at with Dr. . If you do not wish to continue follow-up on this study, other options will be discussed with you. You do not have to continue to participate in the study. You will not suffer any penalty or loss of benefits by leaving the study.

In order for you to continue your participation in this research study, the North Shore-Long Island Jewish Health System must first obtain your written authorization to use or disclose your protected health information (PHI) for the research purposes described during the informed consent process and in the attached consent form.

This form provides that authorization. By signing it, you authorize the use and/or disclosure of your PHI described below.

What information will be used or disclosed?

The entire research record and any medical records held by NSLIJHS that are needed for the research may be used and disclosed, including:

  • The history and diagnosis of your disease;
  • Current and previous treatments you received;
  • Other medical conditions that may affect your treatment;
  • Laboratory, radiology and pathology test results;
  • Follow-up information about your general health, the status of your disease and late effects from treatment.

Who will receive, and/or use or disclose the information?

This form will authorize the following person(s), class(es) of persons, and/or organization(s) to disclose, use, and receive the information specified in this form.

  • Every research site for this study, including NSLIJHS, and including each sites’ research staff and medical staff
  • Every health care provider who provides services to you in connection with this study
  • Any laboratories and other individuals and organizations that analyze your health information in connection with this study in accordance with the study’s protocol
  • The following research sponsors, people, and companies that oversee, administer, or conduct the research:
  • Any government agencies such as the United States Food and Drug Administration and the Federal Office of Human Research Protection, etc., as authorized or required by law
  • The members and staff of NSLIJHS’s affiliated Institutional Review Board (IRB)

The IRB is the committee that oversees research at this institution.

  • The Principal Investigator and other Investigators
  • The Study Coordinator and members of the Research Team
  • Members of NSLIJHS’s administrative staff responsible for administering clinical trials and other research activities
  • Data Safety Monitoring Boards and/or others authorized to monitor the conduct of the Study
  • Others:

If the researchers learn about potential serious harm to you or someone else or other public health concerns, it will be shared with the appropriate authorities.

When your PHI is disclosed to people or entities that are not required to abide by federal or state medical privacy laws, those people and entities may re-disclose your PHI to others and use it without being subject to penalties under those laws.

Subject to certain legal limitations, you have the right to access your PHI that is created during this research that relates to your treatment or payment provided. This includes information that is used to make decisions related to your care, and does not include information related to procedures or tests that are not clinically validated. You may access this information only after the study analysis is complete. To request this information, or for any questions related to your PHI, you may contact the Research Privacy Officer at 516-562-2018.

This authorization does not have an expiration date. If you change your mind about being in the study, you may withdraw at any time. If you want us to stop collecting your health information, you need to send a letter to the researcher at the following address:

PI Name:

Address:

Your letter needs to say that you have changed your mind and do not want the researcher to collect and share your health information. You may also need to leave the research study if we cannot collect any more health information. We may still use the information we have already collected.

You will receive a copy of this form after you have signed it.

Contacts:

If you have any questions about this study, you may call Dr. at . Further information regarding your rights can be obtained by calling the Office of the Institutional Review Board (IRB) of the North Shore-Long Island Jewish Health System at (516) 321-2100.

Revised 2/12