IRB Study #:

Protocol #: (if not applicable, please delete this line)

Version: 12.22.2017

/ SUNY DOWNSTATEMEDICAL CENTER
NYC Health +Hospitals, Kings County
BROOKLYN, NY 11203
INFORMATION SHEET
TITLE OF RESEARCH STUDY:
Location/Department:
Principal Investigator:

TIP: Informed consent is a “PROCESS,” not just a FORM!!!

This template focuses on the regulatory requirements for the “form”.

Please review additional IRB Guidanceon “Obtaining Legally Effective Informed Consent and HIPAA Authorization.

Items in italics are general instructions and should be deleted and substituted as indicated.

To the extent possible, technical, medical, and scientific concepts should be explained in lay terms that are understandable to someone who is educated to the 6th to 8th grade level. Avoid long sentences and medical/technical jargon, and define any technical terms clearly whenever they are used. If the definitions of technical terms are lengthy, describe in separate sentences.The PI is encouraged to use readability resources, such as:

  • Readability Formulas
  • MS Word -Test your document's readability

Add pictures, diagrams, tables, or charts if they will improve understanding.

If applicable, change the title in header (e.g., PARENTAL PERMISSION, CONTROL GROUP INFORMED CONSENT, etc.).

You may wish to refer to additional language in the informed consent template to see if anything else should be added to this form.

Introduction and Purpose

We are asking if you want to be in a research study. This study is for (fill in the research participant’s condition or circumstance that makes them eligible for the study).

If you are enrolling healthy volunteers state: We are asking if you want to be in a research study because you are a healthy individual.)

The study is sponsored by the SUNY Downstate Medical Centerand NYC Health + Hospitals, Kings County.

If this form is used both for parent or legal guardian permission for a child, add the following:

If you are a providing permission for a child to be in the study, the terms “you” and “your” refer to your child.

If this form is used to obtain consent from a legally authorized representative for a cognitively impaired adult, add the following:

If you are deciding if an adult can be in this study,the terms “you” and “your” refer to the adult who cannot make the decision. Please consider the wishes and beliefs or the best interests of this person. The participant will be asked to give consent if his/her ability to make decisions is regained after you give your permission for him/her to be in the study.

Why is this research being done?

You must explain to the subject the purpose of the study in simple, everyday language. Tell the subject the background of the research problem (e.g., why current treatments are unsatisfactory).

Include a clear description of the purpose of the research study. For example, state “The purpose of this research study is to…” or “We are doing this study to find out if…”.

Please be reminded that the purpose of the study is to gather generalizable knowledge, therefore, avoid using the term “You” in this section. For example, the phrase “We want to find out if you have…” would not be an acceptable phrase in this section. The more acceptable phrase to use would be “We want to find out if people with…”.

Who is doing the study?

(Principal Investigator) is in charge of this study at (specify the location, e.g. SUNY Downstate Medical Center, Kings County Hospital Center, etc....) About(# of subjects) people will be in the study at (specify the location, e.g. SUNY Downstate Medical Center, Kings County Hospital Center, etc....)

About(# of research participants)people will be in the study around the country (include if this is a multi-site study, if this study is not multi-site study delete this sentence.)

About (# of research participants) people will be in the study around the world (include if study is multi-national, if this study is not multinational study delete this sentence.)

You cannot be in this study if you:

Provide a list of exclusion criteria that may be relevant to the subjects in order to make an informed decision regarding their participation in the study. Do not include the criteria listed in the sponsor’s protocol for use of the investigators. If there are no specific exclusion criteria, leave this section out of the consent form.

What will happen to you if you decide to be in this study?

Tell the subject what to expect. Give a brief description of the procedures to be performed. Describe all procedures in lay terms such that the description will be readable at the 6th grade level. Avoid long sentences and medical/technical jargon, and define any technical terms clearly whenever they are used.

Will you receive any compensation or reimbursement for being in the research?

Describe any gifts, rewards, compensation (payment), or reimbursement (e.g., in terms of expense, such as travel or inconvenience) that will be provided.

Include when applicable:

You will NOT receive any gifts, rewards, compensation, or reimbursement for your participation in this research study.

Include when applicable:

You will NOT receive any type of rights for discoveries, patents or products that may be developed from this research.

If it is anticipated that a U.S. Citizen or Resident Alien will receive payment compensation of $600 (not including travel reimbursements)or more during the calendar year from SUNY Downstate, please include the language below. Please note that there is no dollar limit for reporting income to the IRSif the research participant is a Non US Citizen that is a Nonresident Alien (NRA); therefore, if you anticipate the recruitment of a NRA, always include the language below, regardless of payment amount. For more information please review the SUNY RF policy on reimbursement or contact Elliot Feder in Post-Awards.

By accepting payment(s) from the Downstate Medical Center for participating in this study, certain identifying information about you may be made available to professional auditors to satisfy federal and state reporting requirements, but confidentially will be preserved. The research amounts are reported as "Other" income to the Internal Revenue Service (IRS).

  • If you are a U.S. Citizen or Resident Alien for tax purposes and receive $600 or more in a calendar year, the SUNY Downstate Medical Center Research Foundation (RF) must report the amount in box 3 ("Other") income on IRS form 1099-MISC.
  • If you are a Nonresident Alien (NRA) for tax purpose – research payments are subject to 30% withholding and the RF must withhold and report the payments and tax on IRS form 1042-S, therefore NRA payments must be paid through the RF business systems to withhold tax.

You should consult with a tax advisor on the impact for filing federal and/or state tax returns.

The following information will be shared with the SUNY Research Foundation in order to process payment and report your information to the IRS.

Indicate status for tax purpose:

__ (initials) (1) U.S. Citizen

__ (initials) (2) Permanent Resident (Green Card)

__ (initials) (3) Resident Alien (Meets substantial presence test)

__ (initials) (4) Nonresident Alien (NRA)

__ (initials) (5) Other (please specify): ______

If item 1, 2, or 3 is checked, you will be asked to complete an IRS Form W-9.

If item 4 is checked, all income must be reported and you will be asked to complete part I only of IRS Form W-8BEN.

Full Legal Name of Research Participant: ______

Address For Payment to Research Participant: ______

______

______

Taxpayer Identification Number (Social Security Number or Individual Taxpayer Identification Number (or indicate none): ______

Signature of Research Participant: X ______Date: ___/___/___

(Save copy to research records)

If it is anticipated that a research participant will receive compensation of $600 (not including travel reimbursements)or more during the calendar year through NYC H+H, Kings County, please include the language below:

You will receive compensation as part of your participation in this research study. If you receive $600.00 or more per calendar year in income for any reason from NYC Health + Hospital, Kings County, we must report it to the Internal Revenue Service (IRS) and issue an IRS form 1099. In order to receive reimbursement, you must supply the appropriate Social Security number for IRS reporting.

What are the possible risks or discomforts and benefits of being in the study?

Risks or discomforts may be physical, psychological, social, legal and economic.

Describe the risks for each procedure or drug clearly in lay terms.

What are the possible benefits of being in the study?

If the study is of no direct benefit to the participant the first sentence should be: There is no benefit to you for participating in the study.

Otherwise use: We cannot promise that you will benefit from being in this study. However, possible benefits include ______. (Describe the possible benefits of participation. Describe any potential direct benefits to the subject first, then any benefits to others. If benefits may not continue after participation in the study is over, be sure to inform the subject. Monetary compensation for participation should be described in section 4 and must NOT be listed as a benefit.)

What are your other choices?

The alternative to being in this study is to not participate. Your participation is voluntary. You don’t have to be in this research study. You can agree to be in the study now and change your mind later.

Who may you contact if you have any additional questions?

Only use the number(s) for the location(s) where the research is being done. Always include the IRB number.

questions about: / May be directed to:
The research
Research related injury
How to withdraw from a study / ENTER NAME(S)
Telephone: (718) XXX-XXXX
Pager:(718) XXX-XXXX
ENTER NAME(S)
Telephone: (718) XXX-XXXX
Pager:(718) XXX-XXXX
Your rights
Privacy rights
How to withdraw from a study
Concerns to be directed to an institutional representative who is not part of this research study / Institutional Review Board: (718) 613-8480
Hospital Privacy Officer: (718) 270-4033
Interpreter or translation services / Patient Relations Department: (718) 270-1111

Certificate of Confidentiality:

The NIH has updated their policy for issuing a Certificate of Confidentiality (CoC) to automatically apply more broadly to NIH funded studies, including those which commenced or are ongoing on or after 12/13/16. CoCs are intended to prohibit disclosure of sensitive, identifiable information in response to legal demands. The general applicability has been broadened to automatically apply to any of the following types of NIH funded research:

  • All human research (including exempt research) when individuals can be readily identified.
  • Research involving identifiable biospecimens data sources that could be used to deduce the identity of an individual’s biospecimens.
  • Research that generates individual-level human genomic data from biospecimens, or the use of such data.
  • Any other research that involves information about an individual that could be used to deduce the identity of an individual.

For NIH funded studies, NIH will no longer provide a paper certificate. The award itself may be used as confirmation that CoC protections are in place. The NIH CoC website has now been updated and includes FAQson this topic.

If the study is/will be conducted under a certificate of confidentiality (COC) granted by NIH, include the following language below, otherwise delete. For more information on COCs and their limitations see:

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.
[Use the following language as applicable] The Certificate cannot be used to refuse a request for information from personnel of the United States federal or state government agency sponsoring the project that is needed for auditing or program evaluation by [THE AGENCY] which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.

[language such as the following should be included if researcher intends to disclose information covered by a Certificate, such as potential child abuse, or intent to hurt self or others in response to specific federal, state, or local laws.] The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law of [list what will be reported, such as child abuse and neglect, or harm to self or others and ensure this is consistent with the above language regarding release of IHII].

[language such as the following should be included if researcher intends to disclose information covered by a Certificate, with the consent of research participants.] The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document [restate what will be disclosed, such as including research data in the medical record].

FINAL TIP. To avoid IRB requests for modifications, please check the readability of the consent before finalizing the document. The PI is encouraged to use readability resources, such Readability Formulasor MS Word -Test your document's readability

REMINDER: To the extent possible, technical, medical, and scientific concepts should be explained in lay terms that are understandable to someone who is educated to the 6th to 8th grade level. Avoid long sentences and medical/technical jargon, and define any technical terms clearly whenever they are used. If the definitions of technical terms are lengthy, describe in separate sentences.

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