Black Text = Instructions for Investigator
Green text = required template language
Blue Text = study-dependent language

For all consents:

• MUST be written IN LAY LANGUAGE below 8th grade reading level. Use MSWord programs to assess reading level.
• use a large font (at least 12 point) and bullets
• use short paragraphs
• use short, simple and direct sentences
• use bullets
• define all abbreviations and acronyms when they first appear in text
• put all medical terminology in lay language  
• DO NOT CHANGE THE GREEN HEADINGS OR THEIR ORDER

1. delete this preamble,
2. delete black text instructions,
3. delete any blue sections that are not applicable, and
4. finally, change all text to black

_______________________________________________________________________________

RESEARCH CONSENT FORM

Project Title:
Principal Investigator: must be a faculty member or acceptable BNL Employee
Co-Investigators: Names of all co-Investigators, with faculty/student status identified

Department:

You are being asked to be a volunteer in a research study.

• For protocols with experimental treatments or the potential risk to the subject is high, add:

PURPOSE

The purpose of this study is:

• brief statement  why the subject is eligible for this study (e.g., certain type of cancer).
• brief description of the background and purpose of the study in lay terms.
• If the study involves use of an experimental drug or drug with IND, add: “This drug is not approved by the Food and Drug Association (FDA) and is therefore considered experimental”. 
• If the study involves use of an experimental device with IDE, add: “This device is not approved by the Food and Drug Association (FDA) and is therefore considered experimental”. 
• brief statement regarding the # of subjects in study overall, and then the # expected to enroll at SBU

PROCEDURES Use bullets for clarity

If you decide to be in this study, your part will involve:

• short description of all procedures done for the purpose of the research activity, in the order they occur (e.g., Screening visit, Visit #1, Visit #2 etc.).
• outline frequency, scheduling and time commitment of each procedure/ visit; include total time commitment
• use tables or schema format to provide complicated information or scheduling.
• Procedures that will be done whether or not the subject is in the research (‘standard of care’), should not be included. span>
• blood drawing – indicate the amount (in teaspoons or tablespoons), frequency and scheduling of draws
• If randomly assigned to different groups add:    "You will be randomly (by chance) assigned to one of….”
• An investigational drug/device should be referred to as an 'experimental drug/device' throughout document
• A placebo should be referred to as 'inactive substance'.
• Any audio- or video-taping should be addressed in this section

RISKS / DISCOMFORTS

The following risks/discomforts may occur as a result of you being in this study:

• describe reasonably foreseeable risks and discomforts, including nonphysical risks (i.e., inability to work, inability to drive)
• Group risks/discomforts by probability of occurrence (i.e., 'rare', 'common') and by temporary or permanent.
• If there are no anticipated risks/discomforts:   “There are no foreseeable risks or discomforts associated with your participation in this study."
• list the risks for each specific drug (experimental or standard) subject receives
• With experimental treatments/drugs, include “Since this is a research study, not all risks may be known at this time; there may be unforeseen risks associated with study participation”.
• where genetic analysis of identifiable biological specimens is proposed (where inherited factors may be assessed in current or future proposed studies),add: The genetic analysis to be conducted on your tissue in this study may pose future risks that are not known at this time.
• risks with blood drawing should be stated as: "temporary pain and bruising where the needle enters the skin, and sometimes, fainting and/or infection".
• If there are known or unknown risks to pregnant/nursing females, fetuses, and/or females of childbearing potential that may be applicable to your study, these must be discussed in boldfaced print, with special instructions regarding need for effective birth control:

“Being a part of this study while pregnant may expose the unborn child to significant risks that are not justified, given the purpose of the study. Therefore, pregnant females will be excluded from the study. If you are a female who can become pregnant, a pregnancy test must be done, and must be negative before you can enter this study. [* Follow-up pregnancy tests may be required. The scheduling for these are outlined in the procedures section of this form.] If you are sexually active, you or your partner must agree to use appropriate contraceptive measures for the duration of the study. Medically acceptable contraceptives include:

• surgical sterilization
• approved hormonal contraceptives, such as birth control pills, Depo-Provera, or Lupron Depot
• Barrier methods (such as condom or diaphragm) used with a spermicide, or
• an intrauterine device (IUD).

If you do become pregnant during this study, you must inform your study physician immediately.”

* Add this sentence about follow-up pregnancy tests only if it is applicable to your study and address scheduling requirements in the Procedures section of the consent form.

• Similar discussion for males should be included for studies in which effects on sperm are possible.
• If study involves Radiation risk, add this section:

You will get radiation from being in this study.  To help you understand how much you will get, we will compare it to amounts you get in your daily life. Everyone is exposed to some radiation every year. There is natural radiation in the world we live in, and in the medical tests we take for our health. The radiation dose you get from your daily life is between 200 to 500 millirem (mrem; a unit of radiation) each year. A chest x-ray at the doctor’s office is about 10 mrem. An x-ray of your belly is 500 mrem.

Then, choose which of the following 3 paragraphs are applicable:

Insert this next paragraph if your research activity involves Diagnostic Procedures using Radioactive Drugs or Ionizing Radiation (e.g., Chest X-ray, X-ray of any organ/system, CT scan, Nuclear Medicine procedure, PET scan etc)

In this study, you will get radiation from these research tests: ________________.   The radiation dose from this/these procedure(s) will be no more than ______ mrem. This is about equal to the amount of radiation you get in _____ days of daily life.  The risk from this amount of radiation is too small to be measured directly.  It is considered to be low risk when compared with other every day risks.  The Food and Drug Administration (FDA) believes it is OK to get this amount from research.

If you have questions about the radiation you will get in this study, contact Edward J. O’Connell, Radiation Safety Officer for Stony Brook University, 631-632-9674.
 

Insert this next paragraph if your research activity involves only Therapeutic Procedures using Radioactive Material or Ionizing Radiation (e.g., Low dose irradiation of any organ, High Dose Brachytherapy, Seed implantation to Prostate, I-131 thyroid treatment, Cs-137 treatment for gynecologic procedures, etc.):

In this study, you will get radiation from these research procedures:  ___________.  Some parts of your body and organs may receive a large amount of radiation. There are side effects that may occur soon, and/or over time because of this radiation.  The risks are__________________*.   

If you have questions about the amount of radiation you will get in this study, contact Edward J. O’Connell, Radiation Safety Officer for Stony Brook University, 631-632-9674.

*(list organ systems that will receive significant radiation exposure in this study, along with a listing of acute and late side effects that may occur, and their probabilities of occurrence at the proposed radiation levels).   

Insert these next paragraphs if your research activity involves both Diagnostic and Therapeutic Procedures using Radioactive Drugs or Ionizing Radiation

In this study, you will get radiation from these research tests: ________________.   The radiation dose from this/these procedure(s) will be no more than ______ mrem. This is about equal to the amount of radiation you get in _____ days of daily life.  The risk from this amount of radiation is too small to be measured directly.  It is considered to be low risk when compared with other every day risks.  The Food and Drug Administration (FDA) believes it is OK to get this amount from research.

In this study, you will get also radiation from these research procedures:  ___________.  Some parts of your body and organs may receive a large amount of radiation. There are side effects that may occur soon, and/or over time because of this radiation.  The risks are__________________*.  

*(list organ systems that will receive significant radiation exposure in this study, along with a listing of acute and late side effects that may occur, and their probabilities of occurrence at the proposed radiation levels).   

If you have questions about the amount of radiation you will get in this study, contact Edward J. O’Connell, Radiation Safety Officer for Stony Brook University, 631-632-9674.

BENEFITS

Include one of the following statements, as applicable:

There is no health benefit expected as a result of you being in this study (use in applicable studies that are either not biomedical at all in nature; e.g., political science surveys etc, or where an intervention is not being tested for efficacy in improving health, e.g., a phase I clinical trial, tissue banking study, etc)

'OR'

The following benefits to your health may occur as a result of being in this study:

Now, describe any possible direct health benefits (to the subject) that may be derived from participation in the study (use in applicable studies where there is an intervention being tested for efficacy)

Then, once you choose one of the statements above, you can, if applicable, discuss the benefits that may come to others as a result of the subject’s participation in the study, e.g., in a phase I clinical trial, participation is not intended to yield direct benefit to the subject, but is intended to provide indirect benefit to others through the information obtained about an experimental agent’s safety, pharmacokinetics etc, that will be helpful in drug development for a disorder)

PAYMENT TO YOU  - if subject pool is involved, this section should be titled 'Credit to Subjects'

• address compensation/reimbursement (money, subject pool credits).
• Compensation must be prorated - address the scheduling of prorated payment (e.g., $25 per visit, $10 per blood draw, etc).
• If the subject is not going to be paid or receive credit (in the case of subject pools), you should  say so.

PAYMENT TO THE INSTITUTION (use this section when the study is externally funded)  

This project is funded, in part, by a grant or contract from {the Acme Pharmaceutical Company} to the Research Foundation of Stony Brook University, in support of the Investigators' work on this study. Amount of payment from this sponsor is dependent upon…

PAYMENT TO THE INVESTIGATOR: (use this section when the investigator has a significant financial interest in the entity that is sponsoring the study. For definitions, see www.stonybrook.edu/research/HSG/HSGsec24.html)

Dr. ______________, who is one of the investigators conducting this study, has a significant financial interest in the company supporting this study, which means he/she may receive personal financial benefit from the results obtained. Dr. _____________will not be involved in the recruitment or consenting of subjects.*

INVESTIGATOR’S PERSONAL COMMERCIAL INTEREST (use this section if  a member of the study team has a vested personal interest in the future commercial success of the drug, device, etc under study (e.g., was involved in discovery, patent, licensing, IND/IDE filings etc.), but does not, at this time, have a financial interest that reaches the level of significant, as defined and discussed in the next section)  

One or more of the investigators on this study has a personal commercial interest in or may financially benefit in the future from the development of the [drug, device, etc] being tested in this study.

CONFIDENTIALITY 

Protecting Your Privacy in this Study

If you are only obtaining completely anonymous data (no identifiers or codes at all) from your subjects, use this as your first and only paragraph:

All the information we get about you will be kept private. We will do this by not writing down your name or anything else that could link you in any way to the answers you give us for our study. All the study data that we get from you will be kept locked up. If any papers and talks are given about this research, your name will not be used.

For all other studies, use this as a first paragraph:

We will take steps to help make sure that all the information we get about you is kept private. Your name will not be used wherever possible. We will use a code instead. All the study data that we get from you will be kept locked up. The code will be locked up too. If any papers and talks are given about this research, your name will not be used.

We want to make sure that this study is being done correctly and that your rights and welfare are being protected. For this reason, we will share the data we get from you in this study with the study team, the sponsor of the study (and those who work for them), Stony Brook University's Committee on Research Involving Human Subjects, applicable Institutional officials, and certain federal offices. However, if you tell us you are going to hurt yourself, hurt someone else, or if we believe the safety of a child is at risk, we will have to report this.

In a lawsuit, a judge can make us give him the information we collected about you.

Special case if applicable - If you or the sponsor has obtained a Certificate of Confidentiality from the NIH, delete the sentence above that starts ‘In a lawsuit…’, and add:

This study requires that we collect very private information about you. Therefore, we had the National Institutes of Health give us a Certificate of Confidentiality (COC). This piece of paper says that nobody can force the researchers to give out your information, even if a court of law asks for it. This will give you more protection. The only time information about you can be given out is:

• If you are going to hurt yourself,
• If you are going to hurt someone else
• If we believe the safety of a child is at risk.
• (if applicable) If the Department of Health and Human Services, who pays for this study, wants to look over the study.
• (if applicable) If data about the study drug/device needs to be reported to the Food and Drug Administration.

This Certificate doesn’t mean you can’t talk about this study. If you give written permission, your insurance company, your boss, or your private doctor can be given the research information too.

For all, if you are obtaining or generating data regarding your subjects’ mental or physical health, add:

While you are in this study we will get data about your health from your medical record. We will also get health data from the results of the tests you will have done in this study. You have a right to privacy but the data we get about your health in this study can be shared with the people referenced above (the study team, the sponsor of this study, those who work for the sponsor, Stony Brook University's Committee on Research Involving Human Subjects, applicable institutional officials, and certain federal offices) as well as (as applicable):

• your insurance company
• your private doctor
• A board that reviews the safety of the study on an on-going basis.

Your health data are shared to make sure the study is being done correctly, costs are charged correctly, and to make sure your rights and safety are protected. Not all of these people are required by law to protect your health data. They might share it with others without your permission. For example, the sponsor of this study does not have to make the same promise under the law to protect your health data. (Add detail here concerning how the sponsor will protect health data; see contract language)

Some of the health information we get from you in this study cannot be shared with you until the end of the study.

You have the right to stop allowing us to use or give out your health data. You can do this at any time by writing to (name of Principal Investigator). If you do this, we will stop collecting any new health data from you, except if we need to keep an eye on a bad side effect you were having in the study. We will use any data we collected before you wrote your letter. When you sign the consent form at the end, it means:

• That you have read this section.
• That you will allow the use and reporting of your health data as described above.
• (If the subject is a patient at UH) You have received a form from the University Hospital. It is called the Notice of Privacy Practices form.

If you are paying your subjects for their participation, add:

If you are paid $600 or more a year as a research subject, your social security number will be reported to those in charge of taxes. You may have to pay taxes on this money.

COSTS TO YOU  

• Describe the financial obligation of the subject that is specific to them being in the study (not as a result of their clinical care).
• If there are no foreseeable costs, this should be specified.
• If the clinical costs are mingled with the research costs or the possible costs to the subject are high, a statement should be added encouraging the subject to contact his/her insurance company and/or discuss the costs with the investigator prior to consenting to be in the study.

ALTERNATIVES

• Describe other treatments, options, or procedures available if the subject chooses not to participate, or if the subject withdraws from the study. The relative risks and benefits of these alternative treatments should be discussed as well.
• For non-treatment studies where the only alternative is to not participate, include the following statement: "Your alternative to being in this study is to simply not participate".
• If the study drugs/procedures can be obtained by the subject outside of the research setting, this should be disclosed in this section as well.

IN CASE OF INJURY (applicable if the study involves the potential for injury to subject {psychological, physical, etc., including blood drawing protocols}).

• Standard text:

'If you are injured as a result of being in this study, please contact [Dr. P. Investigator] at telephone # [XXX-XXXX]. The services of Stony Brook University Hospital will be open to you in case of such injury.

Then, if the study is not externally sponsored, or is investigator-initiated, add this line:

However, you and/or your insurance company will be responsible for payment of any resulting treatment and/or hospital stay'.

 Or, if  the study is sponsored by industry (e.g., pharmaceutical companies etc), add this line (and confirm that the contract between sponsor and the Research Foundation is consistent on this issue):

[Name of Sponsor] will repay Stony Brook University Hospital for any treatment and/or hospital stay that is due to an injury directly resulting from the study [drug/device], as long as all the steps for conducting the study correctly were followed. 

CONSEQUENCES OF WITHDRAWING (if applicable)

• Describe the consequences and steps to be followed if a subject decides to withdraw from the research (e.g., subject must be taken off drug slowly, will be asked to show up for a safety follow-up visit to check for effects, subject will not receive full subject pool credit, etc).

REMOVAL FROM STUDY(if applicable)

• Describe the circumstances under which a subject will be removed from the study (e.g., non-compliance, bad reaction to drug, sponsor decides to stop the study, etc).

SUBJECT RIGHTS  

• Your participation in this study is voluntary. You do not have to be in this study if you don't want to be.
• You have the right to change your mind and leave the study at any time without giving any reason, and without penalty.
• Any new information that may make you change your mind about being in this study will be given to you.
• You will get a copy of this consent form to keep.
• You do not lose any of your legal rights by signing this consent form.

QUESTIONS ABOUT THE STUDY OR YOUR RIGHTS AS A RESEARCH SUBJECT  

• If you have any questions about the study, you may contact [Dr. P. Investigator], at telephone # (631-XXX-XXXX).
• If you have any questions about your rights as a research subject, you may contact Ms. Judy Matuk, Committee on Research Involving Human Subjects, (631) 632-9036, judy.matuk@stonybrook.edu.

_________________________________           ____________________________________________

Subject Name (Printed)                                          Subject Signature                                      Date

_______________________________                 ___________________________________________

Name of Person Obtaining Consent                       Signature of Person Obtaining Consent          Date