This is a template for completing a consent form for a research study.
All blue and red text must be removed before sending the final version to the IRB. 
(Try to keep the language at 8th grade level)
The black text represents recommended language for all studies.  It may be removed; however, if it represents REQUIRED language, the IRB may require it to be replaced. 
The green text is the template language for a study primarily involving a blood draw(s). Please modify this language as needed, and update the text to black when the consent is complete.
PLEASE PROOFREAD THE FINAL VERSION BEFORE SUBMITTING TO THE IRB.

Background 
You are being invited to participate in this research study involving the donation of a blood sample(s) [OR a blood draw(s)]. The study doctor [Insert Name/ Degree] from the Department of [Insert Department] will explain this study to you. If you have any questions, you may ask the study doctor. 
[Please insert any other necessary Background information, including the expected duration of the subject’s participation in the study, and why the potential subject is being asked to participate. Provide subjects with information about the study sponsor(s).] 
[If the PI is both the investigator and the clinical physician of the subject, use the following language - Delete if not applicable:]
Your doctor is also an investigator of this research study. As an investigator, your doctor is interested both in your clinical welfare and in the conduct of this study. Before entering this study or at any time during this research, you may want to ask for a second opinion about your care from another doctor who is not an investigator in this study. You do not have to participate in any research study offered by your doctor.

Purpose 

In this study, the researchers are collecting blood sample(s) to learn more about … [Please try to limit explanation to one or two sentences, in lay language (8th grade).]  

What Happens In This Research Study 

You will be one of approximately [type number here] subjects to be asked to participate at this location. A total of [type number here] subjects at all institutions will be asked to participate in this study. 
The research will take place at the following location(s): Boston University Medical Center.

Provide here a clear, concise description of study procedures in enough detail to give the subject a clear picture of what he or she will experience during the study.  This subsection should explain the overall design of the study, describe in chronological order all procedures to be followed, and identify any procedures which are experimental.  Specify, as well, the location and length of time for each procedure, the frequency of procedures, the total length of time for participation, and, as appropriate, such study details as how subjects will be assigned to study groups, the method, dose, and frequency of medication administration, and specific tasks subjects will be expected to complete on their own.  Avoid technical language unfamiliar to the subject population and use appropriate subheadings to make the subsection more readable.

Blood Draw: If you agree to be in this study, you will go to [clinic or lab location] and give a blood sample. You will be seated, and blood will be drawn by putting a needle into a vein in your arm. You will have [amount] of blood taken [number of times drawn, and frequency]. The total amount of blood taken for the whole study will be [amount in teaspoons or tablespoons].   
[In this “What Happens section,” be sure to also include any other research activities that will occur as part of this study. For example, will investigators also be reviewing medical records to look at past medical history or previous blood test results? If you plan to collect information about the research subject from medical records, by questioning the subject, or by any other means, describe what information will be collected. If additional information will be gathered over time, you must make that clear. List all other study interventions here (in lay terms).] 

Your blood sample will be kept and used for testing until study activities are completed.  At that time any unused blood will be [discarded or banked]. 
[OR If you intend to consent the subject for future use of this sample(s) please add that information below]
 [If this is a repository study with multiple types of recipient investigators, complete and use the following language - Delete if not applicable:]
I allow my blood samples [or the results of my blood samples], to be released to the following:

___ BU/BMC RESEARCHERS ONLY
___ OUTSIDE RESEARCHERS 
___ OTHER (NIH)_____________________
___ COMMERICAL ENTITIES (I.E. 23&me, PFIZER PHARMACEUTICALS, ETC.)

Risks and Discomforts 

Describe here any reasonably foreseeable risks, discomforts, and inconveniences to subjects, the likelihood of occurrence (when appropriate), and the steps you will take to minimize these risks.  Include psychological, social, legal, and financial as well as physical risks.  If there are significant risks to participation that might cause you to terminate the study, describe the circumstances under which you would do so.

Risks of blood draws: The risks and discomforts of drawing blood include temporary discomfort from the needle stick, the possibility of pain or bruising at the site of the blood draw, occasional feelings of lightheadedness and, rarely, infection at the site of the blood draw.

Other risks- include any other risks related to the other study procedures (e.g. risks of loss of confidentiality if investigators with be looking through medical records to obtain research data, risks of putting results of tests into a research repository). 

If your study excludes pregnant women because of potential, known, or unknown effects of the study on the fetus, then this section should contain the following Pregnant Women Language – Delete if not applicable:
 If you become pregnant while you are participating in this study, it could be dangerous for the baby. You must use birth control if you are a woman having sex with men while you are participating in this study and for three months afterward. The only birth control methods that work well enough to be safe while you are on this study are oral contraceptives (the pill), intrauterine devices (IUDs), contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide and condoms with foam. You should not participate in this study if you are a woman who has sex with men and cannot use one of these birth control methods.
[End - Pregnant Women Language]

There may be unknown risks/discomforts involved. Study staff will update you in a timely way on any new information that may affect your health, welfare, or decision to stay in this study.

Potential Benefits

[If there is a potential benefit to subjects, complete and use the following language - Delete if not applicable:]
The benefits of participating in this study may be: (ENTER BENEFITS HERE). However, you may not receive any benefit from participating. 
[If there is no potential benefit to subjects, complete and use the following language - Delete if not applicable:]
You will receive no direct benefit from your participation in this study. However, your participation may help the investigators better understand (ENTER WHAT INVESTIGATORS WILL LEARN HERE).

Alternatives 
[If there are alternatives to participating in this study, complete and use the following language - Delete if not applicable:]
The following alternative procedures or treatments are available if you choose not to participate in this study: (ENTER ALTERNATIVES HERE).

[If there are no alternatives to participating in this study, use the following language - Delete if not applicable:]
Your alternative is to not participate in the study.

Subject Costs and Payments 

[If there are costs or payments:]
Describe here any costs the subject may incur as a result of participation in the study.  In addition, describe any compensation the subject will receive for participation, including any principles for prorating payment should the subject choose to withdraw before completing the study.

You will be paid [$] for taking the time to donate a blood sample(s).  If there will be multiple blood draws specify how and when subjects will be paid and whether payments will be pro-rated. 

[If there are no costs or payments, use the following language - Delete if not applicable:]
There are no costs to you for participating in this research study. You will not be paid to participate in this research study.

Confidentiality 

Describe here how the confidentiality of records identifying the subject will be maintained. Your description might include how information will be coded to protect subject identity, how and where data will be stored, who will have access to study records, how long records will be kept, and any steps you will take to ensure anonymity in publications and presentations. If you have obtained a Certificate of Confidentiality for the study, state that and any limitations to the protections it provides.
 [OR you can modify and use the following suggested language:]
Information from this study and from your medical record may be reviewed and photocopied by the Food and Drug Administration (FDA) and/or state and federal regulatory agencies such as the Office of Human Research Protection as applicable, and the Institutional Review Board of Boston University Medical Center. Information from this study and from your medical record may be used for research purposes and may be published; however, your name will not be used in any publications. Your information may also be used by non-research staff within BUMC who need this information to do their jobs [such as for treatment, payment (billing), or healthcare operations] and by people or groups who we hire to do work for us, such as data storage companies, insurers, and lawyers.

[If you plan to do genetic analyses or Genome Wide Assurance Studies (GWAS) as part of this study, then include this language and modify accordingly. Delete if not applicable]
There is potential risk in genetic testing for uncovering and conveying unwanted information regarding parentage or specific risk of disease. Also, sometimes, knowledge of DNA test results can provoke anxiety and influence decisions regarding marriage and family planning:
Both Massachusetts state laws and a new Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally make it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. These laws generally will protect you in the following ways: 
1.      Health insurance companies and group health plans may not request your genetic information that we get from this research. 
2.      Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums. 
3.      Employers with 6 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment. 
All health insurance companies and group health plans must follow the GINA law by May 21, 2010. All employers with 15 or more employees must follow the GINA law as of November 21, 2009. Massachusetts law currently applies to all employers of 6 or more employees.
Be aware that neither Massachusetts law nor the new Federal law protects you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. Thus, life insurance, disability insurance and long-term care insurance companies may legally ask whether you have had genetic testing and deny coverage for refusal to answer this question.  
OF NOTE: For multi-state studies the text should be modified to (e.g. “Some state laws and a new Federal statute . . .” and deleting Massachusetts references in the remainder. “Be aware that the new Federal law does not protect . . .) [End of genetic language]

[If this is a repository protocol or study that includes repositories, then include the following language. Delete if not applicable]
REPOSITORY operations are conducted according to detailed standard operating procedures which protect patient confidentiality. [PLEASE ADD HOW DATA IS STORED IN THE REPOSITORY AND HOW IT WILL BE DISTRIBUTED TO RECEPIENT INVESTIGATORS; THIS IS SAMPLE WORDING: Patient information is systematically deidentified before release to Archive recipient investigators. All identifying information is stored in a password protected computer which is not connected to a network or in paper records stored in locked filing cabinets and will not be released to investigators using your specimens. Physical access to computer and paper records is restricted to REPOSITORY personnel]. [End of repository language]

[If this is an FDA applicable clinical trial, then include the following mandatory language. Click here for more info about this. Delete if not applicable]
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. [End of clinical trial language]

Subject's Rights 

[This section should contain the following standardized language required by federal regulation and BUMC policy. Do not modify. Only complete the contact information at the end of this language:]  
By consenting to participate in this study you do not waive any of your legal rights. Giving consent means that you have heard or read the information about this study and that you agree to participate. You will be given a copy of this form to keep. 
If at any time you withdraw from this study you will not suffer any penalty or lose any benefits to which you are entitled. 
You may obtain further information about your rights as a research subject by calling the Office of the Institutional Review Board of Boston University Medical Center at 617-638-7207. If this study is being done outside the United States, you can ask the investigator for contact information for the local Ethics Board. 
The investigator or a member of the research team will try to answer all of your questions. If you have questions or concerns at any time, or if you need to report an injury while participating in this research, contact (CONTACT NAME) at (PHONE NUMBER) during the day and (CONTACT NAME) at (PHONE NUMBER) after hours.

Compensation for Research Related Injury 

[For NON-INDUSTRY SPONSORED PROTOCOLS, the consent form should contain the following template language. Use without modification. Delete if not applicable]:
If you think that you have been injured by being in this study, please let the investigator know right away [insert name and contact info]. If your part in this study takes place at Boston Medical Center, you can get treatment for the injury at Boston Medical Center. If your part in the study is not at Boston Medical Center, ask the investigator where treatment for injury would be available locally. Boston University Medical Center and the sponsor do not offer a program to provide compensation for the cost of care for research related injury or other expenses such as lost wages, disability, pain, or discomfort. You will be sent a bill for the medical care you receive for research injury if your medical insurance does not pay for your medical care. You are not giving up any of your legal rights by signing this form.

[For INDUSTRY SPONSORED PROTOCOLS, the consent form should contain one of the following template languages. If the sponsor will not agree to this language, please contact the IRB Analyst assigned to the protocol after the protocol has been submitted. Delete if not applicable]:
BUMC Preferred Language for Industry Sponsored Studies not Involving Children:
If you think you have been injured by being in this study, contact [insert PI name and contact information] right away.  You can get treatment for the injury at Boston Medical Center.   The study sponsor, [insert sponsor’s name], has agreed to cover the reasonable costs of treatment for a research injury that are not covered by your insurance or a government program. [Optional language:  However, a number of factors will influence whether the sponsor will or will not pay for the injury, such as:  if the injury is a result of normal progression of your disease rather than the research; if you do something that contributes to the injury; if you do not follow the instructions of the investigator or the protocol; or if the investigators do not follow the research protocol.]    A research injury is any injury or illness directly caused by your participation in the study.  If you are injured by a medical treatment or procedure that you would have received even if you were not in the study, that is not a research injury.  Payment for such things as lost wages, expenses other than medical care, or pain and suffering is not routinely available.  To help avoid injury, it is very important to follow all study directions.  You are not giving up any of your legal rights by signing this form.  

BUMC Preferred Language for Industry Sponsored Studies Involving Children: 
If you think your child has been injured by being in this study, contact [insert PI name and contact information] right away. Your child can get treatment for the injury at Boston Medical Center. The study sponsor, [insert sponsor’s name], has agreed to cover the reasonable costs of treatment for a research injury that are not covered by your insurance or a government program.   [Optional language:  However, a number of factors will influence whether the sponsor will or will not pay for the injury, such as:  if the injury is a result of normal progression of your child’s disease rather than the research; if you or your child do something that contributes to the injury; if you or your child do not follow the instructions of the investigator or the protocol; or if the investigators do not follow the research protocol.]   A research injury is any physical injury or illness directly caused by your child’s participation in the study. If your child is injured by a medical treatment or procedure that your child would have received even if he/she were not in the study, that is not a research injury. Payment for such things as lost wages, expenses other than medical care, or pain and suffering is not routinely available. To help avoid injury, it is very important to follow all study directions. You and your child are not giving up any of your legal rights by signing this form. 

[Note to PI: If the study is less than minimal risk with no risks of physical injury, then the IRB may determine that Compensation language is not needed in the consent form and may remove this section at the time of IRB review.]

Right to Refuse or Withdraw
 
[This section should contain the following standardized language required by federal regulation and BUMC policy. Do not modify or remove:]  
Taking part in this study is voluntary. You have the right to refuse to take part in this study. If you decide to be in the study and then change your mind, you can withdraw from the research. Your participation is completely up to you. Your decision will not affect your being able to get health care at this institution or payment for your health care. It will not affect your enrollment in any health plan or benefits you can get. 
If you choose to take part, you have the right to stop at any time. If there are any new findings during the study that may affect whether you want to continue to take part, you will be told about them as soon as possible.

The investigator may decide to discontinue your participation without your permission because he/she may decide that staying in the study will be bad for you, or the sponsor may stop the study. 

Protection of Subject Health Information 

[Following is template language for the HIPAA Authorization. Please make sure to edit this language and delete all that does not apply to your research. (If you don't want this section in this consent form, you can delete this whole section including this section’s title):]  
You have certain rights related to your health information. These include the right to know who will get your health information and why they will get it.  If you choose to be in this research study, we will get information about you as explained below.

HEALTH INFORMATION ABOUT YOU THAT MIGHT BE USED OR GIVEN OUT DURING THIS RESEARCH:

•	Information from your hospital or office health records at BUMC/BMC or elsewhere. This information is reasonably related to the conduct and oversight of the research study. If health information is needed from your doctors or hospitals outside of BUMC/BMC, you will be asked to give permission for these records to be sent to the researcher.

•	New health information from tests, procedures, visits, interviews, or forms filled out as part of this research study.

WHY HEALTH INFORMATION ABOUT YOU MIGHT BE USED OR GIVEN OUT TO OTHERS

The reasons we might use or share your health information are:
•	To do the research described here
•	To make sure we do the research according to certain standard set by ethics, law, and quality groups

PEOPLE AND GROUPS THAT MAY USE OR GIVE OUT YOUR HEALTH INFORMATION

•	PEOPLE OR GROUPS WITHIN BUMC/BMC

o	Researchers involved in this research study

o	The BUMC Institutional Review Board that oversees this research

o	Non-research staff within BUMC who need this information to do their jobs [such as for treatment, payment (billing), or health care operations.

•	PEOPLE OR GROUPS OUTSIDE BUMC/BMC

o	People or groups that we hire to do work for us, such as data storage companies, insurers, and lawyers. 

o	Federal and state agencies if they are required by law or involved in research oversight. Such agencies may include the U.S. Department of Health and Human Services, the Food and Drug Administration, the National Institutes of Health, the Massachusetts Department of Public Health.

o	Organizations that make sure hospital standards are met

o	The sponsor(s) of the research study, and people or groups it hires to help them do the research

o	Other researchers that are part of this research study

o	A group that oversees the research information and safety of this study

o	Government agencies in other countries

o	Other: 

Some people or groups who get your health information might not have to follow the same privacy rules that we follow. We share your health information only when we must. We ask anyone who gets it from us to protect your privacy. However, once the information leaves BUMC, we cannot promise that it will be kept private. 

In most cases any health data that is being given out to others is identified by a unique study number and not with your name.  So, although in some cases it is possible to link  your name to the study data, this is not usually done. 

TIME PERIOD FOR USING OR GIVING OUT YOUR HEALTH INFORMATION

Because research is an ongoing process, we cannot give you an exact date when we will either destroy or stop using or sharing your health information.

YOUR PRIVACY RIGHTS

•	You have the right not to sign this form that allows us to use and give out your health information for research. If you don't sign this form, you can't be in the research. This is because we need to use the health information to do the research. 

•	You have the right to withdraw your permission to use or share your health information in this research study. If you want to withdraw your permission, you must write a letter to the researchers in charge of this research study.  

If you withdraw your permission, you will not be able to take back information that has already been used or shared with others. This includes information used or shared to do the research study or to be sure the research is safe and of high quality. 

If you withdraw your permission, you cannot continue to be in the study.

•	You have the right to see and get a copy of your health information that is used or shared for research. However, you may only get this after the research is finished. To ask for this information, please contact the person in charge of this research study. 

IF RESEARCH RESULTS ARE PUBLISHED OR USED TO TEACH OTHERS

The results of this research study may be published in a medical book or journal, or used to teach others. However, your name or other identifying information will not be used for these purposes without your specific permission. )
[End of Protection of Subject Health Information language]

[Signatures - Following are all available signature lines. Please make sure to delete all that does not apply to your research. (If the IRB has waived  don't want this section in this consent form, you can delete this whole section):]  
Signing this consent form indicates that you have read this consent form (or have had it read to you), that your questions have been answered to your satisfaction, and that you voluntarily agree to participate in this research study.  You will receive a copy of this signed consent form.

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Subject (Signature and Printed Name)				Date

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Parent (Signature and Printed Name)				Date

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Second Parent (Signature and Printed Name)			Date

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Mother (Signature and Printed Name)                                      	Date

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Father (Signature and Printed Name)                                       	Date

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Child Assent (Signature and Printed Name)                            	Date

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Family Member Assent (Signature and Printed Name)            	Date

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Study Partner (Signature and Printed Name)                            	Date

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Legally Authorized Representative (LAR) (Sign and Name)       Date

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Surrogate/ Relationship to Subject (Sign and Print Name)   	Date

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Person Obtaining Consent (Signature and Printed Name)      	Date

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Investigator or Designee (Signature and Printed Name)          	Date

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Interpreter (Signature and Printed Name)                     		 Date

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Witness (Signature and Printed Name)                        		Date  

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Follow up - Subject (Signature and Printed Name)                      Date  

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Follow up - Investigator or Designee (Sign and Print Name)       Date    

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Subject's Thumb Print 						 Date

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Thumb Print Witness (Signature and Printed Name)              	Date

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Parent/Legal Guardian (Signature and Printed Name)             	Date