Participant ID:

Protocol Title:
Principal Investigator:
Description of StudyPopulation:
Version Date:
INSTRUCTIONS: To use this template, complete all required sections (substituting appropriate language for any italicized wording) and any applicable additional sections (marked “if applicable”), then delete all shaded instruction boxes, italicized instructions, brackets and/or omitted sections prior to submitting this form. Refer to the Investigator’s Manual for additional instruction and specific examples.

About this consent form

Please read this form carefully. This form provides important information about participating in research. You and your child have the right to take your time in making decisionsaboutyou and your child’s participation in this research. You and your child maydiscuss thedecision with family, friends and/oryour child’sdoctor. If you or your child has any questions about the research or any portion of this form, please ask us. If you decide your child can participate in this research you will be asked to sign this form. A copy of the signed form will be provided to you for your record.

Participation is voluntary

You and your childare invited to take part in this research because[fill in the circumstance/condition that makes the participant eligible]. It is you and your child’s choice whether or not to participate. If you and your child choose to participate, you or your child may change your mind and leave the study at any time. Refusal to participate or stopping participation will involve no penalty or loss of benefits to which you or your child are otherwise entitled.

What you and your childshould know about a research study

  • Someone will explain this research study to youand your child.
  • A research study is something youand your child volunteer for.
  • Whether or not youand your child take part is up to youand your child.
  • You and your child can choose not to take part in the research study.
  • You and your child can agree to take part now and later change your mind.
  • Whatever you and your child decide it will not be held against youand your child.
  • Feel free to ask all the questions you and your child want before you decide.

What is the purpose of this research?

The purpose of this research is to [fill in the purpose].

How many people will take part in thisresearch?

About [fill in number] people will take part in this research.

How long will I take part in this research?

INSTRUCTIONS: Include the following information in this section:
  • Expected time commitment to complete the study, e.g., “We expect that you will be in this research for ______.” Or, “It will take you about 14 months to complete the study. During this time you will be asked to make 14 study visits.”

What can I expect if I take part in this research?

As a participant, you and your child will be expected to complete the following [describe all study procedures,study visits, etc.]

[What are my responsibilities?if applicable]

As a participant, you and your child are responsible for [list responsibilities].

What are the risks and possible discomforts?

INSTRUCTIONS:Describe the reasonably foreseeable risks or discomforts (whether physical, psychological, privacy, legal, social or economic) that may result from study procedures, (e.g., answering study questions, participating in focus group, using investigational products). Do not understate risk and/or discomfort.

Are there any benefits from being in this research study?

INSTRUCTIONS: Unless there are benefits, say: “There are no direct benefits to you/your child from your taking part in this research.” If there may be benefits, say: “We cannot promise any benefits to you and your child or others from your taking part in this research. However, possible benefits include [fill in possible benefits including benefits to a particular population or society at large]

What are my alternatives to participating in this research?

INSTRUCTIONS: Unless this is a treatment study, say: “The alternative to participating in this research study is not to participate.”If it is a treatment study, include the following information:
  • Alternative procedures, tests, evaluations, or courses of treatment for the disease/medical condition. Be specific and name at least some other drugs, tests, or procedures.
  • Palliative care or no treatment, when appropriate.

Can I still get medical care at <insert facility> if I choose not to participate in this research?[Delete this sectionif not applicable]

Yes, you and your child may still get medical care if you and your child choose not to participate in this study. You and your child’s decision will not change the care you and your child receive now or in the future. Taking part in this research is your choice. If you and your child decide to take part in this study, you and your child may leave/stop the study at any time. There will be no penalty to you and your child and your medical care will not be affected. If you and your child would like to stop participating in this research you and your child should let us know. We will make sure that you and your child stop the study safely.

It is possible that the investigator may ask you and your child to stop the study before it is finished. If this happens we will tell you and your child why and arrange for other care for youand your child if needed.

Will I be compensated for participating in this research?

INSTRUCTIONS: Include the following information in this section:
  • Money or other forms of compensation or reimbursement, e.g., gift certificate, meal voucher, parking voucher, and travel expenses
  • Include the method and timing of the compensation
  • Include how the amount of compensation is calculated if the participant does not complete the entire study for any reason, e.g., “If you do not complete all of the study visits, we will give you $25 for each study visit you completed.”
Refer to Harvard’s Human Subjects Payment policy, available at
If participants will not be paid or will not receive other forms of compensation for participation, say: “You and your child will not be compensated for participating in this research”.

What will I have to pay for if I participate in this research?

INSTRUCTIONS:Describe any costs the participant may incur. If participants will not incur any costs, say: “It will not cost you and your child anything to participate in this research”.

What happens if I am injured as a result of participating in this researchstudy?

INSTRUCTIONS: Include this section heading and the wording below in all consent forms. This section will be deleted by the IRB if it is found to be not applicable.

If physical injury resulting from participation in this research should occur, although Harvard’s policy is not to provide compensation, medical treatment will be available including first aid, emergency treatment and follow-up care as needed, and your child’s insurance carrier may be billed for the cost of such treatment. In making such medical treatment available, or providing it, the persons conducting this research project are not admitting that youand your child’s injury was their fault.

Can my taking part in the research end early?

INSTRUCTIONS:Unless there are adverse consequences to withdrawing from the research, say: “You and your child may decide not to continue in the research at any time without it being held against you. The person in charge of the research [or the sponsor – if applicable] can remove you and your child from the research at any time without and your child’s approval for any reason.” If appropriate, include: “Possible reasons for removal include (reasons why the participant may be withdrawn, such as “if it is in your best interest” or “if you and your child do not follow study directions”).”
If there are adverse consequences, say: “You and your child may decide not to continue in the research at any time without it being held against you. If you and your child decide to leave the research (describe adverse consequences). If you and your child decide to leave the research, contact the investigator.

If I take part in this research, how willmy privacy be protected? What happens to the information you collect?

INSTRUCTIONS: Describe confidentiality protections, including who will have access, how long data/specimens will be retained, and the destruction plan, if applicable. Include the following language as appropriate.

Efforts will be made to limit the use and disclosure of you/your child’s personal information, including research study and medical records, to people who have a need to review this information. We cannot promise complete secrecy. Organizations that may inspect and copy your information include the IRB and other representatives of this organization. [Add to this list other organizations that may have access to the subject’s records such as the Food and Drug Administration, when the research if FDA-regulated, the Department of Health and Human Services, when the research is conducted or funded by DHHS, the sponsor, contract research organization, sponsor’s agent and other collaborating institutions.]

[Describe any limitations on confidentiality based on possible legal issues. For example, if the research team is likely to uncover abuse, neglect, or reportable diseases, explain that this information may be disclosed to appropriate authorities.]

[If data or specimens will be retained after the study for future research or data sharing (i.e., required of NIH-funded studies using/generating large-scale human genomic data or as a requirement of publication, e.g., PLoS), explain where the data or specimens will be stored, who will have access to the data or specimens, and how long the date or specimens will be retained.]

[Include for a clinical trial. Otherwise delete.] The sponsor, monitors, auditors, the IRB, the Food and Drug Administration will be granted direct access to you/your child’s medical records to conduct and oversee the research. By signing this document you are authorizing this access. We may publish the results of this research. However, we will keep you/your child’s name and other identifying information confidential.

[Include for NIH funded clinical trials and FDA-regulated controlled drug and device trials (except Phase I drug trials) and FDA-regulated pediatric post-market surveillance trials of devices. Otherwise delete.] A description of this clinical trial will be available on 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.

[Include when a Certificate of Confidentiality has been obtained. Otherwise delete.] To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. The researchers can use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify you, [except as explained below].
[Use the following language as applicable]The Certificate cannot be used to resist a demand for information from personnel of the United States federal or state government agency sponsoring the project and that will be used for auditing or program evaluation of agency funded projects 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 or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, medical care provider, or other person obtains your written consent to receive research information, then the researchers will not use the Certificate to withhold that information.
[language such as the following should be included if researcher intend to make voluntary disclosure about information obtained in the research such as child abuse, or intent to hurt self or others.] The Certificate of Confidentiality will not be used to prevent disclosure to state or local authorities of [list what will be reported, such as child abuse and neglect, or harm to self or others].

If I have any questions, concernsor complaints about this research study, who can I talk to?

INSTRUCTIONS: Include the following information in this section:
  • Name and academic degree(s) of the person(s) in charge of this research study
  • When person is available, e.g., M-F 9am-5pm or 24 hours and what telephone numbers or email addresses (office phone, hospital page) to contact
  • Name and contact telephone number of person responsible for scheduling appointments and study visits, if applicable
  • General contact information (e.g., phone, email address, etc.) for investigator (for student investigators, include this information for faculty sponsors)

The Principal Investigatorof this study:[Insert Investigator Name]. S/Hecan be reached at[Insert Investigator Contact information.]:

  • If you and your child have questions, concerns, or complaints,
  • If you and your child would like to talk to the research team,
  • If you and your child think the research has hurt you and your child,or
  • If you and your child wish to withdraw from the study.

This research has been reviewed by a Harvard Longwood Medical Area Institutional Review Board. If you and your child wish to speak with someone from the IRB, please contact the Office of Human Research Administration (OHRA) at 617-432-2157 (or toll-free at 1-866-606-0573) or 90 Smith Street, Boston, Massachusetts 02120 for any of the following:

  • If you and your child’s questions, concerns, or complaints are not being answered by the research team,
  • If youand your child cannot reach the research team,
  • If youand your child want to talk to someone besides the research team,
  • If youand your child have questions about your rights as a research participant, or
  • If you and your child want to get information or provide input about this research.

Statement of Consent

I have read the information in this consent form including risks and possible benefits. All my questions about the research have been answeredto my satisfaction. I understand that I and my child are free to withdraw at any time without penalty or loss of benefits to which we are otherwise entitled.

I agree for my child toparticipate in the study.

SIGNATURE (see next page)

Signature Block for Child: Parental/Guardian Permission

Your signature below indicates your permission for the child named below to take part in this research.
Name of participant
Signature of first parent or guardian / Date
Parent
Guardian (See note below)
Printed name of first parent or guardian
Signature of second parent / Date
Printed name of second parent
If signature of second parent not obtained, indicate why: (select one)
IRB determined that the permission of one parent is sufficient (NOTE: REMOVE IF THE IRB HAS NOT APPROVED THIS OPTION)
Second parent is deceased
Second parent is unknown
Second parent is incompetent
Second parent is not reasonably available
Only one parent has legal responsibility for the care and custody of the child
Assent / Obtained
Not obtained because: (NOTE: REMOVE ALL OPTIONS NOT APPROVED BY THE IRB)
IRB determined that assent of the child was not a requirement
The capability of the child is so limited that the child cannot reasonably be consulted.
Signature of person obtaining consent and assent
______
Date
Printed name of person obtaining consent and assent
My signature and date indicates that the information in the consent document and any other written information was accurately explained to, and apparently understood by, the participant or the participant’s legally authorized representative, and that informed consent was freely given by the participant or the legally authorized representative.
Note on permission by guardians: An individual may provide permission for a child only if that individual can provide a written document indicating that he or she is legally authorized to consent to the child’s general medical care. Attach the documentation to the signed document.

Harvard Human Research Protection ProgramPage 1 of 6

Consent Form template version date: November 14, 2017