Permission to Take Part in a Human Research Study Page 4 of 4
INSTRUCTIONS: DO NOT COPY
· Please read the instructions below.
· This template is for minimal risk research not subject to FDA regulation.
· Do not copy any of the red text in the consent that you will submit to the IRB.
· Delete sections which are not applicable to your research
· If you have any questions about this consent or what should be in the consent, please contact the IRB at .
Title of research: [insert title of research with protocol number, if applicable]
Investigator and Department: [insert name and Department of investigator]
Why am I being invited to take part in this research?
We invite you to take part in a research study because _____________. [Fill in the circumstance or condition that makes the subjects eligible for the research, for example, “… because you are a single parent.” “… because you are enrolled in the student subject pool.” “… because your child has autism.”]
[If the research involves children, include the following sentence.] If the research involves children, “you” or “your” refers to your child.
What should I know about this research?
· Someone will explain this research to you.
· Whether or not you take part is up to you.
· You can choose not to take part.
· You can agree to take part and later change your mind.
· Your decision will not be held against you.
· You can ask all the questions you want before you decide.
Who can I talk to about this research?
If you have questions, concerns, or complaints, or think the research has hurt you, contact the research team at [Insert contact information for the research team, including the physical address, mailing address, e-mail address, and phone number]
This research has been reviewed and approved by an Institutional Review Board. You may talk to them at (215) 707-3390 or e-mail them at: for any of the following:
· Your questions, concerns, or complaints are not being answered by the research team.
· You cannot reach the research team.
· You want to talk to someone besides the research team.
· You have questions about your rights as a research subject.
· You want to get information or provide input about this research.
Why is this research being done?
[Tell the subject the purpose of the research. Explain the background of the research problem. Explain the scientific problem. Describe how this research will attempt to solve the problem. Describe any procedures that are important to the research that will be performed regardless of whether the subject takes part in the research.]
How long will I be in this research?
We expect that you will be in this research for ________ [hours/days/months/weeks/years, until a certain event].
What happens if I agree to be in this research?
[Tell the subject what to expect using lay language and simple terms. Include all procedures performed because the subject is taking part in the research. If there are any minimal risk experimental procedures, identify them as such. Describe procedures that will be performed regardless of whether the subject takes part in the research in the section titled “Why is this research being done?
When appropriate for your research, include the following items:
· A timeline description of the procedures that will be performed.
· All visits, and telephone or written follow-up
· The length and duration of visits and procedures
· If blood will be drawn, indicate the amount [in English units] and frequency
· With whom will the subject interact
· Where and when this research will be done
· How often procedures will be performed
]
What other choices do I have besides taking part in this research?
[Delete this section when the only alternative is to not participate.]
Instead of being in this research, your choices may include: [List alternatives procedures. For student subject pools, describe alternatives for course credit.]
Is there any way being in this research could be bad for me?
[Delete this section if there are no risks or discomforts.]
[Describe each of the following risks, if appropriate]
· [Physical risks (for example, medical side effect)
· Psychological risks (for example, embarrassment, fear or guilt)
· Privacy risks (for example, disclosure of private information)
· Legal risks (for example, legal prosecution or being reported for child abuse)
· Social risks (for example, social ostracizing or discrimination)
· Economic risks (for example, having to pay money out-of-pocket for research or medical expenses, losing health insurance, or being unable to obtain a job)]
Will being in this research help me in any way?
[Delete this section if there are no benefits.]
[If there are benefits to participation] We cannot promise any benefits to you or others from taking part in this research. However, possible benefits include __________________. [Describe the potential benefits of participation. First, describe any direct benefits to the subject, then describe any benefits to others. If benefits from participation may not continue after this research has ended, describe them. Monetary reimbursement for participation is not a benefit and should be described in the Stipend/Reimbursement section below.]
[Include for research involving prisoners. Otherwise, delete.] Taking part in this research will not improve your housing or correctional program assignments. Taking part in this research will not improve your chance of parole or release.
What happens to the information collected for this research?
To the extent allowed by law, we limit the viewing of your personal information to people who have to review it. We cannot promise complete secrecy. The IRB, Temple University, Temple University Health System, Inc. and its affiliates, and other representatives of these organizations may inspect and copy your information. [Add other organizations that may have access to the subject’s records such as the Department of Health and Human Services, when this 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 samples will be retained for future research, explain where they will be stored, who will have access to them, and how long they will be retained.]
[Include for research involving prisoners. Otherwise, delete.] If you are a prisoner, your medical records may also be given to officials and agencies within the criminal justice system when necessary and permitted by law.
What will I be paid for taking part in this research?
[Delete this section if subjects are not being paid.]
[Include if subjects will be paid. Otherwise, delete.] If you agree to take part in this research, we will pay you ________ [indicate amount] for your time and effort. [Indicate if the amount is pro-rated for each research visit completion.] Federal tax law requires to you to report this payment as income to the Internal Revenue Service.
You may be asked to tell us your social security number. If payments are more than $599.00, we will report them to the Internal Revenue Service and send you a Form 1099-MISC. If you do not give us your social security number, you may take part in this research if you agree to not be paid.
What else do I need to know this research?
[Delete this section if there both of these items are not applicable.]
[For Department of Defense (DOD) research which targets military personnel and where subjects will be paid] You should check with your supervisor before accepting payment for participation in this research.
[Include for research involving prisoners where there may be a need for follow-up examination or care after the end of participation. Otherwise, delete.] If you are released from jail before you finish this research, you should take steps to get insurance or Medicaid coverage. Regular office visits and standard treatment will be billed to you or your health insurance. You may continue in this research after your release from prison. If you move out of the area, we will help you make arrangements to be followed by a physician.
[With rare exceptions, the IRB does not require subjects to sign a consent document when the research involves no more than minimal risk. As such, there are no signature blocks on this template. Please submit this form without a signature block. The IRB will inform you if your research represents an exception.]
Document Revision Date: September 10, 2014