IRB#______
[DELETE ALL INSTRUCTIONS IN BRACKETS. Revise the example language to fit your study.Items in [square brackets] indicate action from you such as making a choice or inserting study relevant information. Instructions are given in italics. Remove quotation marks where applicable. A separate summary is not required given that this information sheet will only be used forrelatively simple research studies with limited risks or benefits and this entire document is relatively brief and satisfies the new requirements under45 CFR 46.
TITLE: [Name of the study. Use the same title as that on the IRQ.]
PRINCIPAL INVESTIGATOR:...... [(503) 494-####]
CO-INVESTIGATORS:...... , ..... [(503) 494-####]
WHO IS PAYING FOR THE STUDY?: Delete if unfunded.
WHY IS THIS STUDY BEING DONE?:
Include and complete the following sentences:You have been invited to be in this research study because you ______. [For example, “have asthma.”] The purpose of this study is to ______. [For example, “learn about how patients with asthma view their quality of life.”]
Include one of these two statements regarding future research (REQUIRED FOR ALL STUDIES):
Include if you WILL store data/samples for future research: We are also asking you to provide [blood/tissue/information] for a [blood/tissue/data] bank, also called a repository. These samples will be stored indefinitely and may be used and shared in the future for research [include if applicable: which may include genetic research]. [Specify if future research may involve whole genome sequencing and provide lay description: We will determine your complete DNA sequence, called whole genome sequencing.]. [Indicate if the repository and/or genetic components are optional].
Include if you will NOT store data/samples for future research:[Data and specimens] collected from/about you in this study will not be used and/or shared for future research. Include if this current study may involve genetic research: This study may include genetic research. [Specify if current research may involve whole genome sequencing and provide lay description: The genetic portions of this research may involve whole genome sequencing which is the process of determining your complete DNA sequence]. [Indicate if genetic portion is optional].
WHAT [EXAMS, TESTS AND PROCEDURES] ARE INVOLVED IN THIS STUDY?:
Describe succinctly and in chronological order the procedures for the research. It is not necessary to describe procedures that subjects would be receiving as routine care. Include a statement describing the duration of participation.
If you will obtain PHI, describe types of health information to be obtained[for example:information about medical conditions, medications, recreational drug use].
At the end of the procedures section, you must insert the following statement:If you have any questions, concerns, or complaints regarding this study now or in the future, or you think you may have been injured or harmed by the study, contact [Contact Name and Number].
If this study includes a repository and data/samples may be shared with the funder and/or other researchers, state:In the future, your [samples/information] may be given to [researchers, the funder, list as appropriate] for other research studies. [If applicable: These studies may include genetic research.] The [samples and/or information] will be labeled as described in the WHO WILL SEE MY PERSONAL INFORMATION? section.
WHAT RISKS CAN I EXPECT FROM TAKING PART IN THIS STUDY?:
Although we have made every effort to protect your identity, there is a minimal risk of loss of confidentiality. [Add other risks if necessary].
WHAT ARE THE BENEFITS OF TAKING PART IN THIS STUDY?:
You [choose one:“may or may not”or“will not”] benefit from being in this study. However, by serving as a subject, you may help us learn how to benefit patients in the future.
WHAT ARE THE ALTERNATIVES TO TAKING PART IN THIS STUDY?:
State: You may choose not to be in this study. [Add other alternatives if applicable].
WILL I RECEIVE RESULTS FROM THIS STUDY?
Inform subjects whether or not you will disclose research findings of any kind (e.g., results of genetic studies, clinically relevant information, or incidental findings) to the subject or their provider(s), describe:
- The disclosure procedures (e.g., who will make the disclosure and to whom; as appropriate, any requirement for repeat testing and/or plan for referral to a genetic counselor or other professional for appropriate medical advice), and
- Any risks associated with receiving this information (e.g. psychological risks, impacts on insurability, employability, family plans, and family relationships, and costs of additional medical care and testing).
- See the Bioethics Commission’s IRB Primer on Incidental and Secondary Findings for further guidance.
If the subjects are not informed in the consent document that they may be re-contacted, any attempt to re-contact the subject by the researcher must first be approved by the IRB.
Lab results to be shared with subjects or their providers must be obtained in a CLIA-approved lab.
Example language for sharing results, modify as appropriate: We will give you the results of your [describe tests or other results; e.g. genetic tests, screening tests, a write up of the study conclusions].
Example language for incidental findings, modify as appropriate: We do not plan to share your [research, genetic, other as applicable] test results with you. However, if we discover information that is important for your health care, either in this study or in the future, we will contact you and ask if you want to know the results. If you choose to receive the results, you may need to have the test repeated in a non-research laboratory. You may learn information about your health that is upsetting or that impacts your [family planning, family relationships, ability to get insurance, career, other as appropriate].
Additional recommended language for sharing genetic results: Because genetic information is complex and sensitive, the results should be discussed with a genetic counselor or your primary care provider who can answer your questions or discuss your concerns. You would be responsible for all costs associated with having the test repeated and visiting a doctor or genetic counselor to discuss the results.
Example language for anticipated secondary findings [modify as appropriate]: The research tests in this study may tell us that you are at risk for [condition]. If we find out that you are at risk, we will contact you and refer you to [provider that can help with condition]. You would be responsible for all costs associated with any follow-up testing and medical care.
If no disclosures are to be made, explain why.Example language [modify as appropriate]: The results of research tests will not be made available to you becausetheresearch is still in an early phase and the reliability of the results is unknown.
WHO WILL SEE MY PERSONAL INFORMATION?:
In this study [choose one:“we are not receiving any identifiable information about you so there is little chance of breach of confidentiality”or “we will take steps to keep your personal information confidential, but we cannot guarantee total privacy.”].If not anonymous, describe confidentiality measures taken. [For example, “However, we will do our best to keep your information confidential by keeping it coded and on an encrypted computer.”].For studies that provide any type of compensation to subjects, state:We may request your social security number in order to process any payments for participation.
If you are collecting PHI, also include: We may have to release this information to others for example, if the study is audited. However, we would try to do so without information that could identify you. This release could be to the Institutional Review Board (ethics review committee) at OHSU, the funder of the study, the FDA or Office of Human Research Protection (agencies that oversee research).
If your information goes outside of OHSU, it might not be protected under federal law from being used or further shared. We would like your permission to keep your [for example, “contact information” and/or“data”][choose one: “indefinitely”orinclude alternative end date]. If you decide you don’t want us to use your name and information for [describe, for example: screening, this research,future contact], you can request this by contacting us at:
Name
Department
Oregon Health & Sciences University
Address
Email address
Your request will be effective as of the date we receive it. However, health information collected before your request is received may continue to be used and disclosed to the extent that we have already acted based on your authorization.
You do not have to allow the use and disclosure of your health information in the study, but if you do not, you cannot be in the study. If you choose not to participate, or if you decide to stop at any time, that will not affect your ability to receive health care at OHSU or insurance coverage.
WILL ANY OF MY INFORMATION OR SAMPLES FROM THIS STUDY BE USED FOR ANY COMMERCIAL PROFIT?[Include this section for ALL STUDIES][Samples and/or information] [if applicable, add: including any photographs, videotapes, or audiotapes] about you or obtained from you in this research may be used for commercial purposes, such as making a discovery that could, in the future, be patented or licensed to a company, which could result in a possible financial benefit to that company, OHSU, and its researchers. There are no plans to pay you if this happens. You will not have any property rights or ownership or financial interest in or arising from products or data that may result from your participation in this study. Further, you will have no responsibility or liability for any use that may be made of your samples or information.
WHAT ARE THE COSTS OF TAKING PART IN THIS STUDY?: NOTE: This is to be included only if applicable, otherwise delete it.
It will not cost you anything to participate in this study.If subjects will be provided any compensation, describe the compensation in detail: You will receive $10 for completing the questionnaire.
WHERE CAN I GET MORE INFORMATION?:
This research is being overseen by an Institutional Review Board (“IRB”). You may talk to the IRB at (503) 494-7887 or if:
•Your questions, concerns, or complaints are not being answered by 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 more information or provide input about this research.
You may also submit a report to the OHSU Integrity Hotline online at or by calling toll-free (877) 733-8313 (anonymous and available 24 hours a day, 7 days a week).
DO I HAVE TO TAKE PART IN THIS STUDY?
You do not have to join this or any research study. If you do join, and later change your mind, you may quit at any time. If you refuse to join or withdraw early from the study, there will be no penalty or loss of any benefits to which you are otherwise entitled.
For studies recruiting OHSU students or employees as subjects, please include the following language: The participation of OHSU students or employees in OHSU research is completely voluntary and you are free to choose not to serve as a research subject in this protocol for any reason. If you do elect to participate in this study, you may withdraw from the study at any time without affecting your relationship with OHSU, the investigator, the investigator’s department, or your grade in any course. If you would like to report a concern with regard to participation of OHSU students or employees in OHSU research, please call the OHSU Integrity Hotline at 1-877-733-8313 (toll free and anonymous).
HOW DO I TELL YOU IF I WANT TO TAKE PART IN THIS STUDY?
Include directions on how potential participants can consent: [For example, Please indicate whether you provide your consent to participate in this study using the check boxes below:
(__) Yes, I would like to participate in the study.
(__) No, I would not like to participate in the study. ]
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