2024年3月8日发(作者：性价比超高的智能手机)

Date received:

IRB#

Participant Informed Consent

Title of Study:

Investigator:

Sponsor:

The (Name of Funded Institution or Awarded Individual) is conducting a research study

called, “_______”. The study is funded by ____________________.

What is the study about?

(A brief explanation of why the study is being conducted (what you hope to learn), how

many people will be in the study, why the participant has been chosen to participate

(eligibility requirements.).

How long will I be in the study?

Your part in the study will last __________.

What will happen in the study?

(Provide an explanation of what will take place during the study and what is expected

from participants. Itemize what will happen at each study visit and the expected visit

length. Use bullets when appropriate. Be careful to use non-coercive language (e.g. "we

will ask you to" versus "you will fill out" or "you will do the following." Explain any

experimental procedures.)

If you are eligible and wish to join the study, you must sign this consent form. If you do

not sign the consent form you cannot join the study.

We will review this consent form with you at/during…… You will be given enough

time to review the consent and have all your questions about the study answered. We

will give you a signed copy of the consent for your records (when, in person, by mail,

etc.).

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Date received:

IRB#

Study staff will not know which group or study drug/treatment you are assigned to. You

should not join the study if you are not willing to take the study drug/treatment (or join

the group) you are assigned to.

What if I have questions?

You can contact _______________ at ___________ if you have questions about the

study. __________________ is in charge of the study. You may also contact

_____________ at _________________ if you have questions about the study.

Do I have to be in the study?

(Use all statements below. White space between key statements is important.)

You decide if you want to be in the study. Deciding not to take part will not affect your

relationship with your medical provider or NCNM. If your health care provider is an

investigator for the study, you may get a second opinion from another doctor not

involved in the study.

You can leave the study at any time and you do not have to give a reason. Leaving the

study will not affect your relationship with your medical provider or NCNM.

If you are an NCNM student or employee, this study is completely voluntary. Your

decision to not participate or to leave the study will not affect your relationship with

NCNM.

The study investigators may ask you to leave the study if it is in your best interest. The

study investigator may ask you to leave the study if you do not follow the study rules.

What if I don’t want to be in the study?

You can choose not to be in the study and you do not have to give a reason. You can

choose to (talk to their doctor about other options, investigate outside resources on their

own, etc.).

Are there any costs?

All study-related treatments are free. OR Your cost(s) for participating in the study

would be……………… (how much, how often, overall approximate total).

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Date received:

IRB#

Will I be paid for being in the study?

You will not be paid for being in the study. OR You will receive (amount, type of

payment, when) as a thank you for your participation.

Are there any risks?

There is always a small risk of a breech of confidentiality to your personal health

information. However, these risks have been addressed and minimized as much as is

possible.

You will be told about any new information that may affect your willingness to

participate in the study.

There could be risks that we are unaware of at the time of the study.

(Itemize risks to participant for all categories of involvement (e.g., physical exams,

questionnaires, blood draws, study drug/treatments, etc. This may mean repeating some

information from the study description.).

If you experience any side affects while on the study contact (clinical investigator name

here) ______________ at ____________________ as soon as possible.

What if I feel I’ve been hurt by taking part in the study?

If you feel you have been injured or harmed by taking part in this study, please contact

(principal investigator name here) _______________________ at

___________________. If you feel you were harmed while taking part in this study, you

may be treated at NCNM. However, NCNM does not offer to pay the cost of this

treatment.

If you feel your rights have been violated or you have been harmed by this study, please

contact the NCNM Institutional Review Board at 503-552-1847.

Are there any benefits?

(Receiving an incentive is not a benefit. Receiving free tests for an unproven treatment,

etc., is not a benefit. Receiving a chest x-ray for example as part of the study could have

other benefits, however.)

It is possible you may receive some benefit from …………………… There is no

guarantee, however, that you will receive any benefit at all. Your participation will help

us learn more about …………

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Date received:

IRB#

Your privacy is important

(Most statements below are required. Modify for your study design if necessary.)

The Health Insurance Portability and Accountability Act (HIPAA) is a federal law to

protect your privacy. Protecting your privacy is very important to us.

During this study we will ask about your (past) and (current) medical history, we will do

this with questionnaires, medical exams, blood draws, etc. This information will be used

to determine your eligibility for the study and provide data for the study. Your personal

health information will be kept private and only authorized study staff will have access to

this information. We will use a study number instead of your name. All paper forms will

be kept in a locked, secure office. All electronic data will be stored on password-protected computers. Your name will not be used in any publications or presentations

about this study.

During the study, you may not be given access to medical information about you that is

part of the study. When the study is over, you may request certain medical information

collected about you that is part of your study medical record.

None of your personal information will be shared outside of NCNM. OR As part of the

study, we will share your information with ………………….. We will share (type of

data, keep it simple and brief) in order to……………………. Agreements are in place

with _______ to protect your privacy.

By signing this consent form you are stating that we can use your health information in

the ways mentioned above for this study. You are not waiving any of your legal rights by

signing this form.

You have the right to take away your permission to use your health information and any

blood and/or tissue samples collected as part of the study. In order to do this you must

send a written request to:

Investigator name, address.

Once your letter is received no additional information about you or blood or tissue

samples will be collected from you for this study. Any data and/or blood and/or tissue

samples that were collected before we receive your letter will continue to be used for the

study. If applicable or include in a second genetic only consent: If you take away your

permission to use your tissue or blood samples for a genetics research study, your

samples will be destroyed or stored without any information that identifies you. Taking

away your permission to use your health information will not affect your relationship

with NCNM.

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Date received:

IRB#

We are collecting only the personal health information that we need for the specific

purpose of this study. Your personal health information cannot be used for additional

research purposes.

NCNM may be required to provide copies of your personal information to Federal or

other government agencies as required by law. It may also be required to provide copies

to the Institutional review Board (IRB) or other groups that monitor the safety and

welfare of study participants.

If your personal health information is disclosed by this authorization to an individual or

agency not covered by laws that prohibit re-disclosure, your personal health information

may not remain confidential. However, Oregon law does not allow redisclosure of

HIV/AIDS information, mental health information, genetic information, and drug/alcohol

diagnosis, treatment, or referral information.

Your permission to use your identifiable health information (your HIPAA authorization)

will expire on ___________________ or when the study is complete/indefinitely/other.

(If a part of this study includes genetic research, additional statements would be required

regarding the storage, destruction, use, sharing, and timeline for that material.

Otherwise, include this information in a second consent about the genetic portion only.)

Signatures:

By signing this consent form it means the following:

 I know my rights have not been waived by signing.

 I have had all of my questions answered and I know whom to ask if I have more

questions.

 I have read this form and understand it.

 I want to join the study.

 I know I can leave the study at any time and do not have to give a reason.

______________________________________________________ ____________

Signature of Participant Date

________________________________________________________________________Printed name of participant

(If appropriate, signature and printed name of parent or legal guardian with date.)

Thank you for participating in our research study!

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