Form 20AD086E "Generic Consent Form - Institutional Review Board (Dhsirb)" - Oklahoma

What Is Form 20AD086E?

This is a legal form that was released by the Oklahoma Department of Human Services - a government authority operating within Oklahoma. As of today, no separate filing guidelines for the form are provided by the issuing department.

Form Details:

  • Released on May 11, 2022;
  • The latest edition provided by the Oklahoma Department of Human Services;
  • Easy to use and ready to print;
  • Quick to customize;
  • Compatible with most PDF-viewing applications;
  • Fill out the form in our online filing application.

Download a fillable version of Form 20AD086E by clicking the link below or browse more documents and templates provided by the Oklahoma Department of Human Services.

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Download Form 20AD086E "Generic Consent Form - Institutional Review Board (Dhsirb)" - Oklahoma

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Oklahoma Human Services
Institutional Review Board (DHSIRB)
Generic Consent Form
Instructions
Form 20AD086E, Generic Consent Form, covers the basic elements required for informed consent.
Investigators, however, may use another form which fits the context, population, and other
parameters of the proposed study, as long as they include the required elements of informed
consent, explained below. Forms for participants must be easily understood in terms of language,
tone, grammar, and content. The information in the consent form must match what is described in the
research protocol of your DHSIRB application. Researchers must submit a copy of everything
provided to participants to DHSIRB for review.
In the case of participants who are minors or are otherwise incapable of giving informed consent,
such as those who have cognitive disabilities, the consent process is conducted with a parent,
guardian, or legal representative. Additionally, researchers must gain assent from study participants
when they are capable of providing it. Assent of children is required when they are seven years of
age or older per recommendations of the National Commission for the Protection of Human Subjects
of Biomedical and Social Science.
Research Description
This section must match the information provided in
Form 20AD085E, DHSIRB Application and
Instructions
and research protocol document. Keep it concise and easy to understand.
About the research project: Include basic information about the project, such as title,
researcher(s), and a succinct description of the project including its purpose(s) and
objective(s).
What participation entails: Provide an accurate description of participation requirements,
the data to be collected/required from them, the duration of participation, the specific study
procedures involved with participation, and the identification of any experimental procedures.
Clearly state that participation in the research study is voluntary. When the participant is
receiving treatment or service at a facility where the study is conducted, emphasize his or her
treatment or service will not be affected by participation and/or refusal to participate in the
study.
Explain to participants their right to withdraw from the research study at any time without any
consequence, and that any information collected from the participants will be destroyed when
they decide to withdraw. Describe study withdrawal procedures. Also, explain any anticipated
circumstances under which the participant's involvement in the research may be terminated by
the investigator without regard to the participant's consent.
Incentives, financial or otherwise, offered to participants are included in this section, as well as
the approximate number of participants involved in the research.
Risks or discomforts and benefits: Describe any risks or discomforts which might
reasonably be expected to occur, and what you, as the investigator/researcher, will do to
minimize them. Include all possible physical, psychological, professional, or personal risks
Page 1 of 4
5/11/2022
20AD086E
Oklahoma Human Services
Institutional Review Board (DHSIRB)
Generic Consent Form
Instructions
Form 20AD086E, Generic Consent Form, covers the basic elements required for informed consent.
Investigators, however, may use another form which fits the context, population, and other
parameters of the proposed study, as long as they include the required elements of informed
consent, explained below. Forms for participants must be easily understood in terms of language,
tone, grammar, and content. The information in the consent form must match what is described in the
research protocol of your DHSIRB application. Researchers must submit a copy of everything
provided to participants to DHSIRB for review.
In the case of participants who are minors or are otherwise incapable of giving informed consent,
such as those who have cognitive disabilities, the consent process is conducted with a parent,
guardian, or legal representative. Additionally, researchers must gain assent from study participants
when they are capable of providing it. Assent of children is required when they are seven years of
age or older per recommendations of the National Commission for the Protection of Human Subjects
of Biomedical and Social Science.
Research Description
This section must match the information provided in
Form 20AD085E, DHSIRB Application and
Instructions
and research protocol document. Keep it concise and easy to understand.
About the research project: Include basic information about the project, such as title,
researcher(s), and a succinct description of the project including its purpose(s) and
objective(s).
What participation entails: Provide an accurate description of participation requirements,
the data to be collected/required from them, the duration of participation, the specific study
procedures involved with participation, and the identification of any experimental procedures.
Clearly state that participation in the research study is voluntary. When the participant is
receiving treatment or service at a facility where the study is conducted, emphasize his or her
treatment or service will not be affected by participation and/or refusal to participate in the
study.
Explain to participants their right to withdraw from the research study at any time without any
consequence, and that any information collected from the participants will be destroyed when
they decide to withdraw. Describe study withdrawal procedures. Also, explain any anticipated
circumstances under which the participant's involvement in the research may be terminated by
the investigator without regard to the participant's consent.
Incentives, financial or otherwise, offered to participants are included in this section, as well as
the approximate number of participants involved in the research.
Risks or discomforts and benefits: Describe any risks or discomforts which might
reasonably be expected to occur, and what you, as the investigator/researcher, will do to
minimize them. Include all possible physical, psychological, professional, or personal risks
Page 1 of 4
5/11/2022
20AD086E
and/or participant discomforts. Risks listed in the research protocol document must be
addressed in this section. If you believe that the research risks or discomforts are greater than
those ordinarily encountered in daily life or during the performance or routine examinations or
activities, then state the research is not of "minimal risk" and inform the participant of the
resources available for assistance. If there are no risks to the participant, clearly state this.
Include a description of benefits the participant may expect from the research. Provide
information as described in
Form 20AD085E Application and
Instructions. Do not overstate the
benefits of participation and be clear when there are no direct benefits to the participant.
Privacy and confidentiality: Describe how participants’ data will be kept private and
confidential during collection, storage, and usage. Explain that information gathered for the
project will not be published or presented in a way which exposes participant identity and
research materials will be returned and/or destroyed to ensure the participant's identity is
protected. When the study is designed to handle a participant's information anonymously,
explain to the participant the information collected will not include identifying information.
Describe who in the research team will have access to the data. Studies cannot be both
anonymous and confidential. Ensure you use the correct term to describe your study.
Contact information: Include contact information for questions about the research,
participant’s rights, and where to report research-related injuries. Upon request, significant
new findings developed during the course of the research can be provided to the participant.
Signatures: Include a section for signatures.
Generic Consent Form
Dear Participant:
You are being asked to participate in the research project described below. Carefully read this form
containing information about the project and your involvement. Feel free to ask the research team
questions using the contact information provided below.
Project title
Project purpose and objectives:
Research Team
Principal investigator
Address
Phone
Email address
Co-principal investigator, when applicable
20AD086E
5/11/2022
Page 2 of 4
Address
Phone
Email address
If you have questions or concerns about your rights as a research participant, contact a DHSIRB
representative who oversees research involving human participants at:
Sequoyah Memorial Office Building
2400 N. Lincoln Boulevard
Oklahoma City, OK 73105
DHS.IRB.Application@okdhs.org
20AD086E
5/11/2022
Page 3 of 4
Participation
What participation entails:
Risks or discomforts, and benefits:
Privacy and confidentiality:
Agreement and Signatures
I have read the Generic Consent Form and my questions have been answered. My signature on this
form means I agree to participate in the described research study. I understand I will be given a
signed, dated copy of this form along with other printed materials deemed necessary by the study
investigators.
Participant name
Age
Participant signature
Date
Participant's parent, guardian or legal representative signature, when applicable Date
20AD086E
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