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This document provides consent information for a research study on the safety and effectiveness of Minocycline in the treatment of HIV-associated cognitive impairment. It covers the study’s purpose,

How to fill out university of pennsylvania health

How to fill out UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM IRB Approval Consent Form

1. Read the Introduction section carefully to understand the purpose of the form.
2. Fill out the title of the research study in the designated field.
3. Provide the names and contact information of the principal investigator and any co-investigators.
4. Clearly state the purpose of the research study in concise language.
5. Explain the inclusion and exclusion criteria for participants.
6. Describe the procedures participants will undergo during the study.
7. Outline any potential risks and how they will be mitigated.
8. Detail the benefits expected from participation in the study.
9. Explain how confidentiality will be maintained.
10. Include information on compensation or reimbursement for participants, if applicable.
11. Ensure that the consent language is clear and easy to understand.
12. Provide space for participants to sign and date the form, indicating their consent.

Who needs UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM IRB Approval Consent Form?

1. Researchers conducting studies involving human subjects at the University of Pennsylvania Health System.
2. Investigators seeking ethical approval for their research projects.
3. Individuals involved in clinical trials or studies that require participant consent.

People Also Ask about

Does the IRB require informed consent?

Informed consent must be obtained before that participant takes part in any aspect of the research study, unless the IRB has approved a waiver of the requirement to obtain consent.

Is there any research that is exempt from obtaining informed consent?

Waiver of All Consent In certain cases, federal regulations allow the IRB to waive the requirement to obtain any informed consent. Most complete waivers of consent involve studies in which there are minimal risks to subjects, but complete waivers are also possible in emergency care and other limited circumstances.

Can the IRB waive informed consent?

However, an IRB may approve a consent or parental permission procedure that does not include, or that alters, some or all of the elements of informed consent, or may waive the requirements to obtain informed consent (45 CFR 46.116(c) or (d)).

How to write an IRB consent form?

The Consent Form used in a study should be edited to match requirements of the specific study: It should include information about the investigator, the topic under study, and a clear description of purpose, risks, and benefits.

Does the IRB review informed consent?

A signed informed consent document is evidence that the document has been provided to a prospective subject (and presumably, explained) and that the subject has agreed to participate in the research. IRB review of informed consent documents also ensures that the institution has complied with applicable regulations.

What are the requirements of an IRB?

An IRB must: have at least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution; make every nondiscriminatory effort to ensure that the membership is not composed of entirely men or entirely women;

How do I contact the Penn IRB?

If you require faster assistance, please call the IRB mainline at 215-573-2540. Please note that the IRB does not have time nor resources to provide 1-on-1 walkthroughs of the online submission system. If you need this type of assistance, please sign up for an IRB 101 session.

Can I make my own consent form?

If you prefer to write your own consent document, you may do so, but be sure to include all required elements of informed consent.

For pdfFiller’s FAQs

What is UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM IRB Approval Consent Form?

The UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM IRB Approval Consent Form is a document that outlines the consent process for participants involved in research studies approved by the Institutional Review Board (IRB). It ensures that participants are informed about the study, risks, benefits, and their rights.

Who is required to file UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM IRB Approval Consent Form?

Researchers conducting studies involving human subjects under the jurisdiction of the UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM are required to file the IRB Approval Consent Form as part of their research protocols.

How to fill out UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM IRB Approval Consent Form?

To fill out the UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM IRB Approval Consent Form, researchers should complete all sections, including study details, participant information, risks and benefits, and confidentiality measures. It must be clear, concise, and understandable for potential participants.

What is the purpose of UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM IRB Approval Consent Form?

The purpose of the UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM IRB Approval Consent Form is to ensure that participants provide informed consent before participating in research studies, thus protecting their rights and welfare.

What information must be reported on UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM IRB Approval Consent Form?

The form must report information such as the study title, principal investigator, purpose of the research, details about participation, potential risks and benefits, alternative options, and participant rights.