Insights

Only available in English

May 30, 2025  •  Podcast

Watch for the launch of our new podcast

PHRP Perspectives episodes are coming soon!

March 7, 2025  •  Article - Joseph Smith, PHRP Advisory Board Member

Best Practices for Research Participant Compensation

The IRB, whether through convened or expedited review, is responsible for reviewing compensation and reimbursements for research participation and ensuring potential participants are not exposed to undue influence.

March 3, 2025  •  Article - Mason Scuderi, PHRP Educational Consultant

Maintaining Public Trust in the Face of Emerging Trends in Research

This year's OHRP conference provided essential information for those in the research community, including exploring important aspects human research subject protection, addressing different conflicts of interest, and looking at where AI stands within the human subject research community today.

December 6, 2024  •  Article - Joseph Smith, PHRP Advisory Board Member

Advertisements & Recruitment

Recruitment methods employed are important, as they are the first step in the informed consent process.  It is an opportunity to make a great first impression.

November 25, 2024  •  Article - Kim Diccianni, PHRP Advisory Board Member

Privacy vs. Confidentiality in Human Research

Institutional Review Boards (IRBs) are tasked with ensuring that a participant’s privacy is respected and confidentiality is maintained. This article outlines key points IRBs should evaluate in research protocols and consent forms to meet federal regulatory standards.

August 19, 2024  •  Article - Joseph Smith, PHRP Advisory Board Member

Research Involving Students

The article explores the protection of student participants in research, highlighting complexities faced by Institutional Review Boards (IRBs).

August 9, 2024  •  Article - Richard Klein, PHRP Advisory Board Member

Significant and Non-Significant Classification in Medical Devices

SR devices, which include life-supporting or life-sustaining equipment, pose a higher risk and typically require more stringent regulatory processes, whereas NSR devices, with lower risk profiles, are subject to less rigorous oversight.

June 25, 2024  •  Article - Joseph Smith, PHRP Advisory Board Member

Insights and Innovations: Highlights from the 2024 AAHRPP Conference

The knowledge transfer and sharing is second to none at this conference. One of the best conversations I had was with a colleague about navigating increasing telework demands with staff while still nurturing a team approach.

April 16, 2024  •  Article - Joseph Smith, PHRP Advisory Board Member

Minimal Risk Analysis & Considerations

Analyzing research activities to determine if no more than minimal risk is present is an essential task of a duly constituted IRB.

April 2, 2024  •  Article - Richard Klein, PHRP Advisory Board Member

FDA posts new draft guidance for comment on informed consent for sponsors, investigators, and IRBs

The FDA has been working to harmonize its human subject protection regulations with the 2018 Revisions.

March 8, 2024  •  Article - Richard Klein, PHRP Advisory Board Member

There’s a lot More to Informed Consent than Just a Date and Signature

While informed consent is documented in a signed form, the interactive consent process ensures that the prospective subject or patient fully understands that they will be involved in research or will be receiving treatment with an investigational agent.

February 9, 2024  •  Article - Joseph Smith, PHRP Advisory Board Member

Research Involving Deception

Understanding if one is utilizing deception requires review of basic elements of informed consent.

February 9, 2024  •  Article - Kim Diccianni, PHRP Advisory Board Member

Public Responsibility in Medicine and Research (PRIM&R) Conference December 2023: Summary

PRIM&R held it’s annual conference for research compliance professionals in Human Research Protection and Animal Protection in December 2023.

October 19, 2023  •  Article - Richard Klein, PHRP Advisory Board Member

Ten Steps for Children’s Assent in Biomedical Research and Treatment Access

Ensuring that children are provided with age-appropriate explanations of the research is an important responsibility of the IRB.

August 28, 2023  •  Article - Kim Diccianni, PHRP Advisory Board Member

Research on Artificial Intelligence: Things to Consider

Some forms of Al you may already be using personally are Alexa, Siri, ChatGPT, geographic identification, and facial recognition. But how can AI be used to help human subjects research and what challenges lie ahead?

March 27, 2023  •  Article - Kim Diccianni, PHRP Advisory Board Member

Research with Children and What to Look For

Medical and higher education institutions are charged with ensuring all populations are represented in research. One of these populations, also considered a vulnerable population, is children.

February 17, 2023  •  Article - Richard Klein, PHRP Advisory Board Member

Access to Unapproved Medical Products

Unapproved or investigational therapies are those that are still in development and have not been proven to be safe and effective.

November 1, 2022  •  Article - Richard Klein, PHRP Advisory Board Member

Considerations for Informed Consent in Clinical Trials

It is important that a prospective research subject understands the research nature of a trial they are considering.

August 30, 2022  •  Article - Kim Diccianni, PHRP Advisory Board Member

What is an IRB?

The Institutional Review Board (IRB), also known as an Ethics Review Board or Research Ethics Review Board, is a committee established at an institution that ensures the protection and safeguards the rights of the human research subject.

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