Changes to the Common Rule (45 CFR 46): What this Means for You

Tuesday, May 02, 2017 at 10:00AM - 1:00PM

Event Details

45 CFR 46 is called the Common Rule because a number of different federal agencies agreed to abide by this rule when conducting human subjects' research. This regulation came out of a national commission charged with reviewing instances of research involving humans where the research participants were not treated appropriately as per the existing ethical codes of the time: The Nuremberg Code and the Declaration of Helsinki. With the establishment of 45 CFR 46, any research conducted under the Department of Health and Human Services (DHHS) or any other agency that agreed to this federal regulation was subject to review and approval by an Institutional Review Board (IRB). This regulation also gave IRBs the flexibility to use an expedited review. Changes to The Common Rule hope to strengthen the consent process and bring the regulation up to date with current types of human subjects' research being conducted.

Objectives Of The Presentation
  • Provide a historical perspective on what brought these proposed changes
  • Brief review of current literature regarding what research participants want
  • Review proposed changes to 45 CFR 46
  • Elaborate on changes most relevant to clinical research
  • Discuss the potential impact to researchers
Why Should you Attend
The Common Rule, 45 CFR 46, has not been updated since 1974. To keep up with the changing face of research federal agencies have put out guidance documents. Although this provides some clarifications, this can also add to the confusion as different agencies have different interpretations. So, when a study is governed by more than one agency as well as federal laws and state statues, it can make it difficult for the researcher and her team to discern what is most important as well as what must be followed, when. This confusion can lead to noncompliance. For those reviewing the studies, working with outdated federal regulations often makes it difficult to determine when certain requirements, such as expedited review, may or may not apply as the examples provided in the federal regulations are outdated. In addition, there are the wants and needs of the potential research participants. All this has come into play in the proposed changes to the Common Rule, 45 CFR 46.

Who will Benefit
  • Principal Investigators / Sub-investigators
  • Clinical Research Scientists (PKs, Biostatisticians)
  • Safety Nurses
  • Clinical Research Associates (CRAs) and Coordinators (CRCs)
  • Recruiting staff
  • QA / QC auditors and staff
  • Clinical Research Data managers & Human Research Protection professionals.

For Registration


Note: Use Promo code WE3PL and get 10% off on registration (Valid till MAY 31st 2017)

Organization Details

Online Compliance Panel (OCP) creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. OCP largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

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Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. OCP closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

Online Event
38780 Tyson Lane, Apt 210
Fremont 94536

Starts May 02, 2017 at 10:00AM - 1:00PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896