Month: January 2018

HHS and 15 Other Federal Departments and Agencies Announce an Interim Final Rule That Delays Both the Effective Date and General Compliance Date of the Revisions to the Federal Policy for the Protection of Human Subjects to July 19, 2018

From the Office for Human Research Protections (OHRP):

January 17, 2018

The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149). Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018.

The IFR delays the effective date and general compliance date to July 19, 2018, providing regulated entities additional time to prepare to implement these revisions.

The IFR has been put on public display by the Office of the Federal Register and can be accessed at:

Until July 19, 2018, regulated entities will be required to comply with the pre-2018 Common Rule as published in the 2016 edition of the Code of Federal Regulations (i.e., the Federal Policy for the Protection of Human Subjects, originally published on June 18, 1991, and subsequently amended on June 23, 2005) that can be accessed at: – PDF
An example of a revised provision that does not conflict with the pre-2018 rule is one that addresses new elements of informed consent (revised rule at §__.116(b)(9), (c)(7)-(9)). It is permissible to incorporate these new elements of consent now because the pre-2018 rule does not prohibit including these elements in informed consent.

An example of a revised provision that conflicts with the pre-2018 rule, and thus could not be implemented prior to July 19, 2018, is the provision eliminating the requirement for continuing review in certain circumstances (as described in the revised rule at §__.109(f)). Because the pre-2018 regulations require continuing review at least annually for all ongoing non-exempt human subjects research, halting continuing review for such research before that date would be considered non-compliance.

The IFR does not delay the compliance date for the cooperative research provision of the revised Common Rule (found at §__114(b)), which remains January 20, 2020.

Federal departments and agencies listed in the IFR are also in the process of developing a notice of proposed rulemaking (NPRM) seeking public comment on a proposal for further delay in the required implementation of the revised Common Rule (for example, until January 21, 2019). If such an NPRM is published, after consideration of the public comments, the federal departments and agencies will determine whether a final rule to further delay the revised Common Rule will be issued.

Original Article

Biodegradable Sensor Monitors Pressure in the Body then Disappears

Uconn Today has a new article highlighting the development of a biodegradable pressure sensor that could help doctors monitor chronic lung disease, swelling of the brain, and other medical conditions before dissolving harmlessly in a patient’s body. CICATS is pleased that three of our staff, Dr. Cato Laurencin, Dr. Chia-Ling Kuo and Dr. Kevin Wai Hong Lo, are among of the authors of the corresponding research paper. Additionally, Dr. Thanh Duc Nguyen, the paper’s senior author, is a member of CICATS Biomedical Engineering Core Interest Group.

“We are very excited because this is the first time these biocompatible materials have been used in this way. Medical sensors are often implanted directly into soft tissues and organs,” said Dr. Nguyen. “Taking them out can cause additional damage. We knew that if we could develop a sensor that didn’t require surgery to take it out, that would be really significant.”

To read the full article click here.

CICATS CEO Receives Prestigious New Appointment

Dr. Cato Laurencin, CICATS CEO, has been appointed to the new Scientific Advisory Board of The Rady Children’s Institute for Genomic Medicine. The panel will provide evaluation and guidance for the institute’s work, which began in July 2016 with a mission of working in the area of diagnosis, treatment and clinical care for newborns and children with rare, life-threatening diseases. The institute provides diagnoses through rapid whole genome sequencing, according to Rady.

Dr. Laurencin will be joined by:

  • Dr. James R. Downing, president and chief executive of St. Jude Children’s Research Hospital. He is an expert in molecular diagnostics and a pediatric cancer researcher.
  • Elizabeth Blackburn, president of the Salk Institute for Biological Studies. She won the Nobel Prize in Physiology or Medicine in 2009 for discovering the molecular nature of telomeres, the ends of chromosomes that serve as protective caps essential for preserving genetic information, and for co-discovering telomerase, an enzyme that maintains telomere ends.
  • George Church, a professor at the Wyss Institute at Harvard University. He helped found projects that serve as the world’s only open-access personal precision medicine data. His innovations in synthetic biology have been the basis for launching several companies.
  • Dr. Thomas R. Insel, former director of the National Institute of Mental Health and current president of Mindstrong Health. He is a neuroscientist and psychiatrist.
  • Dr. Isaac Kohane, professor and chairman of the Department of Biomedical Informatics at Harvard Medical School.

“Each of these brilliant scientists is an authority in their respective field,” said Dr. Stephen Kingsmore, president and chief executive of the institute. “By sharing their expertise and leadership with us, they will play a vital role in helping to calibrate our goals and oversee our progress in advancing pediatric genomic medicine.”

The information provided above can be found in the Times of San Diego.

Science Café on Youth Substance Abuse & Depression: A KAVLI Brain Event (2/20/2018)

Please note: pre-registration is required for this cafe.

You are invited to attend our Science Café on Youth Substance Abuse and Depression: A Kavli BRAIN Event.

Title: Youth Substance Use Disorders with Co-occurring Depression: The Nature of the Association and Implications for Treatment

Speaker: Dr. Yifrah Kaminer, Professor of Psychiatry & Pediatrics, Alcohol Research Center & Injury Prevention Center, University of Connecticut School of Medicine

Description: Join us for an informal discussion about the association between substance use disorders and co-occurring depression in youth. We will discuss treatment outcome findings, an ongoing study by the presenter, and explore potential future treatment directions. Questions and audience participation are highly encouraged.

Date: Tuesday, February 20th

Time: 4:30 p.m. – 7:00 p.m.

Location: Butterfly Chinese Restaurant, 831 Farmington Ave, West Hartford, CT 06119

Food and beverages will be provided. This event is free and open to the general public. Space is limited.

Please use this link to RSVP for the event. Pre-registration is required. For questions, contact

Science Cafe on Medicine and Latino Culture: A Kavli BRAIN Event (1/27/2018)

You are invited to attend our Science Café on Medicine and Latino Culture: A Kavli BRAIN Event. This event is a collaboration with the Latino Medical Student Association.

Title: Medicine and Latino Culture: Understanding and Addressing Latino Health Issues

Description: Join us for an informal discussion on the role of nutrition and genetics on the risk for diabetes and heart disease in the Latino community.

Speaker: Dr. Annabelle Rodriguez Oquendo, Linda and David Roth Chair of Cardiovascular Research, UConn Health

Date: Saturday, January 27th

Time: 6:00 p.m. – 8:00 p.m.

Location: Costa del Sol, 901 Wethersfield Ave., Hartford, CT 06114 (parking is available at the restaurant and across the street in a gated parking lot)

Food and beverages will be provided. This event is free and open to the general public. Space is limited.

For questions, contact