MedStar Health Blog

The MedStar Health Research Institute (MHRI) Office of Research Integrity (ORI) would like to provide some details on recent changes to the Common Rule and how it may affect you.

The U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule on January 18, 2017, to update regulations that safeguard individuals who participate in research. Most provisions of the new rule will go into effect on January 19, 2018.

What is the Common Rule and Why Should I Care?

Regulations that govern institutional review boards (IRBs) and human subjects research is often referred to as the “Common Rule” because they were adopted by the HHS and 15 other federal agencies. Changes to the Common Rule will affect how IRBs, including the MHRI IRB, will operate. These changes also affect investigators who conduct research with human subjects.

Why Was this Done?

The Revised Common Rule represents the first systematic reform to the Common Rule since its promulgation in 1991. These regulations were developed at a time when the research was conducted predominantly at universities and medical institutions, and each study generally took place at a single site. Since then, the research enterprise has changed dramatically. Research involving human participants has grown in scale and become more diverse and the data have become digital.

To address these changes, the HHS undertook a nearly decade-long process to overhaul and update the Common Rule. Goals of the Revised Final Rule include the following:

• To more thoroughly address broader types of research issues, such as behavioral and social science research.
• To harmonize human subject policies across federal departments and agencies.
• To improve the oversight system to reduce unnecessary regulatory burden and enhance protections for research participants, particularly for low-risk studies.

What are the Key Changes to the Revised Common Rule?

Important elements in the final rule include the following:

• To require, in many cases, use of a single IRB for multi-institutional research studies. This change mirrors recent changes to NIH policy for single IRB review of multi-site research.
• To authorizes Common Rule departments and agencies to enforce the Common Rule against independent IRBs. It is expected that this change will ease liability concerns of institutions that rely on independent IRBs, because HHS can now direct its enforcement action against an independent IRB for noncompliance. This change likely will increase the use of commercial, independent IRBs, consistent with both industry and National Institutes of Health policy.
• To require consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
• To allow researchers the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement for studies on stored identifiable data or identifiable biospecimens. As under the current rule, researchers will not have to obtain consent for studies on unidentified stored data or biospecimens.
• To establish new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants are protected under the HIPAA rules.
• To remove the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
• To require that consent forms for certain federally funded clinical trials be posted on a public website.

What is the MRHI ORI Doing to Prepare for These Changes?

Changes to prepare for the January 19, 2018, compliance date are underway. The 2018 Requirements have been reviewed in detail and the changes have been classified as easy, medium, hard and those that can be implemented now (before January 19, 2018, compliance date) and later (after January 19, 2018).

Whether a policy or procedure has been updated to reflect the 2018 requirements can be identified from the reference section of the policy, which will include (1/19/2017) after the regulation citation to indicate its compliance with the Revised Common Rule.

During July, August and September, our changes have focused on updating policies/procedures that affect only the internal operations of the IRB and can be implemented now. Intensive planning for the 2018 requirements to be implemented by January 19, 2018, will begin in October.

Where can I get more information about these upcoming changes?

Stay tuned. From now until January, regular announcements and training opportunities will be presented as various elements of the 2018 Requirements are implemented.  

Come Join Us. Training sessions will be provided for various key topics between now and January. Additional information on these sessions will be forthcoming.

Keep Communications Open. If you have any questions, please do not hesitate to contact MHRI's Office of Research Integrity at MHRI-ORIHelpDesk@MedStar.net. 

General Resources:

• Learn more about the Final Revisions to the Common Rule.
• Read the Final Rule (PDF - 794 KB - PDF).

Researchers from MedStar Health Research Institute (MHRI), MedStar Washington Hospital Center (MWHC) and National Institute of Health (NIH) have recently sought to identify outcomes for HIV-positive women during pregnancy.

“Delivery After 40 Weeks of Gestation in Pregnant Women With Well-Controlled Human Immunodeficiency Virus” was published in Obstetrics & Gynecology. This research was led by Rachel K. Scott, MD, MPH, scientific director of women’s health research at MHRI and obstetrician/gynecologist and director of the Women’s Center for Positive Living at MWHC. The research team included Nahida Chakhtoura, MD; Margaret M. Burke, MD; Rachel A. Cohen, MS; and Regis Kreitchmann, MD.

This secondary analysis identified pregnant women with HIV-1, comparing delivery outcomes at 38-40 weeks estimated gestational age with outcomes of women who delivered at 40-42 weeks estimated gestational age. This research was conducted to fill a gap in formal guidelines for timing of delivery in well-controlled HIV-positive pregnancies. The researchers found that in pregnant women with well-controlled HIV-1, “the risk of mother-to-child transmission did not differ significantly by estimated gestational age at delivery.” The data suggest that pregnant women with viral loads of 1,000 copies/mL or less can be safely delivered per current obstetric indications.

Dr. Scott also presented two related studies at the International AIDS Society scientific meeting. These abstracts are the result of a DC-Center for AIDS research pilot award to investigate maternal and neonatal pregnancy outcomes of pregnancies complicated by HIV. In these studies, “Neonatal Outcomes of Pregnancies Complicated by HIV: Preliminary Results of a Retrospective Matched Cohort Study from 2004 to 2014” and “Pregnancy Outcomes of Women Living with HIV: Preliminary Results of a Retrospective Matched Cohort Study from 2004 to 2014,” Dr. Scott shared preliminary results from the soon-to-be completed retrospective matched cohort study of pregnancy outcomes at MWHC. This cohort of HIV-positive pregnancies is the largest single-site matched cohort in the United States.The preliminary findings have demonstrated increased maternal psychosocial and behavioral morbidity and increased proportions of complications for HIV-exposed neonates.

Obstetrics & Gynecology, 2017. DOI: 10.1097/AOG.0000000000002186

Lee Ann Richter, MD, is one of the few urologists in the country with obstetrics and gynecology-based training in Female Pelvic Medicine and Reconstructive Surgery. That combination of specialized training, which she completed at MedStar Georgetown University Hospital and MedStar Washington Hospital Center’s National Center for Advanced Pelvic Surgery, make Dr. Richter uniquely qualified to treat all female urology and urogynecologic issues, including pelvic organ prolapse, urinary and fecal incontinence, hematuria, kidney stones and other pelvic floor disorders.

“One of every three women will have pelvic floor disorder in their lifetime,” Dr. Richter says. “Fortunately, there are many treatment options to help them. As more women undergo these treatments to improve their quality of life, they’re sharing their experience with others, and encouraging them to get help too.”

Starting in Public Health

Dr. Richter has a longstanding interest in bringing quality medical care to those most in need. Before entering the University of Connecticut School of Medicine, she spent a year teaching public health and nutrition in a rural village in Ecuador.

“I originally thought I’d go into public health, either on a policy level, or working with individuals,” she explains. “The exposure to an entirely different culture and set of needs solidified my desire to become a physician.”

And it was through her husband, who works for the non-profit Save the Children, that Dr. Richter learned about the prevalence of urinary fistula in the developing world. “That was surgical expertise I wanted to have,” she says, “so I focused my fellowship in order to perform those procedures here and wherever else they were needed.”

Life Outside MedStar Washington Hospital Center

Now, along with her busy schedule at the Hospital Center and teaching at the Georgetown University School of Medicine, Dr. Richter travels to Rwanda each year to perform fistula surgeries through the International Organization for Women and Development.

“It’s exciting to be an advocate for women with urogynecological issues, regardless of who my patients are, or where they live,” she says.

Given her world view and hectic schedules, it’s hardly surprising that Dr. Richter is an avid runner, and has completed several marathons. She also loves spending time outdoors with her husband and two children, aged 6 and 3.

Congratulations to all MedStar researchers who had articles published in August 2017. The selected articles and link to PubMed provided below represent the body of work completed by MedStar Health investigators, physicians, and associates and published in peer-reviewed journals last month. The list is compiled from PubMed for any author using “MedStar” in the author affiliation. Congratulations to this month’s authors. We look forward to seeing your future research.

View the full list of publications on PubMed.gov here.

 Selected research:

1. Gastric Adenocarcinoma: A Multimodal Approach.
   Frontiers in Surgery, 2017. DOI: 3389/fsurg.2017.00042.
   Quadri HS, Smaglo BG, Morales SJ, Phillips AC, Martin AD, Chalhoub WM, Haddad NG, Unger KR, Levy AD, Al-Refaie WB
2. Graft loss: Review of a single burn center's experience and proposal of a graft loss grading scale.
   The Journal of Surgical Research, 2017. DOI: 1016/j.jss.2017.05.004
   Nosanov LB, McLawhorn MM, Hassan L, Travis TE, Tejiram S, Johnson LS, Moffatt LT, Shupp JW
3. Bicuspid and unicuspid aortic valves: Different phenotypes of the same disease? Insight from the GenTAC Registry.
   Congenital Heart Disease, 2017. DOI: 1111/chd.12520
   Krepp JM, Roman MJ, Devereux RB, Bruce A, Prakash SK, Morris SA, Milewicz DM, Holmes KW, Ravekes W, Shohet RV, Pyeritz RE, Maslen CL, Kroner BL, Eagle KA, Preiss L; GenTAC Investigators, Asch FM
4. Integrating natural language processing expertise with patient safety event review committees to improve the analysis of medication events.
   International Journal of Medical Informatics, 2017. DOI: 1016/j.ijmedinf.2017.05.005
   Fong A, Harriott N, Walters DM, Foley H, Morrissey R, Ratwani RR.
5. A Prognostic Model for Predicting Overall Survival in Patients with Peritoneal Surface Malignancy of an Appendiceal Origin Treated with Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy.
   Annals of Surgical Oncology, 2017. DOI: 10.1245/s10434-017-5847-x
   Ihemelandu C, Fernandez S, Sugarbaker PH

Researchers at MedStar Union Memorial Hospital (MUMH) have published the results of a laboratory investigation that used a novel diagnostic tool for diagnosing subtle injury to the ankle in cases of ankle sprain.

“Arthroscopic Correlates of Subtle Syndesmotic Injury” was published recently in Foot & Ankle International, the research publication of the American Orthopaedic Foot and Ankle Society. The investigators included Gregory Guyton, MD; resident Kenneth DeFontes, MD; fellow Cameron Barr, MD; laboratory director Brent Parks, MSc; and medical editor and writer, Lyn Camire, MA, ELS. The purpose of this research was to determine whether the extent of the ankle syndesmosis correlates with an injury to soft tissues in the ankle. Previous studies had assumed that a certain amount of opening in the syndesmosis indicated injury to these tissues, but no study had established that criterion using objective measures. Therefore, surgical decisions were potentially being made based on an unproven assumption.

The syndesmosis is a slightly movable fibrous joint that joins the tibia and fibula with connective tissue. The opening of the syndesmosis beyond the normal range indicates disruption of one or more of the surrounding ligaments. Extensive syndesmotic disruption is readily diagnosed using radiography, but subtle injury is difficult to discern clinically.

The study determined that passage of a 3-mm probe into the syndesmosis opening was the most likely criterion upon which further clinical investigation of ligament injury should be based. This size of the opening is larger than that previously considered to represent subtle ligament injury. This study represents one step forward in the process of treating syndesmosis injury. Future studies are needed to establish clinical data correlating specific anatomic lesions identified by spherical probe passage.

The Department of Orthopedics at MUMH is a growing group of fellowship-trained physicians who specialize in diagnosis and treatment of musculoskeletal pain or injury. These specialists are leading research that will contribute to improvements in patient care now and in the future.

Foot & Ankle International, 2017. DOI:10.1177/1071100716688198

To mark the sixtieth anniversary of the first clinical use of metformin for diabetes treatment, Diabetologia, the journal of the European Association for the Study of Diabetes, produced a special edition dedicated to the many evolving aspects of metformin use.

Vanita Aroda, MD, was the lead author for “Metformin for Diabetes Prevention: Insights Gained From the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study,” which focused on the long-term effects of metformin in the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study (DPP/DPPOS). Susana Shapiro, RN, serves as the program manager for DPP/DPPOS at MedStar.

The DPP/DPPOS is the largest and longest clinical trial of metformin for the prevention of diabetes. At MedStar Health, the DPP/DPPOS has been conducted at the MedStar Health Research Institute research location on Capitol Hill. The DPP was designed and initiated in the early 1990s to identify the possibility of delaying or preventing diabetes. Two interventions were identified: treatment with metformin and intensive lifestyle changes.

The DPP enrolled more than 3,200 patients at multiple sites throughout the nation. The study ran until 2001, one year ahead of schedule, “owing to demonstrated efficacy of both metformin and the lifestyle intervention” in preventing or delaying diabetes in participants. Preliminary findings from the study were released in 2002, “showing that the intensive lifestyle intervention and metformin groups had a respective 58% and 31% lower incidence of diabetes than the placebo group.”

Following the DPP, 88% of participants continued into the DPPOS study for an investigation into the long-term effects of the interventions on diabetes prevention, diabetes-associated microvascular complications and cardiovascular disease risk factors.

The impact of prediabetes and diabetes worldwide is enormous, with 415 million adults currently living with diabetes, with a projected increase to 642 million adults by 2040.

Diabetologia, 2017. DOI: 10.1007/s00125-017-4361-9