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  • OB/GYN Clinical Alert - Full March 2014 Issue in PDF

  • Should You Advise Your Patients to Eat Peanuts During Pregnancy?

    Synopsis: In this study, women without allergies who consumed peanuts or tree nuts five times or more per month around the time of pregnancy compared to less than one time per month had reduced odds of having children with peanut or tree nut allergies.
  • First Trimester Anatomy

    A meta-analysis of 19 studies involving first trimester screening for fetal anomalies has shown that a majority of major structural abnormalities can be diagnosed between 11 and 14 weeks and that even cardiac abnormalities can be identified with ultrasound with reasonable efficiency.
  • Emergency Contraception

    We now have three options for emergency contraception the copper IUD, oral ulipristal acetate, and oral levonorgestrel. One of the most important considerations in using emergency contraception is the initiation of ongoing regular contraception. The special feature will discuss the opportunities and considerations for use of these three different methods of postcoital contraception.
  • Try this 30-second QI solution for IC

    Informed consent templates are useful when an IRB office starts a new process or when there are new employees or new investigators submitting applications, but an experienced office can improve IC review quality by weaning its staff off of templates, an expert suggests.
  • Translation services may improve trial enrollment

    Non-English speakers often are under-represented in clinical trials because of the language barrier and the lack of resources to provide clear and up-to-date translations of informed consent. This leads to questions of equity, an expert notes.
  • More subjects enrolled than previously

    Recruiting patients in many areas of clinical trial research is a very slow process, contributing to delays in getting new treatments through the research pipeline.
  • IRB Advisor - Full March 2014 Issue in PDF

  • Essentials document defines protocol ethics

    Developing a sound, ethical protocol is the top goal for any researcher or IRB. But the basic ethical elements and the considerations behind an investigator's choices may not always be clear, often resulting in back-and-forth discussions between investigators and IRBs reviewing the protocol. A group from Harvard University collaborated with other research stakeholders to develop an ethics reference tool for investigators.
  • New HIPAA rules clarify authorizations

    In March 2013, the Department of Health and Human Services (HHS) issued a final omnibus rule modifying various aspects of the Health Insurance Portability and Accountability Act (HIPAA) to implement provisions of the Health Information Technology for Economic and Clinical Health Act (HITECH). These rules include a few notable changes that affect research programs, including provisions related to compound authorizations and authorizations for future research use and disclosure of protected health information (PHI).