• Revised common rule to bring welcome changes to exempt status research categories

    • 10.15.2018

    The Revised Common Rule will bring some largely welcome changes to the Exempt categories of research. In general, the language changes expand the type of research to which exempt status review will apply. As a reminder, “exempt” does not mean the same thing in research-land as it does in real life. An “exempt” study is […]

  • Revised Common Rule to bring changes* to informed consent

    • 10.11.2018

    The Revised Common Rule (RCR), slated to go into effect Jan. 21, 2019, will bring some changes* to informed consent requirements. And that asterisk by “changes” is intentional, as the federal Office for Human Research Protections (OHRP) has said that it may issue guidance regarding some RCR consent requirements. Well, here we are, a mere […]

  • Revised Common Rule Resources

    • 10.5.2018

    The Revised Common Rule, slated to take effect Jan. 21, 2019, will bring some significant changes to our UAMS/ACH policies and procedures related to human subject research. Note that we can’t accuse the federal Office for Human Research Protections (OHRP) of rushing through this rule-making process; this is the first major revision since the original […]

  • Publication bias in research

    • 10.5.2018

    It’s great when your study results support your hypothesis. Less appreciated, but equally importantĀ  is when your study results show your hypothesis wasn’t correct. Researchers tend to be more enthusiastic about publishing the former than the latter, we’ve noticed. Here’s a New York Times piece that discusses the importance of letting the world know about […]

  • Well-known food and decision-making researcher resigns — Sound Research Design questions

    • 10.4.2018

    While the name “Brian Wansink” may not be immediately familiar, some of the research he’s known for probably is. Dr. Wansink’s research into how people make decisions about what and how much to eat gets a lot of play in the popular media. He’s one of those rock star scientists. At the end of the […]

  • No docs allowed with staff-only modification forms

    • 09.14.2018

    When making changes to study staff, please keep in mind the IRB cannot and will not review any revised documents submitted with staff-only modifications. Many staff changes can be made without revising any documents, which is why we created the “staff-only” modification form option. These “staff-only” changes can be reviewed and acknowledged by the IRB […]

  • Failure to disclose competing interest lands researcher on the front page above the fold

    • 09.14.2018

    A New York Times pieceĀ that appeared in the printed paper Sept. 9 addressed what it termed a prominent researcher’s failure to disclose conflicts of interest in research publications. We know that appropriate disclosure is a typical requirement of conflict of interest management plans. Please click on the link above to read more. Update: The researcher […]

  • A very quick tour of the Revised Common Rule

    • 08.31.2018

    We’re working furiously to prepare for the implementation of the Revised Common Rule, now scheduled for Jan. 21, 2019. Below is a recap of some of the more notable changes in the rule, followed by an explanation of how we anticipate incorporating those changes at UAMS. Please note this is only the tip of the […]

  • Reminder about IRB confidentiality

    • 08.23.2018

    Please remember discussions that happen inside the IRB’s meeting room need to stay inside the meeting room. IRB determinations and contingencies are considered group decisions. Those decisions are relayed to the research team via correspondence through CLARA. Reviewers — If someone on a research team asks you for specifics about their project’s IRB review, please […]

  • Data and sample handling and storage tips for protocol drafters

    • 08.9.2018

    We’ve noticed a few things in new submissions regarding data and sample handling and storage that slow down approvals. Here are some reminders of things to keep in mind when drafting protocols and CLARA completing new submission forms: UAMS Administrative Guide Policy 3.2.01 requires research data, reports, and analyses to be kept for “7 years […]