A stolen laptop containing research subjects’ personal information will cost one medical research institute close to $4 million dollars to settle the resulting HIPAA case, according to the Office for Civil Rights (OCR), the federal agency that enforces HIPAA. The Feinstein Institute for Medical Research in New York has agreed to pay $3.9 million to settle potential […]
Another risk to using genetic information?
The issue of whether genetic information or material can be considered identifiable prompts a great deal of discussion among researchers and IRBs. On the one side are those who believe that nothing is more uniquely identifiable than an individual’s genetic information. On the other are those who say that genetic information by itself cannot readily […]
Simplifying consent forms, Chapter 3
Ensuring the right steps are taken to prevent pregnancy can be an important part of research subject safety, particularly for drug studies, as the effects of a research intervention on an embryo or fetus are often unknown. But what’s the best way to describe the requirement to avoid pregnancy in a consent form? Quorum Review […]
More research in the news
Research involving human materials is again in the news at The New York Times. A recent news article about fetal tissue researchers highlights some of the nuances involved in this type of research, and not just the ethics of it. The article highlights issues related not just to sourcing of fetal material, but also to concerns relevant to the broader […]
The risks and benefits of research can be unpredictable
The decision to join a research study can have unpredictable long-term results. A man with autism who, at age 50, joined a study examining transcranial magnetic stimulation found the effects life-changing, in both positive and negative ways.
Simplifying consent forms, Part 2
Many research studies involve multiple visits, with specific procedures to be carried out at each visit. Consent forms often describe this kind of research in visit-by-visit lists that include each procedure at every visit. This format can lead to a long consent form that includes a lot of repetition, if procedures will be repeated. We encourage […]
Students (and their faculty advisors): Remember to close completed studies in CLARA
So your study is done, your dissertation is written, and you’re gearing up for graduation and bigger and better things now that you’ve completed this part of your education. It’s a busy and exciting time for you, we know, but we do have one last piece of research-related advice for you – you’re not really out […]
Returning genetic testing results
Genetic testing poses all kinds of questions for IRBs. Are genetic testing results potentially identifiable? Are they meaningful? Should they be returned to patients? Our current ability to do genetic testing may have outpaced our ability to answer these questions, at least for now. When reviewing research, we sometimes are asked to put ourselves in […]
Please Excuse My Dear Aunt Sally — She can only understand a lay summary that’s written in plain language
The CLARA new submission form includes a question asking “What is the lay summary of this study?” When we say “lay summary,” we mean “lay summary.” As the help text indicates, this response should be written in simple, non-technical vocabulary at a no-greater-than-high-school level. Cutting and pasting text from the study summary in your informed […]
Remember, we can’t approve studies until CITI training is current
Well, you may recall the good news from a few weeks back – the required human subject protection training taken through citiprogram.org is now valid for 3 years, instead of the previous 2 years. The not-so-good news is that we still need to have all study staffers’ CITI training current before we can approve a […]