“Hot Topics for Institutional Officials” boils over with valuable information

By: Wendy R. Tate, PSM, CIP, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

Institutional interests, conflicts of interest, cooperative agreements, promoting research, minimizing compliance liabilities, accreditation, international research, funding, subject rights, and the federal government. This list of items (plus many more) keeps an institutional official (IO) extremely busy. I am not the IO at my institution; however, part of my job is to provide information to research administration so that the best decisions can be made. And now you know the reason I am attending the Hot Topics for IO pre-conference session at the 2010 Advancing Ethical Research Conference.

I cannot put all of the information from a daylong session into one post , so I decided to capture some short statements of great advice and valuable updates that I took away. Though they were given to an audience of IOs, these “nuggets” are applicable to anyone working in human subjects protections.

  • The National Institutes of Health (NIH) has said that in all the cases of high-profile disclosures of conflicts of interest, there has not been a single case of research misconduct.
  • Remember that federal funding is granted to the institution, not the investigator. When an investigator fails to disclose required items, it is the institution that is penalized.
    Conflict of interest is about preserving objectivity.
  • If your institution has “unchecked the box” on the federalwide assurance, then utilize flexibility in the regulations. The Federal Demonstration Partnership (FDP) is a consortium of agencies and institutions dedicated to reduce regulatory burden and is ready to partner with you.
  • We tend to forget how much researchers gain from subject contributions (paraphrase, “Blood Journeys,” The New York Times)
  • Opinion: To think that we can de-identify in our increasingly identifiable world is fiction.

There are a lot of guidances and regulations either finalized or proposed; here’s a snapshot of what we discussed:

  • The FDA released new regulations regarding investigational drug safety reporting that will be effective on March 28, 2011. These regulations integrate FDA and International Conference on Harmonization reporting rules and guidance.
  • The FDA has proposed a regulation on Scientific Misconduct Reporting.
  • The FDA has proposed an updated Public Health Service (PHS) policy on conflict of interest.
  • There is a proposed change to an OHRP rule, shifting regulatory responsibilities and liabilities to the institution providing IRB review and away from the grant recipient organization.
  • The Secretary’s Advisory Committee on Human Research Protections (SACHRP) has given 20 frequently asked questions and answers to OHRP on biobanking. They have feedback from the Office of Civil Rights (OCR) regarding the HIPAA answer to each of the proposed scenarios.
  • There is a proposed, and in-use, HIPAA-HITECH rule. Need I say more?

We also had the pleasure of some truthful humor from Ivor Pritchard, senior advisor to the director, OHRP (I have paraphrased some of his quotes):

  • OHRP compliance people are dealing with upset people, education people are transmitting information to the regulated, and policy people just don’t get out much.
  • Bureaucrats are not very brave. Government feels much better to know that the regulated are behind the rule making. Comment when you think that proposed rules are good.
  • Based on an impromptu survey (not performed for research purposes), at least 25% of the room thinks they are a safer driver than they really are.

Finally, if I had to summarize the theme of the day, I would have to say it is harmonization; harmonization between the institution and regulatory committees, among collaborating entities, and among government agencies. In order to reduce regulatory burden, increase compliance with federal and accreditation standards, and have a top-notch research program, harmonization is necessary. In fact, it will lead to fewer regulations (since we all agree on the same thing) and make all of our jobs easier in the end. Harmonization is not easy. To achieve meaningful harmonization that betters the research process, thoughtful input from people of different disciplines over a significant period of time is required. Don’t be discouraged: thousands of professionals sharing this desire have gathered in San Diego for the next three days to do this very thing. These professionals will go home to other professionals and discuss these ideas. Collaborations that are formed in San Diego will expand into a global network. Meet, greet, and network. If you aren’t in San Diego, do it virtually. We will all make the process better if we choose to think about the whole research picture like the IO does.