January, 2016 - Printable Version 

Inside this issue:



Message from the Director

We have closed the book on 2015 and can look forward to an interesting and challenging new year. Change is coming as the UIC Human Subject Protection Program progresses. While change can be unsettling, 2016 will be rewarding as several advances in human subject research protections move forward.

“The art of progress is to preserve order amid change and to preserve change amid order.”
Alfred North Whitehead

First, electronic submission of research applications will become a reality at UIC in 2016. Pilot testing and training for investigators, IRB members and OPRS staff is on-going and feedback from the UIC research community has been positive. Conversion from paper to electronic submissions is a large undertaking. We know there will be a learning curve and speed bumps along the way; however, we also know that electronic submissions will be easier to submit, quicker to review and enhance human subject protections at UIC.

In 2015, the Department of Health and Human Services announced proposed revisions to the regulations that govern research on individuals who participate in research. While not finalized, as per HHS, the proposed rule changes include:

  • Strengthened informed consent provisions to ensure that individuals have a clearer understanding of the study’s scope, including its risks and benefits, as well as alternatives to participating in the study.
  • Requirements for administrative or IRB review that would align better with the risks of the proposed research, thus increasing efficiency.
  • New data security and information protection standards that would reduce the potential for violations of privacy and confidentiality.
  • Requirements for written consent for use of an individual’s biological samples, for example, blood or urine, for research with the option to consent to their future use for unspecified studies.
  • Requirement, in most cases, to use a single institutional review board for multisite research studies.
  • The proposed rule would apply to all clinical trials, regardless of funding source, if they are conducted in a U.S. institution that receives funding for research involving human participants from a Common Rule agency.

Once the rules are finalized, it is anticipated that institutions will have a specified period of time to implement them. Clearly, significant change in human subject protections is coming, and we all must prepare for the changes. Link to HHS September 2, 2015 announcement: http://www.hhs.gov/about/news/2015/09/02/hhs-announces-proposal-to-update-rules-governing-research-on-study-participants.html#

UIC will begin the process of obtaining Association for the Accreditation of Human Research Protection Programs (AAHRPP) reaccreditation in 2016. The reaccreditation application will be submitted to AAHRPP in early 2017. It is anticipated that revision of institutional policies and procedures will be required in 2016 to meet current AAHRPP standards.

The goal of these initiatives is to further promote the ethical conduct of excellent research. The key to successfully achieving this goal at UIC will be building upon our many strengths through innovation, cooperation and hard work. Please stay tuned for announcements and additional OPRS newsletters detailing change in 2016.

The following topics are addressed in this issue of the newsletter:

“The speed at which progress rolls is not determined by the number of people who started pushing it, but by the number of people who are passionate to hold on doing so.”
Israelmore Ayivor, Leaders' Ladder
  • When to submit a Final Report to the IRB;
  • Registration information for the Community Engaged Research Boot Camp 2016; and
  • How the purposes of the “Determination of Whether an Activity Represents Human Subject Research” and “Development/Center/Training Grant” applications differ.
  • Did you know?

To all UIC faculty, staff and students- Happy New Year and much academic and research success in 2016!

Jim Fischer
OPRS Director


When to submit a Final Report to the IRB

Contributed by Barbra Corpus and Charles Hoehne
 

Investigators frequently contact OPRS staff to determine when they should submit a Final Report closing out a study.

As per institutional policy: Final reports must be submitted upon completion of the study.

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Registration information for the Community Engaged Research Boot Camp 2016 

Contributed by Lynn Podraza and Charles Hoehne
 

Community Engaged Research (CER) Boot Camp is an intensive, three-day, hands-on, interactive, program that provides the knowledge and tools Community Engaged Research Staff needs to carry out successful research studies.

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How the purposes of the “Determination of Whether an Activity Represents Human Subject Research” and “Development/Center/Training Grant” applications differ

Contributed by Charles Hoehne
 

Investigators occasionally confuse the “Determination of Whether an Activity Represents Human Subject Research” (“Determination”) and “Development/Center/Training Grant” applications.The purpose of this article is to briefly explain the different purposes of the applications and thus avoid unnecessary delays due to the submission of the incorrect application to OPRS.

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Did you Know?

Contributed by Charles Hoehne
 

  • As per the UIC Information Technology Security Program (http://security.uic.edu/policies/), “The Workforce, including select student employees as identified by a Unit in Policy PER.2 Job Descriptions, Responsibilities, and Training, must use university administered messaging systems (e.g. email, instant messaging, document sharing) to conduct university business.” Consistent with this campus-wide policy, OPRS strongly encourages investigators to ONLY use their UIC email address for conducting human subject research, including completion of investigator training, submission of research applications, communications with OPRS and ALL conduct of human subject research.

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