Texas Tech University

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September 9, 2013

Reporting Adverse Events

Principal Investigators (PIs) are reminded of their responsibilities for reporting unanticipated problems or adverse events that occur during research. Failure to do so is a violation of 45 CFR 46.103(b)(5) and could result in the suspension or termination of the protocol.

TTU IRB Policy 5.4: Reporting Adverse Events or Unanticipated Problems

If a project is not being conducted in accordance with a protocol approved by the IRB, if there is harm to a subject, or there is any other failure to conform to the requirements of 45 CFR 46 and/or these policies and procedures, the Principal Investigator is required to report the details of these deviations immediately to the IRB Chair. The Chair may ask the IRB to consider the matter. The IRB has the authority in such cases to suspend or terminate the research and/or to report them to the Vice President for Research. Reports to the Vice President for Research will be made as soon as possible. In the case of serious adverse events or deviations from an approved protocol, Texas Tech University is required by its assurance of compliance with federal government to report such incidents to the federal Office for Human Research Protections. In addition, the university may need to report the events to research sponsors. Thus, the reporting requirement for investigators is an extremely serious one.

http://www.hhs.gov/ohrp/policy/advevntguid.html#Q1


April 2, 2013

Consent Form Readability Level:

A general rule of thumb used by federal regulators is that consent forms aimed at the general public should be written at a 7th grade reading level. Adjustments up or down from that standard can be made depending on the target population of subjects. Short sentences and the use of smaller words help to achieve lower reading levels. The Flesch-Kincaid grade level estimate is available in Microsoft Word. It may be helpful but is only an aid for writing at the appropriate level. Common sense is sometimes a better guide.

MS Word 2010

Setup

Level Check

With the Consent form open, press the F7 key to run spellchecker. Spell Check will open and run. After the process is complete, a box will appear asking if you want to continue. Click Yes. Readability Statistics show up in the bottom portion of the table after the Spelling & Grammar check is complete.

MS Word 97-2003

Setup


April 11, 2012

Human Subjects Research with Sponsored Projects:

When you submit a grant proposal that involves human subjects, keep two things in mind:

  1. Some federal and private agencies require IRB approval before a grant can be funded.
  2. It takes 10 working days before the IRB can complete a proposal review and more than that when changes are necessary or special populations are involved. Some proposals will require a review by the Full Board, which meets once a month.

For several years, some federal funding awards have been made with very short time frames required for funds to be awarded. This has led to situations in which the investigator had as little as 24 hours to document IRB approval. In other words, an investigator had to write an IRB proposal and submit it to the IRB and the proposal had to be reviewed and necessary changes made, all within 24-hours. This is an impossible situation for us and for IRBs across the country.

It is in your best interest to submit your IRB proposal when you submit a grant proposal or soon after. If you receive a promising priority score or call from your Program Officer, and haven’t yet submitted your IRB proposal, submit it right away! We do not want you to have any risk of having to turn back funds that have been awarded to you because of a lack of IRB approval.



O.P. 62.25 Payments to Research Participants - http://www.depts.ttu.edu/opmanual/OP62.25.pdf

The revised O.P. 62.25 is now available to researchers. The HRPP staff wishes to thank Noel Sloan for her efforts in facilitating these changes and supporting researchers in their endeavors to pay subjects.

Key elements of interest to researchers: