Texas Tech University

Hot Topics

April 8, 2016

What does it mean to be a Research Principal Investigator at Texas Tech University?
The Office of Human Research Protections (HHS/OHRP, 2016)) describes the role and responsibilities of a research investigator in the following way:
"Investigators play a crucial role in protecting the rights and welfare of human subjects and are responsible for carrying out sound ethical research consistent with research plans approved by an IRB. Along with meeting the specific requirements of a particular research study, investigators are responsible for ongoing requirements in the conduct of approved research that include, in summary:
obtaining and documenting informed consent of subjects or subjects' legally authorized representatives prior to the subjects' participation in the research, unless these requirements have been waived by the IRB (45 CFR 46.116; 45 CFR 46.117);
obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to subjects (45 CFR 46.103(b)(4)) ; and
ensuring that progress reports and requests for continuing review and approval are submitted to the IRB in accordance with the policies, procedures, and actions of the IRB as referenced in the institution's OHRP-approved Federalwide assurance (45 CFR 46.103(b)(4), 45 CFR 46.109(e), 45 CFR 46.115(a)(1)) . In certain circumstances, investigators also would be responsible for meeting the following additional regulatory requirements:
providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others 45 CFR 46.103(b)(5);
providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB (45 CFR 46.103(b)(5)); and
keeping certain records as required by the HHS regulations for at least three years after completion of the study (45 CFR 46.115(b))."
TTU Policy 74.09 (5) outlines the criteria for those researchers who are eligible to assume the responsibilities as a Principal Investigator (PI) over a research study. The Principal Investigator must be:
• a full time faculty member; or
• a tenured faculty member; or
• a full time employee with a terminal degree in his/her discipline.

February 5, 2016

HHS Announces Proposal to Improve Rules Protecting Human Research Projects
In 2011, the U.S. Department of Health and Human Services (DHHS) announced a proposal to improve the rules protecting human research subjects. This was followed by a Notice of Proposed Rulemaking (NPRM) published in the Federal Register in September 2015. The deadline to submit comments regarding the proposed changes ended on January 6, 2016. Ref. HHS.gov website. The Office of Human Research Protections (OHRP) offers more on the subject >>

NPRM 2015 - Summary
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015 (PDF 1063 KB). The NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. Read more >>


October 19, 2015

Definition Change for Inclusion of Children in Research

NIH will be changing the inclusion policy for children with a different age definition effective January 25, 2016. Read more about it here >>


September 1, 2015

HRPP/IRB Training

Preparing an IRB proposal and not completely sure what level of review it is or what is required? Do you need individual training or are you a Professor that has a class needing to know what the HRPP/IRB is all about? Are you teaching a undergraduate research class to students who have yet to know or understand what it is to utilize human subjects in research?

The HRPP staff would love to work with you one-on-one or come to present the information to your class. All it takes is a phone call. Our presentations are tailored to the needs of the audience. We hope to hear from you soon! Your success is our success. Guns UP!


April 1, 2015

International Requirements for Human Subject Research

If I am going to do human subject research outside the continental United States, where can I go to see the requirements for conducting research in a particular country?

The answer can be found here >>


July 2, 2014

Total Online Electronic Submissions

The proposal submission process will be changing.

In an effort to make the proposal submission process more effective and the review process more efficient, the HRPP/IRB will be migrating to a new Envisions Cayuse software application in 2015. The current paper process will be ending and all proposals will be submitted online. ORS has recently gone live with Cayuse and utilizes the application to track sponsored project applications. The interface should provide researchers with a seamless approached to submitting both grants and IRB proposals.


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

  • Click the File tab, and then click Options
  • Click Proofing
  • Under When correcting spelling and grammar in Word, make sure the Check grammar with spelling check box is selected.
  • Select Show readability statistics.

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

  • Click on the File tab, and then click Options
  • Click Proofing
  • Under When correcting spelling and grammar in Word, make sure the Check grammar with spelling check box is selected.

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:

  • Noncash items are allowed but need prior approval by the Office of Tax Compliance & Reporting. (1.c.)
  • “Participants who are being paid $25 or less are not required to provide their SSN…” (2.b.)
  • Gift cards are allowed. Use the cash advance to purchase the gift cards. Do not use the pcard or TechBuy methods. (2.c.)
  • Gift cards by online vendors are allowed. Review the policy and procedure in this section for details. (2.c.)
  • Payments to employees have been revised both in participation conditions and payment procedures. (3.c.)
  • New forms to report and process research payments are available as attachment links at the end of the document.

Contact

Office of the Vice President for Research