• The U.S. Food & Drug Administration (FDA) found that a physician-investigator conducting two GlaxoSmith-Kline multisite studies of albiglutide (to treat diabetes) failed to follow the investigational plan.  Specifically, FDA’s Warning letter found that an ineligible subject was enrolled and received a dose correction after screening, rather than within the specified time frame.  The investigator’s response can be paraphrased as “I promise to do better next time.”  FDA was unable to determine whether this corrective action was adequate to prevent similar violations in the future.

If you need clarification about avoiding Protocol Violations or how to prospectively obtain a protocol exception from the IRB, call Anu Diekmann at x86215.

1. Is the study ethical (respect for persons, beneficence, and justice)?
2. Are subjects appropriately informed of the nature of the study as well as its risks and benefits?
3. Are applicable federal regulations addressed (i.e. Investigational New Drug)?
4. Are institutional policies followed (billing, collaboration with support services)?

To avoid having your study tabled, be sure that your IRB submission answers the questions above.   For copies of Dr. Losey’s presentation powerpoint, contact Anu Diekmann at x86215.

• Protocols should be clearly written, direct, and internally consistent. The scientific rationale should be included in the protocol, references should be cited for reviewers who have additional questions, but critical findings from these references should be included in the protocol. Risks should be clearly and directly addressed.  For IRB templates on protocols, go to the Sample Protocol Outline.

• Informed consent documents should avoid medical jargon, clearly inform potential subjects of common and serious potential risks of the study, and explain how treatments in the study differ from standard care. A person who does not have a medical background should be able to understand the study after reading the consent.  You can find IRB’s consent templates here.

1)  “Role or Responsibility” of new personnel changed to “Obtaining consent (yes/no).”

2)   Attestation of PI expanded to include confirmation that new personnel will perform duties within the scope of clinical practice and have received appropriate protocol training.

Call Christine at x44531 if you have any questions about this form.

Don’t be disappointed!  If you miss this outstanding presentation you probably will be, but you still have a chance to enroll.  At this next installment of the Research Affairs Noontime Seminar, the Chairman of Loma Linda University’s IRB, Dr. Travis Losey, will enlighten you about not one, but 3 very timely and important issues for researchers, all in the time it takes you to enjoy your (free) lunch:

1. “But I think my project is Quality Improvement, not Research. Do I need to go through IRB?”  Come and learn how to actually
    tell the difference between a QI project and research.
2. Hear how and why it is so important to define the risks of research studies that involve “standard of care” treatments.
3. Understand both serious and minor protocol violations; the difference between them, and why you need to know this.

The program will be held in the Research Affairs main conference room on April 5 (Tuesday) from 12-1pm. Physicians attending this session will earn CME. 

You must register to receive credit and so we can have lunch ready for you. Seating is limited.

 Please click link Register    

Also, attendees who submit an evaluation form after the program will be entered into a drawing for a $25 gift card.  Congratulations to Lidia Abelar Mendoza  for winning the drawing for a $25 gift card at the last seminar.  

Thank you for your attention. We look forward to seeing you there.

Call for Presentations

You are invited to submit a proposal for a presentation at the Adventist Human-Subjects Research Association (AHSRA) Conference at Oakwood University in Huntsville, AL from May 9 – 11, 2016. 

Information About Workshop Submissions

AHSRA’s 2016 conference solicits presentations that investigate the internalization of faith.

 The conference will explore:

• Factors that facilitate faith internalization from programs to relationships
• Obstacles and barriers to faith internalization
• The impact of faith internalization on mental health, physical health, risk-behaviors, and decision making

Presentations will be approximately 30 minutes each including 10 minutes for discussion.

Criteria for Workshop Selections:

A peer review process focusing on the following criterion will guide in the selection of proposals:

• The presentation will add to the body of knowledge currently available on the topic addressed.
• The presentation includes a practical component that participants can readily apply in practice/ministry/service.
• The proposal is clearly informed by the current literature.
• The concepts in the proposal are clear and the proposal is understandable and well organized.

Procedure for Presentation Submissions:

Please submit your presentation proposal directly to Sarah Burton sgane@andrews.edu no later than March 30, 2016 (note extended deadline). All proposals most be submitted electronically.

Your proposal must include the following information:

• Name and contact information for the person(s) making this submission

• A title and one page (250-500 words) summary of the presentation
• A 50-word abstract suitable for printing in the final program
• A list of references/bibliography which includes some sources published within the past 5 years

Proposal Selection

Proposals are blind peer reviewed (that is, the reviewers will not know the names of the person(s) submitting proposals).  By April 8, 2016, presenters will be notified about whether or not their proposals have been accepted for the conference. 

Presenter Registration

Persons who submit proposals for the AHSRA Conference 2016 are expected to agree to the following terms:

If my presentation proposal is accepted, I agree to the following:

• To attend the AHSRA Conference 2016 in Huntsville, AL and present my presentation unless a bona fide emergency occurs
• To register (at my/our own expense) no later than Friday, April 30, 2016
• I understand that if I do not register for the convention by April 30, 2016, my presentation may have to be removed from the conference program
• I understand that no honorarium will be paid to me for my presentation
• To make my presentation at the time selected by the AHSRA 2016 planning committee
• To provide at least 25 copies of my/our handouts at no expense to workshop participants

Conference Fees (Includes conference registration, housing, and meals)

Early Bird Registration (prior to April 30) AHSRA Members: $120

Early Bird Registration (prior to April 30) Non-members: $145

Regular Registration AHSRA Members:  $150

Regular Registration Non-members: $175

One-day Registration (May 10/11; no meals or accommodation):$50

AHSRA Annual Membership Dues:  $20

• The U.S. Food & Drug Administration (FDA) found that a California investigator persistently failed to ensure that a number of his research subjects fulfilled enrollment inclusion criterion.  FDA’s Warning Letter suggests that the physician attempted to change subject enrollment data months after actual enrollment.

• The Office of Human Research Protections investigated a major medical center in New York and found that researchers changed the informed consent before getting IRB approval.  Investigators suspended enrollment for two affected studies until revisions were approved by the IRB.

If you need clarification about avoiding Protocol Violations or how to prospectively obtain a protocol exception from the IRB, call Anu Diekmann at x86215.

You can check the approval end dates of all your studies at the Investigator’s Portal and submit Research Report Forms accordingly.  If you need help with your username and password, call Deborah at our Investigators Help Desk (x43042).  Go to the Lapse of IRB Approval procedure for further guidance.

Research records must be prepared and maintained, and kept, stored, and accessed as allowed by federal regulation and approved by institutional policy.  A procedure will be developed to address each of the areas pertaining to research records.  Currently, we have developed a procedure for Clinical Research Records Documentation that identifies specific requirements that must be followed in setting up and maintaining research records when they have the potential to impact current or future care of the patient.  Three charts have been attached that outline which research records belong in the Medical Record, Investigational File for Clinical Research, and in the Investigator’s Research files (administrative).  Subsequent procedures will also be developed in the future to address retention, storage, and access. 

Both documents are now available online at:  http://www.llu.edu/pages/handbook/lluahsc_policies/index.php?dir=H-Research%2520Affairs/

Please review the documents.  Plans for training are in process, and a subsequent announcement will be sent out with details on when training will occur. 

If you have any questions about this policy, please contact Lorraine Sarmiento at ext. 49478 or lsarmiento@llu.edu.  For more information, visit Integrity, Storage, and Retention of Research Data.

Refer to Examples of Serious or Minor Protocol Violations to help you determine if a violation is:

• serious (submit the Protocol Violation Report Form within 5 working days of awareness) or
• minor (record event on the Minor Protocol Violation Log and submit with the study’s Research Report Form at the end of the IRB approval period).

Call Anu Diekmann at x86215 if you have any questions.  

Research Affairs would like to invite you to the November 10 Lunch Seminar:

Have your IACUC submission approved the very first time it is reviewed

Why experience frustration and lose valuable time getting your project started?  By knowing exactly what information IACUC needs to approve your study, you can be sure all those elements are included and sufficiently developed in your application before submittal. Then, sit back and watch your first-time approval rate jump!  See attached flyer for more about this comprehensive presentation by Obed Rutebuka.

The seminar will be held in the Research Affairs main conference room from 12-1pm. Physicians attending this session will earn CME. 

You must register to receive credit and so we can have lunch ready for you. Seating is limited.

 Please click link Register    

Also, attendees who submit an evaluation form after the program will be entered into a drawing for a $25 gift card.  Congratulations to Julie Lacanlale for winning the drawing for a $25 gift card at the last seminar.  

Thank you for your attention. We look forward to seeing you there.

Protocol Violations:  Don’t let this happen to you!

Recently published findings from investigations by federal regulators [Human Res Rept, Oct. 2015, 30(10), 8-9]:

• The U.S. Food & Drug Administration found that a California investigator failed to ensure that the trial was conducted according to the investigational plan.  Specifically, subjects were enrolled that did not fit inclusion/exclusion criteria.
• The Office of Human Research Protections investigated a major medical center in New York and found that the informed consent documents contained inadequate information.  Specifically, the consent did not describe possible risks.

If you need clarification about avoiding Protocol Violations or how to prospectively obtain a protocol exception from the IRB, call Anu Diekmann at x86215.

A recent notice from the NIH will likely change how human subject research is planned, reviewed, and conducted.  Although women now account for roughly half of all participants in NIH-supported clinical research, basic and preclinical biomedical research has focused on male animals and cells. NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies.  Strong justification from the scientific literature, preliminary data, or other relevant considerations must be provided for applications proposing to study only one sex.

The following IRB application names have been updated on the IRB Toolkit for Investigators to clarify when to use them:

• “Social Behavioral” > “Minimal Risk Studies”
• “Standard” > “Clinical Trial”

The IRB Applicant Checklist has been updated to provide information about naming conventions for full board electronic submissions.  Further details about naming conventions are provided in this guidance document.

And now, moving forward . . .

Research is to see what everybody else has seen, and to think what nobody else has thought.  - Albert Szent-Gyorhyo, Hungarian Biochemist, 1937 Nobel Prize for Medicine

• Where can I find an IRB/IACUC application forms on-line?
• What is the status of my study? (Note that contact information is also provided in your initial review communication)
• How can I access my log-in and password to submit a change request or view my studies?
• Why is my approval on hold?
• When is the next IRB or IACUC deadline?

• Where can I find an IRB/IACUC application forms on-line?
• What is the status of my study?
• What is my log-in and password to submit a change request or view my studies?
• Why is my approval on hold?
• When is the next IRB or IACUC deadline?

The “IRB Reviewer’s Help Desk” is also newly designated to assist all IRB reviewers with reviewer assignments, scheduling committee attendance, screening incoming submissions for completeness, and distributing protocols to reviewers (Susan Fajardo, x42448 or rpp@llu.edu).  

Christine Peña, Administrative Assistant, will be assisting you as needed to avail yourself of RPP support.  Additional support includes:   

• Anuradha Diekmann, IRB Full Board reviews (x86215 or adiekmann@llu.edu).
• Linda G. Halstead consultation on IRB policies/regulations (x43570 or lhalstead@llu.edu).
• Obed B. Rutebuka consultation on IACUC submissions, policies/regulations (x87130 or orutebuka@llu.edu).

The Characters

"In this simulation, you get to become a principal investigator, a clinical research coordinator, a research assistant, and an institutional review board (IRB) chair and make decisions that affects the outcome of the story.

• Dr. Richard Sowers, a principal investigator (PI), a busy oncologist who must strike a balance between doing what he thinks is best for his patients and his research;
• Jan Klein, RN, a clinical research coordinator, an overworked nurse who works for a PI who pressures her to falsify data and violate study protocols;
• Megan Boyle, a research assistant who has difficulties obtaining informed consent and following research protocols; and
• Marcy Rosenberg, an IRB Chair, who is tasked with ensuring that research subjects and the integrity of the research enterprise are protected while dealing with a culture resistant to change."

This training tool can be found at http://ori.hhs.gov/TheResearchClinic. The press release is located at: http://www.hhs.gov/news/press/2014pres/03/20140331a.html.

2. Be sure to download the latest versions of the applicant checklist, IRB applications, templates, and change request forms from the IRB Toolkit for Investigators.  Rather than saving these items on your hard-drive, we suggest you book-mark this link. IRB forms for investigators are frequently revised, either to clarify in response to investigators’ inquiries or to incorporate changes in regulatory and institutional policies.  Using outdated IRB forms can result in delays in the approval process.

• Applicant Checklist (updated with additional required worksheets)

• California Experimental Subject’s Bill of Rights  English (updated signature lines)

• HIPAA Authorizations for Adults [Standard] [Dependency Treatment] (added paragraph regarding diagnostic and laboratory tests)

HIPAA Authorizations for Minors [Standard] [Dependency Treatment]  (added paragraph regarding diagnostic and laboratory tests)

Call us at x44531 if you need any help navigating our website!

2.  Free webinar -  Understanding Reporting Obligations to the IRB

You are invited to watch a free webinar on Tuesday, May 13^th OR Thursday May 15^th from 10-11 AM PST, hosted by Quorum IRB.  Discussion will cover how reporting practices differ from the actual regulatory requirements; distinguish safety versus non-safety reporting; and provide recommendations to sites and sponsors for improving event reporting.  You can watch this free webinar from your desk!  Click here to register for your preferred day.

• HIPAA Authorizations for Adults [Standard] [Dependency Treatment] (removed paragraph regarding diagnostic and laboratory tests)
• HIPAA Authorizations for Minors [Standard] [Dependency Treatment]  (removed paragraph regarding diagnostic and laboratory tests)
• LLU Waiver of Consent/Authorization (modified to fit longer IRB study number)
• Protocol Change Form (Word) (removed wording about formatting the form)

Call us at x44531 if you need any help navigating our website!

• Investigators must provide the LLU IRB with some form of documentation that their planned research meets local ethical standards and will protect human subjects. Having a letter that addresses local/cultural sensitivities from an independent representative from a local university, non-governmental organization, or other appropriate institution indicates that the study design meets such standards.
• In some instances (such as research in smaller tribal communities), investigators should provide the IRB with an explanation of how they will be invited into the community.
• Propose any necessary changes to the consent document and/or process to be culturally appropriate.
• When necessary, allow for extra time in getting translations for informed consent.