Grants Bulletin

January 26, 2007

February 5 is First Electronic Submission of NIH R01 Proposals

February 5 is fast approaching. It marks the first time the National Institutes of Health will require submission of R01 proposals through Grants.gov. We anticipate a high volume of proposals at UK and across the country. Here are some reminders and tips for successful proposal submission.

Requirements:

• PI must have correct eRA Commons username. If you are not registered, contact OSPA.
• Download free PureEdge and pdf conversion software at www.grants.gov/resources/download_software.jsp
• Use correct and current form from Grants.Gov (www.grants.gov) using PA, RFA, or RFP number.
• PI should check the application package for errors prior to submitting to OSPA.
• You do NOT need to register in Grants.gov, UK is registered

Deadlines:

• OSPA Internal Deadline for Electronic Submission:  Wednesday, Jan. 31, 2007. Grants must be uploaded to NIH through OSPA, this constitutes institutional approval. OSPA must review the proposal and clear errors on each submission prior to successful uploading.

• NIH deadline for Electronic Submission:  Monday, February 5, 2007, 5:00 p.m.

How to get your proposal to OSPA:

• Via OSPA Web upload interface: “Upload Proposal to OSPA” link on left menu of homepage: www.research.uky.edu/ospa 
  Direct URL:  http://www.research.uky.edu/cfdocs/ospaupload/Upload.cfm

• Email to your OSPA Research Administrator

Help and Assistance:

• Contact your Research Administrator or College Grants Officer
• Grants.gov Help support@grants.gov  800-518-4726
• eRA Commons Help commons@od.nih.gov  866-504-9552
• NIH: http://era.nih.gov/ElectronicReceipt
• Dr. Louis Hersh PowerPoint tutorial

• Charles Moore presentation on Grants.gov, see “Latest News” on www.research.uky.edu/ospa

• Sample 424 pdf with UK administrative information completed

“Clinical Applications of Angiogenesis Research” - Feb. 1

Noon to 1 p.m.
Thursday, February 1, 2007
Hospital Auditorium, HG611

Judah Folkman, M.D., Andrus Professor of Pediatric Surgery and Professor of Cell Biology, Harvard Medical School and Children’s Hospital

Objectives:

1. How are today’s FDA-approved angiogenesis inhibitors currently being used in clinical practice?
2. Will “endogenous” angiogenesis inhibitors become the next generation of this new class of drugs to receive FDA approval?
3. How are “endogenous” angiogenesis inhibitors transported in the circulation?
4. Can this novel mechanism of transport be used as a biomarker to detect recurrent cancer years before symptoms or signs?

Lunch available at 11:45 a.m. Presentation begins at noon.

Please RSVP by 1/08/07 to Jessica Wehle, gcrc@email.uky.edu. If you require special physical arrangements to attend this meeting, please call 323-8150.

Sponsors:

• Dr. Jay A. Perman, M.D., Dean, College of Medicine
• C. William Balke, M.D., Sr. Associate Dean for Research, Director of the Center for Clinical and Translational Science
• Emery A. Wilson Lecture Series
• Groves Memorial AOA Student Research Symposium

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January 16, 2007

Human Research Accreditation Training #10 Answers

The Association of the Accreditation for Human Research Protection Programs (AAHRPP) is here January 17 - 19, 2007!!

While on-site, AAHRPP has on occasion requested interviews of individuals not previously identified on the site-review agenda. It is for this reason we have been sending weekly training "blurbs" through our listserv to help everyone get up-to-speed on the University of Kentucky's policies and procedures for human research protections, and to share information which should help with an AAHRPP interview.

If you know of someone that is not receiving these training bulletins who should, please have them contact our office at 257-8295 to sign-up. For future reference, all Human Research Accreditation Training blurbs will be archived on the ORI Listserv Archives web page. You can also visit ORI’s Educational Materials, Regulations and Policy Guidance web page to download the individual case studies and quizzes

Quick Quiz ANSWERS for Human Research Accreditation Training #10:

1. Studies involving a level of risk no greater than that encountered in the daily lives of those in the general population (i.e. healthy subjects) should be considered minimal risk.

True or False?

ANSWER: True. “Minimal risk” means the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [45 CFR 46.102].

2. On “Form Z” (Signature Assurance Sheet) of the IRB application, the Principal Investigator (PI) documents his/her agreement to use only IRB-approved advertisements for recruitment of subjects.

True or False?

ANSWER: True, although not directly. When the PI signs “Form Z” (Signature Assurance Sheet) [WORD], (s)he is agreeing to comply with all IRB policies, decisions, conditions, and requirements. It is an IRB requirement that direct recruitment materials, intended to be seen or heard by prospective subjects to solicit their participation in a research study, receive IRB review and approval (because direct advertising for study subjects is the start of the informed consent and subject selection process). Guidance on recruitment can be found in the “PI Guide to Identification and Recruitment of Human Subjects for Research” [PDF].

3. The informed consent template (“Form C” of the IRB Application which must be used as a guide when developing your informed consent document), includes the ORI Research Compliance Officer's toll-free phone number (1-866-400-9428) for subjects to call in case of an emergency.

True or False?

ANSWER: False. Each IRB approved informed consent document should include the ORI Research Compliance Officer's toll-free phone number (1-866-400-9428) to serve as a subject's primary contact point for submitting concerns or suggestions.

It is IRB policy that a safe confidential, and reliable channel for current, prospective, or past research participants, their representatives or others, is provided that permits them to discuss problems, concerns, and questions; obtain information; or offer input with an informed individual who is unaffiliated with the specific research protocol. For standard operating procedures regarding how the Research Compliance Officer handles concerns or complaints from research subjects, download the UK IRB/ORI Standard Operating Procedure (SOP) “Subject Concerns or Complaints” [PDF]).

4. A waiver of the requirement for obtaining documentation of informed consent means you do not need to tell a subject (s)he is participating in a research study.

True or False?

ANSWER: False. Waiver of the requirement for obtaining documentation of informed consent means the subject does not put in writing/document his/her agreement to participate in the study. The subject is still informed about the study and given the opportunity to decide whether to participate (e.g., mail survey, telephone survey). Waiver of the requirement for obtaining informed consent means the subject is not informed about his/her participation in the research (e.g., deception research, medical record review).

If you found the listserv Human Research Accreditation Trainings helpful and would like to continue to receive similar human subject protection trainings via e-mail, contact Judi Kuhl at Judi.Kuhl@uky.edu. Please also share any other comments about the listserv trainings with Judi Kuhl by e-mail.

“Promising Transitions in Drug Development: A Global Perspective” - Jan. 31

Thomas Foster, Pharm.D., Professor, College of Pharmacy & Medicine, Executive Chairman, Medical IRB

Wednesday, January 31, 2007
PH223, Pharmacy Building

Lunch: 11:30 a.m.
Presentation: Noon to 1:00 p.m.

OBJECTIVES
At the conclusion of this presentation, participants will understand the

1. Challenges of developing new drug products in a global economy.
2. Changing public expectations for pharmacotherapy.
3. Ethical and regulatory dilemmas in drug and biopharmaceutical development.
4. Evolving and synergistic programmatic efforts by the NIH and FDA to change the
   pharmaceutical development blueprint.

PLEASE CALL OR E-MAIL THE UKCRO OFFICE (323-8545 OR UKCRO@UKY.EDU) BY FRIDAY, JANUARY 26, 2007 TO RESERVE YOUR PLACE.

The American Nurses Credentialing Center’s Commission on Accreditation (ANCC) accredits the University of Kentucky, College of Nursing as a provider of continuing education. Provider refers only to its continuing education activities and does not imply ANCC Commission on Accreditation endorsement of any commercial products. The Kentucky Board of Nursing (KBN) approves the college of Nursing as a provider as well. KBN approval of an individual nursing continuing education provider does not constitute endorsement of program content.

This educational activity is approved for a maximum of 1 contact hour for nurses who complete the program. Provider #: 3-0008-7-07-13. Expiration date: July 2007, print a certificate upon successful completion.

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January 8, 2007

Interim Guidance on Salary Limitation for Grants, Cooperative Agreements and Contracts

Notice Number: NOT-OD-07-033

Issued by: National Institutes of Health (NIH)

For the past 18 years Congress has legislatively mandated a limitation on direct salary for individuals under NIH grant, cooperative agreement and contract awards (referred to here as a grant). The mandate appears in the annual appropriation act that provides authority for the NIH to incur obligations for a given Fiscal Year (FY). At this time NIH has not received a FY 2007 appropriation, and is operating under a Continuing Resolution that applies the terms of the FY 2006 Appropriation Act.

The FY 2006 Appropriation Act (P.L. 109-149) restricts the amount of direct salary to Executive Level I of the Federal Executive Pay scale. The Office of Personnel Management has recently released new salary levels for the Executive Pay scale. Effective January 1, 2007, the salary limitation for Executive Level 1 is $186,600. For a historical record of the salary cap, including effective dates see: http://grants.nih.gov/grants/policy/salcap_summary.htm.

Once the Department of Health and Human Services Appropriation for FY 2007 is enacted, NIH will publish the annual Notice of legislative mandates to provide information on any statutory provisions that limit the use of NIH grant funds in FY 2007. Final guidance on the salary cap will be provided at that time.

Inquiries Questions concerning this notice or other policies relating to grants or contracts should be directed to the grants management or contract management office in the appropriate NIH Institute or Center. For more information on grants policy, please visit: http://grants.nih.gov/grants/policy/policy.htm.

For more information on contracts policy, please visit: http://ocm.od.nih.gov/contracts/contract.htm.

Human Research Accreditation Training #10

Only seven working days until the University of Kentucky's on-site review by the Association of the Accreditation for Human Research Protection Programs (AAHRPP) January 17 - 19, 2007!!

While on-site, AAHRPP has on occasion requested unscheduled interviews. It is for this reason we are sending out weekly training "blurbs" through our listserv to help everyone get up-to-speed on the University of Kentucky's policies and procedures for human research protections, and to share information which should help you with an AAHRPP interview. If you know of someone that is not receiving these training bulletins who should, please have them contact our office at 257-8295 to sign-up. For future reference, all Human Research Accreditation Training blurbs will be archived on the ORI Listserv Archives web page. You can also visit ORI’s Educational Materials, Regulations and Policy Guidance web page to download the individual case studies.

Quick Quiz ANSWERS for Human Research Accreditation Training #9:

1. Your IRB-approved protocol describes provisions for maintaining confidentiality of the study records (e.g., secure and locked location that is available to only authorized research staff as needed), but you have finished the study and closed it with a Final Review. How long do you need to maintain the research records now?

ANSWER: IRB policy requires investigators to maintain their research records (includes data collection form(s) including source documents and case report forms) for six years after completion of the study. For research which falls under authority of other agencies or statutes with longer research record retention requirements, the longer retention period applies. For more details on Investigator recordkeeping responsibilities, see the Investigator Records and Documentation section in "A Principal Investigator’s Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research". [PDF]

2. In order to receive federal funds for research, the University of Kentucky submits an agreement to follow all federal regulations; review all human research; monitor on-going studies; and report as appropriate, to the applicable agencies. To what federal agency does the University of Kentucky submit this agreement, and what is the name of the “agreement”?

ANSWERS: To what federal agency does the University of Kentucky submit this agreement?: Office for Human Research Protections (OHRP).

What is the name of the “agreement”?: Federalwide Assurance (FWA).

3a. What are the categories of vulnerable populations for which the Department of Health and Human Services (DHHS) regulations provide additional protections?

ANSWER: Pregnant Women, Human Fetuses and Neonates (Subpart B); prisoners (Subpart C); and children (Subpart D).

b. For what vulnerable populations does the University of Kentucky have a policy and guidance to provide additional protections which are not provided in the HHS regulations?

ANSWER: Decisionally impaired/challenged, students as subjects.

4. You have some research staff to assist you on a project you are preparing to submit to the IRB. Some of the research staff will be responsible for subject enrollment and data collection, and other research staff will conduct data analysis. Which of your staff needs to complete the University of Kentucky mandatory human research protections training?

ANSWER: Any individual who will interact and/or intervene with human subjects or who handles personally identifiable data of a human subject is considered by the IRB as study personnel and should be listed on a study personnel list approved by the IRB. All study personnel are required to complete one of two options for human research protections training recognized by the University of Kentucky. Re-certification for human research protections training is required every three years. Study personnel who have not completed appropriate human research protections training will not be approved by the IRB to implement research activities.

Human Research Accreditation Training #10

Quick Quiz

1. Studies involving a level of risk no greater than that encountered in the daily lives of those in the general population (i.e. healthy subjects) should be considered minimal risk.
True or False?

(Hint: Download the guidance document “Assessing the Research Risk” [PDF] and/or review HHS regulation 45 CFR 46.102.)

2. On “Form Z” (Signature Assurance Sheet) of the IRB application, the Principal Investigator (PI) documents his/her agreement to use only IRB-approved advertisements for recruitment of subjects.

True or False?

(Hint: Download “Form Z” [WORD] from the IRB application, and/or the “PI Guide to Identification and Recruitment of Human Subjects for Research” [PDF])

3. The informed consent template (which must be used as a guide when developing your informed consent document), includes the ORI Research Compliance Officer's toll-free phone number (1-866-400-9428) for subjects to call in case of an emergency.

True or False?

(Hint: Visit ORI’s Concerns or Suggestions web page and/or the IRB Application “Form B” (Research Description) section on Subject Complaints.

4. A waiver of the requirement for obtaining documentation of informed consent means you do not need to tell a subject (s)he is participating in a research study.

True or False?

Hint: Download the UK IRB/ORI Standard Operating Procedure (SOP) “Informed Consent” [PDF].)

ANSWERS will be provided in Human Research Accreditation Training #11 message coming soon!

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January 5, 2007

"Sponsored Projects Essentials" - Jan. 23

National Council of University Research Administrators Satellite Teleconference
Sponsored by the Office of Sponsored Projects Administration

January 23, 2007
11:30 a.m. - 4:00 p.m.
Student Center Theater

In an ever-changing environment, the core building blocks of sponsored project administration are essential. Whether you are new to the profession or a seasoned veteran, this workshop is intended to help you look at basic principles from a different perspective. Every time you approve or sign on the dotted line, you should be thinking about reasonable, allocable, allowable and consistent. And -- if you have forgotten some of the basics and have fooled yourself into believing everything will be all right…it won’t.

This veteran workshop faculty will address due diligence when making decisions and, what the process should be. They will discuss the underlying themes that every research administrator (pre-award, post-award, departmental, costing, audit, and compliance) should be thinking about with every transaction they process.

Areas to be covered include:

• Proposal Phase – Budget Development
• Revised Budget Phase
• Award Acceptance Review of Final Budget
• Sub-recipient Monitoring
• Purchase Orders
• Accounts Payment Vouchers
• Cost Transfers
• Financial Reporting
• Time and Effort
• Project Monitoring

This interactive workshop will provide a number of case studies that will cover the gamut of the good, the bad, and the ugly. You’ll hear about the best ways of ensuring compliance and…how to stay out of trouble.

Moderator: Jerry G. Fife, Assistant Vice Chancellor for Research Finance, Vanderbilt University

Faculty:

• Denise J. Clark, Director, Research Administration and Finance, Rensselaer Polytechnic Institute
• F. Edward Herran, Director of Sponsored Projects, Memorial Sloan-Kettering Cancer Center
• Laura L. Wade, Associate Director, Research Center Administration, Texas Center for Superconductivity
• Pam Whitlock, Director, Office of Sponsored Programs, University of North Carolina at Wilmington

We will schedule 30 minutes following the telecast for discussion and questions.
Lunch will be provided for participants who register prior to the conference. To register, contact Heather Crowley (257-9424 or heather.crowley@uky.edu).

Human Research Accreditation

Only 10 working days until UK's on-site review by the Association of the Accreditation for Human Research Protection Programs (AAHRPP) January 17 - 19, 2007!!

While on-site, AAHRPP has on occasion requested unscheduled interviews. It is for this reason we are sending out weekly training "blurbs" through our listserv to help everyone get up-to-speed on the University of Kentucky's policies and procedures for human research protections, and to share information which should help you with an AAHRPP interview. If you know of someone that is not receiving these training bulletins who should, please have them contact our office at 257-8295 to sign-up. For future reference, all Human Research Accreditation Training blurbs will be archived on the ORI Listserv Archives web page. You can also visit ORI’s Educational Materials, Regulations and Policy Guidance web page to download the individual case studies.

Human Research Accreditation Listserv Training Overview:

Over the last several weeks through listserv messages, ORI has provided AAHRPP interview tips and case studies covering a range of topics. The topics covered to-date, and the links to the corresponding listserv message are as follows:

Interview Tips:

• Know your resources [PDF]
• Know your responsibilities [PDF]
• Know your study [PDF]
• Know the policies [PDF]
• When asked a question, answer only the question. Do not meander onto other topics. [PDF]
• Do not use your time in the interview to complain about the UK/IRB/ORI system. [PDF]
• If you do not immediately know an answer, or how to respond, know your options. [PDF]

Case Studies:

• #1 Quality Improvement versus Research [PDF]
• #2 Changing study procedures [PDF]
• #3 Obtaining Informed Consent vs. Documenting Informed Consent [PDF]
• #4 Privacy vs. Confidentiality [PDF]
• #5 IRB Approval Lapses [PDF]
• #6 Human Participation in Research: Blood in the Lab [PDF]
• #7 Conflict of Interest [PDF]
• #8 Vulnerable Populations [PDF]

Case Study #7 and ANSWER: Conflict of Interest

Professor Grain is conducting research on human behavior related to consumption of brand-name health foods in schools. Professor Grain sits on the board for School Vendor Marketing Inc. and owns $12,000 in stock with them. The company has recently begun investigating new methods for promoting health foods in schools, with the intent of competing with “junk food” brands already in the market. The results of Professor Grain's study, if positive, could have a significant impact on product development within School Vendor Marketing Inc.

Does Professor Grain’s situation exceed the University of Kentucky’s threshold for declaring financial conflict of interest?

Yes.

The University of Kentucky has established policies, principles, and procedures to ensure that the financial interests of University of Kentucky employees do not compromise the objectivity with which research is designed, conducted, and reported, and to comply with state and federal regulations that are designed to promote objectivity in research activities. To accomplish this, UK’s Conflict of Interest Policy requires all UK investigators and key personnel (any faculty, staff, and/or students who may influence the protocol design, conduct, or reporting of activities) to disclose to OSPA when proposing a research project, relevant potential financial conflicts of interest of the investigator and the investigator’s family members. The institution needs to be informed if a potential significant financial interests exist, so the conflict can be reviewed and managed or eliminated.

Significant financial interests are anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options, or other ownership interests), and intellectual property rights (e.g., patents, copyrights, and royalties from such rights), excluding the following:

1. Salary, royalties, or other remuneration from the University;
2. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
3. Income from service on advisory committees or review panels for public or nonprofit entities;
4. Income (e.g., salary, fees, or other continuing payments) in an amount of $10,000 or less per annum from any one business enterprise or entity when aggregated for the investigator and members of the investigator’s family; and
5. Financial interests in any one business enterprise or entity if the value of those interests does not exceed $10,000.00 in value as determined through public prices or other reasonable measures of fair market value, and does not represent more
   than a 5% ownership interest when aggregated for the investigator and members of the investigator’s family.

Case Study #8 and ANSWER: Vulnerable Populations

Professor Rhythm teaches music at a Community College for gifted individuals. He has been encouraged by his department chair to develop a study which would involve recruitment of the college attendees. Professor Rhythm has several of his own students he would like to include in the study because they are not even college-age yet, but have incredibly advanced musical talent.

Does Professor Rhythm need to describe any special provisions in his proposal for this subject population? If yes, what issues should he address?

Yes, Professor Rhythm needs to describe protections for students as research subjects, and because he may recruit students not of college-age yet (presumably under the age of 18), he should also describe provisions for protection of children (in Kentucky, a child refers to anyone less than 18 years of age unless the individual(s) is/are legally emancipated).

The Institutional Review Board (IRB) gives special consideration to protecting the welfare of vulnerable subjects such as children, prisoners, fetuses/neonates, pregnant women, and decisionally challenged/impaired persons. The IRB also recognizes that additional populations such as students may qualify as vulnerable populations and need safeguards in place for their protection during study participation.

For research involving students:

An underlying principle of the regulations governing use of human subjects in research is that the subject’s participation is voluntary and based upon full and accurate information. The student-teacher relationship raises the issue of volunteer participation. Care should be taken to eliminate or reduce the risk that undue influence of faculty or coercion affects student participation in research.

Guidelines to assist faculty who engage in research projects in which students will be asked to be research subjects can be found in the document “Guidance for Enrolling University Students as Subjects” [PDF].

If Professor Rhythm includes recruitment of the children in his research:

Parental permission must be obtained if the research involves children under the age of 18 unless the individuals are legally emancipated or the IRB waives the requirement. A written form must be reviewed by the IRB and used to document both parents’ permission unless the requirement is waived by the IRB. Documentation of assent is required for subjects aged 12 to 17, unless the requirement is waived by the IRB. In most cases, a written assent form should be used to document assent. A copy of the assent form must be submitted to the IRB for review. Professor Rhythm would also need to include IRB Application “Form W” in his IRB submission.

Although this scenario does not specify the nature of the research, if it were to involve accessing students’ educational records, the document Family Educational Rights and Privacy Act (FERPA) Guidance [PDF] would be of assistance to Dr. Rhythm.

Human Research Accreditation Training #9: Quick Quiz

1. Your IRB-approved protocol describes provisions for maintaining confidentiality of the study records (e.g., secure and locked location that is available to only authorized research staff as needed), but you have finished the study and closed it with a Final Review. How long do you need to maintain the research records now?

(Hint: Download the document “PI Guide to Responsibilities, Qualifications, Records, and Documentation of Human Subjects Research” [PDF] under the topic Investigator Responsibilities on ORI’s Educational Materials, Regulations and Policy Guidance web page.)

2. In order to receive federal funds for research, the University of Kentucky submits an agreement to follow all federal regulations; review all human research; monitor on-going studies; and report as appropriate, to the applicable agencies. To what federal agency does the University of Kentucky submit this agreement, and what is the name of the “agreement”?

(Hint: Visit ORI’s Educational Materials, Regulations and Policy Guidance web page and click on the topic Assurance Information.)

3a. What are the categories of vulnerable populations for which the Department of Health and Human Services (DHHS) regulations provide additional protections?

b. For what vulnerable populations does the University of Kentucky have a policy and
guidance to provide additional protections which are not provided in the HHS regulations?

(Hint: Download the UK IRB/ORI Standard Operating Procedure (SOP) for Protection of
Vulnerable Subjects [PDF] from ORI’s Standard Operating Procedures web page, and/or review DHHS regulation 45 CFR 46.)

4. You have some research staff to assist you on a project you are preparing to submit to the IRB. Some of the research staff will be responsible for subject enrollment and data collection, and other research staff will conduct data analysis. Which of your staff needs to complete the University of Kentucky mandatory human research protections training?

(Hint: Download the document “What Constitutes Study Personnel on a Protocol Involving Human Subjects?” [PDF]. Also, see the human research Mandatory Education [PDF] document.)

ANSWERS will be provided in Human Research Accreditation Training #10 message coming
soon!