text:
Office of Research Integrity
HRPP 1.1 Description Principles and Authority for MUSC HRPP
|Policy Name: Description, Principles and Authority for MUSC HRPP
|Effective Date: 01/27/2012
|Page 1 of 17
|Section: HRPP 1.1
|Replaced Policy: Effective 10/01/2010
The mission of the Medical University South Carolina (MUSC) is to improve health and maximize quality of life through education, research and patient care. Human subjects research is an important element in meeting this mission. Our key values include integrity, trust, respect, social responsibility, fiscal responsibility, cultural competence, adaptability and sustainability. The University has established policies, procedures, and programs for the review of human subject research to promote the ethical conduct of research, safeguard the integrity of and protect human subjects, and maintain strict compliance with regulatory standards. MUSC investigators are granted the privilege of using human subjects under assurance to the government that research conducted at MUSC complies with all federal and local regulations protecting individuals involved in human subjects research.
MUSC operations abide by the Federal Policy for the Protection of Human Subjects (the Common Rule) and the principles outlined in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Declaration of Helsinki, the Nuremberg Code, and the VA Handbook 1200.05. The ethical conduct of research on human subjects is an essential component of our research mission, and the rights and welfare of all persons participating in research are vigorously protected.
MUSC has a long-standing human research protection program and human subjects research program that includes our Clinical and Translational Research Center (CTRC) first funded by the National Institutes of Health as a General Clinical Research Center in 1977. The CTRC has long been a focal point for stimulating, facilitating and conducting multidisciplinary clinical and translational research. This program provided the foundation for formation of the South Carolina Clinical and Translational Research Institute (SCTR) and the successful application for a Clinical and Translational Research Award from the National Institutes of Health in 2009.
All human research studies operate under the auspices of a campus-wide Human Research Protection Program (HRPP) with oversight and management from the Office of the President of MUSC through the Associate Provost and the Vice President for Academic Affairs/Provost as the responsible organizational officials for its operation. Individual elements of HRPP operation include the following:
a) education and training of all personnel involved in human subject research (researchers and research staff, IRB members and IRB staff);
b) submission and review of human subject research protocols by independent review committees (Institutional Review Boards) with required expertise and community representatives;
c) human subject outreach, communication and education;
d) financial management and review;
e) risk management;
f) research integrity;
g) conflict of interest disclosure and management;
h) clinical services and investigational drug pharmacy;
i) community outreach and engagement;
j) monitoring of all approved human subject research; and
k) quality improvement programs.
We have a number of programs in place to educate and reach out to the community on human subjects research and mechanisms are in place to allow human subjects to voice complaints, issues, concerns and suggestions providing ongoing connectivity and mechanisms for quality improvement (see HRPP Program Guide Section 7.7 - Subject Complaints, Issues, Concerns and Suggestions Policy and Procedures and Section 10.3 - Quality Improvement Initiatives, MUSC Community Engaged Research).
These individual elements blend to form a system that is robust, interactive and constantly improving with the ability to adapt and address any issue in a prompt and transparent process.
MUSC is committed to providing the best possible program for protection of human research subjects under the auspices of our institutional wide HRPP to ensure the allocation of necessary resources, continued oversight and compliance, and to nurture these programs for the benefit of human subject participants and society.
MUSC has 1940 active research projects involving human subjects in the biomedical, behavioral sciences, social sciences and medical economics as well as Phase 1 through Phase IV medication trials. These studies are conducted by approximately 500 active Principal Investigators (MD, PhD, PharmD, DDS and/or RN) and 1000 study coordinators and research staff. Surgical studies involving innovative therapies, device trials, and organ transplantation are also conducted at MUSC. The MUSC Tissue Bank and Biorepository serves as a repository for human samples for various research projects.
Funding Source
Review Type
Not Human Research
Foundation Philanthropy
No Sponsor
Total Initial Review Protocols
In FY11, total extramural research funding to MUSC was $243M with $118M from the National Institutes of Health. Of the $243M, ~60% is federal funding and ~13% is corporate funding. ~31% of federal funding and ~77% of corporate funding involves human research protocols submitted to the IRB. The majority of human research studies operate under the oversight of the Department of Health and Human Services and the Food and Drug Administration.
The categories of study participants include adults with normal decision-making capacity, adults with impaired decision making capacity, pregnant subjects, children, prisoners, employees and students. No categories of human subjects are specifically excluded. We have a limited number of transnational studies. Special oversight mechanisms are in place for the review and monitoring of studies with vulnerable populations (Six components of the HRPP Program Guide Section 8 address vulnerable subject populations).
The MUSC human subjects research program operates under a Federal Wide Assurance (FWA #00001888) from the Office for Human Research Protections (OHRP).
MUSC becomes engaged in human research whenever (a) the Institution's employees or agents intervene or interact with human subjects for purposes of federally-conducted or -supported research; (b) the Institution's employees or agents obtain individually identifiable private information about human subjects for purposes of federally-conducted or -supported research; or (c) the Institution receives a direct federal award to conduct human subjects research, even where all activities involving human subjects are carried out by a subcontractor or collaborator.
MUSC is the University Affiliate IRB for the Ralph H. Johnson Veterans Affairs Medical Center (VAMC). The VA operates under FWA #00001591. The specific guidelines and governance articulating the operational agreement are described in the Memorandum of Understanding between MUSC and Ralph H. Johnson VAMC concerning the Utilization of MUSC's Institutional Review Boards.
All research involving human subjects at MUSC must comply with all Federal Regulations and requirements that address the protection of human subjects, including Regulations and requirements that address the protection of human subjects, including 21 Code of Federal Regulations (CFR) Parts 45, 50, 56 and all related policy and procedural documents (45 CFR) in accordance with the regulations and expectations of the Department of Health and Humans Services and other organizations such as the Food and Drug Administration, the Veterans Administration (38 CFR, VA Handbook 1200.05) and the State of South Carolina as applicable. These regulations and requirements, along with approval of our Institutional Review Board, must be met before any research involving human subjects is initiated and adherence must be sustained throughout the conduct of research. The regulations specific for the Veterans Administration (38 CFR 16 and VHA Handbook 1200.05) guide all studies conducted at the Ralph H. Johnson VA Medical Center in Charleston for which MUSC serves as the University Affiliate for the IRB.
All individuals involved with human subjects research at MUSC are required to complete training prior to initiating any such research. MUSC is registered for training through the Miami Collaborative Institutional Training Initiative or CITI (http://www.musc.edu/citi/). All individuals involved in human research must complete the initial 17 basic modules focused on biomedical or social/behavioral research when commencing such research. All individuals involved in human research must also complete the MIAMI CITI COURSE REFRESHER MODULE 101 every three years providing a mechanism of continuing education. Additional training requirements are in place for VA investigators through the federal regulations described in the VA Handbook 1200.05.
IRB approval is required before commencing any human subjects research protocol and several mechanisms (see below) are in place to assure that this policy is followed.
Education and outreach
HRPP Program Guide Section 5.1 Principal Investigator Responsibilities - The section entitled "Supervision of Staff and Protection of Subjects" states that "No research will be initiated without prospective IRB review and approval".
* Human Subject Regulations Decision Charts are provided to assist investigators in determining whether an activity is research that must be reviewed and approved by the IRB.
* The IRB management and staff routinely present to research groups and research support teams on campus providing information on IRB operations and the requirement for IRB approval for human subject research.
* All investigators and staff involved in human subject research must complete specific training modules before commencing research.
* Core Clinical Research Training - A two week course for investigative teams that covers human research policies and procedures including the requirement for IRB approval before commencing any human subjects research protocol.
* Mentoring - Students and trainees involved in human subject research are assigned mentors familiar with IRB operations.
* Faculty Research Orientation - Provides information to new faculty on policies and procedures for human subjects research.
* South Carolina Clinical and Translational Research Center - Staff with experience in human subject research policies and procedures provide support and guidance for research teams.
* There are regular lunch and learn sessions focused on various aspects of human subjects research.
* The Principal Investigator, the Department Chair and the Mentor if applicable must all electronically sign the human research protocol submitted to the IRB before it is reviewed.
* The Clinical and Translational Research Center requires IRB approval on all human subjects research protocols prior to beginning research.
* The signature of the Associate Provost for Research is required for non-funded human subject research studies.
* For industry-sponsored human subjects research, the Office of Research and Sponsored Programs and the Office of Research Integrity review the IRB-approved informed consent and the contract to validate consistency prior to release of funds for expenditure.
* IRB approval is required for expenditure of research funds awarded in support of human subjects research.
* Investigative Drug Services requires IRB approval prior to releasing the study drug.
* Human subjects research involving cancer requires approval by Hollings Cancer Center Protocol Review Committee prior to release of IRB approval.
* Human subjects research involving the MUSC Simulation Center requires ancillary review by the center director.
* For human subjects research involving non-routine radiation, approval by the Office of Radiation Safety approval is required prior to release of IRB approval.
* For human subjects research involving biohazardous material, approval by the Institutional Biosafety Committee is required prior to release of IRB approval.
* The Research and Development Committee of the Ralph H. Johnson VA Medical Center, which reviews all human subjects research at the VA, requires IRB approval prior to commencing research.
* The University provides whistle-blowing protection to anyone who reports an activity that violates any regulations or policies related to human subjects research.
The HRPP program involves all aspects of our operations at MUSC including research teams and their staff, the Office of Research Integrity, Institutional Review Boards, Office of Sponsored Research, Office of Grants and Contracts, Clinical Services, University General Counsel, the Office of Compliance and many other aspects of our organization. The overall organizational structure for these offices is indicated in the organizational charts provided as MUSC Organizational Charts (HRPP Program Guide Section 1.2).
President Ray Greenberg is recorded as the Institutional Official (IO) on the FWA and he has appointed the Associate Provost (Stephen M. Lanier, Ph.D.) and the Vice President for Academic Affairs/Provost (Mark S. Sothmann, Ph.D.) as the responsible organizational officials for the operation of the MUSC HRPP. Drs. Lanier and Sothmann have signatory authority for the IO. These three individuals form the leadership core for the University and have offices adjacent to each other facilitating communication. The active involvement of senior administration ensures that adequate resources are provided to operate an effective HRPP. The description of the Individual elements of the HRPP and their interaction is described in the following text.
Associate Provost for Research and Vice President of Academic Affairs and Provost - Serve as the Responsible Institutional Officials for administration and oversight of the HRPP. The Associate Provost for Research serves as the coordinating individual for the HRPP and meets regularly with Directors of each component of the HRPP. In the office of the Associate Provost for Research, Loretta Lynch-Reichert, M.S. and Lynn M. Veatch, Ph.D. facilitate connectivity among the multiple components of the HRPP program. Dr. Lynn M. Veatch serves as the point person for the AAHRPP accreditation program.
Office of Research Integrity - Responsible for review of all human research protocols for the Medical University of South Carolina and the Ralph H. Johnson VA Medical Center. This office serves as the administrative unit for the Institutional Review Board, the Institutional Biosafety Committee, the Institutional Animal Care and Use Committee and the Research Integrity Officer for scientific misconduct. The Office of Research Integrity developed a course "Core Clinical Research Training" that is now offered through our Clinical and Translational Research Center for all research teams and coordinators involved in human research. Kathryn M. Magruder, Ph.D. serves as the Director of this office and reports to the Associate Provost for Research. Dr. Magruder meets weekly with the Associate Provost for Research.
Office of Research and Sponsored Programs - Responsible and institutional signatory authority for submission of sponsored research proposals. R. Darren McCants, MPA serves as the Director of this office and reports to the Associate Provost for Research. Mr. McCants meets weekly with the Associate Provost for Research.
Office of Grants and Contracting - Responsible for monitoring and reporting financial information related to the University's externally sponsored grants and contracts. Velma G. Stamp, BS, serves as the Director of this office and reports to the Vice President of Finance and Administration. Velma Stamp meets monthly with the Associate Provost for Research.
University Compliance Office - Provides a proactive program to ensure full compliance with all applicable policies, procedures, laws and regulations while promoting ethical behavior in accordance with MUSC's core values as expressed in the MUSC Mission Statement and Code of Conduct. Cynthia Teeter, MPA, CHC serves as the Director of this office and reports to the Vice President of Academic Affairs and Provost. Ms. Teeter meets regularly with the Associate Provost for Research.
Investigative Drug Services - Supports clinical investigations conducted by scientists affiliated with MUSC by 1) randomization and blinding of study drug, 2) controlling drug inventory including performance of routine audits, 3) preparation and dispensing of oral and parenteral admixture study drugs, 4) in-service training for patients and staff. Kimberly Porter, R.PH is the lead Pharmacist.
South Carolina Clinical and Translational Research Institute (SCTR) - Facilitates cross-disciplinary research in translational research including support for development and management of human subjects research. SCTR, which serves as the home of our Clinical and Translational Sciences Award from NIH, includes the Clinical and Translational Research Center, a specialized, JCAHO-accredited patient unit facilitating investigator-initiated, peer-reviewed, clinical research projects within the institution. Kathleen Brady, MD, Ph.D. serves as the Director of SCTR and meets regularly with the Associate Provost for Research.
Office of Risk Management - Responsible for the prevention of harm, protection of assets and the financial resources of MUSC by affirming and assuring compliance with applicable statutory and regulatory codes. Wayne Brannan, CPHRM, CHSP, CBCP, ARM serves as the Director of this office and reports to the Vice President for Finance and Administration. Mr. Brannan meets regularly with the Associate Provost for Research.
Office of the General Council - Joseph C. Good, Esq. serves as General Counsel and reports to the President. Mr. Good also serves on the Research Conflict of Interest Review Committee and meets regularly with the Associate Provost for Research.
Community Outreach - class="A6"Establishing research partnerships between medical and communal societies that advance the health of its citizens is fundamental for the University. In its promotion of community-engaged research, MUSC sustains programs and activities that facilitate cross-disciplinary research that can provide answers to complex health concerns and disparities by coordinating expertise and resources throughout the community.
The Medical University of South Carolina has a long history of community partnerships that promote health and reduce the risk of illness and disease class="A6". In 1997, the Medical University of South Carolina launched a significant new effort referred to as the Healthy South Carolina Initiative with the goal of improving the health and well being of the community. Under this broad banner, 28 separate projects were funded to address particular health concerns with an emphasis on vulnerable populations. Our community based partnerships are currently led through the Center for Community Health Partnerships (CCHP) and S.C. Clinical and Translational (SCTR) Institute Community Engagement Program.
The combined efforts and activities of these programs, projects and educational avenues have strengthened the capacity and resources for existing and potential academic-community partnerships, stimulating new research discoveries through community based participatory research, and facilitating the translation and adoption of new research findings into community settings.
Conflict of Interest - The organization has in place a series of policies and oversight mechanisms regarding code of conduct, ethical behavior and conflict of interest. These policies and oversight mechanisms provide the process for annual disclosure, review and management of faculty, staff and institutional conflicts of interest related to research, professional relationships and clinical operations. Current operations provide additional checkpoints for disclosure of real or potential conflicts of interest to the appropriate review committee. Such mechanisms include the checklist that accompanies any submission of a proposal for extramural funding and any research protocol submitted to the IRB for review. As a state institution, the South Carolina State Ethics Law also provides policy and guidelines for many aspects of our operation. A Research Conflict of Interest Committee reviews all conflict of interest disclosures related to research and is under the direction of Dr. Andrew K. Gelasco, Ph.D. Dr. Gelasco meets regularly with the Associate Provost for Research.
Research Subject Ethics and Advocacy - A number of resources are available for ethical issues related to patient advocacy are accessed through the Institute for Human Values at MUSC under the direction of Dr. Robert Sade (MUSC Institute on Human Values in Health Care), the MUSC Ethics Committee chaired by Dr. Walter Limehouse and the Research Subject Advocate program (HRPP Program Guide Section 7.6 - Research Subject Advocacy Policy and Procedures). As Director of the Office of Research Integrity and as a participant in the South Carolina Clinical and Translational Research Institute (SCTR), Dr. Kathryn M. Magruder interacts with both initiatives and serves on the MUSC Ethics Committee. These areas of subject advocacy are also covered in the "Core Clinical Research Training" offered through SCTR.
Ralph H. Johnson VAMC - MUSC has a longstanding, close working partnership with the Ralph H. Johnson VAMC, which is adjacent to campus, with many of our physicians serving as VA staff. MUSC and the VAMC also share a ~100,000 sq ft research building and an increasing partnership on healthcare delivery. The VAMC research program is led by the Director Ms. Carolyn L. Adams (Institutional Official for the VAMC FWA) and the Associate Chief of Staff/Research and Development M. Rita I. Young, Ph.D.
The former Vice President for Academic Affairs/Provost at MUSC is the former Associate Chief of Staff/Research and Development at the VAMC. The Associate Provost for Research at MUSC served on the board of the VAMC non-profit entity Charleston Research Institute for several years and regularly interacts with Dr. Young for program development. The current director of the Office of Research Integrity is both an MUSC faculty member and a research investigator at the Ralph H. Johnson Veterans Affairs Medical Center (VAMC). MUSC is the University Affiliate IRB for the Ralph H. Johnson VAMC and the two institutions run a joint Animal Laboratory Program. Additional connectivity within the context of the HRPP is also present through cross-training and joint funding of staff in compliance and review at the two institutions.
The Institutional Review Boards (IRBs) provide the primary review of all human research protocols and are organized under the Office of Research Integrity directed by Kathryn M. Magruder, Ph.D. who reports to the Associate Provost for Research. The Office of Research Integrity includes the Institutional Animal Care and Use Committee, the Institutional Biosafety Committee and the Research Integrity Committee. Additional internal review mechanisms are provided through Department Chairs, various mentoring groups, the Hollings Cancer Center Clinical Trials Office and our South Carolina Clinical and Translational Research Institute.
Research involving Human Subjects must be reviewed by the MUSC IRB where one or more of the following apply.
i. The research is sponsored by this institution.
ii. The research is conducted by or under the direction of an individual in connection with his/her institutional responsibilities.
iii. The research is conducted by or under the direction of an individual who is receiving remuneration from the institution.
iv. The research is conducted by or under the direction of an individual using any property or facility of this institution.
v. The research involves the use of this institution's non-public information to identify or contact human research subjects for prospective studies.
vi. The institution's name is used in any way in connection with the study including procurement of sponsorship, announcement, advertisement or other mechanisms for recruitment of subjects.
The IRB(s) review, and have the authority to approve, require modification in, or disapprove all research activities, including proposed changes in previously approved human subject research. The decisions of the IRB in all matters relating to the protection of humans involved in research shall not be influenced by any outside entity, including institutional officials. Research that has been reviewed and approved by the IRB may be subject to further review and disapproved by officials of the institution. Institutional officials may not, however, approve research if it has been disapproved by the IRB.
In reviewing research protocols involving transnational study sites, the MUSC IRB must obtain sufficient knowledge of the local research context and comply with all applicable required standards. All policies and procedures that are applied to research conducted domestically are applied to research conducted in other countries, as appropriate.
There are currently three IRBs, each under the direction of a Chair and Vice-Chair, that focus on different areas of research and consist of faculty with appropriate expertise, community representatives and staff support as detailed in our governance document (see HRPP Program Guide Section 2). The IRB serves to safeguard the rights and welfare of human subjects who participate in research at MUSC including special protection for vulnerable participants. Procedures are in place to review the quality of human subjects research protocols (see HRPP Program Guide Section 1.4 - Scientific/Scholarly Review of Protocols Policy and Procedures), and these procedures include the review by the Department Chair or their designee, external peer review and various internal review mechanisms offered through individual units such as the Hollings Cancer Center and SCTR.
The three Institutional Review Boards focus on different areas of research within their scope of work. All three IRBs may review studies involving investigational drugs and devices, questionnaires and surveys or behavioral modification. Each of the IRBs may have expedited studies that include retrospective chart reviews, blood draws, prospective collection of biological samples by non-invasive procedures, and research involving materials collected for nonresearch purposes.
IRB-I - IRB-I currently has approximately 676 active protocols involving human subjects (579 Full Board and Expedited, 97 Exempt). IRB-1 reviews protocols from Cell Biology and Anatomy, Cell and Molecular Pharmacology & Experimental Therapeutics, Clinical Services, College of Health Professions, College of Nursing, College of Pharmacy, Harper Student Life Center, Dermatology, Medical Lab Sciences, Otolaryngology, Pathology and Laboratory Medicine, Pediatrics, Pharmaceutical Sciences, Pharmacy Practice, Physical Therapy, Psychiatry and Behavioral Sciences, Radiology and Urology.
Psychiatry protocols may involve cognitively impaired subjects, subjects with addictions to alcohol, illegal drugs and/or nicotine, schizophrenic, and depressed subjects. The second largest volume of work for IRB-I involves pediatric studies related to cancer, cardiology or neonatology. IRB-I also has active protocols involving the prisoner population. Such protocols receive review by the prisoner representative on the IRB membership roster and follow the certification procedures outlined in the federal regulations.
IRB-II - IRB-II has approximately 666 active protocols (598 - Full Board and Expedited, 68 - Exempt) from Anesthesiology, Biochemistry and Molecular Biology, the Center For Health Care Research, College of Graduate Studies, Experimental Oncology, Family Medicine, General Dentistry, Medicine, Microbiology and Immunology, Molecular and Structural Biology, Neuroscience, Obstetrics and Gynecology, Ophthalmology, Oral & Maxillofacial Surgery, Orthopedic Surgery, Pediatric Dentistry/Orthodontics, Physical Medicine & Rehabilitation, Prosthodontics, Radiation Oncology, Stomatology, and Surgery.
Human subject research protocols include investigational drug cancer trials, digestive disease studies and transplant surgery. Protocols may include vulnerable populations (i.e. pregnant subjects, cognitively impaired from stroke or dementia).
IRB-III - IRB III has approximately 444 active protocols (441 - Full Board and Expedited, 3 - Exempt) and reviews all corporate sponsored studies. Protocols may include vulnerable populations (i.e. children, pregnant women, cognitively impaired).
The MUSC FWA includes the use of the National Cancer Institute Central IRB #1 (IRB00000781) for adult protocols, the National Cancer Institute Central IRB #2 (IRB00004296) for pediatric protocols and Western Institutional Review Board (IRB00000533) for selected multi-site clinical trials as needed or defined for specific studies. We currently have 42 protocols approved by the National Cancer Institute Central IRB #2. We also began using the NCI Central IRB for adult Phase III clinical trials in the fall of 2008. Ralph H. Johnson VA studies may use the central VA IRB.
The seven components of HRPP Program Guide section 2 detail operational elements crucial for an effective review and management of human subjects research. Records and documentation of all activities indicate the implementation of the policies and procedures and ensure effective operation of review and management process. HRPP Program Guide Section 1.3 - Definitions of Terms, defines all terminology used throughout the MUSC HRPP, ensuring consistency of application throughout the various components of the plan.
The Principal Investigator (PI) is the ultimate protector of the human subjects who participate in his/her research and is expected to abide by the highest ethical standards (see HRPP Program Guide Section 5.1 - Principal Investigator Responsibilities - Supervision of Staff and Protection of Subjects). The Principal Investigator is responsible for developing a protocol that incorporates the principals of the Belmont Report. He or she is expected to conduct the research in accordance with the approved protocol and to oversee all aspects of the research, including supervision of the research support staff, students, post-doctoral fellows, residents, and other staff involved in the project. The Principal Investigator is responsible for ensuring that all subjects give true informed consent and for establishing and maintaining an open line of communication with his or her research subjects. The Principal Investigator is expected to comply with the institutional policies and administrative requirements for conducting research and is accountable for compliance with institutional policies and administrative requirements.
Appropriate mechanisms are in place for the IRBs and any individual to inform appropriate institutional officials of any unanticipated problems involving risks to subjects or others and/or serious or continuing noncompliance with federal regulations or IRB requirements. Mechanisms are in place to act upon such information and to suspend or terminate research studies upon review of the problems or noncompliance. Findings and actions taken by all IRBs at each of their meetings are on file and made available at the IRB office for examination by University Compliance and any delegated representatives of the Institutional and Organizational Officials.
The Institution provides legal protection for members of the IRB and to Principal Investigators granted approval to conduct research, provided they have met their obligations in good faith. The Institution provides whistle-blowing protection to anyone who reports an activity that violates any regulations or policies on the use of human subjects. The University Compliance Officer and/or designated representative conducts a regular review of the HRPP and this may be conducted together with the MUSC Office of Internal Auditing with results reported to the senior leadership and the MUSC Board of Trustees. The Institution is responsible for investigating incidents or allegations of misconduct pertaining to the use of human subjects in research.
Outreach, education and post review monitoring form the foundation of initiatives to maximize compliance with policies and procedures. These activities include the items listed above related to education and outreach regarding IRB approval as well as the following items.
* Continuing education on human research protocol regulations is provided through special training sessions, visiting scholars and HRPP program directors.
* Updates on regulations and compliance awareness are communicated to investigators and research staff by the Associate Provost for Research and the Director of the Office of Research Integrity by a list serve email platform.
* The HRPP web site describes the components of the program (http://research.musc.edu/hrpp/index.html) and highlights updates on regulations and compliance.
* Distribution of Human Research Participant Brochure in English and Spanish.
* Regular communication with departmental business managers on compliance monitoring.
* Mechanism for reporting compliance issues via a Compliance hotline (Confidential Hotline Posters). The University provides whistle-blowing protection to anyone who reports an activity that violates any regulations or policies on the use of human subjects.
* Post-review random audits conducted by the University Compliance Office.
* Posting and distribution of Guidelines for Ethical Conduct of Research (MUSC Guidelines for the Ethical Conduct of Research).
The MUSC Institutional Review Board was most recently a component of the accreditation process through the National Committee for Quality Assurance (NCQA) in July 2005 as the University Affiliate of the Ralph H. Johnson Veterans Administration Medical Center (VAMC). The IRB Structure and Operations Category of the NCQA review received a score of 95.9%.
In 2007, MUSC's Accreditation by the Southern Association of Colleges and Schools was reaffirmed with an exemplary recommendation that cited many achievements and the creativity of initiatives in inter-professional education.
MUSC has been proactive in providing the operational structure required for an effective HRPP and its oversight. Leadership places high priority on compliance and regulatory monitoring to ensure that all aspects of research integrity are valued and that the proper mechanisms are in place for education, training and continuing review. The Ralph H. Johnson VAMC was among the first in the country to appoint a monitor for post-approval review of all human subjects research. This culture of operational compliance and education is a core, integrated philosophy for the university. Monitoring by the Office of Compliance includes validation of required training, annual review of each individual research protocol, internal audits and mechanisms to follow implementation of any required corrective action. The process of post-approval review of human subjects protocols was established at MUSC in 2002 under the Office of University Compliance. This concept was expanded in 2007 to include post-approval review of animal research protocols and in 2008 for work involving recombinant DNA and infectious materials as reviewed by the Institutional Biosafety Committee.
An important indicator of the quality of our operations and the MUSC/VAMC partnership as well as our commitment to compliance and oversight is provided by the recent review of our Division of Laboratory Animal Resources by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). In July 2011 AAALAC granted MUSC/Ralph H. Johnson VA Medical Center full accreditation for three years with a complementary review by the site visit team and the AAALAC Council. This is the ninth consecutive "full accreditation" for our animal program since 1987, a record that may be unprecedented for academic institutions.
The ongoing improvement and quality of our HRPP is initiated through multiple mechanisms including post-review monitoring, education, quarterly visits and/networking with external advisors and consultants, ongoing monitoring by the Office of Compliance, ongoing review of best practices, regularly scheduled reviews of the IRB operations and weekly discussions among the multiple offices involved in our HRPP (see HRPP Program Guide Section 10.1 - Human Research Audit Policy and Procedures and Section 10.3 - Quality Improvement Initiatives). Visiting academicians and consultants meet with staff and consult with the institutional and organizational officials responsible for our HRPP.
We consider the ongoing review of educational and training requirements for all individuals involved in human research to be another important vehicle for quality improvement and have training requirements in place for individuals just beginning in research and for continuing education through the CITI. In addition, the Office of Research Integrity developed a course "Core Clinical Research Training" that is now offered through our Clinical and Translational Research Center for all research teams and coordinators involved in human research. In addition, many centers and institutes on campus have training and mentoring opportunities in place to assist in education and awareness. Finally, we have active community-based outreach and education programs to increase awareness in the community for human subjects' research, including a Human Research Participant Brochure (English and Spanish Versions). Our community based partnership initiatives are currently led through the Center for Community Health Partnerships (CCHP) and S.C. Clinical and Translational (SCTR) Institute Community Engagement Program,
Many of the core aspects of our HRPP are captured in our MUSC Human Research Protection Program Guide that will be posted on the MUSC web site and freely available to guide both investigators and human research participants. The Guide provides an organizational scheme that serves as an important educational tool for all aspects of our HRPP.
MUSC Human Research Protection Program Guide
Section 1 - Overview of the MUSC Human Research Protection Program
Section 1.1 - Description, Principles and Authority for MUSC HRPP
Section 1.2 - MUSC Organization
Section 1.3 - Definitions of Terms
Section 1.4 - Scientific/Scholarly Review of Protocols Policy and Procedures
Section 1.5 - State Laws Affecting Human Subjects Research
Section 1.6 - Communicating Conflict of Interest (COI) among IRB, ORSP and University COI Committees
Section 2 - IRB Governance and Operations
Section 2.1 - Responsibilities, Ethical Principles, Authority and Independence
Section 2.2 - Functions of the IRB
Section 2.3 - Membership of the IRB
Section 2.4 - Approval of Research Activities by the IRB
Section 2.5 - Convened Meetings of the IRB
Section 2.6 - Retention of Review Activities Records by the IRB
Section 2.7 - Management of the IRBs
Section 3 - IRB Review Process
Section 3.1 - Human and Not Human Research Policy and Procedures
Section 3.2 - Exempt Research Review Policy and Procedures
Section 3.3 - Expedited Research Review Policy and Procedures
Section 3.4 - Full Board Initial Review Policy and Procedures
Section 3.5 - Full Board Continuing Review Policy and Procedures
Section 3.6 - Full Board Amendment Policy and Procedures
Section 3.7 - Case Reports Policy
Section 3.8 - Quality Improvement Projects Policy and Procedures
Section 4 - Operational Guidelines for Human Research Protocols
Section 4.1 - Review of Research Involving Drugs or Biological Drug Products Policy and Procedures
Section 4.2 - Single Emergency Use of an Investigational Drug Policy and Procedures
Section 4.3 - Review of Research Involving Medical Devices Policy and Procedures
Section 4.4 - Medical Devices Risk Determination Policy and Procedures
Section 4.5 - Emergency Use of an Investigational Device Policy and Procedures
Section 4.6 - Humanitarian Use Device Policy and Procedures
Section 4.7 - Unanticipated Problems and Adverse Events Policy and Procedures
Section 4.8 - Management of Non-Compliance Policy and Procedures
Section 4.9 - Suspension or Termination of IRB-Approved Research
Section 4.10 - Data and Safety Monitoring Plans
Section 4.11 - Human Gene Transfer Studies Policies and Procedures
Section 4.12 - Clinical Trials Registration Policy and Procedures
Section 4.13 - Privacy and Confidentiality Policy
Section 4.14 - Protocol Deviation Policy and Procedures
Section 5 - The Research Team
Section 5.1 - Principal Investigator Responsibilities - Supervision of Staff and Protection of Subjects
Section 5.2 - Principal Investigator Responsibilities - Recordkeeping and Record Retention Requirements
Section 5.3 - Education and Training Requirements for Individuals Involved in Human Research
Section 6 - Informed Consent
Section 6.1 - Informed Consent to Participate in Research Policy and Procedures
Section 6.2 - Hyperlinks to IRB Informed Consent Information and Guidance
Section 6.3 - Waiver or Alteration of the Consent Process and Waiver of Consent Documentation Policy and Procedures
Section 7 - Human Subject Participation
Section 7.1 - Equitable Selection of Subjects
Section 7.2 - Advertisements for Research Participants Policy and Procedures
Section 7.3 - Payment for Participation Policies and Procedures
Section 7.4 - Recruitment Incentives Policy and Procedures
Section 7.5 - Research Involving Non-English-Speaking Subjects Policy and Procedures
Section 7.6 - Research Subject Advocacy Policy and Procedures
Section 7.7 - Subject Complaints, Issues, Concerns and Suggestions Policy and Procedures
Section 8 - Vulnerable Populations
Section 8.1 - Vulnerable Subject Populations
Section 8.2 - Research Involving Persons with Impaired Decision Making Capability (Cognitively Impaired)
Section 8.3 - Research Involving Prisoners
Section 8.4 - Research involving Pregnant Women, Fetuses, and Neonates
Section 8.5 - Research Involving Children
Section 8.6 - Research Involving MUSC Employees or MUSC Students
Section 9 - Human Subjects Research Conducted at Multiple Sites
Section 9.1 - Multi-Site Research Studies Policy and Procedures
Section 9.2 - Management of Reporting Events in Multi-Site Research Studies Policy and Procedures
Section 9.3 - Transnational Studies Policy and Procedures
Section 10 - Quality Assurance
Section 10.1 - Human Research Audit Policy and Procedures
Section 10.2 - Research Data Ownership and Record Retention Policy and Procedures
Section 10.3 - Quality Improvement Initiatives within the Human Research Protection Program of MUSC


text: The Repository is managed by the USDA-ARS National Plant Germplasm System in cooperation with the University of California Agricultural Experiment Station. The Repository receives policy advice from the National Plant Germplasm Committee and technical advice from the Citrus and Date Crop Germplasm Committee. Regulations of the Animal and Plant Health Inspection Service (APHIS), USDA-ARS, California Department of Food and Agriculture and other regulatory agencies controlling introduction and distribution of plant material are followed.

subset: commoncrawl


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OCT 25, 2013 - Cleveland Plain Dealer
A Must Read - Share
Fake news stories from satirical websites are managing to fool not just people on social media, but national news organizations.
Editor's Picks
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African Marigold, French Marigold
Tagetes erecta, T. patula, T. patula x erecta
AFRICAN Marigold Seeds
African Marigolds boast huge, fully double blooms up to 4 inches across. Plants are compact and sturdy, growing 12-20 inches tall. Marigolds look fantastic in beds, borders, or containers.
LADY MIX African Marigold Tagetes erecta
Refined 3-4 inch, double carnation-shaped blooms cover sturdy 20 inch tall plants that never need staking. Colors include clear yellow, gold, orange and primrose.
VANILLA IMPROVED HYBRID African Marigold Tagetes erecta
Elegant 2.5-3 inch soft, creamy-white fully double flowers on compact 16 inch tall plants. 'Vanilla Improved Hybrid' is an outstanding garden performer, a major improvement compared to previously introduced white marigolds. Prefers afternoon shade.
MOONSONG DEEP ORANGE African Marigold Tagetes erecta
Large, fade-resistant, orange flowers. Other orange marigolds look golden by comparison. Fully double, 2.5-3.5 inch blooms cover vigorous, upright, 12-15 inch tall plants. Without deadheading, plants continue to flower, look fresh all season. Stress resistant, tolerates heat and drought, easy to grow in beds, mixed borders or 6 inch pots. A 2010 All-America Selections Winner.
INCA II SERIES African Marigold Seeds Tagetes erecta
Huge, fully double, vibrant 4 inch flowers on sturdy, upright 12-14 inch tall plants. Heat tolerant, compact, and heavy flowering, 'Inca II' series plants are truly great marigolds for massing. They are also an outstanding series to use in containers.
INCA II PRIMROSE African Marigold
Fully double 4 inch pastel yellow flowers.
INCA II ORANGE African Marigold
Rich orange 4 inch fully double blooms.
INCA II GOLD African Marigold
Vivid, fully double 4 inch true gold flowers.
FRENCH Marigold Seeds
Early, heavy blooming plants covered in bright 2-inch flowers. Branching plants are 8-12 inches tall. Spectacular in beds or containers. French Marigolds offer a wide variety of warm colors.
ALUMIA SERIES French Marigold Seeds Tagetes patula
ALUMIA VANILLA CREAM French Marigold
A new French marigold with large, very early blooming, 2.5 inch soft lemon yellow, anemone-type flowers. Vigorous branching plants grow 10-12 inches tall, spreading slightly wider. A Fleuroselect Novelty Award winner.
CRESTA SERIES French Marigold Seeds Tagetes patula
A new series of large, long lasting 2-2.5 inch crested marigolds. They are the earliest blooming crested French marigolds. Uniform, branching plants grow 9-12 inches tall, spread 12-16 inches across. Cresta marigolds are exceptional performers in containers and garden beds.
CRESTA FLAME French Marigold
CRESTA YELLOW French Marigold
CRESTA DEEP ORANGE French Marigold
Intense orange flowers.
BONANZA SERIES French Marigold Seeds Tagetes patula
BONANZA BEE French Marigold
Large, 2-2.5 inch golden flowers flecked in red. Upright, branching, early, heavy blooming, 10-12 inch tall plants.
BONANZA DEEP ORANGE French Marigold
Large, luminous, deep orange 2-2.5 inch flowers on upright, branching 10-12 inch tall plants. They are early and heavy blooming. 'Bonanza Deep Orange' is the deepest orange crested French marigold.
BONANZA HARMONY French Marigold
Large, 2-2.5 inch maroon and orange bicolor flowers. Early, heavy blooming, upright, branching, 10-12 inch tall plants.
FRENCH-AFRICAN HYBRID Marigold Seeds
The best of both worlds, heavy-blooming plants with huge flowers! Vigorous, 14-16 inch tall plants do not require dead-heading. Constant flowering. Plants bloom weeks longer than other marigolds.
ZENITH SERIES French-African Hybrid Marigold Seeds Tagetes patula x erecta
This new triploid marigold is a cross between an African and French marigold. The richly colored double flowers reach 3-4 inches across and are stunning when viewed en masse. A remarkable ability to thrive in Texas heat has awarded the Zenith Series a place on the Dallas Arboretum's "Flameproof" plants list.
ZENITH MIX French-African Hybrid Marigold
Solid and bicolor flowers in golden yellow, lemon yellow, orange and red, orange, red and gold, and red shades.
ZENITH RED French-African Hybrid Marigold
Huge, rich mahogany-red flowers shade to an eye-catching red-gold as they age.
How to Plant Marigold Seeds
Sow seed in cell packs or flats, press into soil and lightly cover. Kept at 70-75°F. germination is in 5-20 days. Transplant into the garden 8-18 inches apart (spacing is variety specific, and is on our packets) after all danger of frost.


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And I'm back!
3 days ago
Just stumbled across your blog and I'm going to try these fresh rolls this week!! I'm not a vegan, or even a vegetarian, but love to find fun, healthy things to eat! Thanks!ReplyDelete
Glad you found something you can enjoy! How did you find the blog?ReplyDelete


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WNC bird watchers participate in count
Published: Friday, February 13, 2009 at 7:38 a.m.
Last Modified: Friday, February 13, 2009 at 7:39 a.m.
ASHEVILLE, N.C. (AP) Bird watchers in western North Carolina are among those participating in the 12th annual Great Backyard Bird Count.
The Asheville Citizen-Times reports that the count begins Friday and continues through Monday. It's sponsored by the Cornell Lab of Ornithology and the National Audubon Society.
Members of the Elisha Mitchell Audubon Society, based in Asheville, are among those participating. Birders are asked to spend at least 15 minutes looking for, identifying and writing down the highest number of birds of each species they see.
Steven Semanchuk is a board member of the Elisha Mitchell Group. He says it's best to go with another person so one can write down the species as the other identifies them.
Reader comments posted to this article may be published in our print edition. All rights reserved. This copyrighted material may not be re-published without permission. Links are encouraged.
Comments are currently unavailable on this article


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Nellie M. Hull, beloved mother and grandmother, 87, of Ripley, and formerly of Crawford, went to sleep and woke up with Jesus on the evening of Oct. 6, 2012.
She was born on May 23, 1925, to the late John and Rosie Riffle.
In addition to her parents, she was preceded in death by her husband of 50 years, Willis Hull; one brother, Jacob "Bud" Riffle; and three sisters, Jessie Curry, Nadia Helmick and Reba McKisic.
She is survived by two daughters, Helen Bragg and husband, Dana, of Ripley and Martha Hefner and husband, Mike, of Crawford; three granddaughters, Amy Miller and husband, Mark, Amanda Burford and husband, Jon, and Amber Haddox and husband, Fred; and five great-grandchildren, Zachary and Adam Miller, Abigail and Tyler Burford, Chase Horn, plus his soon-to-be-arriving sister. She is also survived by her brother, William "Ford" Riffle.
The family will receive friends from 4 to 8 p.m. today at Heavner and Cutright Funeral Chapel. The body will lie in state from 12:30 to 1 p.m., the funeral hour, Wednesday, Oct. 10, at Crawford United Methodist Church with Pastor Doug Smailes officiating. Interment will follow in Post Chapel Cemetery in Crawford.
The family would like to thank Kanawha Hospice Care. In lieu of flowers, donations may be made to Kanawha Hospice Care, 1606 Kanawha Blvd. W., Charleston, WV 25312. The family also offers special thanks to their close friends and neighbors who have helped lift them up in prayers and well-wishes. Online condolences may be extended to the Hull family at www.heavnerandcutright.com. The Hull family has entrusted Heavner & Cutright Funeral Chapel with the arrangements.


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Home > Ways To Give Overview > Corporate Giving & Sponsorship > Become a CAF Partner
Become a CAF Partner
Challenged Athletes Foundation® (CAF) strives to connect and develop long-term relationships with corporate partners who share our commitment to improving the lives of others. We're looking to align with partners who can share in the passion for our cause, collaborate on projects and initiatives engage their employees to make a lasting, quality impression.
We encourage you to ask us these five important questions to see if they intersect with your mission or that of another company you may know:
There are many ways for companies to become involved with CAF, here are a few to consider:
We welcome the opportunity to explore all the good things we could do together, please contact: Director of Development, Nancy Reynolds at firstname.lastname@example.com or 858-210-3516.


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tag:blogger.com,1999:blog-27945607.post4659594459825470038..comments2016-08-23T20:21:39.818-04:00Comments on Dave's Cupboard: Campbell's Chicken Wonton SoupDavehttp://firstname.lastname@example.com:blogger.com,1999:blog-27945607.post-40984447871036643662011-06-26T11:28:05.730-04:002011-06-26T11:28:05.730-04:00i ADORE this stuff, especially the textureless chi...i ADORE this stuff, especially the textureless chicken paste inside the doughy "wontons". campbell's doesn't sell these in canada so i always buy, like, a pallet of them when i'm in the states.

then again, i'm also a fan of artificial-chicken-flavoured salt water, so take my opinion with a grain of oxo firstname.lastname@example.com:blogger.com,1999:blog-27945607.post-5236184316500194632011-01-25T13:02:44.069-05:002011-01-25T13:02:44.069-05:00I'm on a wonton soup kick and thought I'd ...I'm on a wonton soup kick and thought I'd look up reviews for the Campbells variety. The consensus is in. Everyone says it is HORRIBLE! Thanks for the review!juleshttp://firstname.lastname@example.com:blogger.com,1999:blog-27945607.post-88637677918215871812011-01-13T09:06:51.867-05:002011-01-13T09:06:51.867-05:00Of course, dogs know their cuisine. A little of t...Of course, dogs know their cuisine. A little of that soup with some tasty Libby's Vienna sausage and...firstname.lastname@example.com:blogger.com,1999:blog-27945607.post-91837861434922996882011-01-12T11:36:23.471-05:002011-01-12T11:36:23.471-05:00I haven't had that in years, like, 20 years (a...I haven't had that in years, like, 20 years (at least) and from your description, it hasn't changed at all. I guess you could give it some credit for staying consistent through all these years:)michellehttp://email@example.com


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(The Best.)
Someone told TIME magazine about trolling and now we all just have to deal with it.
Ex-Post Office secret agent Steven Seagal shoots his way through Poland while wheezing heavily
It's the pictures of a cool dog you ingrates crave! Please click
Available in Large, which is actually a Medium stretched out to appear bigger.
The Something Awful front page news tackles anything both off and on the Internet. Mostly "on" though, as we're all incredible nerds.
Copyright ©2016 Rich "Lowtax" Kyanka & Something Awful LLC.


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The item is on special. Add to cart to see the special price.
Super tight, exquisitely detailed, hand-painted luscious lips and supple but firm ass is made of the ultra life-like, super-soft Futurotic material. Experience vibrating, pulsating and surging sensations with the removable five function power pack. Renewing talc included. 2 AA batteries (not included). Micro cell batteries (included).
Catalog ID: SE811301


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Articles by Author
When the weather is steamy hot, no wine is more refreshing than a chilled rosé. This 2013 Château de Trinquevedel, with its complex spice and cherry flavors with hints of refreshing grapefruit, will be delicious after Labor Day, too.
In the past few years, the meaning of rosé has changed from cotton candy sweetish plonk to a powerful symbol of summer in the U.S. Pink wine has become the sophisticated beach and patio drink, a fashionable accessory to the good life. Too bad so few people drink it during the rest of the year. Yes, I'm a fan of the seasonal approach to wine, but just because pale pink wine is gulpable and refreshing in July and August doesn't mean we should drop it like a beach towel when we get back from our vacations.
Elin McCoy's Wine of the Week
2013 Château de Trinquevedel Rosé
Price: $17
Region: Rhone Valley, France
Grape: 57 % Grenache Noir, 11% Cinsault, 15 % Clairette, 11 % Syrah, 5% Mourvèdre
1% Bourbelenc
Alcohol: 13.5%
Serve with: Grilled fish, spicy Chinese noodles with chicken, barbecued pork chops
The Tavel region of the southern Rhône Valley, where Château de Trinquevedel is located, is unique — it's France's only all-rosé appellation. The land has a long history: Greeks planted the first vines back in the fifth century B.C., and rosés from the region were favorites of Louis XIV.
Built in the 18th century, the château is now in the hands of Guillaume and Céline Demoulin. Guillaume is the fourth generation in his family to farm these vineyards filled with the rounded white stones called galets roulés that also grace the vineyards of Chateauneuf-du-Pape. The hot sun and warm climate concentrate the grapes and result in rosés with more power and tannin than the pale, pale pink wines of the Côtes de Provence and Château de Trinquevedel makes a couple of different cuvées; this is their cuvée traditionelle offering, brought in by well-known importer Kermit Lynch.
More from Zester Daily:
» Don't judge a rosé by its color, and other tips
» A French rosé to crave in the heat
» How artisans harvest wine corks off living trees in Portugal
In France, red and white wine can't be mixed to create a rosé except in Champagne. That was reaffirmed a few years ago, after a controversial proposal by the EU minister of agriculture to permit mixing them met with giant protests from top producers all over France and she had to back down. Chateau de Trinquevedel uses a version of the saignée method, macerating grapes with their skins to pick up color. Then they draw off the free-run juice, press the grapes and add the pressed juice to the free-run.
The result is a serious, full-bodied rosé with a deep pink color that's amazingly food friendly and rich enough to serve with all kinds of food, including spicy barbecued pork chops.
Sadly, at the end of the summer, wine shops usually stop ordering more rosé for their shelves. My advice is to stock up now.
Main photo: 2013 Château de Trinquevedel Rosé. Credit: Elin McCoy
I discovered this under-$20 French red wine on a recent visit to Burgundy, though it wasn't from that famous, fashionable region. Legendary wine broker Becky Wasserman poured the deliciously light and fruity 2012 Domaine des Bérioles Saint-Pourçain Les Grandes Brières at a family-style staff lunch of creamy asparagus risotto and a pork casserole, both cooked by her husband, Russell Hone, at their homey offices in the center of Beaune. The domaine is one of the 100-odd fine producers that their company, Le Serbet, represents.
Elin McCoy's Wine of the Week
2012 Domaine des Bérioles Saint-Pourçain Les Grandes Brières
Price: $18
Region: Loire Valley, France
Grape: 90% Gamay, 10% Pinot Noir
Alcohol: 13 %
Serve with: Asparagus or mushroom risotto, roast pork, grilled chicken
Saint-Pourçain appellation
The appellation Saint-Pourçain was new to me, though it's actually one of the oldest viticultural regions in France, its wines prized by royalty in the Middle Ages and served at the coronations of kings. The group of 19 villages surrounds the small, dull market town of Saint-Pourçain-sur-Sioule in the cool, gently hilly landscape of the Auvergne region in central France, west of the Maconnais. Though it's generally regarded as a Loire Valley satellite, the connection is pretty tangential — the vineyards are on a significant tributary of the Loire river, but closer to the Macon. Sort of a lost appellation of Burgundy, Saint-Pourçain is better known for whites made from Chardonnay and local grape Tressallier than for reds, and only started attracting interest in 2009, when it was upgraded to an Appellation Contrôlée wine region.
The domaine's owners, Odile and Olivier Teissèdre, originally bought an old seven-acre walled vineyard named Clos des Bérioles in 1989, and over the years gradually acquired another 10 acres. One-third of their vineyards are devoted to red grapes Gamay and Pinot Noir.
More from Zester Daily:
» Dalila that has the spirit of two revolutions
» 2010 Vietti Barbera d'Asti Tre Vigne offers charming value
» 2011 Inama Soave Classico climbs the Soave ladder
» 2011 Masseria Li Veli Askos Verdeca is more expressive than the price suggests
With its bright flavors and hint of spice and minerals in the finish, this vivacious blend of mostly Gamay with a dash of pinot noir is just the kind of red I like to drink in the summer. It's crisp and refreshing, has expansive aromas of red fruit and rose petals, and still tastes good when very slightly chilled, all of which means it pairs well with an amazing variety of summer foods.
Main photo: 2012 Domaine des Bérioles Saint-Pourçain Les Grandes Brières.
Sunny Sicily is in the throes of a wine revolution. This rich apricot-and-citrus-toned white, 2012 Feudo Arancio Dalila, is an example of just how much has changed since the island turned from producing industrial plonk to quality wine from native grapes. With a 2,000-year wine history, Sicily is now one of Italy's most exciting, cutting edge regions — and the source of dozens of current bargains. This is one of them.
Dalila is one of the two blends in the Stemmari portfolio, which also includes single varietal reds and whites made from native and international grapes. The Dalila blend is mostly Grillo, a local Sicilian white varietal used traditionally to produce fortified Marsala. Highly fragrant, with exotic notes of mango, Grillo can be exciting on its own, but the addition of some Viognier, a Rhône Valley grape, gives this wine a round, rich texture and contributes aromas of honey and wildflowers. I'm guessing the wine's name is supposed to evoke the Dalila (of the Bible and the opera), who renders her former lover Samson powerless by cutting off his hair.
Elin McCoy's Wine of the Week
2012 Feudo Arancio Dalila
Price: $13
Region: Sicily, Italy
Grape: 80% Grillo, 20% Viognier
Alcohol: 13%
Serve with: Seafood risotto, soft cheeses
More from Zester Daily:
» Rare white from Mount Etna in Sicily
» 2010 Vietti Barbera d'Asti Tre Vigne offers charming value
» 2011 Inama Soave Classico climbs the Soave ladder
» 2011 Masseria Li Veli Askos Verdeca is more expressive than the price suggests
Stemmari is the Sicilian project of Mezzacorona, a company originally founded more than a century ago in northern Italy as a winegrowers' association. In Sicily, the company sources grapes from its 1,700 acres of vineyards at two large estates on the island's south coast, near Agrigento and Ragusa, where winds sweep in from the Mediterranean. The winery is built in traditional rustic villa style.
Considering this is a fairly big project, Stemmari's commitment to "green" ideas and sustainable winegrowing is commendable. Though the vineyards are not organically farmed, the company uses "good" insects as an alternative to chemical treatments, as well as "sexual confusion" — a biological system that fights destructive bugs by limiting their reproduction. Thanks to Sicily's hot, dry, windy climate, it's also relatively easy to use few chemicals here. Solar panels generate the winery's electricity, wastewater is recycled, and Feudo Arancio even desalinates seawater to keep its reservoirs full.
Sicily's long winegrowing history began even before the Greeks arrived to colonize the island in 750 B.C. On a wine tour a few years ago, I wandered the ruins of magnificent ancient temples just outside Agrigento that they left behind. The group of eight buildings, strung out along a road of big stones, is deservedly one of the island's most famous archeological attractions.
For most of the 20th century, Sicily was known for industrial-quality bulk wine. The wine renaissance started in the 1990s, as forward-thinking producers planted international grapes such as Chardonnay and focused on quality instead of quantity. The 2000s brought the rediscovery of fascinating native grape varieties such as Grillo. The 2012 Feudo Arancio Dalila is a tasty, food-friendly blend of the two revolutions.
Top photo: 2013 Feudo Arancio Dalila. Credit: Courtesy of Feudo Arancio
The snow outside has me longing for the beginning of rosé season. But sampling this bright 2012 Bokisch Vineyards Rosado, with its lively flavors of cassis and pomegranate, at dinner recently reminded me that you don't have to wait for hot weather to enjoy savory, medium-bodied pink wines. This food-friendly example was perfect with grilled pork chops and sautéed kale and would be delicious with tapas like olives and sharp cheese.
The wine's origin, Lodi, Calif., surprised me, as did the varietals in the juicy blend. Bokisch Vineyards has made a specialty of growing Spanish varietals and two found their way into this wine. Made mostly from Barbera, it includes percentages of Graciano and white Albariño that add notes of dark cherry, smooth tannin and a nice crispness. Graciano is a very old variety in Spain, supposedly dating back before the Romans arrived. Aging in stainless steel preserves the wine's acidity and fruit.
Elin McCoy's Wine of the Week
2012 Bokisch Vineyards Rosado Belle Colline Vineyard
Price: $16
Region: Clements Hills, Lodi, Calif.
Grape: 86% Barbera, 8% Albariño, 6% Graciano
Alcohol: 13%
Serve with: Barbecued chicken or pork chops; tapas; paella
More from Zester Daily:
» Taken with a Spanish red from Cune
» Generous red from France warms up winter
» Crowd-pleasing party red wine from the Loire Valley
Markus Bokisch, who owns the eponymous winery with his wife Liz, has a deep family connection with Spain, where he spent summers in Catalonia with his mother's relatives. He started his career at Joseph Phelps in Napa, but spent a few years working in the wine industry in Spain, where he fell in love with Spanish grapes. When the couple returned to the U.S., they bought land in Lodi, planting varietals such as Tempranillo and Garnacha. Now they farm 1,000 acres, selling the grapes to 40 wineries.
I've always thought of the Lodi AVA (American Viticultural Area), southeast of Sacramento and west of the Sierra Nevadas, as the place big producers such as Sutter Home and Gallo turn to for grapes for their basic, somewhat boring blends. Few realize it has a 150-year-long vineyard tradition; many families have grown grapes — especially Zinfandel and Tokay, used for brandy — for a century or more.
Although Zinfandel is still the most planted grape, a new generation of adventurous growers is branching out. The Bokisches are at the forefront of the experimentation. Many of their vineyards are organic and others are certified green according to "Lodi Rules." This complicated system includes using solar and biodiesel energy and monitoring the land ecosystem and water, but also permits some use of synthetic pesticides.
The 2012 Bokisch Vineyards Rosado leans toward the bigger, fruitier Spanish style of rosé, which makes it ideal for drinking at any time of the year. So don't wait for summer to sample its delights over a long brunch or dinner.
Top photo: 2012 Bokisch Vineyards Rosado Belle Colline Vineyard. Credit: Courtesy of Bokisch Vineyards
Red wine blends are booming in popularity in the U.S., and I predict that in 2014 white blends will follow suit. The floral and citrus-scented 2012 Tenuta Sant'Antonio Scaia Garganega/Chardonnay is a bargain Italian example: dry, fresh, fruity, tangy and perfect as an apéritif or with steamed mussels. It also happens to be more interesting than you might expect for an under-$15 wine.
Satisfying white blends have a long history in European wine regions, and in the past few years innovative California winemakers have turned to Italy for inspiration.
Elin McCoy's Wine of the Week
2012 Tenuta Sant'Antonio Scaia Garganega/Chardonnay
Price: $13
Region: The Veneto, Italy
Grape: 60% Garganega, 40% Chardonnay
Alcohol: 12.5%
Serve with: Aperitifs, mussels in broth, vegetable risotto
More of Elin's wine picks:
» A rare white from Mount Etna
The Veneto region in northeast Italy, where the Tenuta Sant'Antonio Scaia comes from, has a mild climate, thanks to nearby Lake Garda, and a winemaking history that goes back to the ancient Greeks. It's a region of wine contrasts, home to Amarone, a unique red made by a labor-intensive process of semi-drying grapes, and mass-market commercial companies that pump out millions of boring bottles a year.
The Tenuta Sant'Antonio Scaia blends a familiar international variety with a local Italian grape that's widely planted throughout the Veneto. Late-ripening, Garganega is the variety that dominates Soave Classico, which must be made in a specified district near the city of Verona. The grape resembles Chardonnay in that both vary widely in taste depending on where they're grown, when they're picked, and how the wine is made.
Garganega grown on the Veneto's flat plains for quantity rather than quality becomes simple, mediocre plonk. At Tenuta Sant'Antonio, grapes are planted on rolling hills, yields are kept low, and bunches are harvested by hand, all in the name of quality.
The four Castagnedi brothers — Massimo, Armando, Tiziano, and Paolo — who founded Tenuta Sant'Antonio worked as viticultural and technical wine consultants before starting the winery in 1989. They bought land in the Valpolicella zone adjacent to their father's vineyard property, joined the two, then planted grapes and began making wine.
The Castagnedis produce a wide range of classic reds and whites under the Tenuta Sant'Antonio label, and are best known for their more expensive, top-quality Amarones, Valpolicellas, and Soaves. They describe the Scaia wines (the word refers to stone flakes in the chalky soil where the vines grow) as "modern interpretations" of traditional classics.
Happily, this doesn't include aging in oak, which overwhelms the Garanega grape. The 2012 Sant'Antonio Scaia Garganega/Chardonnay is fermented at cold temperatures and aged in stainless steel, which preserves fruit and crispy acidity. The wine is much better than the ocean of easy-drinking whites from the Veneto. While it doesn't have the character and style of the very best Soaves, it does have a juicy, mouth-filling personality and an attractive, everyday-drinking kind of price.
Top composite photo: 2012 Tenuta Sant'Antonio Scaia Garganega/Chardonnay label and vineyard. Credit: Courtesy of Tenuta Sant'Antonio
When the temperature drops to zero and snow piles up in drifts outside my door (as it did last week), I want a rich, filling stew for dinner and a warm, generous red wine to match. The ripe, plummy 2011 Château de Saint Cosmé Gigondas is a classic choice, meaty and structured, yet fresh, savory and exuberantly fruity, with notes of blackberry and pepper. It was one of my highlights at a recent tasting with Gigondas producers at New York's Rouge Tomate restaurant.
Gigondas is a village with a very pretty town square and an appellation in France's southern Rhône Valley that produces only red wine. It lies in the foothills of the Dentelles de Montmirail, jagged limestone formations with 2,600-foot peaks that resemble sharp teeth or a rooster's comb.
Elin McCoy's Wine of the Week
2011 Château de Saint Cosmé Gigondas
Price: $34
Region: Gigondas, Southern Rhone, France
Grape: 60% Grenache, 20% Syrah, 18% Mourvèdre, 2% Cinsault
Alcohol: 14.5%
Serve with: Daube of beef with olives and tomatoes, braised short ribs
More from Zester Daily:
» A juicy, organic red from Montepulciano
» A crowd-pleasing party red wine from the Loire Valley
» A rare white wine from Mount Etna
The wine, based on the Grenache grape, is often called the the poor man's version of more famous and expensive red from Châteauneuf-du-Pape 10 miles to the south. It's not a comparison producers like. At the dinner, Château de Saint Cosmé owner and winemaker Louis Barruol pleaded, "We want to be loved for what we are, not as a cheap Châteauneuf!"
In fact, the terroir in Gigondas is different from that of Châteauneuf, and wines from vineyards at higher elevations, like those from Saint Cosmé, can have more perfume and finesse, though usually less complexity. The blend of grapes must include no more than 80% Grenache, at least 15% Syrah and/or Mourvèdre, and up to 10% other Rhône varieties.
Saint Cosmé Gigondas
Built on what was once the site of a Roman villa, Saint Cosmé is the most ancient estate in the region, with cellar vats that were carved into rock in Roman times. The Barruol family has owned the property since 1570, and Barruol, who took over in 1992, is the 14th generation.
Saint Cosmé produces several single-vineyard Gigondas bottlings in addition to this standard cuvée, which includes a greater percentage than usual of the gnarled old vines around the château. Tucked into the hills above the valley floor, the vineyards are shaded by the Dentelles, which helps preserve the wines' bright acidity. A regime of aging in old oak barrels keeps them from being too oaky.
I plan to savor more 2011 Château de Saint Cosmé Gigondas again very soon. The end of winter is a long way away.
Top composite photo: 2011 Château de Saint Cosmé Gigondas bottle and label. Credit: Courtesy of Château de Saint Cosmé


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A new study by UMass Dartmouth Charlton College of Business Professor Adam Sulkowski and student Cassandra Walsh suggests that company's commitment to the environment is more likely to result in employee job satisfaction than a company's financial success.
"The results of the analysis indicate a significant positive relationship between employee satisfaction and level of perceived environmental performance," the study concludes. "This study does not find a significant relationship between employee satisfaction and firm financial value."
The study, which began has Walsh's undergraduate honors program project, appeared in the Interdisciplinary Environmental Review. The study analyzes data on employee satisfaction and perceived environmental responsibility from 113 companies and thousands of employees. The same test was repeated using the employee satisfaction data and company financial performance metrics.
"The big take-away is that companies with a greener reputation are much more likely to have satisfied employees,'' Sulkowski said. "The strength of that relationship is remarkable. There was no relationship found between financial performance and employee satisfaction, which makes sense when one considers that a company's financial performance may improve when it streamlines and lays off people.''
Walsh, who began the research with Prof. Sulkowski as an undergraduate honors student and graduated in May, 2010, said, "Businesses are continuously looking for low cost ways to improve employee satisfaction. What better method than by increasing environmental performance and communicating it to the workforce? By increasing a company's perception of environmental performance the business wins, and the employees win."
Now a human resources coordinator at EMC Corporation in Hopkinton, Walsh said, "I couldn't be more proud of the research Professor Sulkowski and I have completed and published. It began as an assignment for the UMass Dartmouth Honors Program and developed into something much more than I could have imagined. It was a lot of hard work, but the payoff has definitely been worth it."
Sulkowski said the findings should encourage managers and owners of businesses to invest in credibly communicating about their sustainability and social responsibility efforts. He noted that UMass Dartmouth MBA students recently produced a sustainability report that achieves the highest level of compliance with the Global Reporting Initiative's G3 standard, used by a majority of the Global Fortune 250 to gauge environmental success. UMass Dartmouth is the first university in the world to have achieved this benchmark. "UMass Dartmouth is a good role model," he said.
Noting the undergraduate research opportunities offered by UMass, Walsh added, "My experience at UMass Dartmouth has been invaluable. I have worked with students and faculty who have challenged me and provided me with skills that I can apply both academically and within the business world. The four years I've spent at UMass Dartmouth have provided me with a sense of fulfillment."
UMass Dartmouth is the only research university located south of Boston. Its $26 million research enterprise offers undergraduate and graduate students opportunities to work with faculty conducting cutting edge research in economics, business, marketing, life science, marine science, engineering, education, criminal justice, health care, the arts, and dozens of other fields.


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Pereira, G, Freitas, SR, Moraes, EC, Ferreira, NJ, Shimabukuro, YE, Rao, VB, Longo, KM (2009). Estimating trace gas and aerosol emissions over South America: Relationship between fire radiative energy released and aerosol optical depth observations. ATMOSPHERIC ENVIRONMENT, 43(40), 6388-6397.
AbstractContemporary human activities such as tropical deforestation. land clearing for agriculture, pest control and grassland management lead to biomass burning, which in turn leads to land-cover changes. However, biomass burning emissions are not correctly measured and the methods to assess these emissions form a part of current research area. The traditional methods for estimating aerosols and trace gases released into the atmosphere generally use emission factors associated with fuel loading and moisture characteristics and other parameters that are hard to estimate in near real-time applications. In this paper, fire radiative power (FRP) products were extracted from Moderate Resolution Imaging Spectroradiometer (MODIS) and from the Geostationary Operational Environmental Satellites (GOES) fire products and new South America generic biomes FRE-based smoke aerosol emission coefficients were derived and applied in 2002 South America fire season. The inventory estimated by MODIS and GOES FRP measurements were included in Coupled Aerosol-Tracer Transport model coupled to the Brazilian developments on the Regional Atmospheric Modeling System (CATT-BRAMS) and evaluated with ground truth collected in Large Scale Biosphere-Atmosphere Smoke, Aerosols, Clouds, rainfall, and Climate (SMOCC) and Radiation, Cloud, and Climate Interactions (RaCCI). Although the linear regression showed that GOES FRP overestimates MODIS FRP observations, the use of a common external parameter such as MODIS aerosol optical depth product could minimize the difference between sensors. The relationship between the PM2.5 mu m (Particulate Matter with diameter less than 2.5 mu m) and CO (Carbon Monoxide) model shows a good agreement with SMOCC/RaCCI data in the general pattern of temporal evolution. The results showed high correlations, with values between 0.80 and 0.95 (significant at 0.5 level by student t test), for the CATT-BRAMS simulations with PM2.5 mu m and CO. (C) 2009 Elsevier Ltd. All rights reserved.
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Might & Magic: Clash of Heroes
If you stripped out Clash of Heroes' combat, you would be left with a fairly simplistic RPG
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Seasonal snowfall across New Mexico varies considerably, due largely to our unique topography. The lowest elevations are near 3,000 feet in the far southeast plains (around Jal), while the highest elevations tower above 13,000 feet (Wheeler Peak). Higher elevation locations generally accumulate more snow and see snowfall earlier and later in the season than lower elevation locales.
We define "first snowfall' as the first occurence of snowfall accumulation of 0.1 inch or greater during the season. Generally, the first snowfall occurs earlier in the season across the higher elevations and northern locations of the state compared to southern locales. The first snowfall often occurs late in the summer for many of the higher peaks in northern New Mexico. In some years for many southern locations there is no snowfall, or the first snowfall occurs very late in the season.
The graphic below will display snowfall data for locations across New Mexico, including the earliest on record and the average first dates. Place your cursor over a location to view the data. For a tabular view of the same data shown below, click here.
Dates of the Earliest & Average First Snowfall Around the Albuquerque Metro Area


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War of the Week 10-25-13
POSTED: 06:00 PM MDT Oct 25, 2013 UPDATED: 11:17 PM MDT Oct 25, 2013
Nicole Gomez brings you this weeks war of the week between El Dorado and Bel Air.
Copyright 2016 KVIA. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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Take a sneak peek at the new NIST.gov and let us know what you think!
(Please note: some content may not be complete on the beta site.).
NIST Authors in Bold
|Jeffrey Parrell; Y. Zhang; Michael Field; M Meinesz; Yonghua Huang; H Miao; Seungok Hong; Najib Cheggour; Loren F. Goodrich;
|Internal tin Nb3Sn conductors engineered for fusion and particle accelerator applications
|June 22, 2009
|The critical current density (Jc) of Nb3Sn strand has been significantly improved over the last several years. For most magnet applications, high Jc internal tin has displaced bronze process strand. The highest Jc values are obtained from distributed barrier strands. We have continued development of strands made with Nb-47wt%Ti rods to supply the dopant, and have achieved Jc values of 3000 A/mm2 (12 T, 4.2 K). Such wires have very good higher field performance as well, reaching 1700 A/mm2 at 15 T. To reduce the effective filament diameter in these high Jc strands, the number of subelement rods incorporated into the final restack billet has been increased to 127 in routine production, and results are presented on experimental 217 stacks. A new re-extrusion technique for improving the monofilament shape is also described. For fusion applications such as ITER, we have developed single-barrier internal tin strands having non-Cu Jc values over 1100 A/mm2 (12 T, 4.2 K) with hysteresis losses less than 700 mJ/cm3 over non-Cu volume. The Jc-strain behavior of such composites is also presented.
|IEEE Transactions on Applied Superconductivity
|pp. 2573 - 2579
|Superconducting materials,Nb3Sn,Internal tin
|Research Areas:
|Advanced Materials, Superconductivity, Materials Science
|PDF version:
|Click here to retrieve PDF version of paper (1MB)