INSTITUTIONAL REVIEW BOARD
POLICIES AND PROCEDURES
University Position Statement
Akamai IRB Registration with US Health and Human Services
Guidelines for Research Faculty
Guidelines for Graduate Students
Akamai IRB Membership
Akamai Summary IRB Process Guidelines
IRB Activities Timeline
IRB Process Forms
IRB Modification Approval Process
IRB Student Fees
IRB Decision Charts
IRB Federal Guidelines
Email IRB Chair
UNIVERSITY POSITION STATEMENT
Akamai University understands and supports the need for research on all fronts of the human experience, from the arts and humanities, religious and spiritual arenas of ideas, to the concrete world of hard political and business decisions. The scope of our research reaches from the realm of public health and disease control to the recognition of the whole person in the healing process and from the study of the depth of human psyche to the community as an incubator of social and psychological health. Our research ventures encourage the development of new technological systems addressing the need for global communication and educational systems to bring each world citizen the knowledge to empower themselves to change their world. The research philosophy of Akamai University, then, is to create and organize new knowledge toward ameliorate of major world problems and improvement of the human condition.
The research efforts of the Akamai University are based on the premise that amelioration of world problems and the creation of sustainable lifestyles and global practices are the hallmarks of responsible individual and corporate world citizenship. As part of the higher education community and as a generator of new knowledge and developer of worldwide solutions based in scholasticism, Akamai University fosters research dedicated to the improvement of the human condition.
In support of Akamai’s research mission, the Institutional Review Board is comprised of a team of faculty members and student representatives that collaborate to ensure the integrity of the research being produced at AU. Our IRB represents the federally mandated committee charged with the responsibility to review proposed research in order to ensure that the rights of research participants are protected, and that risk of harm to participants is minimized. We are excited to have such a dynamic group to support our students and faculty with their research.
Dr. Sandra Kolbl-Holman
AKAMAI IRB REGISTRATION WITH US HEALTH AND HUMAN SERVICES
The Akamai University Institutional Review Board is a registered body with the United States Department of Health and Human Services Office of Human Research Protections. Our Akamai IRB is registered under the IORG #0008821 The following IRB is registered with Office of Human Research Protections as IRB00010536 Akamai University IRB #1.
Find Akamai IRB listed online
IRB GUIDELINES FOR COMMITTEE CHAIRS
Please become familiar with the materials available on this AU Institutional Review Board webpage, especially the document IRB Procedures for Approval of Proposals for Research with Human Subjects. This document will explain the process of what will happen with the research proposal after it has been submitted to the IRB, and when communication and results can be expected. It is important to get formal approval from the IRB before any research takes place. When a student presents a research proposal to the graduate committee, the Committee Chairperson then submits the proposal to the IRB Chair together with you application and needed attachments, for the approval process to begin. Any questions or concerns about the process can be addressed to the IRB Chair at any time.
IRB GUIDELINES FOR GRADUATE STUDENTS
Any research conducted by AU graduate students, or its affiliates under written agreement, must first be approved by the Institutional Review Board, prior to the final approval of the research proposal. Students will create a research proposal to be given to the graduate committee. After working closely with the student to upgrade and polish the proposal, and to gain its tentative approval, the Committee Chairperson will then submit the proposal and attachments to the IRB Chairperson for the approval process to begin. More details regarding the approval process can be obtained from the document IRB Procedures for Approval of Proposals for Research with Human Subjects. Students will receive further information from the Graduate Committee Chair on how to proceed after the IRB has completed a preliminary review of the proposal. Even if the initial research proposal is not approved by the IRB, there will be an opportunity for the student to resolve any issues so that the proposal can be reevaluated and the research may proceed.
Rejection of the Research Proposal Should the preliminary IRB reviewer reject the research proposal due to inefficiencies or lack of compliance, a rewrite by the student may be expected. If the required rewrite still does not meet compliance expectations of the reviewer, the student would be required to return to the Faculty Committee and to rework the research proposal for resubmission. Should a proposal be resubmitted for IRB review, the student must repeat the entire application process and again pay the fees, as a new primary reviewer must be assigned to review the resubmission.
AKAMAI IRB MEMBERSHIP
Dr. Sandra Kolbl-Holman, IRB Chair
Dr. Ruth Hine, IRB Co-Vice Chair
Dr. Rod Floyd, IRB Co-Vice Chair
Dr. Juanita Rinas, IRB Member
Dr. Niranjan Ray, IRB Member
Dr. Anthony Maranto, IRB Member
Dr. Kemal Yildirim, IRB Member
Dr. Traian Stanciulescu, IRB Member
Prof. Antonio Cardona, IRB Member
Dr. Prasanna Keru, IRB Member
Sandra Kolbl-Holman, MS, Ph.D.
Dr. Sandra Kolbl Holman is an ecopsychologist, energy medicine pioneer, academic researcher, successful public and private sectors consultant and writer whose intellectual giftedness enabled her to attend her senior high school year at the age of 15. She has studied Art in Europe and with the Academy of Art in San Francisco, She wandered the Black Forests of Germany and spent time living in a medieval castle while building forest trails and protecting young fawns when she participated in German forestry school. It was here that her love for nature was nurtured. Kolbl Holman has a multi-lingual and multi-cultural background, graduated with Honors with Distinction in Psychology from Saint Thomas University (Canada) and attended graduate studies in Research Psychology and Program Development at Carleton University (Canada), where she won a graduate award for creating a new program logic model design. She furthered her studies in counseling, psychology and nursing, while attending Lethbridge Community College and the University of Lethbridge (Canada). Her final MS degree and PhD (High Honors) was awarded by Akamai University. Kolbl Holman worked for the Learned Society, was the lead researcher for the Canadian federal S.O.A.C Justice Committee in New Brunswick (Canada), taught university statistics, and was awarded research assistantships, teaching fellowships and numerous academic scholarships. She is a past member in good standing of the Canadian Psychological Association, the Psychological Association of Alberta and the Canadian Evaluation Society. Her scholarly research contributions focus upon intelligence, ecological intelligence, cognition, addictions, stress and anxiety, depression and causal attribution analysis. Community service has been a significant part of her life. Particularly important has been her work in many volunteer capacities, as well as designing, developing, managing and evaluating volunteer programs. She currently serves as Chief Advisor for Project NatureConnect. Her research interests include: intelligence, ecological intelligence, cognitive processing, consciousness, studying and mapping intentional healing pathways, energy medicine, global sustainability and integrative health education.
Ruth Huffman Hine, Ph.D., IRB Vice Chair
Dr. Hine has a wide range of experience, with twenty-four years in Adult Education designing and implementing programs for adult students in the Metropolitan School District of Wayne Township, Indianapolis. During her tenure at MSD Wayne Township, she served as director, manager, curriculum author and consultant, instructor, tutor trainer, and advisor for new program implementation. She possesses extensive experience in Human Resources, Organizational Development and Adult Education. Dr. Hine has initiated services for local business and industry including Allison Engine, Chevrolet Truck & Bus, National Starch, Chrysler Foundry, and the Midwest U.S. Army Recruiting Center. She currently serves as an adjunct faculty member at Akamai University, graduate and undergraduate levels. Dr. Hine has designed and taught courses in English as a Second Language. She has developed programs of instruction for College Preparation, Secondary High School Completion, and Literacy. She completed research on Needs of Volunteer Tutors in Adult Education. She has written articles and presented papers, and authored award winning curriculum in Adult Education. Recognized as a professional in Adult Education, Dr. Hine was a guest of the Deutscher Volkshochschul in Germany. She has maintained interest in genealogy and has written a family history book. Dr. Hine has been active in professional organizations, Kappa Gamma International, Phi Delta Kappa, the International Reading Association and Association for Adult and Continuing Education. She was a member of the Governor Speaker Forums in Indiana and was recognized in the 2008 publication of Adult Education Administrators in Indiana. Dr. Hine holds a Doctorate in Education, San Juan de la Cruz University; a Doctorate in Educational Administration, Greenwich University; M.A. in Adult Education, Indiana University; a B.S. in Education, Butler University, Indianapolis, with permanent teaching certification.
Rod Floyd, D.C., MSPH, CCN, FIAMA, Vice Chair
Dr. Floyd is a 1977 graduate of Palmer College of Chiropractic, Iowa campus (DC). He was in private practice for over 20 years. Then he began his studies at Nova Southeastern University in 1998 and earned a (BS) in special education and taught children with disabilities for five years while continuing his education by getting a masterï¿½s of science degree (MSPH) in community public health and completed additional courses in epidemiology at Walden University. He also holds certifications in clinical nutrition (CCN), medical acupuncture (FIAMA), and Level I and level II proficiency in Quintessential Applications (Applied Kinesiology), Dr. Floyd is currently an associate professor and faculty mentor at Palmer College of Chiropractic, Florida campus where he currently mentors student interns in the outpatient clinic. He is also an adjunct instructor at Everglades University, South University Online, and Allied Health Institute Online. He has been published in peer reviewed journals and has given platform and poster presentations at scientific meetings.
Juanita J. Rinas, MA, LPC
Prof. Rinas is currently finishing a Ph.D. at the Institute of Transpersonal Psychology. She has worked in the mental health and substance abuse fields for several years, and continues to be a licensed counselor in private practice. Ms. Rinas has considerable experience in qualitative methods of research. Her doctoral research uses blended methods of qualitative inquiry to better understand complex relationships between people involved in selected activities, focusing on the psychological and ecological implications of different forms of communication. Ms. Rinas has research interests in consciousness, social change, human-nature interconnections and psychological/ social interdependencies within diverse cultures and societies. Her interests have been fueled by work experiences in job coaching, human resource administration, case management, emergency mental health and crisis-management services and Juanita's personal journey from homelessness to higher education in Western society. She has worked with diverse client populations and belief systems. Ms. Rinas is an active advocate for cultural preservation, multicultural communication, environmental preservation, ecological sustainability, social justice and reform. She is proactive regarding the creation of positive, creative, and sustainable work and living environments, applied education, training, and research. She values indigenous rights, spiritual freedom, women's rights, and integral, life-long learning. Ms. Rinas has a published poem: Seamless Flowing. She writes for a local, independent newspaper and has a column, Beyond the Heard Mentality, which promotes self-care, connections with community, environment, mental health, social issues, and community services.
Niranjan Ray, B.S.E.E., M.S.E.E., Ph.D. (Engineering)
Dr. Ray received his B.S.E.E., M.S. E.E. and Ph.D. (Engineering) from Jadavpur University in India. He has taught at several universities including Jadavpur University, India, Engineering University, Bangladesh and International Institute of Management Science, India. He served as a Faculty Head of Computer Division of the Indian Institute of Material Management, Kolkata, India. He was an adjunct faculty of University of Redlands, California and Greenwich University, Norfolk Island. He served as a Principal Adviser, Software Design and Development of EDSA Micro Corporation., USA. As a corporate trainer he taught Managers, Engineers of Parsons Corporation, USA in Relational Database Management System (DBMS). He also provided training on courses of Computer and DBMS to Managers, Engineers of State Electricity Board, Kolkata, India, and Indian Administrative officers at Administrative training Institute, Kolkata, India. He is a Competent Toast Master (CTM) of Toast Master of International, USA. Dr. Ray was a senior member of IEEE, USA. He has a number of published papers to his credit. His primary interests are in teaching and research in the fields of Computer Science and Engineering, Management Information Systems, Computer Applications in Business Administration including Project Management, and Systems Analysis and Design.
Kemal Yildrim, Ph.D., IRB Committee Chair
Dr Kemal Yildirm specialized in comparative politics and middle east specialization with other subsidiary subjects in Political history and social and economic history and has submitted my Thesisin Diplomacy- Main title is diplomatic practices in the foreign policies of early Islamic political realms.
Traian D. Stanciulescu, Ph.D.
Dr. Stanciulescu, born in 1951 (Potlogi, Romania), has an interdisciplinary academic formation: architecture & philosophy and history faculty (psychology and sociology included). He has worked as an architect, as a lyceum professor, and finally as a university professor at the University of Iai. As a scientific researcher at National Inventics Institute (1993-2008), he auto-didactically studied biophotonics and its emergent implications in the field of human health optimization, having many original contributions, theoretical and practical (inventions) also. He has didactic abilities in the field of teaching "know how" disciplines, such as semiotics, hermeneutics, creatology, persuasion strategies, etc. which he synergetically applied in teaching and research activity. He is involved in many social-cultural events, being an efficient leader, permanently involved in public relationships by conferences, courses, etc. He has abilities in creative fields such as: poetry, music and painting, directly used for a personal "connection energy" preservation.
Antonio Cardona, MPA, MA, CPM, CWDP, GCF
Mr. Cardona holds the Executive Master's in Public Administration from Rutgers University and Master of Arts in Community Counseling from The College of New Jersey. He has been actively involved in diversity and race relations, and the development of anti-discrimination programming for over 10 years. Mr. Cardona is a native speaking Spanish language communicator and has served as an EEO Investigator for the State of New Jersey, including placement within the Office of the Attorney General for assurance of compliance and diversity administration. He is a human resource professional with the New Jersey Department of Human Services and a Workforce Development Coordinator and Career Counselor. Mr. Cardona coordinates mediation scheduling and training for Union County and serves as a professional mediator with the court systems in Union and Somerset Counties. He is an Associate Professor of Psychology with Mercer County College, and an adjunct faculty member with the Human Resource Development Institute, Union County College. Mr. Cardona serves the State of New Jersey as a diversity expert, holds government certifications in EEO/AA, Diversity Programming and Training, Mediation and Employment Dispute Issues, and holds workforce development credentials including Certified Job Counselor, Training-the-Trainer, and Managing Workplace Diversity. He is an active radio and television presenter, trainer and speaker and serves on a number of state boards and community advisor boards.
Prasanna Kerur BAMS, MD (Ayurveda)
Dr. Kerur earned his graduate degree from SDM College of Ayurveda, Udupi and postgraduate degree from AMV, Hubli. He has more than 9 years experience in Ayurveda, both as teacher and clinician. He is specialized in Ayurvedic therapeutics known as Panchakarma (Five Detox Therapies) and has treated over 3000 patients through Ayurveda. Since 1996, Dr. Kerur has served many Ayurvedic institutions in Southern India. He extended his expertise as Consultant to Sanjivini Ayurvedic Health Centre, Dharwad, and presently serves as visiting consultant at the Ayurvedic Centre in Bangalore. Dr. Kerur has presented several scientific papers in various national and international conferences in India, and abroad and was invited to speak at the 3rd International Conference on Ayurveda held at Tapovan Ayurvedic Centre, Paris, France. Dr. Kerur serves as Assistant Professor at SDM College of Ayurveda and Hospital in Hassan, India. He is visiting faculty for Thames Valley University, London, UK, teaching the graduate course in Ayurveda. He is also Ayurvedic Consultant at Ayurvedic Company of Great Britain and Ayurvedic Consultant on the panel of doctors comprising of General Physicians, Rheumatologists and Yoga specialists at Yoga Biomedical Trust, in London. Dr. Kerur has developed a number of rural health camps in India, and is actively involved in public health education and community health promotion. He is actively involved in several research activities and continued professional development (CPD) activities. Dr. Kerur presents talks about Ayurveda on All India Radio and has been interviewed twice by BBC Radio, London.
IRB SUMMARY PROCESS GUIDELINES
The IRB Committee membership follows the process listed in the attached document, as they initiate reviews for approval of research with human subjects and live animals.
IRB Procedures for Approval of Proposals for Research with Human Subjects
IRB PROCESS AND PROCEDURE FORMS
Ihe following forms are use by the IRB membership in processing through the review of student research proposals related to human subjects and live animals:
Application Form for Approval of Research with Human Subjects
IRB Initial Assessment Report Form
IRB Expedited Reviewer Report Form
IRB Full Review Preliminary Committee Form
IRB Full Review Committee Report
IRB Approval Form for Research with Human Subjects of Live Animals
MODIFICATION OF RESEARCH AFTER IRB APPROVAL
Researchers must return to the IRB for approval prior to implementing modifications to their research study, even though the changes are planned for the period for which IRB approval has already been given. Changes to the research protocol may not be implemented until approved by the IRB Committee. Even so, a change should be implemented prior to IRB approval, when the change is needed to eliminate an immediate hazard to a research subject, although the IRB must be notified immediately thereafter.
Modifications are thoses which represent changes in the activities and breadth of what the IRB originally approved. The degree and significance of the changes affect whether the modification receives preliminary,expedited, or full review, as determined by the IRB Chair. The IRB may use a preliminary review procedure for minor changes in an ongoing, previously-approved research study during the period for which approval is authorized. If the proposed change in a research study includes procedures involving increased risk, then an expedited or full review may be required.
Submissions about modifications
Researchers must submit documentation to the IRB Chair about the changes in the status of the study. The following information is required, although additional information may be requested to complete the review and approval process regarding the modifications.
IRB DECISION CHARTS
- A detailed outline of the changes and a full clarification and reasdon for each change. This should be submitted as a separate document by the researcher and should be titled Summary of the Modifications
- The researcher must submit a marked up copy of the originally approved research proposal, indicating clearly what changes are being made to the approved proposal.
- The researcher must submit a marked up copy of any modified forms being used in the research, such as questionnaire, interview scripts and consent form.
- The $300 modification review fee sent to the attention of Akamai University.
The Office for Human Research Protections (OHRP) provides valuable graphic aids as guides for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.
The charts address decisions on the following:
- Whether an activity is research that must be reviewed by an IRB
- Whether the review may be performed by expedited procedures, and
- Whether informed consent or its documentation may be waived.
IRB Decision Charts for Approval of Research with Human Subjects
IRB FEDERAL GUIDELINES
This USA federal policy, TITLE 45, PUBLIC WELFARE, Department of Health and Human Services, PART 46, PROTECTION OF HUMAN SUBJECTS applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research.
Code of Federal Regulations on Protection of Human Subjects