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University Research Services and Administration University Research Services and Administration Office of Research Integrity Institutional Review Board.

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Presentation on theme: "University Research Services and Administration University Research Services and Administration Office of Research Integrity Institutional Review Board."— Presentation transcript:

1 University Research Services and Administration University Research Services and Administration Office of Research Integrity Institutional Review Board Human Research Protections Program

2 Human Subjects  Defined: – Individual about whom an investigator, whether professional or student, conducting research obtains: Data through intervention or interaction with the individual or identifiable private information 45CFR46.102(f)

3 Research  Defined: – a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge 45CFR46.102

4 Historical Ethical Violations  The Willowbrook Hepatitis Study – ( ) – New York – Conducted on mentally retarded, institutionalized children – Involved systematically infecting the children with hepatitis – Parents were coerced into consenting

5  The Brooklyn Jewish Chronic Disease Cancer Study – (1963) – Indigent, elderly subjects were injected with live cancer cells without their consent

6  The Stanford Prison Experiment – (1971) – A psychology study of how ordinary people, college students, can behave in aggressive and dehumanizing ways based on the situation – Subjects were divided into two groups, “guards” and “prisoners”; the guards were allowed to inflict escalating levels of pain and humiliation on the “prisoners” over an extended period of time which resulted in extreme psychological stress

7  Tuskegee Syphilis Study – ( ) – US Public Health Service – 400 poor, rural, southern African American males – Penicillin was accepted as the treatment for syphilis in 1943, it was deliberately withheld – “Sometimes, with the best of intentions, scientists, public officials and others, involved in working for the benefit of us all, forget that people are people"

8  Nazi Medical War Crimes – “Medical experiments” were performed on thousands of concentration camp prisoners, and included deadly studies and tortures – In December 1946, 23 physicians and administrators were indicted before the War Crimes Tribunal at Nuremberg, and 16 found guilty in the August 1947 verdict – Judges included a section called “Permissible Medical Experiments,” now known as the Nuremberg Code

9 Historical Guidelines  Broad ethical guidelines that assist scientists, subjects and society in understanding the ethical issues related to human subject research  These historical guidelines have evolved since the 1940's and serve as a framework for current regulations

10 Historical Documents  The Nuremberg Code, 1947 – Legal responsibilities – (written by lawyers)  The Declaration of Helsinki, 1964 – Ethical responsibilities – (written by physicians)  The Belmont Report, 1979 – Separation of research from practice – (written by physicians)

11 Nuremberg Code  10-point policy for ethical constraints obligatory on anyone designing and conducting clinical research studies  Established the right of persons to choose whether to participate in research  Declared fundamental and sacred dignity of human subjects who participate in research

12 Declaration of Helsinki  Internationally recognized document which addresses research personnel conduct and other fundamental principles for experimentation involving humans  Established human subject protection through presumption of investigator integrity and ethical behavior

13 Belmont Report  Ethical Principals – Respect for Persons – Beneficence – Justice  Applications – Informed Consent – Risks and Benefits – Selection of Subjects

14 Elements of the Informed Consent Document  Study involves research – Purpose, duration, procedures, experimental  Risks/discomforts  Benefits  Alternative treatments  Confidentiality  Compensation for injury  Contact Person – Rights as subject – Research related injury – Research in general  Participation is voluntary

15 Additional Consent Elements as Appropriate  Additional costs to subject  Number of subjects in study  Consequences of subject’s decision to withdraw  Conveyance of significant new findings  Investigator termination of subject  Unforeseeable risk to subject, fetus or embryo

16 The Informed Consent Should....  Give subjects all the information that they may need to make a decision. The information should be factual, complete, and accurate  Ensure that subjects understand the information – The document should be written at the lowest reading level of the population being studied – Give subjects an opportunity to consider participation in the study on an initial and ongoing basis

17  It is important to understand that the informed consent is a process of communication that occurs between the subject and the researcher (s) throughout the study  It is not merely written information or a signature on a page

18 Child Assent  Parents must give consent for their children to participate, but the children must assent to participate – Assent is an affirmative action on the part the child indicating willingness to participate – A child is a person who has not attained the legal age of consent, 18 years in the state of Georgia

19  The child assent form must include the same elements as the consent form, but must be written at the appropriate age level for comprehension  The average age when assent can be given is generally age 6 and above  Ages 6-10: verbal assent must be obtained and documented by the researcher  Ages 11-17: This age group must sign a separate assent document

20  The template for a model consent form can be found on our website –

21 Institutional Review Board (IRB) Defined: Any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of research involving human subjects 45 CFR 46

22 What Requires IRB Review?  Any University research that uses humans, human tissue, surveys of human subjects or human subject’s records requires IRB review, irrespective of the funding source

23 Scope of Review IRB review and approval is required for any research involving human subjects that:  Is conducted by University faculty, staff or students  Is performed with or involves the use of facilities or equipment belonging to the University  Considers the University to be engaged in the research

24 More....  Satisfies a requirement imposed by the University for a degree program or for completion of a course of study  Is certified by a dean or department head to satisfy an obligation of a faculty appointment at the University, including clinical or adjunct appointments

25 What is Subject to Review?  Research conducted by “affiliated faculty”  Research projects in which the researcher is a consultant  Research conducted in courses  Research conducted by students  Research as pilot or feasibility stage  Research conducted at another institution by GSU personnel  Research in foreign countries  Research involving secondary use of data  Research using “waste and “extra” material

26 Submitting an IRB Application  New Projects – Complete the IRB application electronically via iRIS and route appropriately for signatures – Necessary documents can be uploaded within iRIS: Interview instrument (s) ● Informed consent (s) Recruitment material ● Survey instrument (s) Audio visual material ● Newspaper Ad Research protocol If applicable –Site permission letter –Copy of the grant

27 Human Subjects Training Collaborative Institutional Training Initiative

28 Human Subjects Training  All researchers who interact with human subjects to collect data or who handle data must complete a required educational program on ethics and procedures for the use of human subjects in research before the IRB may approve a proposal.  Georgia State University (GSU) has selected the Collaborative IRB Training Initiative (CITI) as the best and most efficient mechanism for delivering education to GSU researchers involved with human subjects research.

29  The CITI certification is valid for three years. At that time, it is necessary to complete a refresher course.

30  For Continuing Projects – Completed Renewal Application electronically via iRIS – Upload all necessary documents Informed consents and/or assents (clean copy) If applicable, current site permission letters and current approval letters from cooperating IRBs – Because of the electronic system, reviewers have access to all currently approved documents being used (questionnaires, recruitment materials, and scripts)

31 Review and Approval Process  Exempt Protocols: – Verified by IRB member or IRB compliance staff – Process takes about 72 hours  Expedited Protocols: – Reviewed by: Compliance Staff IRB Member IRB Chairman – Review process takes approximately two weeks

32  Full Board Protocols: – Reviewed and acted upon at regularly scheduled monthly IRB meeting

33 Protocol Approval  Protocols can be voted: – Approved – Approved, pending modifications: requires modifications be made to protocol before approval is obtained – Deferred: requires major modifications and will be reviewed again after revisions are made – Disapproved: extensive modifications and complete resubmission required

34 Approved Protocols  Expedited and Full Board protocols must be reviewed and renewed to continue on an annual basis  Federal regulations require the IRB to review continuing research at intervals appropriate to degree of risk, but not less than once annually  GSU requires review of Exempt studies every three years

35  If you have contact with subjects or are analyzing data, you are required to maintain current IRB approval  Investigators are sent reminder notices approximately 60 days prior to the expiration date of the IRB approval  A lapse in approval mandates that the research cease  It is the ultimate responsibility of the investigator to ensure the renewal application is completed and received by the IRB for review and approval in a timely manner

36 When the Research is Complete...  Exempt Study... – Study Closure Report  Expedited Study... – Study Closure Report  Full Board Study... – Study Closure Report

37 Deadlines  Protocols requiring Full committee review must be submitted no later than the 2 nd Monday of each month  Protocols requiring Expedited or Exempt review may be submitted at any time

38 Additional Information  Susan Vogtner, BBA, CIM, CIP, Compliance Specialist, Sr  Deonne McNeill, MS, Compliance Specialist  Christina Dobrovolny, MA, Assistant Director, HRPP  Shelia White, PhD, CIP, Director, HRPP


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