University Research ServicesUniversity Research Services

and Administration and Administration

Office of Research IntegrityInstitutional Review Board

Human Research Protections Program

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)

Research

Defined:– a systematic investigation, including research

development, testing and evaluation, designed to develop or contribute to generalizable knowledge

45CFR46.102

Historical Ethical Violations The Willowbrook Hepatitis Study

– (1963-1966) – New York – Conducted on mentally retarded,

institutionalized children– Involved systematically infecting the children

with hepatitis– Parents were coerced into consenting

The Brooklyn Jewish Chronic Disease Cancer Study– (1963)– Indigent, elderly subjects were injected with

live cancer cells without their consent

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

Tuskegee Syphilis Study– (1932-1972)– 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"

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

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

Historical Documents The Nuremberg Code, 1947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)

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

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

Belmont Report

Ethical Principals

– Respect for Persons

– Beneficence

– Justice

Applications

– Informed Consent

– Risks and Benefits

– Selection of Subjects

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

Additional Consent Elementsas 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

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

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

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

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

The template for a model consent form can be found on our website– http://www.gsu.edu/irb

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

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

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

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

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

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

Human Subjects Training

www.citiprogram.org

Collaborative Institutional Training Initiative

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.

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

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)

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

Full Board Protocols:– Reviewed and acted upon at regularly

scheduled monthly IRB meeting

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

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

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

When the Research is Complete . . . Exempt Study . . .

– Study Closure Report

Expedited Study . . . – Study Closure Report

Full Board Study . . . – Study Closure Report

Deadlines

Protocols requiring Full committee review must be submitted no later than the 2nd Monday of each month

Protocols requiring Expedited or Exempt review may be submitted at any time

Additional Information Susan Vogtner, BBA, CIM, CIP, Compliance Specialist, Sr.

svogtner1@gsu.edu404-413-3513

Deonne McNeill, MS, Compliance Specialist dmcneill@gsu.edu 404-413-3503

Christina Dobrovolny, MA, Assistant Director, HRPPcdobrovolny@gsu.edu404-413-3638

Shelia White, PhD, CIP, Director, HRPP swhite32@gsu.edu404-413-3514