Policies and Procedures for Human Subjects Research Review

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Policies and Procedures for Human Subjects
Research Review

• Office of Government and Foundation Relations
• Siena Hall, 219
• Tel. [phone], Fax [phone]
• www.siena.edu/osr

Alfredo Medina, Jr., M.S. Human
Compliance Officer Joseph Marrone, Ph.D., Chair,
Human Subjects Research Review Committee (IRB)
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LEGAL REQUIREMENTS

• The United States Department of Health and Human
  Services, Office for Protection from Research
  Risks (Title 45, Part 46 Protection of Human
  Subjects), requires that any institution
  engaging in human subjects research establish an
  administrative body to protect the rights and
  welfare of human research subjects recruited to
  participate in research activities.

• This administrative body is referred to as an
  Institutional Review Board (IRB).

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LEGAL REQUIREMENTS

• The IRB has the authority to approve, require
  modifications in, or disapprove all research
  activities that fall within its jurisdiction as
  specified by both federal regulations and local
  institutional policy.

• Currently, the Siena College Human Subjects
  Research Review Committee (IRB) consist of ten
  members six faculty members from various
  disciplines, three administrators and an external
  representative.

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PURPOSE

• The Siena College IRB responds to all research
  projects involving studies on humans with respect
  to

1) The rights and welfare of the individual(s)
2) The methods used to obtain informed consent
and,3) The risk and the potential benefits of
the research.

• Ensure that all investigators (including
  students) are in compliance with federal and
  institutional policies and, most importantly, to
  protect the rights of the subject(s).

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IRB REVIEW PROCESS

• Before reviewing a protocol, the IRB has to
  determine whether it has jurisdiction over
  approval of the research. In other words, is the
  research subject to IRB review?

What is research? Research as defined by the
Federal regulations is a systematic
investigation, including research development,
testing and evaluation, designed to develop or
contribute to generalizable knowledge.
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IRB REVIEW PROCESS

• What are human subjects?
• As defined by Federal regulations, human subjects
  are living individuals about whom an
  investigator (whether professional or student)
  conducting research obtains (1) data through
  intervention or interaction with the individual,
  or (2) identifiable private information.

Therefore, any project that fits these two
definitions may be subject to IRB review.
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IRB REVIEW PROCESS

• At Siena College, there are two (2) types of
  review

1. Expedited Review (Minimal risk) 2. Full
Review

• According to Federal guidelines, minimal risk
  means that the probability and magnitude of harm
  or discomfort anticipated in the research are not
  greater in and of themselves than those
  ordinarily encountered in daily life or during
  the performance of routine physical or
  psychological examinations or tests.
• The form of review that applies to a research
  project is determined by the IRB, not the
  investigator.

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EXPEDITED REVIEW

• What qualifies for expedited review?
• The expedited review procedure may be used for
  research projects that

• Pose no more than minimal risk
• Involves one or more research activities listed
  in the federal regulations as qualifying for
  expedited review and
• Propose modifications to previously approved
  research during the period (one year or less) for
  which approval has been granted.

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EXAMPLES OF EXPEDITED REVIEW

• Observation of classrooms involving no
  interaction with  students or disruption of
  daily classroom work.
• Anonymous, non-interactive observation of public
  behavior.  
• Research involving no psychological intervention
  or deception.
• Anonymous telephone or mail questionnaires on
  topics oninnocuous topics.
• Interviews or surveys on non-sensitive topic.

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FULL REVIEW

• What qualifies for full review?
• All proposed research that does not meet the
  criteria for an expedited review must be reviewed
  by all members of the IRB. This is referred to as
  full board review.

• Full board review may be required for research
  projects initially submitted for expedited
  review. That decision rests with the IRB Chair.

• An investigator may be asked to be present when
  his/her application is reviewed by the full
  board, in order to clarify any uncertainties that
  may exist in the minds of the IRB members. If
  the investigator is a student and cannot be
  present, his or her adviser is welcome to appear
  in lieu of the investigator.

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EXAMPLES OF FOR FULL REVIEW

• Research that involves interaction with persons
  under 18 years of age
• Research that places humans at psychological or
  physiological risk
• Research on special populations such as prisoners
  and  mentally incompetent
• Research involving deception
• Research involving sensitive topics

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IRB APPROVAL PROCESS

• All applications should be submitted to the Human
  Compliance Officer who will log them and then
  either forward them to the IRB Chair for action
  or return to the applicant if they are
  incomplete.
• Upon receipt of an application for review, the
  IRB Chair will determine what form of review
  applies and inform the investigator by email.
  Expedited review can usually be completed in 2-3
  days. If a full review is required, the IRB
  Chair will distribute copies of the application
  to the full committee. It generally will take
  2-4 weeks for the IRB to complete a full review
  of a research plan, so investigators should plan
  accordingly.

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SPECIAL POPULATIONS

• Subjects considered to be vulnerable typically
  are defined as special populations and require
  special protection. The most common classes of
  special populations are

• Children (under the age of 18)
• Prisoners
• Pregnant women
• Mentally incompetent individuals
• Economically or educationally disadvantaged
  persons

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RESEARCH INVOLVING CHILDREN

• What are some of the basics in conducting
  research with children?

• A child (minor) is anyone under the age of 18.

• Assent a child's affirmative agreement to
  participate in research must be attained from the
  child as well as permission from
  parent(s)/guardian(s).
• Permission means the agreement of parent(s) or
  guardian to the participation of their child or
  ward in research.

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RESEARCH INVOLVING CHILDREN

• Federal regulations specify four categories of
  risk to children as subjects

• Minimal risk (requires both assent of the child
  and permission of parent/guardian).
• Greater than minimal risk, but direct benefit to
  individual subject (requires both assent of the
  child and permission of parent/guardian).
• Greater than minimal risk, with no direct benefit
  to the individual, but likely to yield
  generalizable knowledge about the subjects
  disorder or condition (requires both).

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RESEARCH INVOLVING CHILDREN

• Continued
• Research not otherwise approvable which presents
  an opportunity to understand, prevent, or
  alleviate a serious problem affecting the health
  or welfare of children.

• Under Federal and Siena College policy, any
  research involving children are required to
  undergo full review.

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CHILDS ASSENT

• Assent of the child must be obtained if s/he is
  capable of giving consent.
• Elementary school-age children should provide
  oral assent to participate after the project is
  explained at their level of understanding.
• Middle school-age children and older can provide
  written assent.

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INFORMED CONSENT

• What is informed consent?
• Informed consent is the process by which
  prospective human subjects, or their legal
  representatives, are informed

• Of the nature and purpose of the proposed
  research, including risks, in a manner
  appropriate to their level of understanding and
  in non-technical language
• That they have the right to decline to
  participate or to withdraw from participation at
  any time without penalty and
• Given adequate time to decide if they want to
  participate.

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INFORMED CONSENT

• Informed consent should be documented by the use
  of a written consent form approved by the IRB and
  signed by the subject or the subject's legally
  authorized representative. A copy should be given
  to the person signing the form.

• It is important that the investigator
  communicate, rather than just provide
  information. Asking questions in order to elicit
  questions or comments from the subject(s) is a
  good way to ascertain that s/he understands what
  is being proposed.

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INFORMED CONSENT

• What exactly is involved in informed consent?

• An investigator should cover the essentials of
  informed consent in his/her oral explanation to
  the prospective subject.
• The investigator should meet with the prospective
  subject, determine if he or she is capable of
  giving consent, and then explain the study
• To give valid informed consent, a potential
  subject should truly understand what he or she is
  giving consent to.

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BASIC ELEMENTS OF INFORMED CONSENT

• Statement that the study involves research and is
  being conducted through Siena College.
• Explanation of the purpose of the research and
  the expected duration of the subjects
  participation.
• Description of the procedures to be followed.
• Identification of any procedures that are
  experimental.
• Description of any reasonably foreseeable risks
  or discomfort to the subject.
• Description of any benefits to the subject or to
  others that reasonably may be expected from the
  research.

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BASIC ELEMENTS OF INFORMED CONSENT

• Statement describing the extent, if any, to which
  confidentiality of records identifying the
  subject will be maintained

• Explanation of whom to contact about
• 1. The research project
• 2. Research subjects rights
• 3. Research-related injury to the subject

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BASIC ELEMENTS OF INFORMED CONSENT

• Statement regarding participation
• 1. Participation is voluntary.
• 2. Refusal to participate will not involve a
  penalty or loss of
• benefits to which the subject is
  otherwise entitled
• 3. Termination of participation at any time will
  not involve
• a penalty or loss of benefits to which
  the subject is
• otherwise entitled

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DECEPTION DEBRIEFING

• If deception is involved in a research project,
  the IRB Chair will determine if the research
  should undergo full review.
• Deception can not be used where there is risk to
  the subject.
• No information can be withheld from subjects that
  can significantly affect their decision to
  participate.
• Subjects need to be informed about the nature of
  the research in a way that it does not invalidate
  the data.

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DECEPTION DEBRIEFING

• All subjects must be debriefed regarding the true
  nature of the study after their participation.

• A debriefing statement should
• Explain all truths not revealed and all
  falsehoods told to the subjects.
• Address why deception was necessary.
• Reassure subjects that their reactions to the
  deceptions were normal.

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IRB APPLICATION

• The Siena College IRB review packet consist of
  five (5) parts

1. Cover Letter (background information) 2.
Criteria for Proposal Review (general
guidelines) 3. Application 4. Informed
Consent (sample and guidelines) 5. Checklist
Documents to be submitted for review
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USEFUL RESOURCES

• The Belmont Report Ethical Principles and
  Guidelines for the Protection of Human Subjects
  of Research http//ohsr.od.nih.gov/mpa/belmont.ph
  p3

• Office of Human Subjects Research,
  NIHhttp//ohsr.od.nih.gov/

• Oklahoma State University IRB Training Quiz
  http//www.vpr.okstate.edu/irb/quiz/

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IRB Committee

• Members, 2006-2007
• Joseph Marrone, Ph.D., Chair
• Gil Brookins, M.S., Marketing and Management
• Robert Colesante, Ph.D., Education
• Salvatore Lombardo, Ph.D., Political Science
• Edward McGlynn, Ph.D., Sociology
• Alfredo Medina, M.S., ex-officio
• Jeanne Obermayer, M.A., Student Affairs
• Robert Rivas, M.S.W., Social Work
• Carol Sandoval, M.A., Academic Affairs
• External Representative
• Russell Moore, Ph.D., Building Principal
• Shaker Junior High School