The New SU Human Subjects Policy Manual

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The New SU Human Subjects Policy Manual

• Presented by
• Kathy Reinhard. Director
• Patty Brundage, Administrative Assistant
• Office of Regulatory Compliance (ORC)

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Preface

• The manual is designed to provide guidance to the
  IRB in decision-making and to inform members of
  the university community and other interested
  persons and bodies of the IRBs role and
  functioning.
• The IRB acknowledges the inherent tension between
  its educational and regulatory compliance roles.
  To those unfamiliar with the Syracuse
  Universitys IRBs decision-making and
  deliberations, IRB requirements may seem rigid
  and bureaucratic.

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Preface (contd)

• The IRB operates in the context of regulations
  and does not have the authority to waive or
  modify requirements, unless explicitly provided
  for in the regulations. Further, in its policies
  and procedures as well as its decisions on
  specific applications, the IRB may require
  certain safeguards that go beyond the minimum
  requirements of the regulations. This reflects
  the IRBs experience reviewing hundreds of
  research protocols and having encountered
  potential and actual harms to human beings that
  were unanticipated by investigators.

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Preface (contd)

• Although the IRB supports the research mission of
  the university and believes that research can
  benefit society, it also is aware that the
  pursuit of knowledge, the extrinsic and intrinsic
  rewards that accompany research productivity, and
  the influence of external funding have caused
  some investigators and some institutions to
  ignore or downplay risks to research
  participants. The IRBs primary responsibility is
  to protect the rights and welfare of those who
  participate in research.

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Preface (contd)

• The greater the potential risks to participants,
  the greater the oversight exercised by the IRB
  and the greater the protections it will impose on
  investigators, whether or not these are required
  by the regulations.
• Steve Taylor

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2a. Definition of Research

• Research is defined by federal regulations as a
  systematic investigation, including research
  development, testing and evaluation, designed to
  develop or contribute to generalizable
  knowledge.

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2a. Definition of Research (contd)

• This definition may include
• qualitative and quantitative research studies
• survey
• case studies
• experiments
• interventions
• analysis of specimens
• demographic and epidemiological research
• program evaluations, oral histories, secondary
  analyses of documents and records, and
• other methods associated with the biomedical,
  behavioral, and social sciences.

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2a. Definition of Research (contd)

• Research Versus Non-Research.
• Researchers and non-researchers might use the
  same procedures and techniques in pursuit of
  their goals.
• Both may rely on written responses to questions,
  interviews, observations, videotaping, and
  document analysis.
• Research is characterized by an intent to share
  knowledge with others in professional, scholarly,
  or scientific publications or forums.

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2a. Definition of Research (contd)

• Journalism, art, literature, and music do not fit
  the definition of research subject to IRB review.
• Practitioners in these fields engaged in normal
  professional practice are not expected to submit
  their planned work to the IRB.
• Journalists and others who use the methods of
  social and behavioral science to contribute
  knowledge to members of their professions are
  expected to undergo IRB review.

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2a. Definition of Research (contd)

• Evaluations
• Evaluations are subject to IRB review if they fit
  the definition of research provided above a
  systematic investigation designed to contribute
  to generalizable knowledge.
• Evaluations conducted exclusively for quality
  assurance, quality improvement, or accountability
  purposes are not research and do not require IRB
  review. In these evaluations, there is no
  intention to share knowledge and information with
  external audiences.

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2a. Definition of Research (contd)

• Covered Research
• All human research conducted by faculty, staff,
  and students in conjunction with their official
  roles at Syracuse University is subject to IRB
  review.
• Student human research used to fulfill any
  requirements for their degree programs, including
  but not limited to thesis and dissertation
  research, must be approved by the IRB.
• Faculty and staff human research must be
  approved by the IRB, whether or not the research
  is externally funded.

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2a. Definition of Research (contd)

• Student Projects Research Versus Pedagogy.
• Many research methods courses at Syracuse
  University require students to complete projects
  as a way of teaching them research methods and
  skills.
• Syracuse Universitys IRB does not require
  student projects conducted in research methods
  courses to be reviewed if the purpose of these
  projects is pedagogical in nature. Activities not
  intended to provide generalizable knowledge are
  not subject to IRB review.

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2b. The Definition of Human Subjects

• Human subjects are defined as living
  individual(s) about whom an investigator (whether
  professional or student) conducting research
  obtains
• Data through intervention or interaction with the
  individual, or
• Identifiable private information

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2b. The Definition of Human Subjects (contd)

• Public Use Data Files
• Research involving public use data files that are
  stripped of all identifiers prior to being made
  publicly available does not involve human
  subjects and does not require IRB review or an
  application for exemption.
• Research involving public data containing
  identifiable private information does involve
  human subjects, under the federal definition.
  Such research may qualify for an exemption from
  IRB review.

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2b. The Definition of Human Subjects (contd)

• Third Parties
• Persons who are not the primary subjects of
  research, but about whom information is collected
  are sometimes referred to as third parties or
  secondary subjects.
• Information collected about third parties
  generally should be recorded in a manner that
  protects their identities, and special steps must
  be taken to safeguard confidentiality in the case
  of sensitive information that could cause harm to
  persons unless this jeopardizes the rights and
  welfare of the research participants.

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2b. The Definition of Human Subjects (contd)

• The IRB considers the circumstances under which
  third parties should be considered research
  subjects.
• the amount of private information collected about
  third parties
• the sensitivity of that information
• the ability of investigators to maintain the
  confidentiality of third parties
• the welfare of the originally designated
  research subjects and
• the right of the originally designated research
  subjects to provide information on their personal
  life experiences

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3a. Institutional Authority of the IRB

• The MPA (multiple project assurance), signed by
  the Vice President of Research and Computing at
  Syracuse University, the authorized institutional
  representative, creates the authority of the IRB.
• The MPA provides assurances that Syracuse
  University will comply with all federal
  regulations and provide authority to the IRB to
  make determinations regarding human subjects
  protections in research.

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3c. The Principal Investigator

• The IRB recognizes one Principal Investigator
  (PI) for each project. The PI must be a member of
  the faculty or an administrative department head
  at Syracuse University.
• Research conducted by students, must name a
  faculty member as PI and must assume
  responsibility for exercising appropriate
  oversight of the students research.

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3e. IRB Policies

• The IRB's policies are drafted by the IRB Chair,
  or designee, and approved by a majority of
  members present at a convened IRB meeting at
  which a quorum is present. The policies may be
  changed or revised as warranted by the majority
  of the IRB at the convened meeting.
• When warranted and appropriate in specific
  situations, the IRB may waive any of its policies
  and procedures if
• (1) the waiver is not inconsistent with federal
  regulations and
• (2) the waiver does not increase the risks to
  participants in research.

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3f. Conflict of Interest

• No IRB member may participate in the review of or
  vote on any initial or continuing application,
  amendment, or other matter involving research in
  which he or she has a conflict of interest.
• A conflict of interest is assumed to be present
  when the member is the Principal Investigator,
  faculty advisor, or member of a funded project on
  any research being reviewed by the Board or when
  the member has a financial interest in the
  sponsor of research under consideration.

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4. EXEMPTIONS FROM IRB REVIEW

• In accord with federal regulations, certain
  categories of research may be exempt from IRB
  review. Determinations regarding exemption from
  IRB review are made by the Chair or a designee
  and not by investigators.
• Exemptions are approved for a maximum of five
  years after approval. To continue research after
  that time period, investigators must apply for
  another exemption or complete a regular IRB
  application.

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4b. Responsibilities of Investigators of Exempt
Research

• Since exempted studies are considered human
  subjects research, investigators are expected to
• adhere to ethical standards for the conduct of
  research. Specifically, investigators are
  expected to obtain informed consent (when
  appropriate given the nature of the research)
• take all necessary steps to minimize risks and
  maximize research benefits, and ensure the
  equitable selection of subjects
• Investigators who have committed ethical
  breaches in their research will have the exempt
  status of their studies revoked and may be denied
  the ability to apply for exemption in the future.

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4b. Responsibilities of Investigators of Exempt
Research (contd)

• Investigators of exempt studies may not make
  substantive changes in the design of their
  studies without written approval of the IRB.
  Changes may
• involve investigators
• research instruments and procedures
• the location of their research, and
• sources of subjects or data

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4b. Responsibilities of Investigators of Exempt
Research (contd)

• All applications, continuations, and amendments
  to the IRB must be in writing and on approved
  forms and submitted to the IRB office.
• Investigators should not send formal
  communications to the Chair or any member of the
  IRB.

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5c. Full IRB Review

• Convened meetings are scheduled for 10 months per
  year, from September through June.
• The schedule is publicized on the IRBs web site.
  
• The deadline for submission of materials for full
  IRB is 10 days prior to the scheduled meeting.

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5c. Full IRB Review (contd)

• The IRB makes one of four decisions on reviewed
  research
• (1) Approval
• (2) Provisional Approval (the IRB authorizes the
  Chair or another member to review and approve
  required revisions)
• (3) Postponed (tabled, pending further
  information) or
• (4) Withheld (disapproved)

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5d. Continuing Reviews

• The IRB conducts reviews of all approved research
  on at least an annual basis.
• The IRB may require research to be renewed at an
  interval less than 365 days when it has
  determined
• (1) the research involves a high level of risk
  to subjects
• (2) the research involves an intervention or
  procedure that is highly experimental in nature
• (3) the investigator has violated IRB policies
  and procedures in the past or
• (4) the investigators initial application
  required substantial revisions and changes prior
  to receiving IRB approval such that the IRB
  believes that the investigator requires ongoing
  guidance to protect subjects.

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5d. Continuing Reviews (contd)

• Research may be renewed up to five years after
  initial approval on either an expedited or full
  IRB basis.
• After five years, investigators must submit a new
  IRB application to continue their research.
• The IRB, or Chair on expedited approvals, may
  grant a one-time extension, no longer than three
  months, of this five year limitation when
  circumstances warrant (e.g., an investigator is
  in the final stages of completing a five year
  externally funded study).

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5e. Amendments

• Any substantive changes or modifications in
  research approved by the IRB on an expedited or
  full IRB basis must be approved by the IRB.
• Investigators must request a formal amendment
  prior to making any changes or modifications.

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5f. Reviews of Adverse Events, Unanticipated
Risks, and Harms to Subjects

• Investigators are required to report immediately
  any adverse events, unanticipated risks, or harms
  to subjects.
• Adverse events, unanticipated risks, and harms
  include, but are not limited to
• death
• life-threatening adverse reaction to drugs or
• a research intervention, hospitalization or
  prolongation of hospitalization, serious injury,
  incapacity, congenital anomaly, severe
  psychological distress and trauma
• and violations of confidentiality and privacy
  that result in or threaten an individuals
  financial standing, employability, insurability,
  reputation, and social and family relationships.

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5f. Reviews of Adverse Events, Unanticipated
Risks, and Harms to Subjects (contd)

• In the event of an adverse event, the
  investigator shall
• notify the Office of Regulatory Compliance and
  IRB by phone immediately
• followed by a detailed written memorandum
  explaining the nature and scope of the harms and
  the reason for their occurrence.
• The investigator shall cease research activities,
  pending a full review by the IRB.
• Based on its review, the IRB may suspend or
  terminate approval for the research, impose
  sanctions on the investigator, or require the
  implementation of corrective steps.
• The research may not be resumed without formal,
  written approval by the IRB.

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5f. Reviews of Adverse Events, Unanticipated
Risks, and Harms to Subjects (contd)

• In the event of serious adverse events or
  incidents, the Office of Regulatory Compliance
  will inform the Office for Human Research
  Protections (OHRP) immediately by writing.

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6b. Summary of Proposal Rationale and Methods

• Investigators must provide a summary of their
  proposed research in non-technical terms.
• When research is to be carried out in cooperation
  with another institution or with an investigator
  at another institution, a letter of cooperation
  from the institution or investigator should be
  filed with the IRB
• When another IRB will review the research
  submitted to the Syracuse University IRB, a copy
  of the approval letter must be filed with the IRB
  prior to initiating the research.

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6b. Summary of Proposal Rationale and Methods
(contd)

• The IRB discourages deception in any form of
  experimental procedure. If an investigator
  believes that deception is necessary to conduct
  the research and is the only way to answer the
  research question(s), he or she must provide
• a detailed rationale to the IRB and
• ensure that psychological, social, and other
  risks will be minimized.
• Before approving deception in research, the IRB
  will require a procedure to be put into place
  that provides for a debriefing process.

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6b. Summary of Proposal Rationale and Methods
(contd)

• For Internet research
• investigators must protect the privacy and
  confidentiality of participants and obtain their
  informed consent. Investigators may not be
  required to obtain consent of persons to record
  information or communications in public Internet
  forums in which people do not have a reasonable
  expectation of privacy.
• In communications with persons in public or
  private Internet forums, investigators must not
  conceal their identities as investigators or
  mislead people about their purposes.
• Investigators must not communicate directly on
  the Internet with persons whom they believe are
  minors without their parents permission.

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6b. Summary of Proposal Rationale and Methods
(contd)

• In electronic surveys or interviews,
  investigators must take reasonable steps to
• protect peoples privacy and confidentiality,
  taking into account the sensitivity of questions
  asked of them.
• For interviews or surveys on non-sensitive
  topics, e-mail is generally acceptable.
• Interviews or surveys on sensitive topics should
  be conducted on a secure Web site.

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6d. Characteristics of Participants

• Equitable Selection.
• The selection of participants must be based on
  fair exclusion and inclusion criteria. All groups
  (based on gender, class, disability, ethnicity,
  age, and similar factors) should have the
  opportunity to benefit from research and to share
  equally in potential risks.
• Persons should not be included or excluded from
  research arbitrarily or based on the convenience
  of the investigators.

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6d. Characteristics of Participants (contd)

• The inclusion or exclusion of groups must be
  fully justified and based on a sound scientific
  or scholarly rationale.
• Statistical considerations (e.g., treating gender
  or ethnicity as a confounding variable in a
  study with a small sample size) cannot be used to
  include or exclude members of certain groups.

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6d. Characteristics of Participants (contd)

• Identification and Recruitment.
• Investigators must specify how they will identify
  and recruit research participants.
• Investigators are responsible for ensuring that
  anyone in a position of authority at an agency or
  organization does not exert pressure on persons
  to participate in the research.
• Recruitment letters or flyers should be submitted
  to the IRB and contain a brief description of the
  research, contact information on the
  investigators, and any inducements for people to
  participate. Letters or flyers should not
  exaggerate the benefits of participation in the
  research.

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6d. Characteristics of Participants (contd)

• Use of Syracuse University Faculty, Staff, and
  Students.
• The IRB determines whether investigators can
  recruit members of the university community for
  their research.
• Investigators are expected to ensure that
  participation of Syracuse University faculty,
  staff, or students in research is voluntary and
  free of coercion or pressure.
• The IRB discourages recruitment of participants
  by persons who have direct authority over them
  and will disapprove such research unless there is
  a clear rationale for recruiting such persons and
  participation is voluntary.
• Participation in research must not be made a
  condition of employment at the university or to
  satisfy the requirements of any university
  disciplinary proceeding.

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6d. Characteristics of Participants (contd)

• Students enrolled in Syracuse University courses
  may be offered extra credit to participate in
  research projects under the following condition
• (1) the research has been approved by the
  chairperson of the department in which the course
  is offered
• (2) students derive some benefit from
  participation in the research (e.g., learning
  about the nature of research)
• (3) students are offered an alternative
  assignment of a non-research nature that entails
  the comparable level of time as the research
• (4) informed consent is obtained for the
  specific research project from students
  themselves and, in the case of students under
  18, one or more of their parents (i.e., blanket
  consent to participate in non-specified research
  is not acceptable for students or parents)

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6d. Characteristics of Participants (contd)

• (5) students who participate in part, but not all
  of the research are offered partial credit for
  participation according to the amount of time
  spent (an alternative assignment comparable in
  time must be offered to enable students to
  receive full credit) and
• (6) the investigator submits the recruitment
  flyer or sign-up sheet to the IRB.
• The IRB will determine when these conditions are
  met. Whenever possible, the instructor of these
  courses should not know the identities of
  students who participate in research projects for
  credit.

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6d. Characteristics of Participants (contd)

• Incentives for Participation. The IRB reviews
  and approves incentives offered to subjects to
  participate in research. Incentives may include
• monetary payment
• course credit
• gift certificates, toys or educational materials
  for children and
• other items or services.
• Incentives or payments must not be of such an
  amount as to result in undue influence on an
  individuals decision to participate, especially
  in the case of persons who are poor.
• Incentives must not be provided on a schedule
  that results in coercion or undue influence on an
  individuals decision to continue participation.

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6d. Characteristics of Participants (contd)

• Payment to research participants must be arranged
  in a way that minimizes potential violations of
  privacy.
• Syracuse University employees who participate in
  research projects on a voluntary basis must be
  paid in the same manner as other participants.
  Since participation in research is independent of
  their employment, payment should not be reported
  as part of their regular salary or wages.

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6d. Characteristics of Participants (contd)

• The IRB discourages lotteries for the payment of
  research participants, since these may create
  unrealistic expectations.
• Incentives for participation in research are not
  considered as benefits of the research and should
  not be reported as such on the IRB application.

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6f. Informed Consent

• Consent forms must
• be typed on Syracuse University departmental
  letterhead.
• have the name of the principal investigator or
  faculty advisor in the case of student research
  must be provided on the consent form
• have the IRB, with its phone number listed
• Informed consent should be thought of as an
  ongoing process, rather than a one-time event of
  having someone sign a form. Investigators should
  be attuned to participants preferences or
  second-thoughts about participating in research
  and periodically remind them of the voluntary
  nature of their participation.
• Subjects should be able to withdraw consent
  either orally or in writing.

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6f. Informed Consent (contd)

• Elements of Informed Consent
• Unless a waiver is granted by the IRB, informed
  consent must be obtained in order for the subject
  to participate in the research (see the IRB's web
  site for a sample consent form).

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6f. Informed Consent (contd)

• For research that involves more than minimal risk
  and poses the possibility of injury, an
  explanation as to whether medical treatments and
  compensation are available if injury occurs and
  where further information may be obtained

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6f. Informed Consent (contd)

• Documentation of Informed Consent. The IRB
  requires that informed consent be documented in a
  written consent form approved by the IRB prior to
  formal recruitment of participants and signed by
  the participant or the participants authorized
  representative.

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6f. Informed Consent (contd)

• Compensation for Injury and Liability. In
  research that entails a reasonable risk of
  injury, the IRB requires that procedures and
  payment for medical or other care and
  compensation be explained to participants during
  the consent process.
• Investigators must not use exculpatory language
  through which participants or representatives are
  made to waive or appear to waive any legal rights
  or releases or appears to release the
  investigator, sponsor, university, or the
  universitys agents from liability for
  negligence.

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6f. Informed Consent (contd)

• Language such as We cannot provide compensation
  in the case of research related injuries is not
  acceptable.
• The IRB has approved standard language to be used
  in research that poses a risk of injury.
• The consent form must state We have not set
  aside funds for research related injuries.
  Signing this form does not waive any legal
  rights.

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6h. Risks to Participants

• The IRB assesses the risks of research and
  requires that investigators implement procedures
  to ensure that the risks of research are
  minimized.
• Investigators can minimize risks by using
  procedures that are consistent with sound
  research design, do not unnecessarily expose
  participants to risk, and, whenever appropriate,
  are already being performed on participants for
  diagnostic or treatment purposes.
• The IRB considers risks to both research
  participants and third parties (e.g., violations
  of privacy or confidentiality).

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If you have any questions, please do not hesitate
to contact our office! (See below)

• Office of Regulatory Compliance (ORC)
• 621 Skytop Road
• Kathy Reinhard, Director
• Patty Brundage, Administrative Assistant
• 443-3013, e-mail regcomp_at_syr.edu