IRB Guidelines for CourseRelated Research on Human Subjects

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IRB GuidelinesforCourse-Related Research on
Human Subjects

• Presented By
• Office of Research Compliance
• Christina Booth, Director

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ORC Objective

• To form a partnership with students and their
  advisors and provide general research ethics and
  protections
• To facilitate student protocol submissions in
  conjunction with your advisor prior to review by
  the IRB
• To provide information on IRB guidelines

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Definition of Research with Human Subjects
www.hhs.gov/ohrp/humansubjects
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Facilitating Student Submissions
Students should not re-invent the wheel that
is, they can use sample forms on the ORC
website http//www.usm.maine.edu/orc/irb/

• Sample Forms select appropriate consent form
  template(s) and adapt to type of project
• Investigator Guidelines follow the USM IRB
  Application Checklist

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Why Is This Importantand Necessary?

• The templates meet basic federal guidelines
• IRB reviewers are familiar with the consent
  templates and protocol summary format, thus
  facilitating the review process

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Categories of Review/Determinations

• Full Board Review
• Expedited Review
• Exemption
• Not Human Subjects Research (is not a systematic
  investigation...designed to develop or contribute
  to generalizable knowledge (45 CFR 46.102 (d)
  is not going to be part of a public presentation
  or article for publication).

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How We Work Together to Facilitate the IRB Process

• Your professor is aware that they must complete
  the Course-required Data Collection form
• You are aware of IRB review criteria and check to
  see that your protocol meets that criteria
• You complete your NIH on-line certificate and
  forward your copy to ORC, or hand into your
  professor, who will collect everyones and
  forward in a packet
• You make sure your application and materials are
  in the best possible shape, utilizing the
  Application Checklist, prior to sending to ORC

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Analysts Role

• To assist in determining what level of review the
  protocol will require, or if it is exempt, not
  human subjects research, etc.
• Are the risks and benefits to participants
  indicated in the protocol summary included in the
  informed consent procedure?
• Does the research tool reflect the specific aims
  in the protocol summary and informed consent?
• Are informed consent procedures consistent with
  degree of risk noted in the protocol summary?

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The Use of Confidential Agency List Records

• Students must be mindful of how they are
  recruiting prospective subjects. For example,
  students must have permission from agencies to
  use confidential mailing lists, etc. (privacy
  issues)
• At their discretion, agency may agree to mail out
  a student survey on behalf of the student

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The Use of Confidential Agency Lists/Records
Contd

• An agency may agree to allow a records review by
  the student. If the agency falls under HIPAA
  regulations, students must abide by the policies
  and procedures of the agency as the covered
  entity under HIPPA. Trained if necessary by the
  agency.

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How to Get the NIH Online Training Certificate
Out of the Way!

• Suggestions for meeting this requirement?
• Some professors have made it a class assignment,
  and faculty have completed it at the same time
  students do.
• Faculty advising students do need to have a copy
  of their NIH certificate also. (On-campus RCR
  training is not a substitute!)

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training continued

• Students and faculty may also be required to have
  additional training (on-campus RCR, if they have
  NSF grants, etc.)
• HIPAA training may also be required (primarily
  from the covered entity where student collects
  the data)

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Tried and True Approaches to Course Assignments

• For students, without any prior research
  experience
• Literature reviews
• Hypothetical research projects that students do
  not carry out live
• Students serve as data collectors for one large
  course project developed by a faculty member
  (will require exemption determination or IRB
  review)

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Tried and True Approaches to Course Assignments
Contd

• Minimal risk studies such as with non-vulnerable
  populations/non-sensitive subject matters
• Minimal risk studies by proxy. Students
  interested in research with vulnerable
  populations use key informants. (e.g., people who
  work with trauma survivors)
• Students who have a lot of clinical
  experience/contact with a vulnerable population
  does not mean they have research experience
• Both will require either exemption determination
  or IRB review

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Addressing Privacy Issues

• Students conducting voluntary anonymous surveys
  of other students/staff must have options of
  places where participants can return surveys
  (e.g. a box in the Social Work Dept., mail-back
  locations, etc.)
• Group administered surveys are not out of the
  question. However, students who conduct surveys
  with their classmates should offer options of
  where to return surveys if their classmates do
  not wish to complete in a group setting, etc

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ORC Input

• Analyst can provide some assistance to students
  and make suggestions so that a study meets
  exemption criteria. However, students need to
  work directly with faculty on research
  methodology.
• Some research projects do not qualify for
  exemptions under any circumstances focus
  groups, oral history projects (Expedited Review),
  greater than minimal risk (Full Board)

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Definition of Minimal Risk

• Minimal Risk 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. (45 CFR
  46.102 (i))

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Greater than Minimal Risk Projects

• Federal Definition where identification of
  subjects and/or their responses would reasonably
  place them at risk of criminal or civil liability
  or be damaging to the subjects financial
  standing, employability, insurability,
  reputation, or be stigmatizing (Code of Federal
  Regulations)
• If so, have reasonable and appropriate
  protections been implemented so that risks
  related to invasion of privacy and breach of
  confidentiality are no greater than minimal?
  (45 CFR 46.110 (c))

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What are Greater than Minimal Risk Projects?

• Greater than minimal risk projects include the
  use of vulnerable populations (children,
  prisoners, pregnant women, people with diminished
  capacity to give consent, mentally or physically
  challenged individuals) and protocols/questions
  posed that are sensitive in nature for the
  previously named populations.

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Categories of Sensitive Information

• Information relating to sexual attitudes,
  preferences, or practices
• Information relating to the use of alcohol,
  drugs, or other addictive products
• Information pertaining to illegal conduct
• Information that if released could reasonably
  damage an individuals financial standing,
  employability, or reputation within the community

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Categories of Sensitive Information Contd...

• Information that would normally be recorded in a
  patients medical record and the disclosure of
  which could reasonably lead to social
  stigmatization or discrimination
• Information pertaining to an individuals
  psychological well being or mental health
• Genetic information

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Full Board Reviews

• It has been determined by the Board and
  Administration that Full Board Reviews are not
  appropriate for student protocols.

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IRB Approval Criteria

• Risks to subjects are minimized. Procedures used
  are consistent with sound research design and do
  not unnecessarily expose subjects to risk.
  Whenever appropriate, the research uses
  procedures already performed on subjects for
  other purposes, such as diagnosis or treatment
• Risks to subjects are reasonable in relation to
  anticipated benefits, if any, to the subjects,
  and the importance of the knowledge that may
  reasonably result from the study

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IRB Approval Criteria Contd

• The selection of subjects is equitable taking
  into account the purposes of the research and
  the setting in which the research will be
  conducted
• Informed consent is sought from each
  prospective subject or the subjects legal
  representative
• Informed consent is appropriately documented
  from each prospective subject in accordance with,
  and to the extent required by state and federal
  regulations

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IRB Approval Criteria Contd...

• Where appropriate, the research protocol makes
  adequate provisions for monitoring the data
  collected to ensure the safety of participants
• There are adequate provisions to protect the
  privacy of subjects and to maintain the
  confidentiality of data and
• Where some or all of the subjects are likely to
  be vulnerable to coercion or undue influence,
  additional safeguards have been included in the
  protocol to protect the rights and welfare of
  those subjects.

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Case Study 1

• A student who works for a small local mental
  health agency would like to conduct a voluntary
  anonymous survey of his co-workers about their
  experience with daily stress on the job. He
  plans to share the grouped results of his study
  with the agency and co-workers.

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Case Study 1 Contd...

• He has received permission of the agency to leave
  the surveys in co-workers mailboxes. He plans to
  offer options to participants as to how they can
  return the completed survey. They can put it
  into a designated box in the employee lounge or
  leave in his office mailbox.
• Will this study require IRB review?

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Case Study 1 Contd...

• Student will need to complete an IRB application,
  submit survey questions and recruitment letter
• Analyst will review
• This project will qualify for an Exemption

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Case Study 2

• A student who works for a healthcare agency plans
  to conduct a patients records review, and
  present the grouped results in a poster
  presentation. It is pre-existing data and will
  not be recorded in such a manner that there are
  identifiers/links to the records. (Cannot
  include Protected Health Information (PHI)
• Will this require IRB review?

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Case Study 2 Contd...

• The student will need to complete a Request for
  IRB Review application
• Analyst will review
• The project will qualify for an exemption with
  conditions

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Case Study 3

• A nursing student plans to conduct a focus group
  with some of his classmates regarding their
  experiences during their internship, and write an
  article for possible publication. The student
  has submitted the focus group consent form based
  on the IRB template, along with general aims of
  the questions to be asked.
• Will this require IRB review?

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Case Study 3 Contd

• Student must complete IRB request for review
• Because this is a focus group, the study does not
  qualify for an exemption, but it does qualify for
  an expedited review. IRB member will complete
  review and approval process

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Case Study 4

• A student wishes to conduct an oral history
  project about the experiences of Greek immigrants
  in Portland, and publicly archive the material as
  part of her thesis requirement. The student has
  filled out the IRB request for review and
  submitted the oral history consent form along
  with the protocol summary and general aims of her
  questions. The questions are minimal risk.
• Will this require IRB review?

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Case Study 4 Contd

• The study does not qualify for an exemption, but
  it does qualify for an expedited review. An IRB
  member will complete the review and approval
  process.

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Guidance on Informed Consent

• Waivers/alterations of Informed Consent
• When students apply for a waiver/alteration of
  informed consent, the rationale they provide
  makes a big difference!
• Written consent is required, unless waiver
  criteria are met.
• Under federal code, passive informed consent is
  not recognized.
• Very specific criteria must be met!

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Federal Waiver Requirements

• 2 categories of federal regulations (45 CFR 46.
  116 117) that outline what qualifies for a
  waiver of informed consent

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Federal Waiver Requirements Contd

• An IRB may approve a waiver/alteration of IC if
  the IRB finds and documents one of the following
• 1) the research or demonstration project is to
  be conducted by or is subject to the approval of
  state or local government officials and is
  designed to study, evaluate, or otherwise examine
  (i) public benefit or service programs, (ii)
  procedures for obtaining benefits or services
  under those programs (iii) possible changes in or
  alternative to those programs or procedures (iv)
  possible changes in methods or levels of payment
  for benefits or services under those programs
  and
• 2) the research could not be practicably
  conducted without the waiver

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Federal Waiver Requirements

• Further, an IRB may approve a waiver or
  alteration of IC if the IRB finds and documents
  that
• the research involves no more than minimal risk
• the waiver or alteration will not adversely
  affect the rights and welfare of the subjects
• the research could not practicably be carried out
  without the waiver or alteration and
• whenever appropriate, the subjects will be
  provided with additional pertinent information
  after participation

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Notification of Changes Required

• Students need to send in changes/clarifications
  promptly and highlight the changes they make on
  the protocol/materials
• Minor changes must be reviewed and verified prior
  to commencing research activities
• If major revisions/clarifications are required,
  they will need to be sent out to the IRB
  revieweragain!

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Final Remarks

• Students, faculty, and the ORC working together
  in partnership will help us all manage the IRB
  process.

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Useful Links

• NIH Training Module
• http//cme.cancer.gov/clinicaltrials/learning/hum
  anparticipant-protections.asp
• Office for Human Research Protection
• http//www.hhs.gov/ohrp/
• Belmont Report
• http//www.nihtraining.com/ohsrsite/guidelines/be
  lmont.html

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Useful Links

• Common Rule
• http//www.hhs.gov/ohrp/policy/common
• Declaration of Helsinki
• http//www.wma.net/e/policy/b3.htm
• Nuremberg Code
• http//www.nihtraining.com/ohsrsite/guidelines/nu
  remberg.html

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Useful Links Contd

• CDC Human Subjects Research Page
• http//www.cdc.gov/od/ads/opspoll1.htm
• Ethical and Legal Aspects of Human Subjects
  Research on the Internet
• http//www.aaas.org/spp/sfrl/projects/intres/main
  .htm
• National Bioethics Commission
• http//www.georgetown.edu/research/nrcbl/nbac/

Acknowledgement for Content Kathryn Kidder