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Informed Consent

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					Role and Responsibility of the IRB
 and the Investigator in Research
    Involving Human Beings
    What is Considered Human Research?
                (45 CFR 690.102d)

Any systematic or organized collection of data
 including research development, testing, and
 evaluation designed to develop or contribute to
 generalizable knowledge whether funded or
 non-funded.
Any data that are collected with the intent or
 probable intent to publish.
    General Requirements for Protection of
       Human Subjects [CFR 50.20]


“No investigator may involve a human being as a
  subject in research covered by these regulations
  unless the investigator has obtained the legally
  effective informed consent of the subject or the
  subject’s legally authorized representative.”
        Multiple Project Assurances

Temple operates has two IRB Committees:
 Two committees for the Hospital and Medical
 School

 One committee for Behavioral and Social
 Sciences on the Main Campus
 Temple University: Compliance to General
           Project Assurances
Assurances for Behavioral and Social Sciences
  Require:
Investigators must following ethical principles set
  forth in the “Belmont Report”, and All
  institutional and non-institutional performance
  sites for this institution, domestic or foreign, are
  obligated by Temple University to conform to
  ethical principles which are at least equivalent to
  those of the institution.
     Major Documents For Protection of
     Human Subjects Used in Research
• Nuremberg Code in 1947
• Declaration of Helsinki in 1964
• Belmont Report in 1979
• Council for the International Organization of Medical
  Sciences in 1982
• The “Common Rule” in 1991
    – Review of Research by an IRB
    – Informed consent of subjects
    – Institutional assurances of compliance
           Why is an IRB Necessary?


Nazi use of sterilization laws in 1933. German
 racial hygienists expressed their envy of the U.S.
 achievements in sterilization of 15,000 persons
 who were mostly incarcerated in prisons or in
 homes for the mentally ill.
            Why is an IRB Necessary?

Nuremberg Laws of 1935 excluded Jews from citizenship
 and prevented marriage or sexual relations with non-Jews
 -- reason for marital health. German racial theorist
 learned this from the U.S. in treatment of blacks with
 1/32 black ancestry made a person black whereas a
 person who was 1/8 Jewish was considered Aryan.
 AMA in 1939 turned down a petition of 5,000 black
 doctors to become members of the all-white society.
            Why is an IRB Necessary?

Nazi doctors injected prisoners with typhus (determine the
  course of the disease and effective treatments) or
  hepatitis (determine who was a carrier). In the U.S., the
  Willowbrook experiments (injected institutionalized
  retarded children with hepatitis) were performed. The
  Tuskegee Syphilis Study where treatment was withheld
  from men with syphilis without their consent to study the
  natural course of the disease. Exposure of U.S. troops to
  radiation from nuclear warheads.
Three Basic Ethical Principles of the Belmont
           Report [April 18, 1979]
Contains the Ethical Principles upon which the
 federal regulations for protection of human
 subjects are based.

          Respect for Persons
          Beneficence
          Justice
          Respect for Persons

Individuals should be treated as autonomous
agents.
Persons with diminished autonomy are entitled to
protection.
                 Beneficence
“Persons are treated in an ethical manner not only
  by respecting their decisions and protecting
  them from harm, but also by making efforts to
  secure their wellbeing.”
The obligation of beneficence is: “to do no harm
  and maximize possible benefits and minimize
  possible harm.”
                     Justice
“Who ought to receive the benefits of the research
  and bear its burdens?”
Seek “fairness” in distribution (selection) of
  subjects. Each person should have an equal share
  in the research, serve according to their needs
  and their individual effort, serve according to
  societal contribution, and each person serves as a
  subject according to merit.
Subject selection must be equitable.
    Assurances for Behavioral and Social
  Sciences Require That the Institution Will
       Give Proper Consideration to:

1. The risks to subjects (informants, interviewees),
2. The anticipated benefits to the subjects and
     others,
3. The importance of the knowledge that may
      reasonably be expected to result, and
4. The informed consent process to be employed.
         Institutional Responsibilities
Comply with all Federal, State, and Local Laws
Provide additional safeguards in research that
  involves:
   Fetuses or pregnant women
   Prisoners (see 45 CFR 46 subpart C)
   Children (see 45 CRF 46 subpart D)
   Cognitively Impaired or Other Vulnerable
    Populations
             IRB Responsibilities

Authority to Approve, Require Modification in,
  or Disapprove all Research Activities;
Initial and Continued Review of All Research
  Activities;
Ensure That Legally Informed Consent is
  Obtained and Documented; and
Determine Adequate Additional Protections and
  Safeguards for At-Risk Groups.
Other Professional/Organizations With Ethical
                 Guidelines

Oral History Evaluation Guidelines, Oral History
 Association, Pamphlet Number 3, Adopted 1989,
 Revised Sept. 2000
 [www.dickinson.edu/organizations/oha/Evaluation
 Guidelines.html]
Code of Ethics of the American Psychological
 Association [www.apa.org/ethics]
Other Professional/Organizations With Ethical
                 Guidelines

American Anthropological Association’s Code of
 Ethics [www.aaanet.org/committees/ethics/ethcode.htm]
Handbook of Ethical Issues in Anthropology
 [www.aaanet.org/committees/ethics/toc.htm]
         Categories of IRB Review


Exempt

Expedited

Full Committee
General Guidelines for Exempt Research

Research Conducted in established or commonly
 accepted educational settings, involving normal
 practices such as:
Research on special education instructional
 strategies
Research on the effectiveness of or the
 comparison among instructional techniques,
 curricula, or classroom management.
General Guidelines for Exempt Research
Research involving the use of educational tests,
 survey procedures, interview procedures, or
 observation of public behavior, unless:

 Information obtained is recorded in a manner that the
 human subject can be identified.

 Any disclosure of the human subjects’ response(s)
 could place the subjects at risk of criminal or civil
 liability or be damaging to the subjects’ financial
 standing, employability, or reputation.
   General Guidelines for Exempt Research

Research involved with the collection of existing
 data, documents, records, pathological specimens,
 or diagnostic specimens, if these sources are
 publicly available or if the investigator can record
 this information in a way that the subjects cannot
 be identified.
   General Guidelines for Exempt Research
Research or demonstration projects which are
  conducted by or subject to approval of
  Department or Agency heads with are designed to
  study, evaluate, or otherwise examine:
Public benefit or service programs, procedures for
  obtaining benefits or services under these
  programs, possible changes in or alternatives to
  those programs or procedures, or possible changes
  in method or levels of payment for benefits or
  services under those programs
 How Do I Know If My Research Is Exempt

A letter or protocol must be submitted to the IRB
 outlining the research design of the proposed
 research.
The IRB has the responsibility to determine
 exempt status, not the investigator
At least two members of the IRB make the
 determination for exempting a protocol
            Expedited Review Process
Expedited review procedures are for certain kinds of
 research involving no more than minimal risks,
 and for minor changes in previously approved
 research.
“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 through the performance of
  routine physical or psychological examinations or tests.”
  (45 CFR 610.102h)
           Expedited Review Process
Used for situations when there is a high volume of
  protocols to be reviewed and there is no at-risk or
  vulnerable subjects.
At least two members of the IRB at Temple review
  any protocol that has been submitted to the
  Manager or Chairperson of the IRB for expedited
  review.
Either or both reviewers can refer the protocol to the
  full committee for review.
            Full Committee Review


Full Committee Review is required for all protocols
  that involve vulnerable or at-risk subjects.

Full Committee Review is required for all protocols
  involving more than minimal risks.
           Role Conflict of Patient/Subject

 Patient                      Subject
Get Well                    Get Well
Stop Treatment              Add to Knowledge
Minimize Impact             Aid Interest Group
       Role Conflict of Student/Subject

  Student                Subject
Gain Knowledge         Gain Knowledge
Use Optimal Learning   Limited Learning
 Styles/Experiences     Styles/Experiences
Get Good Grade         Grade Secondary to
                        Learning Experience
   Investigators Must Recognize Potential
   Conflict(s) and Assure that Subjects are
        Protected from the Conflict(s)
Conflict(s) must be addressed in the Research
  Protocol submitted to the IRB for review.
Proper Informed Consent Process should minimize
  conflict(s).
For Action Research, what is normal educational
  practice and what is experimental must be
  clarified.
   Research In Schools: Family Educations
       Rights & Privacy Act (FERPA)

Defines rights of students and parents (guardians)
Requires written permission must be obtained to
 disclose personally identifiable information from
 student educational records.
Written parental permission to inspect student
 records if identifiers are linked to data.
Survey Research in Schools Governed by Protection
       of Pupil Rights Amendment (PPRA)
Surveys. Questionnaires, and Instructional Materials can be inspected
    by parents or guardians; and, Parental permission REQUIRED
    for minors to participate in survey revealing any of the following
    information:
Income                            Mental and psychological problems
Political Affiliation             Sex behavior and attitudes
Critical appraisals of other individuals with close family relationships
Illegal, anti-social, self-incriminating, and demeaning behavior
Legally recognized, privileged relationships
  Research Using College Students or Employees
            (Subordinated Individual)
Subject must have the ability to decline to participate
Incentives may not be unduly influencing choice to
   participate.
Confidentiality must be maintained for self-disclosure of a
   personal nature.
If course credit given, alternatives for receiving additional
   credit cannot be more burdensome than participation in
   the research.
Policies regarding giving course credit for participating in
   research must be clearly understood.
         Purpose of Informed Consent

As outlined in the Belmont Report:
 Informed consent is one of the primary ethical
 principles governing human subject research.
 Informed consent assures that prospective
 human subjects will understand the nature of the
 research and can knowledgeably and
 voluntarily decide whether or not to participate.
            Explanation of Research

Are the timing and setting for the explanation of
 the research conducive to good decision
 making?
Who will explain the research?
What can be done to enhance the prospective
 subject’s understanding/comprehension of the
 research to make an informed decision?
            Explanation of Research

Why is a particularly at-risk or vulnerable subject
 population being used?
Explanation of purpose of research and expected
 duration of the subject’s participation.
Description of procedures to be followed and
 identify those procedures that are
 experimental.
            The Consent Process

Informed consent is not a single event or just
  a form to be signed -- rather, it is an
  educational process that takes place
  between the investigator and the prospective
  subject.
 The Basic Elements of the Consent Process
                Include:
Full disclosure of the nature of the research and the
 subject’s participation
Adequate comprehension on the part of the
 potential subject, and
The subject’s voluntary choice to or not to
 participate in the research protocol.
          Consent vs Consent Forms
The consent form is merely the documentation of
  informed consent and does not, in itself,
  constitute informed consent.
Informed consent is a process which is
  documented by a signed consent form.
The fact that a subject signed a consent form does
  not mean he/she understood what was being
  agreed to or truly gave their voluntary consent.
     Comprehension of the Consent Form

Avoid technical terms and complex sentences,
 even for the educated lay person.
Translation is required if English is not the subject
 population’s primary language.
Age level writing is critical for understanding.
           Documentation of Consent

Format can help comprehend and remember
  complex material. Good format uses: headings;
  indents; bolded type; lists; extra spacing between
  sub-topics; repetition; reasonable-size type; and
  plenty of margins and empty space in general.
A Better Way To Format a Consent Form
Format can help comprehend and remember complex material.
  Good format uses:
• headings;
• indents;
• bolded type;
• lists;
• extra spacing between sub-topics;
• repetition;
• reasonable-size type; and,
• plenty of margins and empty space in general.
      Comprehension of the Consent Form
Informed consent is not valid unless the consentor
  understands the information that has been
  provided.
It is the responsibility of the investigator to do what
   he/she can to enhance each prospective subject’s
   comprehension of the information.
The investigator must consider the nature of the proposed
   subject population, the type of information to be
   conveyed, and the circumstances under which the
   consent process will take place in determining the
   appropriate way to present information.
     Comprehension of the Consent Form

For children, care must be take to ensure that the
  language is appropriate to their age level. For
  elderly subjects, oral information may have to be
  presented slowly and loudly and forms printed
  in large type.
When the subject population is not homogenous,
  different consent procedures may be required
  with different populations.
     Comprehension of the Consent Form

Even if the IRB has approved a consent procedure,
 it is the investigator’s responsibility to ensure
 that each potential subject understands the
 information and to take whatever steps are
 necessary to gain that comprehension.

Individuals may not be used as research subjects
  unless they understand the information that has
  been provided.
                  Voluntary Consent
Consent is a legal concept and only legally
 competent adults can give consent.
In most cases, minors cannot give consent, only parents or
   legal guardians can give consent for minors to participate
   in research.
Incompetent adults cannot give consent. This may
   include the developmentally disabled, the cognitively-
   impaired elderly, and unconscious or inebriated
   individuals.
The evaluation of competence must be made on a case by
   case basis.
                 Voluntary Consent
Even though children and incompetent adults cannot
 give consent to participate in research, their
 “assent” or agreement to participant should be
 obtained whenever possible.
Assent is “knowledge agreement” to participate and
  should be used whenever the potential subject has
  sufficient capacity to understand what is happening and
  express his/her wishes.
The “deliberate objection” of a subject should be
  construed as a veto of the consent of a parent or legal
  guardian, whether that objection is verbal or non-verbal.
Consent by Parents or Guardians [45 CRF
          46.406] for Child if:
1. No greater than minimal risk
2. Intervention or procedure holds out the prospect of
  direct benefit for the child or monitoring is likely to
  contribute to the well-being of the child.
3. There is only a minor increase over minimal risk and
  the intervention or procedure is likely to yield
  generalizable knowledge about the child’s disorder
  which is vital for the understanding or amelioration of
  the subject’s disorder or condition, or procedures
  reasonably commensurate with those of the expected
  clinical, social or educational experience
  Consent by Parents or Guardians [45 CRF
            46.406] for Child if:
For categories 1 and 2, one parent can sign the
  consent form.
For category 3, both parents have to sign the
  consent form.
The IRB requires a written consent. For children
  there is no passive consent. Assent to participate
  in the study is required depending upon the age of
  the child.
                Voluntary Consent

In order for a consent to be valid, consent must be
  freely given. This means that it is free from all
  forms of coercion.
In addition to overt coercion, the investigator needs
  to be sensitive to more subtle forms of coercion,
  such as social pressures, requests from authority
  figures, and undue incentive for participation.
       Eight Elements of Informed Consent
                 [21 CFR 50.25]
1.   Explanation of Research
2.   Risks/Discomforts
3.   Benefits to Subject or Others
4.   Disclosure of Alternative Procedures (More
      Applicable to Behavioral Research)
5. Involving More Than Minimal Risks
      Statement of compensation if included.
      Explanation of medical or other treatment(s) if available in the
        case of injury.
     Eight Elements of Informed Consent

6. Explanation of confidentiality procedures.
7. Explanation of whom to contact for answers to
    pertinent questions, research subjects’ rights,
    and if a research-related injury occurs.
8. Statement that participation is voluntary and
    refusal to participate will not involve a penalty
    or loss of benefits to which the subject is
    entitled.
           Confidentiality Procedures
Extent to which the institution intends to maintain
  confidentiality of records.
Informed that FDA may audit/review records.
  FDA will treat such information as confidential.
   Disclosure to third parties may be required.
  Absolute confidentiality by FDA should not be stated
   or implied. When clinical study is to be submitted to
   FDA, subjects need to agree to allow FDA access to
   records.
 Legal and Moral Breaches of Confidentiality
Legal: Investigator determines from the Beck Depression
  Inventory that subject is likely to harm her/himself [e.g.,
  suicide question in the Beck]. Subject reports that he/she
  is about to kill someone.

Moral: Investigator asks parent for consent to acquire
 assent from a child concerning the child’s worst
 experience. Child reports that he or she was abused by
 the parent. Although no legal requirement to report, but
 feels morally obligated to report the parent, the Consent
 Process has to address this moral obligation.
      Language in Consent for Breach of
              Confidentiality
“There is only one exception to this guarantee of
  confidentiality. If, during the course of this study,
  we discovered that you pose a serious risk of
  harming yourself, we would be required to break
  confidentiality in order to aid you in finding
  psychological help.”
       Voluntary Participation Statement:

Does the subject know and understand that:
 Participation in this study is entirely voluntary,
 and that refusal to participate will involve no
 penalty of loss of benefits to the subject.

Subject may discontinue participation at any time
  without penalty or loss of benefits.
  Compensation for Time to Participate as a
            Research Subject
Stipends for a subject’s time to participate in
  research should accrue as the study progresses
  and not be contingent upon completion of the
  entire study.
Can have a small additional payment for completion
  of the study (be careful that completion payment
  is not coercive).
           Compensation Statement:
Benefits of Payment
   Does subject receive compensation for time or
   not?
If compensation is received: how much, timing of
   payments, is payment prorated.
          Institutional Contact Statements:
If I have any questions about my rights as a research
   subject, I may contact the Institutional Review Board
   Manager, Ruth S. Smith at 215-707-3249.

If I have any questions about research-related injuries, I
   may contact (name and telephone number of
   principal investigator).
           Standard Injury Statement:
I understand that if I sustain any injury as a result
  of participation in this study, only physician’s
  fees and medical expenses not covered by my
  medical and hospital coverage or other third party
  coverage will be paid at no cost to me. I
  understand that financial compensation for such
  injuries is not available to me. I understand that I
  have not waived any of the legal rights which I
  would otherwise have as a participant in an
  investigational study.
                 Cost Statement:

Does the subject understand that study drug/device,
 physicians’ fees, and tests required by the study
 are provided at no cost?
                - or -
Does the subject understand that that the study
 drug/device, physicians’ fees and tests required by
 the study will be billed to the subject in the usual
 manner?
 Termination Statement and Final Statement
              and Signature:
Does the subject know and understand that:
  The investigator or the sponsor may terminate my
  participation in the study without the subject’s consent.
Can the subject certify that:
  This study has been fully explained with questions
   answered, the consent form has been read and
   explained, the subject voluntarily agrees to participate,
   and the subject will be given a copy of the consent
   form.
Responsibilities of the Investigator Following
            Approval of Protocol
Responsibilities include:
Immediately inform the IRB of any protocol
  modifications or amendments.
  Number of subjects
  Change in protocol
  Change in questionnaires or procedures
Immediately inform the IRB of changes of study
  investigators.
Responsibilities of the Investigator Following
            Approval of Protocol
Responsibilities Include:
Immediately inform the IRB of an anticipated
  change in the study site.
Immediately inform the IRB of any research
  injuries.
Maintain the Informed Consent and other
  appropriate documents in a secure location.
                      IRB Waiver
The IRB may waive the requirements for written
 documentation of consent in cases where:
The principal risk are those associated with a participation
  in the research; and the consent document is the only
  record linking the subject with the research;
OR
The research presents no more than minimal risk; and
  involves procedures that do not require written
  consent when performed outside of a research setting.
                     IRB Waiver
The IRB may approve a waiver of some or all of the
  consent requirements provided that:
The research involves no more than minimal risks to
  subjects;
The waiver will not adversely affect the rights and
  welfare of subject;
The research could not practically be carried out without
  the waiver; and
Whenever, appropriate, the subjects will be debriefed -
  provided with the additional pertinent information after
  they have participated in the study.

				
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