Lessons Learned from Henrietta
Lacks: Rowan’s Policies on
Protecting Human Subjects
Presented by the Office of Sponsored Programs
and
University Advancement
October 25, 2012
What is a Human Subject?
• A living individual about whom an investigator (professional or
student) conducting research obtains:
• Data through intervention or interaction with the individual
• Identifiable private information
Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or
contribute to generalizable knowledge.
Research might look like:
• Surveys, questionnaires, interviews, focus groups, specimens,
behavioral studies, medical chart reviews.
Why Did the Government Get Involved
with Human Subjects Research?
When the federal government began to seriously fund research
in academic institutions, there were very loose rules for human
subjects research.
Prior to the U.S. government involvement in the protection of
human subjects, several milestones occurred to encourage
global change.
1947 Nuremberg Code
• Formed in response to experiments by doctors in Nazi
Germany concentration camps (think of Henrietta’s sister
Elsie)
• Code was formed 4 years prior to the culture of HeLa cells
• Most U.S. researchers were familiar with the code, but
acceptance was not incorporated into U.S. law and therefore
had little overall effect on protecting human subjects
Code established:
 Essential voluntary consent
 Minimal research risks
 Based on pre-clinical studies on animals
 Subject’s right to terminate participation
1964 Declaration of Helsinki
A living document drafted by the World Medical Association.
Like Nuremberg Code, not legally binding in international law.
Identifies 12 markers of ethical research within the Nuremberg
Code and revises clarity of two markers. Some additions include:
• Formation of independent committees to review research
protocols (IRBs)
• Determination of whether research is therapeutic (benefits
subject) or purely scientific (doesn’t benefit subject)
• Removal of sexist language
• Establishment of vulnerable populations
• Requirement to keep patient informed about health
Tuskegee Syphilis Study
(1932-1972)
During a research project conducted by the U.S. Public Health
Service, six hundred low-income African-American males from
rural Alabama with a high incidence of syphilis infection were
monitored for 40 years. Subjects were given free medical
examinations, but they were not told about their disease
(compare to Declaration of Helsinki).
Although a cure (penicillin)
became available in the 1950s,
the study continued with
participants and their families
being denied treatment.
1966 U.S. Public Health Service
PHS’s response to the publicity of the Tuskagee Syphilis Study = first
nationwide policy for protection of human subjects by U.S. govt.
For all institutions that receive federal research funding:
• No funding will be provided unless the grantee has indicated
in the application the manner in which the grantee institution
will provide prior review of the judgment of the principal
investigator or program director by a committee of his
institutional associates. This review should assure an
independent determination: (1) of the rights and welfare of
the individual or individuals involved, (2) of the
appropriateness of the methods used to secure informed
consent, and (3) of the risks and potential medical benefits of
the investigation.
1979 Belmont Report
Drafted by a Commission formed by the U.S. Department of
Health and Human Services and published in the federal register.
Three basic principles:
• Respect for persons (autonomy)
• Beneficence (risk to benefit)
• Justice (fairly administered)
These principles remain the HHS foundation for human
subjection protections.
1991 Common Rule
Policies adopted by 17 federal agencies and based on the three
principles in the Belmont Report.
• Protocols must be reviewed by an IRB board to ensure:
• Respect – Voluntary, informed consent
• Beneficence- Maximize benefits and minimize harm
(risk/benefit assessment)
• Justice- Ensures selection of subjects is fair (i.e. protection
for vulnerable populations)
1996 HIIPA
Health Insurance Portability and Accountability Act
What Information Is Protected
• Information your doctors, nurses, and other health care
providers put in your medical record
• Conversations your doctor has about your care or treatment
with nurses and others
• Information about you in your health insurer’s computer
system
• Billing information about you at your clinic
• Most other health information about you held by those who
must follow these laws
Would it have protected Henrietta and her family?
Rowan University IRB Webpage
• Office of Research – Institutional Review Board (IRB) webpage:
http://www.rowan.edu/open/provost/research/Integrity_and_compli
ance/Irb/Irb.cfm
• Mission of Rowan’s IRB is to assure the safe and ethical treatment
of human subjects in research
• Composition of Rowan’s IRB
• Six volunteer faculty, including Chair
• Current Chair is Harriet Hartman
• Ex-Officio / Administration Representative
• Community Representative
• IRB Committee meeting dates are posted
Training and Policy
Training
• Online training administered by Collaborative Institutional Training
Initiative (CITI) - http://www.citiprogram.org
• Principal Investigators and key personnel need to complete training in
Human Subjects Research
• Current NIH Certificates are good for three (3) years; if expired, then CITI
training is required
IRB Policy
• Human subject research conducted by or under the auspices of Rowan
University will be performed in accordance with Title 45 Code of Federal
Regulations (CFR), Part 46
• All research involving human subjects that is conducted by anyone
affiliated with Rowan must be reviewed and approved by the IRB
Committee prior to such studies being undertaken
Oral History Policy
• Faculty should consult the Department Chair or Dean to determine
whether a project must be submitted to the IRB for approval
Submissions and Full Committee Review
Submission Deadlines and Application Review Results
• Applications are due approximately two weeks before an IRB meeting
• IRB accepts applications at anytime throughout the year
• If a valid reason exists and is provided, an expedited or just-in-time review
of the IRB application may occur
• Summer submissions are handled on a rolling basis, usually within two
weeks of submission date
• Review of IRB applications may result in the following:
•
•
•
•
Approved
Exempted
Declined
Pending
Full Committee Review
• Applications that do not meet Expedited or Exemption Review criteria
• Reviewed at a convened meeting of the full membership of the IRB
Expedited Reviews
• Research that presents no more than minimal risk to human
subjects
• Reviewed by the IRB Chair OR the Chair designates an experienced
IRB committee member
• Applicability:
• Have to meet one of the nine federal categories
• Categories include all subjects, regardless of their age
• Cannot be used when identification of the subjects and/or their
responses are easily identified to the subject and reasonably place
them at risk of criminal or civil liability or cause damage to subjects’
financial standing, reputation, employability, insurability or is
stigmatizing
• UNLESS there are reasonable and appropriate protections to be
implemented that will eliminate or mitigate the risk so that the risk is
not greater than minimal
Exemption Requests and Reviews
• Investigators cannot “self-exempt” from IRB Review
• Exemption does not mean that consent forms are not needed and
does not apply to research involving:
• Deception of subjects where the investigator does not describe the true
nature of the research and/or the results of the subjects participation
in the study
• Sensitive behavioral research
• Research involving pregnant women
• In vitro fertilization research
• Prisoners
• Mentally impaired
• Other vulnerable populations
• Exemptions have to meet federal guidelines and present no more
than minimal risk to the human subject
• IRB may request additional information from the investigator
• IMPORTANT: Investigators need to report any changes to exempt
human subject research; for example, changes to consent forms
Application & Revision Request Form
Application Form
• Use when initially submitting a human subject research project for review by
Rowan’s IRB
• Tips and Notes:
• Read the application carefully and complete ALL sections of the application
• Write responses in a short, concise, and clear manner
• Complete sentences are not necessary, except when conveying the purpose of the study
and sections where the response calls for a sentence or paragraph structure
• Use bullets
• Write in an active voice throughout the application
• Check for spelling and grammar mistakes
• If using a survey instrument or interview schedule, then include the instrument,
schedule, or questionnaire when submitting the application
IRB Revision Request Form
• Use when revising an Approved IRB Application
• Can email revisions to IRB Chair
• Tips and Notes:
• Submit revised application pages, and highlight revisions or additions to text
• List all revisions and follow up requests received from the IRB and include a
statement of how it was addressed
Continuing Review/Final Report Form
• If an IRB application’s research is allowed to be conducted, then it
commonly is referred to as a protocol
• Protocols have a performance period of one year
• Continuing review forms are only required for Approved protocols
• If protocols will be current and in existence after one year, then the form
is required to be completed and submitted to the IRB
• Important:
• Pertaining to regulations, work done under an Approved protocol is good
only for the time the protocol is current
• If work is performed after the protocol has expired and the protocol was
not continued, then it is a violation of the regulations and our federal
assurance
Consent Procedures and Form
• When performing research at a non-Rowan site location, then
evidence of approval to conduct the research at that site is required
• Applies to research participants and legal guardians
• As the Investigator, you should ensure that your consent form
covers the following:
•
•
•
•
•
•
Participation is voluntary and the subject agrees to be a subject
Clearly state the purpose of the study and the reason for the research
Statement of what is expected of the human subject
Statement regarding the confidentiality of the data
State the physical and psychological risks
Name and telephone number of Principal Investigator, faculty sponsor,
and in some cases, the Associate Provost For Research
• Associate Provost for Research contact information should be included
when the Principal Investigator is a faculty member
• If video or audiotapes are being used, a separate place for the
participant to sign or initial indicating that they are aware of this
procedure is necessary
Consent Form for Legal Guardians
Include the following on the consent form:
• Your position – Graduate Student, faculty, etc.
• Name of faculty advisor or Principal Investigator
• Purpose, reason, and goal of the study
• What is expected of the child and participation is voluntary
• Include whether or not audio or video will be used
• Confidentiality of data collected
• What the data will be used for and who may access the data
• Include whether it will be group data or individual data that is reported
• Include that the research results will / can be made available to all legal
guardians
• Statement that participation will not affect class standing, if study is
conducted via classroom setting
• Name and telephone number of Principal Investigator, faculty sponsor, and
in some cases, the Associate Provost For Research
• Associate Provost for Research contact information should be included
when the Principal Investigator is a faculty or staff member
• Provide a place for the legal guardian to indicate whether or not the child
is allowed to participate in the study and a signature line for the legal
guardian to sign
Alternate Consent Procedures
• Need approval from IRB to use in research
• Use when the only identifiable link between the subject and
research is the consent form
• Consent can be obtained by notifying the human subject
• Alternate consent form must include statements indicating:
•
•
•
•
•
•
All participation is voluntary
Clearly state you are conducting research and the reason
Include the purpose of the research
Statement that all responses will be kept anonymous and confidential
Statement that participants do not need to reply to all questions
If participants are students, then provide a statement that participation
in the study will not affect class standing
• Name and telephone number of Principal Investigator, faculty sponsor,
and in some cases, the Associate Provost For Research
• Associate Provost for Research contact information should be included
when the Principal Investigator is a faculty or staff member
Submission Procedures
• Fill out forms in their entirety
• When initially submitting an IRB Application, submit three (3)
hardcopies of the application to the Office of Research
• For multi-year research protocols, complete the IRB Continuing
Review Form and submit to IRB Committee prior to end date of
prior years’ research
• Note: In order to stay in compliance with regulations and our IRB
assurance to the federal government, Continuing Review Forms must
be completed prior to expiration date of original Approved protocol
• If a significant change from the previously Approved protocol is to
occur, then an amendment needs to be completed and submitted
to the IRB Committee
• Use IRB Revision Request Form
Submission Procedures (Cont’d)
Reporting Adverse Events
• Adverse events need to be reported if one or more human subjects
experiences an unanticipated event that involves increased risk to
themselves or others
• Reporting has to be performed by the Investigator
• Component of mandatory continuing review of Approved protocols
• Immediately report serious adverse events
Communication of IRB Review
• Communicated within two weeks of the meeting where the IRB
application is reviewed
• If an application is denied, then a new IRB Application needs to be
submitted to the IRB
Close-out / Protocol Expiration Procedures
• Only need to complete the Continuing Review/Final Report form if
the IRB Application is Approved
• Complete when the protocol will either expire or research is to
continue after the one year expiration date
• Complete the form in its entirety
• Submit to the Office of Research
• Faculty Advisors need to monitor their students to ensure timely
submission of the Continuing Review/Final Report form
• If the Office of Research does not receive a Continuing Review/Final
Report form for Approved protocols, then the Office of Research
may follow up with the Researcher and/or Faculty Advisor
Student Research Projects
• Need to obtain Faculty Advisor approval and signature
• Education Doctoral students need to obtain Doctoral Advisor
approval and signature
• Current Doctoral Advisor is James Coaxum
• Following guidelines are used to determine when a student
research project requires IRB review and approval
• Projects that are solely classroom directed exercises are NOT subject to
IRB review if the following conditions are met:
• Research takes place in a Rowan University classroom, departmental,
dormitory, or other Rowan University campus setting; or in a public setting
with generally unlimited access to the public – such as a shopping center or
street
• Involves only the learning of research techniques
• Does not put the subjects in a position where there is more than minimal
risk
• Data is recorded anonymously by the students – personal identifiable
information is not requested, retained, and used in the study
• Results of the research is NOT prepared for publication or other
dissemination and presentation outside of the classroom
Student Research Projects (Cont’d)
• When a student research project is not solely a classroom exercise,
then it should be submitted for IRB review
• Student projects qualifying under one or more of the six federally
exempted categories MUST BE submitted to the IRB Committee with a
request for exemption
• ALL non-exempt student projects MUST BE submitted to the IRB for full
or expedited review
• Students-Class projects course is available in the CITI training
• Faculty Advisors need to complete training
Cooper Health System, Cooper Medical School at Rowan
University, and Rowan University IRB
• Agreement exists between Cooper Health System and Rowan
University related to School of Medicine IRB Research Protocols
• Protocol template is available on Rowan University website
• Differences between Cooper Health System and Rowan University:
• Training requirements
• Application procedures
• Important: Check which IRB will need to review the research well in
advance of submitting the IRB application
Institutional Review Board – Q & A
Question #1: Do I need to provide a statement on the consent form describing
the extent, if any, to which confidentiality of records identifying the subject
will be maintained?
Answer: Yes, a human subject should have knowledge that their participation
will be confidential and how confidentiality will be maintained – Title 45: Part
46; Subpart A – Section 46.116(a)(5).
Question #2: Do I need to send an application to the IRB Committee when
submitting a research training proposal (institutional type of grants and
contracts) to a sponsor, of which it is known that future activities will involve
human subjects yet the extent of human research is unknown?
Answer: No, the proposal can be awarded without submitting an IRB
application – Title 45: Part 46; Subpart A – Section 46.118
Note: Prior to starting any human subject research, IRB Review Committee
review and approval is required.
Question: Do I need to submit an IRB application for human subject research for
my grant or contract that has already been awarded even though the research
awarded was not intended to involve human subjects?
Answer: Yes, at any time during an awarded research project if it is determined
that human subject research needs to occur, then prior to conducting the
human subject research, and IRB application needs to be filed and approved by
the IRB Committee – Title 45: Part 46; Subpart A – Section 46.119
Rowan IRB Contacts
Dr. Harriet Hartman, Professor
Sociology & Anthropology
x3787, hartman@rowan.edu
Karen Heiser, Secretary to the Associate Provost for Research
Office of Research
x4167, heiser@rowan.edu
Powerpoint slides can be found at:
http://www.rowan.edu/provost/grants/workshops/index.cfm