Lessons Learned from Henrietta Lacks: Rowan’s Policies on Protecting Human Subjects

Presented by the Office of Sponsored Programsand

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 consentMinimal research risksBased on pre-clinical studies on animalsSubject’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 ServicePHS’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 HIIPAHealth 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_compliance/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 PolicyTraining• 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 ReviewSubmission 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

• 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

Exemption Requests and Reviews

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 GuardiansInclude 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 & AQuestion #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, ProfessorSociology & Anthropologyx3787, hartman@rowan.edu

Karen Heiser, Secretary to the Associate Provost for ResearchOffice of Researchx4167, heiser@rowan.edu

Powerpoint slides can be found at: http://www.rowan.edu/provost/grants/workshops/index.cfm