Betsy Ripley, MD, MSProfessor of Medicine Division of NephrologyVCU IRB Senior ChairVCU Clinical Research Compliance OfficerAssociate Chair Faculty Development for [email protected]
Must adhere to Federal regulations
Monitored by local Institutional Review Boards (IRBs)
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979)Three basic principles should govern the
conduct of research involving human subjects:Respect for personsBeneficenceJustice
The Belmont Report. National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research. 1979.
“Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.”
The Belmont Report. National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research. 1979.
Treat individuals as autonomous agentsDon’t use people solely as a means to an
endLet people make their own decisionsProvide additional protections for those
with diminished autonomyPractical applications:
Informed consentInformationComprehensionVoluntariness
Privacy and confidentialityThe Belmont Report. National Commission for
the Protection of Human Subjects of Biomedical and Behavioral Research. 1979.
“Beneficence is understood…as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: do no harm, and maximize possible benefits and minimize possible harms.”
The Belmont Report. National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research. 1979.
Don’t merely be niceDo no harmPromote welfareMaximize possible benefitsMinimize risks of harmsPractical applications:
Study designRisk/benefit analysisQualified and competent investigators
The Belmont Report. National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research. 1979.
Justice requires that we treat persons fairly and we give each person what he is owed
The principle requires that both benefits and burdens be distributed fairly
Practical applications:Selection of subjects is equitableRecruitmentPopulations under study
The Belmont Report. National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research. 1979.
1. Risks minimized2. Favorable risk-potential benefit analysis3. Equitable selection4. Informed consent sought5. Informed consent documented6. Data monitored for safety7. Privacy protected; confidentiality
maintained8. Safeguards for vulnerable individuals
The tension was anticipated and expectedSubjective judgment calls will often be
requiredReasonable people will disagree
45CFR46 “The Common Rule” * HHS research regulations OHRP
21CFR50, 56 * FDA research regulations Federal-wide assurance (FWA)
Responsible conduct of research * Office of Research Integrity
Established to provide ethical review of research
Assure that federal regulations are followedMembers include researchers, non-
researchers and members of the local community
5 IRBs at VCURegulatory and ethical charge: review and
approve ‘human subjects research’
RESEARCH –A systematic investigation designed to develop or
contribute to generalizable knowledge. 45 CFR 46.102(d)
HUMAN SUBJECTA living individual about whom an investigator…
conducting research obtains 1) data through intervention or interaction with the
individual, or 2) identifiable private information
45 CFR 46.102(f)
‘Systematic’: use of data analyses, scientific methods – (can include ‘nonresearch’ projects)
AND What about ‘generalizable’?
Considerations:
Intent to publish/present does not necessarily define a project as research – what is the intent?
Is the intent to contribute to the knowledge base of your profession/discipline by drawing conclusions and/or to make generalizable claims based on systematic methods?
If so, it is ‘research’
A major goal of (non-therapeutic) research is to benefit people other than the immediate research subjects
Quality improvement/ QA projects – designed with goal of improving institutional/organizational practice
Resource utilization reviewCase report or case series – if no systematic
investigation, i.e. no statistical or data analysis; no outcome measures
Public health practice – surveillance, program evaluation
Survey/questionnaire development – no data retained for research purposes
More straightforward Interventions or interactions with living personsAccess to identifiable personal data
Secondary data sets without ANY identifiers or codes generally do not involve human subjects
*Note difference between de-identified and anonymized
Chart/medical record reviews to address hypothesis or research question(s)
Surveys, including Internet-based surveys Randomized intervention and control group Creating data registries/tissue banks Data analysis of primary or secondary data
from data registries or tissue repositories that contain identifiers or codes
Interventions/procedures that utilize randomization or a control group
HOWEVER, if …- there is a question- a project might become research- there is potential to publish or present
THEN…
- Contact ORSP or OECO or IRB member with questions
- Submit to the IRB if unsure: protect your ability to present or publish and ensure subjects are protected
Think about your project.
Do you have any ethical concerns about your project? Are their changes or clarifications or safety measures that could mitigate those concerns?
Does it involve Human Subjects Research? Why or Why not?
Website –Institutional Review Board (IRB) https://irb.research.vcu.edu
RamsIRB
Level of potential risk to subjects determines type of review
Exempt ------ Expedited ------ Full board Low risk ------------ High risk(click on “forms” on the IRB website to receive guidance on
determining review type:
www.research.vcu.edu/forms/vcuirb.htm)
“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 during the performance of routine physical or psychological examination or tests.
Kinds of Risk
Just plain inconvenience and hassle
Emotional or psychological risk
Social riskPhysical riskEconomic riskLegal risk
Risk To Whom?
The subjectThe subject’s
institutionThe familyThe communityThe researcher & his
institutionScienceSociety
Joan Sieber
Reviewed for exemption from informed consent requirement and continuing IRB reviewInvolves a non-vulnerable population (does
not generally include children, prisoners, decisionally impaired,
economically or educationally disadvantaged)Low-risk researchDoes not include recorded identifiers or
codesQuestions generally are not sensitiveFits one of 6 categories of research
1. Typical educational practices
2. *Educational tests, surveys, interviews, or observation of public behavior (non-sensitive, no identifiers) No children for surveys, interviews or obs of public behavior where research is involved.
3. Research with elected public officials, appointed public officials,candidate for public office)
4. *Existing data, documents, pathological specimens, if publicly available or recorded to be unidentifiable
5. Evaluation of public benefit service programs
6. Taste and food quality evaluation and consumer acceptance studies
EXAMPLES: medical record review; surveys/questionnaires with no recorded identifiers or codes
Meets federal criteria for minimal risk research (considers risk of criminal/civil liability, financial risk, employment risk, stigmatization, insurability, and embarrassment)
May include identifiers (direct or indirect) but topics not sensitive OR
May include some sensitive topics, but confidentiality securely protected
Need to consider a formal informed consent process OR justify a waiver of consent
Clinical studies: IND/IDE NOT required
Blood sample collection (routine methods –small amounts)
Prospective collection of biological samples—noninvasive means
Data collected though noninvasive means (routinely practiced in clinical settings)
Materials (data, documents, specimens etc.) have been collected or will be collected for non-research purposes
Collection of voice, video or digital data for research purposes
Individual or group behavior, surveys, interviews, oral histories
What is the risk level of your study? Why?Does your study qualify for exempt,
expedited, or full board review? Remember it must fit completely within that category.
Click on the help icon in RAMSIRBSeek consultation from someone on the IRB
from your area or from an experienced researcher
Call the IRB office or OREC for consultationReview the WPPs and IRB guidance on the
website (links on application)Call/email me [email protected],
804-828-1955
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