University of North Carolina at GreensboroUniversity of North Carolina at Greensboro

Protecting Research Participants

Protecting Research Participants

What is Research?What is Research?

Research is an Research is an organizedorganized way to way to gather gather informationinformation that is useful that is useful for for as many peopleas many people as possible in as possible in the future.the future.

What is a Research Participant? What is a Research Participant?

Anybody we gather information about

The Belmont ReportThe Belmont Report

Respect voluntary consent protect those who cannot make decisions

Benefits Outweigh Harms maximize benefits & minimize risk of harm

Justice the burdens and benefits of research

should be distributed fairly

“I don’t know what they used us for.”

Survivor of Tuskegee Syphilis Study, 1932-72

The Belmont ReportThe Belmont Report

Applying GuidelinesApplying Guidelines

Principle Applications

Respect for Persons

•Informed consent•Privacy (Confidentiality and Anonymity)

Benefits/Harms •Protecting participants from harm•Assessment of risks and benefits

Justice •Choosing participants

Applying the Principles in Your Role

Applying the Principles in Your Role

HonestyHonesty Informed ConsentInformed Consent ConfidentialityConfidentiality

Rights of the Research Participants

Rights of the Research Participants

Right to accurate and complete Right to accurate and complete information about the studyinformation about the study

Right to informed consentRight to informed consent Right to refuseRight to refuse Right to privacyRight to privacy

Elements of Informed ConsentElements of Informed Consent

Your full nameYour full name Who is conducting the studyWho is conducting the study Purpose/content of the studyPurpose/content of the study Approximate length of the study Approximate length of the study Risks and benefits of participating (if any)Risks and benefits of participating (if any) Participation is voluntaryParticipation is voluntary Can stop participating at any timeCan stop participating at any time Responses are confidentialResponses are confidential

INFORMED CONSENT“GETTING PERMISSION FROM RESEARCH

PARTICIPANTS”

INFORMED CONSENT“GETTING PERMISSION FROM RESEARCH

PARTICIPANTS”

Consent is a PROCESS... Researcher tells all important

information Participant has chance to ask

questions Researcher answers questions Participant signs a consent form

agreeing to participate

UNDERSTANDING CONSENTUNDERSTANDING CONSENT

Clearly written Everyday words Plan for participants who cannot

read

Institutional Review Board (IRB)

Institutional Review Board (IRB)

An IRB is a committee that reviews proposed research studies to ensure that participants are protected from unfair treatment and risks that could be caused by the research

Every research project involving human participants must gain the approval of at least one IRB; sometimes more than one

Functions of the IRBFunctions of the IRB Ensure that research participants are treated Ensure that research participants are treated

ethically at all times (principles of the ethically at all times (principles of the Belmont report)Belmont report)

Ensure that researchers are adequately Ensure that researchers are adequately gaining informed consent from every research gaining informed consent from every research participantparticipant

Monitor projects to ensure adherence to Monitor projects to ensure adherence to protocolprotocol

Provide a contact point for participants if they Provide a contact point for participants if they are concerned about their rightsare concerned about their rights

Handle reports of violations of participants’ Handle reports of violations of participants’ rights or adverse outcomes of the researchrights or adverse outcomes of the research

Special PopulationsSpecial Populations

Children and MinorsChildren and Minors PrisonersPrisoners Pregnant women and fetusesPregnant women and fetuses Cognitively impaired personsCognitively impaired persons Students/employeesStudents/employees

ConfidentialityConfidentiality

We are dependent upon the goodwill of We are dependent upon the goodwill of the participants in order to carry out a the participants in order to carry out a valid studyvalid study

This requires their trustThis requires their trust Cornerstone of trust is knowing that we Cornerstone of trust is knowing that we

will keep the information they provide will keep the information they provide confidentialconfidential

Confidential vs. AnonymousConfidential vs. Anonymous

Anonymous means the research Anonymous means the research participant’s identity is not known, even to participant’s identity is not known, even to the interviewer.the interviewer.

Confidential means we have identifying Confidential means we have identifying information about the research participant information about the research participant (in some cases, only a phone number (in some cases, only a phone number and/or first name) but we will not and/or first name) but we will not revealreveal that information to anyone.that information to anyone.

Confidential Means…Confidential Means… Names will not be associated with Names will not be associated with

responses when results are reportedresponses when results are reported Information research participants give you Information research participants give you

must not be shared with must not be shared with anyoneanyone else—not else—not even other interviewerseven other interviewers

Do not tell research participants what other Do not tell research participants what other participants have said, even if they ask you participants have said, even if they ask you what other people thinkwhat other people think

Information about a research participant Information about a research participant and/or his data can and/or his data can notnot be left in an be left in an unsecured place.unsecured place.

Confidentiality is SeriousConfidentiality is Serious

You must sign a Confidentiality You must sign a Confidentiality Statement before calling or speaking Statement before calling or speaking with any research participantswith any research participants

Violation of the terms of the Statement Violation of the terms of the Statement is grounds for immediate dismissal.is grounds for immediate dismissal.

The Only ExceptionsThe Only Exceptions

If you have reason to believe a research If you have reason to believe a research participant is in a situation so dangerous participant is in a situation so dangerous that they are a threat to themselves or that they are a threat to themselves or others, alert your supervisor others, alert your supervisor immediately.immediately.

Suspected child abuse must be Suspected child abuse must be reported to the authorities per North reported to the authorities per North Carolina lawCarolina law

PrivacyPrivacy

All personal information remains confidential (private) Behaviors Lab tests Questionnaire results Age, phone numbers, etc

If Research Participants have Questions…

If Research Participants have Questions…

For questions about the study, what the For questions about the study, what the data will be used for, etc.: principal data will be used for, etc.: principal investigator or study staffinvestigator or study staff

For questions or concerns about rights For questions or concerns about rights as a research participant: director of as a research participant: director of the UNCG Office of Research the UNCG Office of Research Compliance (Provided on Study Info Compliance (Provided on Study Info Sheet)Sheet)

SummarySummary

Research involving peopleResearch involving people Helps make better programs or Helps make better programs or

treatmentstreatments Only done with permission of Only done with permission of

participantsparticipants Rules to make it as safe as possibleRules to make it as safe as possible Must be approved by an IRBMust be approved by an IRB

AcknowledgementsAcknowledgements

Slides adapted from work by Daniel K. Nelson

Director, Office of Human Research EthicsAssociate Professor of

Social Medicine and Pediatrics, UNC School of Medicine

Teresa EdwardsAssistant Director for Survey Research and Development

H W Odum Inst Research Social Sciences, UNC