Ethical Issues

NIH Training &NIH Training &

Berg—Chapter 3Berg—Chapter 3

NIH Course

• National Institutes of Health. National Institutes of Health. http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asphttp://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp

• Belmont Report, 1979Belmont Report, 1979• Respect for Participants (autonomy)Respect for Participants (autonomy)

• Informed consentInformed consent• No pressure to agree or continueNo pressure to agree or continue

• BenificienceBenificience• Potential benefit does not justify potential harm.Potential benefit does not justify potential harm.• Maximize benefit and minimize potential harm.Maximize benefit and minimize potential harm.

• JusticeJustice• Participants should be a group that has potential benefitParticipants should be a group that has potential benefit

NIH Course

• Tuskegee Syphilis Study—1930s, Tuskegee Syphilis Study—1930s, Penicillin shown effective in 1940s, Penicillin shown effective in 1940s, study continued until 1972.study continued until 1972.

• Jewish Chronic Disease Hospital Study, Jewish Chronic Disease Hospital Study, 1963, injected live cancer cells in sick 1963, injected live cancer cells in sick people to show they rejected it more people to show they rejected it more slowly than health people, informed slowly than health people, informed consent not documented.consent not documented.

NIH Course

• The Willowbrook Study, 1963-66The Willowbrook Study, 1963-66  To   To understand the natural history of understand the natural history of infectious hepatitis, children were infectious hepatitis, children were deliberately infected. Parents unable to deliberately infected. Parents unable to admit their children to Willowbrook admit their children to Willowbrook unless they agreed to their participation unless they agreed to their participation in the studies. in the studies.

NIH Course• The The Nuremberg CodeNuremberg Code served served

as the first set of principles as the first set of principles outlining professional ethics.  outlining professional ethics.  The ten points included the The ten points included the statement that "voluntary statement that "voluntary consent of the human subject is consent of the human subject is absolutely essential." absolutely essential." 

NIH Course• The The Declaration of HelsinkiDeclaration of Helsinki was developed by was developed by

the World Medical Association for use by the the World Medical Association for use by the medical community following dissemination of medical community following dissemination of the Nuremberg Code.the Nuremberg Code.

• Declaration made informed consent a central Declaration made informed consent a central requirement while allowing for surrogate consent requirement while allowing for surrogate consent when the research participant is incompetent, when the research participant is incompetent, physically or mentally incapable of giving physically or mentally incapable of giving consent, or a minor. Research with these groups consent, or a minor. Research with these groups should be conducted only when the research is should be conducted only when the research is necessary to promote the health of the necessary to promote the health of the population represented and when this research population represented and when this research cannot be performed on legally competent cannot be performed on legally competent persons. persons.

NIH Course• Who—Who—

• Living individual information Living individual information through intervention or interaction through intervention or interaction with individual, orwith individual, or

• Identifiable private information.Identifiable private information.

• Third party (e.g., questions about Third party (e.g., questions about parents)—need 3parents)—need 3rdrd party approval. party approval.

NIH Course• Vulnerable PopulationsVulnerable Populations

• Children. Children. • Individuals with questionable capacity to Individuals with questionable capacity to

consent. consent. • Prisoners. Prisoners. • Fetuses and pregnant women. Fetuses and pregnant women. • The terminally ill. The terminally ill. • Students/employees. Students/employees. • Comatose patients. Comatose patients.

NIH Course• The informed consent form must indicate the The informed consent form must indicate the

researcher's obligation to report certain researcher's obligation to report certain observations, if such duty exists, as well as to observations, if such duty exists, as well as to offer assistance to participants in needoffer assistance to participants in need

• Where there is a particularly high risk of Where there is a particularly high risk of stigmatization based on participation in a stigmatization based on participation in a research project, the IRB may waive the research project, the IRB may waive the requirement that written informed consent requirement that written informed consent

• There are no clear rules or standards for payment There are no clear rules or standards for payment other than a general prohibition against coercion other than a general prohibition against coercion or the exercise of undue influence. or the exercise of undue influence. 

NIH Course• PrivacyPrivacy has also been defined as has also been defined as

freedom from unwanted intrusion.  freedom from unwanted intrusion.  Privacy may mean the right not to Privacy may mean the right not to know certain information, even about know certain information, even about oneself, and the right to prevent oneself, and the right to prevent others from obtaining or using others from obtaining or using personal information.personal information.

• Breaches of confidentiality are Breaches of confidentiality are disclosures to third parties, without disclosures to third parties, without patient consent or court order.  patient consent or court order. 

NIH Course• Confidentiality--following routine practices: Confidentiality--following routine practices:

• Substituting codes for identifiers or encrypting Substituting codes for identifiers or encrypting identifiable data identifiable data

• Removing face sheets from survey instruments Removing face sheets from survey instruments containing data containing data

• Properly disposing of computer sheets and other Properly disposing of computer sheets and other papers papers

• Limiting access to identifiable data Limiting access to identifiable data • Educating staff on the importance of confidentiality Educating staff on the importance of confidentiality • Storing paper records in locked cabinets or Storing paper records in locked cabinets or

assigning security codes to computerized recordsassigning security codes to computerized records

NIH Course• Under Federal law, and some state laws, Under Federal law, and some state laws,

researchers can obtain an advance researchers can obtain an advance Certificate of ConfidentialityCertificate of Confidentiality that will provide that will provide protection against a subpoena. protection against a subpoena.

• Certain information must be disclosed to third Certain information must be disclosed to third parties by law: parties by law: • Information indicating a risk of harm to others Information indicating a risk of harm to others

(usually homicidal thoughts) (usually homicidal thoughts) • Information indicating a risk of harm to self Information indicating a risk of harm to self

(usually suicidal thoughts) (usually suicidal thoughts) • Disclosures about child abuse Disclosures about child abuse • Disclosures about infectious diseases required to Disclosures about infectious diseases required to

be reported to public health authorities be reported to public health authorities

NIH Course—Informed Consent• Not all of these are needed for every Not all of these are needed for every

studystudy

• A statement that the study involves A statement that the study involves researchresearch

• An explanation of the purpose of the An explanation of the purpose of the research, an invitation to participate and research, an invitation to participate and explanation of why the participant was explanation of why the participant was selected, and the expected duration of the selected, and the expected duration of the participant's participationparticipant's participation

NIH Course—Informed Consent• A description of procedures and identification of A description of procedures and identification of

which are investigational and which might be which are investigational and which might be provided as standard care to the participant in provided as standard care to the participant in another setting. another setting. 

• Use of research methods such as randomization Use of research methods such as randomization and placebo controls should be explainedand placebo controls should be explained

• A description of any foreseeable risks or A description of any foreseeable risks or discomforts to the participant, estimate of their discomforts to the participant, estimate of their likelihood, and a description of steps taken to likelihood, and a description of steps taken to prevent or minimize them. Acknowledgment of prevent or minimize them. Acknowledgment of potentially unforeseeable riskspotentially unforeseeable risks

NIH Course—Informed Consent• A description of any benefits to the participant A description of any benefits to the participant

or to others that may reasonably be expected or to others that may reasonably be expected from the research, and an estimate of their from the research, and an estimate of their likelihoodlikelihood

• A disclosure of any appropriate alternative A disclosure of any appropriate alternative procedures or courses of treatment that might procedures or courses of treatment that might be advantageous to the participantbe advantageous to the participant

• A statement describing to what extent records A statement describing to what extent records will be kept confidential, including examples of will be kept confidential, including examples of who may have access to research recordswho may have access to research records

NIH Course—Informed Consent• For research involving more than minimal risk, an For research involving more than minimal risk, an

explanation of any compensation and any medical explanation of any compensation and any medical treatments that are available if participants are treatments that are available if participants are injured through participation; where further injured through participation; where further information can be obtained, and whom to contact information can be obtained, and whom to contact in the event of research-related injuryin the event of research-related injury

• An explanation of whom to contact for answers to An explanation of whom to contact for answers to questions about the research and the research questions about the research and the research participant's rights (including the name and phone participant's rights (including the name and phone number of the Principal Investigator (PI));number of the Principal Investigator (PI));

NIH Course—Informed Consent• A statement that research is voluntary and A statement that research is voluntary and

that refusal to participate or a decision to that refusal to participate or a decision to withdraw at any time will involve no penalty withdraw at any time will involve no penalty or loss of benefits to which the participant is or loss of benefits to which the participant is otherwise entitled;otherwise entitled;

• A statement indicating that the participant is A statement indicating that the participant is making a decision whether or not to making a decision whether or not to participate, and that his/her signature participate, and that his/her signature indicates that he/she has decided to indicates that he/she has decided to participate having read and discussed the participate having read and discussed the information presented. information presented.

NIH Course--Exempted• Research conducted in established or commonly Research conducted in established or commonly

accepted educational settings, involving normal accepted educational settings, involving normal educational practices—this class project is exampleeducational practices—this class project is example

• Research involving the use of educational tests Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or survey procedures, interview procedures, or observation of public behavior, unless: observation of public behavior, unless:

• Information obtained is recorded in such a manner that Information obtained is recorded in such a manner that human participants can be identified, directly or through human participants can be identified, directly or through identifiers linked to them. identifiers linked to them.

• Any disclosure of the human participant's responses Any disclosure of the human participant's responses outside the research could reasonably place the participant outside the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the at risk of criminal or civil liability or be damaging to the participant's financial standing, employability, or reputation. participant's financial standing, employability, or reputation.

NIH Course--Exempted• Research involving the use of Research involving the use of

educational tests (cognitive, educational tests (cognitive, diagnostic, aptitude, achievement), diagnostic, aptitude, achievement), survey procedures, interview survey procedures, interview procedures, or observation of public procedures, or observation of public behavior if: behavior if: • The participants are elected or appointed The participants are elected or appointed

public officials or candidates for public public officials or candidates for public office. office.

NIH Course--Exempted• Research involving the collection or study of Research involving the collection or study of

existing data, documents, records, pathological existing data, documents, records, pathological specimens, or diagnostic specimens, if these specimens, or diagnostic specimens, if these sources are publicly available or if the information is sources are publicly available or if the information is recorded by the researcher in such a manner that recorded by the researcher in such a manner that participants cannot be identified, directly or through participants cannot be identified, directly or through identifiers linked to them identifiers linked to them

• Research and demonstration projects conducted by Research and demonstration projects conducted by or subject to the approval of Federal department or or subject to the approval of Federal department or agency heads and designed to study, evaluate, or agency heads and designed to study, evaluate, or otherwise examine public health benefit or service otherwise examine public health benefit or service programs programs

• Taste and food-quality evaluation and consumer Taste and food-quality evaluation and consumer acceptance studies acceptance studies

Passive vs. Active Consent

• Passive consent. You have children take a Passive consent. You have children take a form home and if it does not come back form home and if it does not come back saying no, you include the child.saying no, you include the child.

• Active consent. You must exclude any child Active consent. You must exclude any child who does not return a form with the parent’s who does not return a form with the parent’s consent.consent.

• Now active consent is expected, but how do Now active consent is expected, but how do you exclude those who do not have it from you exclude those who do not have it from participating in the experiment?participating in the experiment?

Anonymity vs. Confidentiality

• Anonymous means there is no way to Anonymous means there is no way to connect the participants name to their data.connect the participants name to their data.• Student evaluations in a large classStudent evaluations in a large class• Small class if you check gender and expected Small class if you check gender and expected

grade, instructor could identify.grade, instructor could identify.

• Confidential means that the name and data Confidential means that the name and data link are known only to research staff.link are known only to research staff.

Written, Verbal, & Implied Consent

• We have focused on written consent. Difficult We have focused on written consent. Difficult to do with telephone surveys.to do with telephone surveys.

• Verbal consent involves reading informed Verbal consent involves reading informed consent document and asking for approval consent document and asking for approval verbally.verbally.

• Some say if you describe the study, risks, etc. Some say if you describe the study, risks, etc. and they do it, then you have implied and they do it, then you have implied consent. This does not go over well with consent. This does not go over well with IRBs.IRBs.

Data Management

• You want to keep the link between the You want to keep the link between the name and the data as separate as name and the data as separate as possible. possible. • Only keep an identification number with the Only keep an identification number with the

stored data.stored data.• Destroy the link to the person after data is Destroy the link to the person after data is

entered and validated.entered and validated.• Store link and original data in locked file in Store link and original data in locked file in

a locked room that has controlled access.a locked room that has controlled access.

Web Based Surveys

• Participants may presume they have Participants may presume they have anonymity. anonymity.

• Depending of software this may or may Depending of software this may or may not be the case.not be the case.