Ethical Issues
NIH Training &
Berg —Chapter 3

NIH Course
• National Institutes of Health. http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp
• Belmont Report, 1979
• Respect for Participants (autonomy)
• Informed consent
• No pressure to agree or continue
• Benificience
• Potential benefit does not justify potential harm.
• Maximize benefit and minimize potential harm.
• Justice
• Participants should be a group that has potential benefit

NIH Course
• Tuskegee Syphilis Study —1930s,
Penicillin shown effective in 1940s, study continued until 1972.
• Jewish Chronic Disease Hospital Study,
1963, injected live cancer cells in sick people to show they rejected it more slowly than health people, informed consent not documented.

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

NIH Course

NIH Course
• The Declaration of Helsinki was developed by the
World Medical Association for use by the medical community following dissemination of the
Nuremberg Code.
• Declaration made informed consent a central requirement while allowing for surrogate consent when the research participant is incompetent, physically or mentally incapable of giving consent, or a minor. Research with these groups should be conducted only when the research is necessary to promote the health of the population represented and when this research cannot be performed on legally competent persons.

NIH Course
• Living individual information through intervention or interaction with individual, or
• Identifiable private information.
• Third party (e.g., questions about parents) —need 3 rd party approval.

NIH Course
• Vulnerable Populations
• Children.
• Individuals with questionable capacity to consent.
• Prisoners.
• Fetuses and pregnant women.
• The terminally ill.
• Students/employees.
• Comatose patients.

NIH Course
• The informed consent form must indicate the researcher's obligation to report certain observations, if such duty exists, as well as to offer assistance to participants in need
• Where there is a particularly high risk of stigmatization based on participation in a research project, the IRB may waive the requirement that written informed consent
• There are no clear rules or standards for payment other than a general prohibition against coercion or the exercise of undue influence.

NIH Course
• Privacy has also been defined as freedom from unwanted intrusion. Privacy may mean the right not to know certain information, even about oneself, and the right to prevent others from obtaining or using personal information.
• Breaches of confidentiality are disclosures to third parties, without patient consent or court order.

NIH Course
• Confidentiality--following routine practices:
• Substituting codes for identifiers or encrypting identifiable data
• Removing face sheets from survey instruments containing data
• Properly disposing of computer sheets and other papers
• Limiting access to identifiable data
• Educating staff on the importance of confidentiality
• Storing paper records in locked cabinets or assigning security codes to computerized records

NIH Course
• Under Federal law, and some state laws, researchers can obtain an advance
Certificate of Confidentiality that will provide protection against a subpoena.
• Certain information must be disclosed to third parties by law:
• Information indicating a risk of harm to others
(usually homicidal thoughts)
• Information indicating a risk of harm to self
(usually suicidal thoughts)
• Disclosures about child abuse
• Disclosures about infectious diseases required to be reported to public health authorities

NIH Course—Informed Consent
• Not all of these are needed for every study
• A statement that the study involves research
• An explanation of the purpose of the research, an invitation to participate and explanation of why the participant was selected, and the expected duration of the participant's participation

NIH Course—Informed Consent
• A description of procedures and identification of which are investigational and which might be provided as standard care to the participant in another setting.
• Use of research methods such as randomization and placebo controls should be explained
• A description of any foreseeable risks or discomforts to the participant, estimate of their likelihood, and a description of steps taken to prevent or minimize them. Acknowledgment of potentially unforeseeable risks

NIH Course—Informed Consent
• A description of any benefits to the participant or to others that may reasonably be expected from the research, and an estimate of their likelihood
• A disclosure of any appropriate alternative procedures or courses of treatment that might be advantageous to the participant
• A statement describing to what extent records will be kept confidential, including examples of who may have access to research records

NIH Course—Informed Consent
• For research involving more than minimal risk, an explanation of any compensation and any medical treatments that are available if participants are injured through participation; where further information can be obtained, and whom to contact in the event of research-related injury
• An explanation of whom to contact for answers to questions about the research and the research participant's rights (including the name and phone number of the Principal Investigator (PI));

NIH Course—Informed Consent
• A statement that research is voluntary and that refusal to participate or a decision to withdraw at any time will involve no penalty or loss of benefits to which the participant is otherwise entitled;
• A statement indicating that the participant is making a decision whether or not to participate, and that his/her signature indicates that he/she has decided to participate having read and discussed the information presented.

NIH Course--Exempted
• Research conducted in established or commonly accepted educational settings, involving normal educational practices —this class project is example
• Research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:
• Information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to them.
• Any disclosure of the human participant's responses outside the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing, employability, or reputation.

NIH Course--Exempted
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior if:
• The participants are elected or appointed public officials or candidates for public office.

NIH Course--Exempted
• Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the researcher in such a manner that participants cannot be identified, directly or through identifiers linked to them
• Research and demonstration projects conducted by or subject to the approval of Federal department or agency heads and designed to study, evaluate, or otherwise examine public health benefit or service programs
• Taste and food-quality evaluation and consumer acceptance studies

Passive vs. Active Consent
• Passive consent. You have children take a form home and if it does not come back saying no, you include the child.
• Active consent. You must exclude any child who does not return a form with the parent’s consent.
• Now active consent is expected, but how do you exclude those who do not have it from participating in the experiment?

Anonymity vs. Confidentiality
• Anonymous means there is no way to connect the participants name to their data.
• Student evaluations in a large class
• Small class if you check gender and expected grade, instructor could identify.
• Confidential means that the name and data link are known only to research staff.

• We have focused on written consent. Difficult to do with telephone surveys.
• Verbal consent involves reading informed consent document and asking for approval verbally.
• Some say if you describe the study, risks, etc. and they do it, then you have implied consent. This does not go over well with
IRBs.

Data Management
• You want to keep the link between the name and the data as separate as possible.
• Only keep an identification number with the stored data.
• Destroy the link to the person after data is entered and validated.
• Store link and original data in locked file in a locked room that has controlled access.

Web Based Surveys
• Participants may presume they have anonymity.
• Depending of software this may or may not be the case.