Three principles of Belmont Report
Respect for Persons
The Belmont Report
Principle of Beneficence
MAXIMIZATION of benefits and MINIMIZATION of risks
Belmont Report indicates it is necessary to rigorously avoid conflicts of interest
The Belmont Report
Respect for Person
Requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent)
The Belmont Report defines and delineates...
"Practice" and "Research"
The Belmont Report
The Principle of Justice
Research benefit and burden distribution and that selection of subjects is fair.
The Belmont report describes the necessity to effectively manage conflicts of interest
Students in Research
The history of ethical regulations in human subjects research began with the
Human subjects research guidelines and regulations
Year of the Nuremberg Code
Additional resources regarding IRB approval process
Faculty advisor/Research Mentor
Human subjects research websites
What element must be included in an informed consent?
All foreseeable risks and discomforts
Which type of IRB review does not require and IRB approval but DOES require a Determination by the IRB?
If the study qualifies for EXEMPTION
Another name for the "Exempt" status
the Common Rule
stated in Title 45 Part 46 Subpart A
How can faculty researchers avoid coercion of student subjects?
Avoid using their own students in their research
Name the type of Review: Research study that involves use of educational tests, survey, interviews, or observations of public behavior without identifiable information.
Name the type of review: A study involving data collected that could have an impact on human subject's careers and it contains identifiers of the subjects.
Type of review that qualifies if no identification of subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal
Type of review: data that is collected does not meet definition of human subjects research as stated by federal regulations. No info ABOUT human ie. info about a business
Federal regulations define human subjects as "living individual about whom an investigator conducting research obtains"...? (2 components)
"1.data through intervention or interaction with the individual
2. identifiable private information"
Name the 3 responsibilities the IRB is charged with
1. Protecting the rights and welfare of human subjects
2. Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed
3. Reviewing subject recruitment materials and strategies
IRB's investigate scientific misconduct
IRB's do not review manuscripts prior to submission for publication
Depts. IRB's review for current policies
-Department of Health and Human Services
-Food and Drug Administration
Name the study that links most directly to the establishment of the National Research Act in 1974 and ultimately the Belmont Report and Federal regulations for human subject protection
The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male
The Tuskegee Study relates to which Belmont principle?
The principle of beneficence: Potential benefits justify the risks of harm
Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:
Respect for persons
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
How is the principle of beneficence applied to a study involving human subjects?
Ensuring that risks are reasonable in relationship to anticipated benefits.
Human subject study or not?
Developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression
Human subject study or not?
The study of a list with deceased passengers
No:Human subject is a living individual
Human subject study or not?Questioning individuals to acquire data about the number of newly diagnosed HIV cases?
No: 'what' question rather than 'who' question
Human subject study or not?
Conducting linguistic analysis of comments posted on a public blog
Not: involves neither interaction with individuals nor collecting private identified info
Human subject study or not?
A study proposed by developmental psychologist involving interactions with living individuals and designed to contribute to field of knowledge
Human subject study?
A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors
Yes: Interacting w/ living individuals.
Human subject study or not?
Questioning a superintendent of schools to acquire data about the ethnic composition of a school
No: it is an "about what" question rather than "about whom" question
Human subject study or not?
Study of 20 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over 3-month period
Yes: contributes to generalizable knowledge about student performance and research question can only be answered using systematic investigation
Human subject study or not?
Info collected by play ground designer
No: does not involve info about human subjects even though there is interactions between designer and school staff.
Human subject study or not?
An analysis of aggregate data
No: doesn't involve interactions w/ living individuals nor collection of private identifiable data
Human subject study or not?
An economic feasibility study
No: does gather info from people with relevant info and expertise but does not meet the definition of research w/ human subjects, because the intention of the study is to answer "about what" ? rather than "about whom" ?
According to fed. regulations, human subjects are living human beings about whom an investigator obtains data through interactions or intervention with the individual or:
identifiable PRIVATE information
(Public info does not meet criteria)
Subpart of DHHS regulations provides additional protections for which vulnerable populations?
1. Pregnant women
Subpart of DHHS regulations Does NOT provide additional protections for which vulnerable populations?
3. for persons whose decision-making capabilities are impaired
The expedited review process may be used when the study procedures pose:
No more than minimal risk and the research activities fall within regulatory categories identified as eligible
The expedited review process may NOT be used when the study procedures pose:
-more than minimal risk, even if the subjects are adults,
-the sponsor is in a hurry
-the study replicates previously approved research
Continuing review of an approved and ongoing protocol...?
Must occur within 12 months of the approval date
(even if no additional risks have been identified)
Continuing review process must include:
-number of subjects accrued
-recent relevant literature
-copy of current consent form
Officials of the institution may overrule an IRB approval
True, however no one may overrule if an IRB disapproved a protocol
An investigator wishes to study generational differences in coping mechanisms among adults who experiences abuse as children. Adequate meausre will be instituted to obtain consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:
Experience emotional or psychological distress
If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which would be the most helpful?
Obtain a waiver of documentation of informed consent
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research info from compelled disclosure
Certificates of Confidentiality protect sensitive info provided by research subjects from:
civil, criminal, or administrative subpoena
Risk should be evaluated solely by the magnitude or severity of expected harm, not probability
False: Risk must be determined by assessing magnitude (or severity) and probability (or likelihood) of harm. Both elements must be considered.
Time, situation, and culture
A researcher who is also a care provider needs to be very clear that a decision to participate or not in a study will:
The fact that a therapist has access to her clients' records as a clinician entitles her to use info in the records for research purposes w/out parental permission nor child assent
False: S/he needs both parental permission & child assent
School authority's permission to conduct research replaces the need for permission and assent
Children's right to choose cannot be overridden in the pursuit of an indeterminate community interest
True, it cannot be overridden
Appropriate criterion for waiving informed consent when subjects are provided additional pertinent information after the study
informing participants they were assigned to a study based on undesirable or unflattering physical characteristics for example, or anything that may be judged negative or distressing would be considered appropriate criterion
A waiver of the requirement for documentation of informed consent may be granted when:
The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality
As part of the consent process, the federal regulations require researchers to:
Provide potential subjects with information at the appropriate reading comprehension level.
Data are made anonymous by
Destroying all identifiers connected to the data.
In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which confidentiality procedure would protect against compelled disclosure of individually identifiable information?
Securing a Certificate of Confidentiality.
When a focus group deals with a potentially sensitive topic, which statement about providing confidentiality to focus group participants is correct?
The researcher cannot control what participants repeat about others outside the group.
A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?
There was neither a violation of privacy nor a breach of confidentiality
Which of the following constitutes both a breach of a confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.
An investigator is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that:
Confidentiality of the prisoners' health status is maintained
Which of the following statements about prison research is true?
Researchers may study the effects of privilege upgrades awarded by the prison.
An investigator is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:
Not an excessive incentive.
A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:
Not approve this project because the prisoners are merely a population of convenience for the student.
Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research
Federal regulations do not require the documentation of minors' assent.
According to Subpart D, research with children may be eligible for exemption when:
The research involves the use of educational tests
A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?
The research must pose no more than minimal risk.
A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate?
Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.
Parental notification, in lieu of active parental permission, is allowed when:
An IRB has approved a waiver of the requirement for parental permission.
According to Subpart D, which of the following research activities with children would qualify for an exemption?
Research about educational testing
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:
Provide parents certain rights over their children's educational records.
Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records?
The Family Educational Rights and Privacy Act.
Which of the following is the LEAST important activity when protecting human subjects in international research?
Assessing transportation conditions
The age of majority in international research is determined by the
Laws, customs, and norms in the area in which the research will be conducted.
Which of the following activities constitutes engagement in research?
Obtaining informed consent and conducting research interviews.
Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is:
Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers
Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?
A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?
Designing the survey so that subjects are not forced to answer one question before going to the next.
To minimize potential risks of harm, a researcher conducting an on-line survey can:
Design the survey so that no direct or indirect identifiers are collected.
Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?
Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group.
A HIPAA authorization has which of the following characteristics:
Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.
When required, the information provided to the data subject in a HIPAA disclosure accounting ...
must be more detailed for disclosures that involve fewer than 50 subject records
If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.
Recruiting into research ...
can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.
HIPAA's protections for health information used for research purposes...
supplement those of the Common Rule and FDA.
Health Insurance Portability and Accountability Act of 1996
HIPAA privacy protections supplement those of
other federal regulations (viz., the Common Rule and FDA), state law, and certification/accreditation requirements.
protects identifiable health information (PHI) originating or held in covered entities. De-identified data is not protected, and not all identifiable health information is considered PHI either
Under HIPAA, research activity using PHI generally requires
authorization. However, there are several alternatives that allow bypassing the authorization requirement.
Minimum necessary standards, disclosure accounting requirements, and the characteristics of authorizations (when required) must be
understood by researchers when HIPAA applies
If you're unsure about the particulars at your organization or have questions,
consult with your organization's IRB, Privacy Board or Privacy Official. For data security issues, consult with your organization's Security Official.
2.All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census:
a.The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and
bThe initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
3.All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;
6.Electronic mail addresses;
7.Social security numbers;
8.Medical record numbers;
9.Health plan beneficiary numbers;
12.Vehicle identifiers and serial numbers, including license plate numbers;
13.Device identifiers and serial numbers;
14.Web Universal Resource Locators (URLs);
15.Internet Protocol (IP) address numbers;
16.Biometric identifiers, including finger and voice prints;
17.Full face photographic images and any comparable images; and
18.Any other unique identifying number, characteristic, or code.
those who are less able to protect themselves than other persons in a given situation.
The Common Rule (45 CFR 46) has specific requirements for the following vulnerable populations,
Pregnant Women, Human Fetuses and Neonates (Subpart B), Prisoners (Subpart C) and Children (Subpart D).
Workers are considered vulnerable populations
When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:
pressure from their co-workers, unions and employers. Pressure can be applied to workers in subtle ways such as an employer who comments that if the research concludes that the organization is spending more on healthcare than other similar organizations, there may be lay-offs, etc.
When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject.
A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:
Significant financial interest can be defined as:
- Equity/stock interests (regardless of value) in a non-publicly traded company.
- Intellectual property rights upon receipt of income related to such rights.
- Consulting payments in excess of $5,000.
According to the DHHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is
Greater than $5,000 of ownership in any single public entity/public company.
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
Any equity interest in a publicly held company that exceeds $50,000
Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:
Designated institutional officials
What constitutes "research" according to HIPAA?
HIPAA defines research as any "systematic investigation, including research development, testing, and evaluation, designed to develop and contribute to generalizable knowledge
Who enforces HIPAA's protections?
Waivers and alterations of authorization requirement
•Use or disclosure of the PHI involves no more than minimal risk to the privacy of the research subjects, based on the following elements:
oAn adequate plan to protect any data identifiers from improper use and disclosure.
oAn adequate plan to destroy data identifiers at the earliest opportunity consistent with conduct of the research (unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law).
oAdequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of PHI would be permitted by HIPAA.
oThe research could not practicably be conducted without the PHI.
oThe research could not practicably be conducted without the waiver.
Activities preparatory to research, decedents' information exceptions
•Where the PHI will be used solely for reviews preparatory to research (e.g., for protocol development) and will not leave the covered entity.
•Where the PHI refers solely to deceased persons (the covered entity may ask for documentation of death of all data subjects
A researcher may use fully "de-identified" health data without any authorization from data subjects
if all informed consents and other legal permissions required at the time were in place before HIPAA took effect (April 2003 in most cases), and have not changed since, no new HIPAA authorization is required.
minimum necessary standard
the uses/disclosures must be no more than the minimum required for the described research purpose
accounting of disclosures
•A list of all protocols for which their PHI may have been disclosed, along with the timeframe for those disclosures.
•The purpose of those protocols, and the types of PHI sought.
•The researcher's name and contact information for each study
Characteristics of authorizations
•In "plain language" so that individuals can understand the information contained in the form, and thus able to make an informed decision.
•Executed in writing, and signed by the research subject (or an authorized personal representative).
revocations for HIPAA authorizations for research can be revoked at any time
Provided that the revocation is in writing
It is permissible under HIPAA to discuss recruitment into research with patients for whom such involvement might be appropriate
use or disclosure of PHI for retrospective research studies may be done only with patient authorization -- or with a waiver, alteration, or exception determination from an IRB or Privacy Board
An increase in cost is an acceptable reason for excluding women, minorities, and their subpopulations in clinical research
The Code of Federal Regulations (45 CFR 46.111), the U.S. Food and Drug Administration (FDA) and the National Institutes for Health (NIH) address the inclusion of women and minorities in research.
A minority group is a readily identifiable subset of the U.S. population that is distinguished by racial, ethnic, and/or cultural heritage.
All research is expected to include both sexes and members of every racial/ethnic group and subpopulations as participants.
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice.
Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?
at the study has a maximization of benefits and a minimization of risks.
All of the following are true regarding the Belmont Report, EXCEPT:
The Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest.