CITI Quiz
Revisions made to the definitions with the Final Rule
1. Applicability (a new condition that non-institutionally based IRBs reviewing federally conducted or supported research must comply with the Common Rule) 2. Definitions (Definitions have been reordered alphabetically and new terms were defined (including "clinical trial," "public health authority," "written or in writing" to include electronic formats, "data," and "research").) 3. Exempt research
Requirements of the Belmont Report
1. Informed Consent (information, comprehension, voluntariness) 2. Assessment of Risks and Benefits 3. Selection of Subjects
A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:
A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.
Application of the federal definition of research with human subjects to internet research
Asking subjects to complete an online survey or studying behavior in an online support group would meet the definition of research with human subjects because there are live humans about whom information is being collected and the researcher is interacting or intervening with them.
An example of when situation and time are key to assessing risk of harm in a research study:
Asking women if they have had an abortion
Risk of harm in social and behavioral sciences generally fall in three categories, which are
Invasion of privacy, breach of confidentiality, and study procedures
The Final Rule added the requirement that:
Key information essential to decision making receive priority by appearing at the beginning of the consent document and being presented first in the consent discussion.
The definition of "research" was expanded to:
List activities that are specifically deemed not to be research
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:
Must occur within 12 months of the approval date.
Revisions associated with the informed consent process
New subsections were added to address consent form formatting, consent form discussion, and posting of consent forms. includes requiring that only the key information essential to decision making receive priority by appearing at the beginning of the consent document and being presented first in the consent discussion.
According to federal regulations, 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.
Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?
Officials of the institution may overrule an IRB approval.
How to distinguish between probability and magnitude of harm when assessing risk
One is the probability of harm - the likelihood that a specific harm might occur. The fact that not all possible harms are equally probable should be taken into consideration when assessing risk. The second element of risk is the magnitude or severity of harm should it occur.
The Belmont Report's principle of 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.
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?
Prisoners
Distinguish between privacy and confidentiality
Privacy is related to methods of gathering information from research subjects; confidentiality refers to the obligations of researchers and institutions to appropriately protect the information disclosed to them.
A medical record is an example of:
Private information
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research information from compelled disclosure
As part of the consent process, the federal regulations require researchers to:
Provide potential subjects with information at the appropriate reading comprehension level.
The Final Rule added a definition for three new terms, including: clinical trial, written or in writing, and:
Public health authority
How ethical principles that guide research with human subjects can be applied to internet research
Respecting the autonomy of subjects and minimizing potential risks of harm to subjects are ethical principles most relevant to internet-based research.
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture.
Parental permission and child assent processes
The basic model when working with children is that parents (or legal guardians) provide permission for their children (or wards) to participate in research and then subsequent to the parental permission the researcher contacts the children. Children then provide their assent to become subjects.
What is the criteria for the use of expedited review procedures and IRB review
To be eligible for expedited review for initial approval, research must meet criteria, including the following: 1. Pose no more than minimal risk to subjects "Minimal risk" means "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 examinations or tests" (Protection of Human Subjects 2018). 2. Consist of only one or more research activities specified in the federal regulations as eligible for expedited review
Issues related to accessing prison populations
accessing prisoners might involve an entirely different process depending upon the facility housing the prisoners Approval by an IRB is frequently not sufficient to get a researcher inside a state prison. The superintendent has the final authority to allow a researcher access to prisoners.
Define unanticipated problems.
any incident, experience, or outcome that meets all of the following criteria: 1. Unexpected ( in terms of nature, severity, or frequency) 2. Related or possibly related to participation in the research 3. Greater risk of harm than was previously known or recognized
Definition of "prisoner" in the federal regulations
any individual involuntarily confined or detained in a penal institution
Requirements for documenting parental permission and child assent
Documentation of child's assent is not federally required
What is an example of how the principle of beneficence is applied to a study involving human subjects?
Ensuring that risks are reasonable in relationship to anticipated benefits
Impact of the Family Educational Rights and Privacy Act (FERPA) and the Protection of Pupil Rights Amendment (PPRA) on research
FERPA allows schools to disclose identifiable records without permission to certain parties, including organizations conducting research initiated by a school district or a state department of public instruction. (directory information such as a student's name, address, telephone number, date and place of birth, honors and awards, and dates of attendance. However, schools must tell parents and eligible students that directory information is not protected and they must allow parents and eligible students a reasonable amount of time to request that the school not disclose directory information about them.) Under PPRA, if research conducted under an "applicable program" of the ED asks students to provide information about any of the eight sensitive topics (for example, sexual behavior), parental permission for the students to participate cannot be waived.
What is the authority of an IRB
Federal regulations stipulate that an IRB can: Approve research Disapprove research Require modifications to secure approval Conduct continuing reviews Suspend or terminate approval Observe, or have a third party observe, the consent process and the research procedures
What is an.example of how the principle of beneficence can be applied to a study employing human subjects?
Determining that the study has a maximization of benefits and a minimization of risks.
Four categories of permissible research with prisoners allowed by the federal regulations
1. No more than minimal risk research on the possible causes, effects, and processes of incarceration and of criminal behavior, provided that there is no more than inconvenience to the subjects. 2. No more than minimal risk research that studies prisons as institutional structures or of prisoners as incarcerated persons, provided that there is no more than inconvenience to the subjects. 3. Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on diseases such as hepatitis and HIV which are more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults). 4. Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subjects. Studies that require the assignment of prisoners to control groups in which they may not benefit from the research may need federal-level review.
Three principles of the Belmont Report
1. Respect for persons (respecting autonomy and protecting those with diminished autonomy) 2. Beneficence (an obligation to treat persons with kindness and charity. Two rules: do not harm; maximize possible benefits & minimize possible harms) 3. Justice (equals ought to be treated equally)
New exemptions added by the Final Rule
1. an exemption for research involving benign behavioral interventions in conjunction with the collection of information from adults 2. adds a new subcategory at for educational tests, surveys, interviews, or uninfluenced/unmanipulated observation of public behavior that collects potentially sensitive or harmful identifiable private information from adults if an "IRB conducts a limited IRB review and makes a determination that there are adequate provisions for protecting privacy and maintaining confidentiality" 3. Secondary research (secondary research for which consent is not required,
Identify some of the ways in which social, behavioral, and educational researchers are using new internet technologies
1. as a research tool 2. as an environment to study human behavior 3. data collection (data scraping)
Features of informed consent process
1. disclosing information needed to make an informed decision 2. facilitating understanding of what has been disclosed 3. promoting voluntariness of the decision
Elements of Consent
1. statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental description of any reasonably foreseeable risks or discomforts to the subject description of any benefits to the subject or to others that may reasonably be expected from the research. disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. For research involving more than minimal risk, an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, what compensation will be provided, and where further information may be obtained. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. On usage of identifiers Warning of potential breaches of confidentiality
The Final Rule's general compliance date is:
21 January 2019
Regulatory obligations of an Institutional Review Board (IRB) reviewing prisoner research
A majority of the IRB members must have no association with the prison(s) involved, apart from their membership on the IRB (Protection of Human Subject 2018). At least one member of the IRB must be a prisoner or a prisoner representative with appropriate background and experience to serve in that capacity.
Examples of research with human subjects
A study of twenty 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 a three-month period. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
Examples about how local context influences research design
An effective child assent process requires an understanding of how relationships between parents and their children are defined. Questions that may be innocuous in the U.S. could be offensive elsewhere.
The following category of research was added to the "Exempt Research" section at 46.104:
Benign behavioral interventions
Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems because wardens of juvenile prisoners (unlike those for adult prisoners) act in loco parentis for juvenile offenders. This statement is false because:
Both subparts apply, as these individuals are under the legal age of consent and are incarcerated
A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:
Both the magnitude (or severity) and the probability (or likelihood) of harm
What kinds of review might approved research need
For more than minimal risk research only (approved by an IRB), continuing review must be conducted at intervals appropriate to the degree of risk, but not less than once per year. For all research, changes to approved research plans must be reviewed and approved before implementation. For all research, reports of unanticipated problems involving risk to the research subjects or others also must be reviewed through procedures developed by the researcher's institution where the research is conducted.
Where research should be reviewed
If international research is carried out without the involvement of foreign collaborators the research may be reviewed by the researcher's home institution. When U.S. researchers collaborate with researchers at foreign institutions, determining the appropriate review type and method depends on whether the collaborating institution is engaged in the research. an "engaged" foreign institution is one that recruits and secures consent from subjects, conducts research procedures, or receives or shares private, identifiable information.
Compliance dates associated with the Final Rule (US Department of Health and Human Services)
If the research was initially approved by the IRB before January 2019, by default subject to the pre-2018 rule. If the research was initially approved by the IRB on or after January 2019, then the studies are subject to the 2018 requirements.
Issues to consider when designing research to be conducted with prisoners
In designing research that includes prisoners as subjects, it is important to consider issues such as informed consent and confidentiality.
When does proposed research meet the criteria for exemption under federal regulations
Of the eight categories, social, behavioral, and educational research typically falls into one of these: Research conducted in established or commonly accepted educational settings, involving normal educational practices. Research only involving educational tests, survey procedures, interview procedures, or observation of public behavior, provided that at least one of these criteria is met: (a) The investigator records the information in such a way that subjects cannot be readily identified (b) Any disclosure of identifiable information outside the research setting would not place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation (c) The investigator records the information and the subjects can be readily identified, and an IRB conducts a limited IRB review. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection. Secondary research for which consent is not required.
Identify the types of actions an IRB may take in response to unanticipated problems.
Requiring modifications to the research plan Modifying the consent document or consent process Requiring that current subjects be re-consented Providing additional information to current and/or past subjects Requiring additional training of the researcher and/or study staff Reporting the unanticipated problem to federal agencies Observe or have a third party observe the consent process and the research Suspension or termination of the research
Examples of research eligible for exemption in the public schools
Research conducted in established or commonly accepted educational settings, specifically involving normal educational practices that are not likely to adversely affect students' opportunity to learn required educational content or the assessment of educators who provide instruction. Research using educational tests (unless an inadvertent disclosure of identifiable data would create the potential for harm). Observation of public behavior in which the researchers do not participate in the activities being observed, for example, playground activities. Research involving the collection or study of existing data or records if the data are publicly available, for example, aggregate system-wide data about student or school performance, or data recorded without identifiers.
How to identify risks of harm associated with participation in social and behavioral sciences research
Risks of harm in social and behavioral sciences generally fall into three categories: 1. Invasion of privacy (can occur if personal information is accessed or collected without the subjects' knowledge or consent; if a subject's participation in a study is revealed despite assurances that this would not happen) 2. Breach of confidentiality (through an unauthorized release of data, which could have a negative impact on the subjects' psychological, social, or economic status) 3. Study procedures (In some cases, simply taking part in research can put subjects at risk)
Laws that limit the ability to ensure confidentiality
State reporting laws may limit the promises of confidentiality that researchers can offer subjects State reporting laws may cover such matters as specific communicable diseases, the intent to harm oneself or others, and elder abuse.
Privacy risks associated with study designs
Studies about possible topics that are of a sensitive nature should include a disclosure in the consent form about the sensitive nature of the questions. The survey instrument or interview process must be designed so that subjects may choose not to answer any question that makes them uncomfortable, or that they want to skip for any reason. Cultural standards should be taken into account when designing research. Topics that are considered appropriate in one setting may be offensive and off-limits in another
Federal regulations for protecting research subjects that apply to research with children
Subpart D (Common Rule) restricts the use of exemptions with children as subjects.
A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?
Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.
The Final Rule revised the definition of "written or in writing" to clarify:
That these terms include electronic formats
Federal regulations and laws that apply to research in the public schools
The Family Educational Rights and Privacy Act (FERPA) The Protection of Pupil Rights Amendment (PPRA) Subpart D of 45 CFR 46, "Additional Protections for Children Involved as Subjects in Research"
Laws regarding the collection of private information
The Family Educational Rights and Privacy Act (FERPA) protects the disclosure of educational records Health Insurance Portability and Accountability Act (HIPAA) protects against the dissemination of private health information.
According to the federal regulations, research is eligible for exemption, if:
The research falls into one of eight categories of research activity described in the regulations.
When research with children may be exempt from the federal regulations and when it may be expedited
The exemption categories that may be used under 46.104 with children when the conditions of the exemption are met are: Research conducted in established or commonly accepted educational settings, specifically involving normal educational practices that are not likely to adversely affect students' opportunity to learn required educational content or the assessment of educators who provide instruction. Secondary research for which consent is not required. Studies conducted by federal departments or agencies about government programs (such as, welfare programs). Taste and food quality evaluations, and consumer acceptance studies under some circumstances. Storage or maintenance for secondary research for which broad consent is required. Secondary research for which broad consent is required. Expedited review is an option when the research activities pose no more than minimal risk to subjects and fall within one or more of the explicitly defined categories of activity.
When are consent waivers appropriate?
The federal regulations at 46.116(f) allow IRBs to authorize researchers to modify the consent process by omitting one or more elements of information or to provide no information at all. The waiver or alteration of any or all of the elements of consent can be authorized only if these five criteria are met: 1. The research involves no more than minimal risk to the subjects 2. The research could not practicably be carried out without the requested waiver or alteration. 3. If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format. 4. The waiver or alteration will not adversely affect the rights and welfare of the subjects. 5. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation
Procedures for ensuring confidentiality
The ideal way to protect research data is not to collect information that could identify subjects. If researchers plan to retain individually identifiable data that could place participants at risk of harm if inadvertently disclosed, researchers need to design procedures to protect the data during collection, storage, analysis, and reporting.
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.
A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?
The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.
Describe the reporting requirements associated with unanticipated problems.
The reporting of an unanticipated problem by the researcher to the IRB begins the process of assessing the unanticipated increased risk(s) to subjects or others, and determining what course of action should be taken to protect the subjects. Each institution's IRB must have policies on what constitutes "prompt" reporting
Consent as a process vs. the documentation of consent.
There are two parts to informed consent: 1. Provision of information to prospective subjects 2. Documentation that the process took place (usually a consent form) and of the subject's agreement to take part in the study
How to apply the concepts of minimizing and managing risk
When a possible disclosure of subject responses is the primary source of potential harm, collecting data anonymously may provide the best protection.
Definition of human subject
a living individual about whom an investigator conducting research: (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
Definition of Research
a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge
How the federal regulations define "children"
persons who have not yet attained the legal age of consent under the applicable laws in the setting in which the research will take place
Differences between private and public information and behavior
private information includes: "Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and Information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public" (for example, a school record). Whether a setting is public, by federal definition, is determined in large part by the potential subjects' reasonable expectations of privacy, rather than any absolute distinctions between public and private spaces.
Belmont Report (1979)
provides the ethical framework for the federal regulations designed to protect human research subjects
Methods for ensuring comprehension of consent
providing sufficient detail about the research and presenting information in a way that is not just a list of facts. This requires preparing material in the subject's language at the appropriate reading level. When a study is complex and/or the reading or educational level of the prospective study population is low, the role of dialog and explanation becomes an even more crucial part of the consent process.
Criteria for waivers of parental permission and child assent
waivers of parental permission may be permitted under the following three conditions: 1. The documentation of consent (informed consent form) is the only record linking the child to the research, and the principal risk would be potential harm resulting from a breach of confidentiality. If subjects wish to have a signed consent form, their wishes will govern. 2. The research presents no more than minimal risk of harm and involves no procedures for which consent is normally required outside the research environment. 3. If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects, and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained. An IRB may waive the requirement to secure child assent if either: 1. The capability of some or all of the children is so limited that they cannot reasonably be consulted. 2. The intervention or procedure involved in the research holds out the prospect of direct benefit to the health or well-being of the children and is available only in the context of the research.
