Psych 20300 citi training
examples of cases that dont follow belmont report
Lack of Informed Consent / Privacy Violations:
Humphreys' Tearoom Trade Study (1970): Observed men in public restrooms without their knowledge and tracked them down at home using license plate numbers.
Facebook "T3" Study (2006–2009): Scraped student profiles; even without names, the data was detailed enough to identify specific individuals.
Harm & Lack of Voluntary Withdrawal:
Stanford Prison Experiment (1971): Students assigned to be "guards" psychologically abused "prisoners." The consent form made it extremely difficult for subjects to leave the experiment early.
Reputational & Legal Risks:
Irish Village Ethnography (Scheper-Hughes): Even with pseudonyms, community members easily identified themselves and felt depicted in an unflattering light.
Boston College IRA Archive: Oral history interviews promised to be secret were subpoenaed by the government for criminal investigations.
Research:
Scholarly and journalistic activities (for example, oral history, journalism, biography, literary criticism, legal research, and historical scholarship)
Public health surveillance activities
Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order or criminal investigative purposes
Authorized intelligence, homeland security, defense, or national security mission operational activities
quantitative vs qualitative
Quantitative researchers may test hypotheses and theories with the data they collect, while qualitative researchers may generate hypotheses or theories based on the data they gather.
Quantitative researchers may focus on statistical analyses based on precise measurements; however, it is not necessary for precise, replicable measurements to be collected in order for research to be considered systematic.
To generalize is to derive general conclusions from particulars. Although some qualitative research may be less generalizable than some quantitative research, it is not the case that only hypothesis-driven, replicable research may be considered generalizable.
determine how systematic investigation differs from research:
For example, university library staff may conduct a survey of members of an academic unit to find out if the library is meeting the department's need. The project may be a systematic investigation, but is not considered research because the intent of the project is to improve the library's service to its patrons, rather than contribute to a body of knowledge (such as, improving all libraries’ service methods).
Defining Human Subject
According to the federal regulations at 45 CFR 46.102 (Protection of Human Subjects 2018), a human subject is a "living individual about whom an investigator (whether professional or student) 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."
The following sections review key words and phrases in the definition.
A Living Individual
Research about deceased people does not meet the federal definition of research with human subjects.
about whom vs about what:
Some research that involves interactions with living individuals does not meet the regulatory definition of research with human subjects because the focus of the investigation is not on the opinions, characteristics, or behavior of the individual. Instead, the individual is asked to provide information about something. How many micro-loans were made last year? What is the average amount of those loans? These are not "about whom" questions, but can be thought of as "about what" questions.
If a researcher calls the director of a shelter for battered women and asks her for the average length of stay of the women who use the shelter, that inquiry would not meet the definition of research with human subjects, even though there is an interaction between the researcher and a living individual, because the information requested is not "about" the director. If the researcher interviewed the director about her training, experience, how she defines the problem of battering, or how she manages stress, then the inquiry becomes about her - and thus "about whom" - and therefore, meets the definition of research with human subjects.
The researcher must obtain the information or biospecimens about the subjects either by intervention or interaction.
Interventions include:
Physical procedures through which data are gathered, such as measuring brain function to supplement paper and pencil inquiries into the development of language
Behavioral interventions such as experimental education programs or unproven psychosocial therapies.
Interventions also include manipulation of the subject or the subject's environment performed for research purposes, for example, studies investigating the effect of music on memory.
Private Information, Identifiable Private Information, and Identifiable Biospecimen
, 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).
An identifiable biospecimen is just that – a biospecimen that the researcher can identify whom it is from or associated with. The regulation uses the wording that the subject’s identify “may readily be ascertained” but does not say what this means.
privact in detail:
\The Family Education Rights and Privacy Act (FERPA) protects the privacy of school records. Similarly, the privacy provisions of the Health Insurance Portability and Accountability Act (HIPAA) protect private health information. Generally, although there are some exceptions, school and medical records can only be released with express written permission
INFORMED CONSENT
Broad Consent is prospective consent for unspecified future research using identifiable private information or identifiable biospecimens.
Key Information is the concise and focused information presented at the beginning of a consent discussion that is most likely to assist an individual in understanding the reasons why or why not to participate in the study.
Legally Authorized Representative (LAR) means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, LAR means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research (Protection of Human Subjects 2018).
Vulnerable means subjects in research studies vulnerable to the possibility of coercion or undue influence.
Informed consent is a process that begins with the recruitment and screening of a subject and continues throughout the subject's involvement in the research. It includes:
Providing specific information about the study to subjects in a way that is understandable to them.
Answering questions to ensure that subjects understand the research and their role in it.
Giving subjects sufficient time to consider their decisions.
Obtaining the voluntary agreement of subjects to take part in the study. The agreement is only to enter the study, as subjects may at any time withdraw, decline to answer specific questions, or complete specific tasks during the research.
Documentation
Documentation of consent provides a record that the consent process took place. It generally consists of a consent form signed by the subject or the subject's LAR. In practice, this document often is used as a tool for engaging in the consent process. Informed consent may be documented by other means, such as audio or video recording, as approved by an IRB.
Information That Must Be Provided to Subjects
Federal regulations at 45 CFR 46 (Protection of Human Subjects 2018) list specific elements of information that must be provided to subjects about informed consent. The elements are divided into two categories.
The first includes basic elements to be provided to subjects.
The second lists elements that must be included if appropriate.
The two lists are provided below with comments.
ederal regulations at 45 CFR 46 (Protection of Human Subjects 2018) list specific elements of information that must be provided to subjects about informed consent. The elements are divided into two categories.
Basic Elements
The basic elements of informed consent list nine items that must be included, as noted in the regulations at 46.116(b). When appropriate, an analysis or commentary regarding the regulatory element is included in italics.
46.116(b)(1)
A 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.
46.116(b)(2)
A description of any reasonably foreseeable risks or discomforts to the subject.
46.116(b)(3)
A description of any benefits to the subject or to others that may reasonably be expected from the research.
If there are no direct benefits, the researchers may tell subjects what they hope to learn, how that knowledge will contribute to the field of study or how the knowledge might benefit others if such a case can be made.
46.116(b)(4)
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
This requirement is primarily relevant for biomedical research. However, it might be applicable to social and behavioral research if behavioral interventions, such as novel teaching or therapeutic methods, are proposed.
46.116(b)(5)
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
The description must include a full disclosure of any state-mandated reporting requirements, such as suspicion of child abuse and/or neglect or harm to others. State requirements vary, so IRBs and researchers must be aware of state-specific information.
46.116(b)(6)
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.
46.116(b)(7)
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.
In some field research, there may not be any way for subjects to call or email anyone about their questions and concerns. Alternative means of communication must be established, such as a local contact on the research team.
46.116(b)(8)
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.
Most researchers in the social and behavioral sciences are not in a position to impose penalties. However, specific study-related assurances that there will be no negative consequences associated with choosing not to take part might be appropriate. For example, parents may need to be assured that if they choose not to participate in a school-based, school-approved study their children's grades or placement will not be affected.
46.116(b)(9)
One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
The requirement does not apply to all research; only research that involves the collection of identifiable information or biospecimens. Research not involving the collection of information or biospecimens would not require this statement.
Limits on Confidentiality.
Additional Elements (46.116[c])
Depending upon the nature of the research and the risks involved, there may be additional required elements, as noted in the regulations at 46.116(c). These additional elements are only required when applicable, so not all consent forms or discussions would include them. When appropriate, an analysis or commentary regarding the regulatory element is included in italics.
46.116(c)(1)
A statement that the particular treatment or procedure may involve risks to the subject (or the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable.
46.116(c)(2)
Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative’s consent.
46.116(c)(3)
Any additional costs to the subject that may result from participation in the research.
46.116(c)(4)
The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
Subjects need to know, for example, how their compensation will be affected if they choose not to complete an interview. Discussion of what happens to data already collected if they withdraw midway through the study also may be addressed in this section.
46.116(c)(5)
A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject.
This requirement applies primarily to biomedical research involving new treatments and procedures, but also may apply to research on experimental behavioral interventions.
46.116(c)(6)
The approximate number of subjects involved in the study.
46.116(c)(7)
A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
46.116(c)(8)
A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
46.116(c)(9)
For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
Incentives
Incentives are payments or gifts offered to subjects as reimbursement for their participation. These must be described during the consent process as well as the conditions under which subjects will receive partial or no payment.
Recruitment
Recruitment is part of the consent process because it begins the process of providing information about the study. All recruitment strategies such as fliers, email messages, newspaper advertisements, phone scripts, and so on must be reviewed and approved by an IRB before they are used.
Broad Consent (46.116[d])
Broad consent, as noted in the regulations at 46.116(d), is an optional alternative process of obtaining consent for the storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens (Protection of Human Subjects 2018). Researchers should consult with their institution and IRB policies as broad consent may not be implemented at all places.
Setting and Time
Researchers should consider ways in which the setting of the consent process might include elements of undue influence. Potential subjects might not feel entirely free to choose whether to take part in a research study if they are:
Adolescents whose parents are in the room
Adolescents in a group of other adolescents being recruited for the same study
Parents who receive a letter from the school principal asking them for permission to enroll their children in a study
Athletes recruited by their coach
Employees asked to take part by their employer
Subjects must be given adequate time to consider whether they wish to take part in a study. This is particularly true if the study procedures involve more than minimal risk or will require subjects to disclose sensitive information.
Compensation or incentives to participate may not be so high that they override other considerations for potential subjects. Determining whether incentives are unduly influential depends on the research context and the financial and emotional resources of the subjects.
Potentially vulnerable subjects include children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. Additional safeguards for three groups are provided in the regulations:
Subpart B for pregnant women, human fetuses, and neonates involved in research
Subpart C for research involving prisoners as subjects
Subpart D for children involved as subjects in research
Informed Consent in Exempt Research
If an institution determines that a study meets the criteria for exempt research, the detailed regulatory requirements for informed consent in 45 CFR 46.116 do not apply.
However, research that is exempt from federal regulations is still research with human subjects and the ethical principles as outlined in the Belmont Report still apply. Each institution or IRB decides how to handle informed consent in research that is eligible for exemption from the regulations.
Under the 2018 Requirements version of the Common Rule, some exempt research requires a limited IRB review (administrative review). In two of the exempt categories, limited IRB review is required to ensure there are adequate confidentiality and privacy safeguards. In the other two categories, limited IRB review is required for broad consent in studies involving identifiable private information or identifiable biospecimens.
Remember, if an individual was asked to provide broad consent and refused, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.
confidentiality
Core Concepts & Definitions
Privacy vs. Confidentiality:
Privacy: Pertains to the person and methods of gathering data (the right to control access to oneself and personal information).
Confidentiality: Pertains to the data (the obligation of researchers to protect information disclosed to them).
Private Information Definition: Information about behavior occurring where an individual reasonably expects no observation/recording is happening, or information provided for specific purposes expected not to be made public (e.g., medical records).
High-Yield Quiz Points by Topic
1. Study Designs & Methodologies
Focus Groups: A researcher cannot guarantee absolute confidentiality in a focus group because other participants may repeat comments outside the group (researchers can only encourage confidentiality).
Snowball Sampling: For sensitive topics, current subjects should pass study information to potential recruits themselves rather than giving potential recruits' names directly to the researcher (to protect privacy).
Observational Studies: Secretly recording/observing individuals in private settings without consent violates privacy rights unless specifically justified by study benefits and IRB approval.
Sensitive Questions: If questions are intrusive or sensitive, consent forms must disclose this in advance, and subjects must be allowed to skip any question.
2. Protecting Confidentiality
Best Method: Not collecting direct or indirect identifiers at all.
Anonymity: Reached only when all identifying details are removed and links between subjects and data are completely severed.
Data Safeguards: Use ID codes/keys stored separately, encrypt files, report data in aggregate, or use pseudonyms.
Consent Wording: Must explicitly state how data will be kept confidential and include a mandatory statement on whether de-identified data will or will not be used/distributed for future research.
3. Relevant Laws & Legal Limits
FERPA & HIPAA: FERPA protects educational records; HIPAA protects private health information. Both generally require written authorization to access records for research.
Mandatory State Reporting: Promises of confidentiality are limited by state reporting laws (e.g., suspected child abuse/neglect, elder abuse, intent to harm self/others, communicable diseases). Consent forms must disclose these limitations if relevant.
Certificates of Confidentiality (CoC):
Issued by NIH/HHS to protect research data from compelled legal disclosure (e.g., subpoenas).
Automatic: Issued automatically for all NIH-funded research collecting identifiable, sensitive data.
Duration: Protections are permanent and do not expire.
Exceptions: CoCs do NOT override mandatory state reporting for child abuse, elder abuse, or threats of self/other harm.
RESEARCH WITH PRISONERS
The 4 Categories of Permissible Prisoner Research
Minimal risk study on causes, effects, and processes of incarceration/criminal behavior.
Minimal risk study of prisons as institutional structures or prisoners as incarcerated persons.
Conditions particularly affecting prisoners as a class (e.g., vaccine trials for hepatitis/HIV, drug addiction, sexual assault).
Practices with intent/probability of improving health/well-being of subjects.
4. IRB Composition Requirements
Majority Association: A majority of the IRB members must have no association with the prison(s) involved.
Prisoner Representative: At least one member must be a prisoner or prisoner representative (e.g., former prisoner, prison chaplain, psychologist, social worker, prisoners' rights advocate). They must be a voting member with working knowledge of prison conditions.
4. IRB Composition Requirements
Majority Association: A majority of the IRB members must have no association with the prison(s) involved.
Prisoner Representative: At least one member must be a prisoner or prisoner representative (e.g., former prisoner, prison chaplain, psychologist, social worker, prisoners' rights advocate). They must be a voting member with working knowledge of prison conditions.
5. Critical High-Yield Scenarios & Edge Cases
Parole Mandate & Consent:
Participation must have zero effect on parole decisions, and prisoners must be explicitly told this in advance.
Even if written consent is waived, informing them about the non-impact on parole is always required.
Undue Influence & Incentives:
Incentives that seem small on the outside (e.g., $25 cash, framed family photos) can cause undue influence in prison, where daily wages are often ~$1.00 and normal amenities are absent.
IRBs must evaluate earnings/amenities against standard prison living conditions.
Limits to Confidentiality:
Researchers cannot promise full confidentiality regarding: threats of self-harm, threats to harm others, or escape plans. These must be reported to authorities.
Physical Consent Forms: Giving a prisoner a copy of a consent form can create a privacy risk if guards or other inmates find it and discover a sensitive condition or offense.
Protecting Offenses & Health Status:
Disclosing specific crime convictions (e.g., sex crimes against minors) or health statuses (e.g., HIV+) inside a prison puts inmates at severe physical risk from other inmates.
Solution: Intermixing target participants with a broader group of inmates (e.g., interviewing 50 inmates with varied convictions to hide the 25 specific target subjects).
Enrolled Subject Incarcerated Mid-Study:
If a non-prisoner subject is incarcerated during an ongoing study, all research activities with that subject must stop immediately.
Exception: They can only remain in the study if it provides a direct health benefit essential to their well-being, while the IRB re-reviews the protocol under Subpart C.
Exempt, Expedited, and Focus Groups:
Focus Groups: High risk because participants may repeat comments to other inmates/guards; researchers cannot enforce confidentiality among inmates.
Exempt Studies: Can include prisoners only if the study targets a broader general population and prisoners are included incidentally.
Expedited Review: Allowed legally, but OHRP strongly discourages expedited review for prisoner research due to vulnerability.
1. Legal Definition of "Prisoner" (45 CFR 46 Subpart C)
Who IS a prisoner: Anyone involuntarily confined or detained in a penal institution (adults or minors). Includes individuals under court order in drug/alcohol treatment facilities or hospitals, as well as those on house arrest or work-release programs.
Who IS NOT a prisoner: Individuals on parole or probation are not considered prisoners under Subpart C.
2. Non-Prisoner vs. Prisoner "Minimal Risk"
Non-Prisoner Standard: Compared to risks in daily life or routine tests of the general population.
Prisoner Standard: Compared to risks normally encountered in daily life or routine examinations of healthy persons who are NOT prisoners.
When research involves juvenile prisoners (minors under involuntary confinement or detention), both Subpart C (Prisoners) and Subpart D (Children) apply simultaneously.
Federal regulations treat these subparts as additive, not alternative. The IRB must apply the stricter standard whenever the two subparts create conflicting requirements.
Key Requirements for the IRB
Dual Regulatory Criteria Approval:
Subpart C Compliance: The study must fit into one of the four allowed categories of prisoner research, use the stricter "prisoner minimal risk" standard (compared against healthy, non-prisoner individuals), and include a voting prisoner representative on the IRB.
Subpart D Compliance: The study must fit one of the permissible risk categories for children (45 CFR 46.404–407).
Permission vs. Assent Dynamics:
Child Assent (Subpart D): Assent must be sought from the juvenile if they are capable.
Parental/Guardian Permission (Subpart D): Permission from at least one parent or guardian is generally required.
Waiver of Parental Permission: In a correctional setting, getting parental permission can be impractical or unsafe for the child (e.g., parental neglect or family disconnection). The IRB may waive parental permission under §46.408(c) if appropriate, but it must replace it with a suitable alternative mechanism—such as appointing an independent subject advocate to protect the minor’s interests.
Absence of Parole Influence:
Just like adult prisoners, the consent/assent materials must explicitly state that participation will have no impact on parole, release, or status within the juvenile facility.
Wards of the State Considerations:
If the juvenile prisoners are wards of the state, additional Subpart D rules apply (§46.409), requiring the appointment of an advocate for each child who acts in place of parents and has no affiliation with the research team or the correctional institution.
Studies with children
1. Definition of "Children" (45 CFR 46 Subpart D)
Legal Age Threshold: Individuals who have not reached the legal age for consent to treatments/procedures involved in the research under the applicable law of the jurisdiction where the research takes place.
State Age of Majority: Usually 18, but varies by state (e.g., 19 in Alabama/Nebraska, 21 in Mississippi).
Emancipated Minors: May have legal authority to grant permission for their own children, but may still require an IRB waiver of parental permission to consent for themselves in research depending on state law.
2. Exemption Restrictions for Children (§46.104)
Category 2 (Surveys, Interviews, Public Observation):
Permissible for children: Educational tests or non-participatory observation of public behavior.
FORBIDDEN for children: Surveys, interviews, participatory observation, or any Category 2 research requiring a limited IRB review (identifiable data).
Category 3 (Benign Behavioral Interventions): FORBIDDEN for children (applies strictly to adults).
3. Risk Categories & Permission Requirements
§46.404 (Minimal Risk) & §46.405 (Greater than minimal risk + direct benefit): Require 1 parent's permission + child assent.
§46.406 (Greater than minimal risk + no direct benefit, but minor increase over minimal risk): Requires BOTH parents' permission + child assent (unless one parent is deceased, incompetent, or not reasonably available).
§46.409 (Wards of the State): Greater than minimal risk studies involving wards require an independent Subject Advocate appointed for each child.
4. Assent & Dissent
Child Assent: A child's affirmative agreement to participate. Mere absence of objection (dissent) does NOT equal assent.
Parental Override: Parents can override a child's dissent ONLY when the research holds out a prospect of direct health/well-being benefit available only in the research context (§46.405).
5. Waivers of Parental Permission
Neglect/Abuse/Runaways: An IRB may waive parental permission under §46.408(c) if requiring permission is not a reasonable requirement (e.g., studies on abused, neglected, or runaway youth). An appropriate alternative mechanism to protect the child must be provided.
Research in public n elementary
Federal Laws Regulating School Research:
FERPA (Family Educational Rights and Privacy Act / Buckley Amendment): Protects the privacy of student educational records (grades, attendance, disciplinary records). Requires written consent before releasing identifiable student records, except under specific administrative/research exemptions (e.g., studies initiated by school districts or state educational agencies). Applies to all institutions receiving U.S. Department of Education (ED) funds.
PPRA (Protection of Pupil Rights Amendment): Protects parental control over surveys, instructional materials, and evaluations involving 8 sensitive topics (e.g., political affiliations, sexual behavior, mental/psychological problems, illegal behavior, income).
PPRA Funding Rules & Parental Permission:
ED Directly Funded Research: Parental permission CANNOT be waived by an IRB if a survey covers any of the 8 sensitive topics. Active written parental consent is mandatory.
General ED Funded Schools (Non-direct ED research): Schools must have policies letting parents inspect third-party surveys and opt out (passive permission/notification).
Subpart D Exemption Limits in Schools:
Category 1 (Normal Educational Practices): Exempt (e.g., comparing two math instructional methods or curricula in an established educational setting).
Category 2 Limitations: Surveys, interviews, or participatory observations with children are NEVER exempt. Category 2 only applies to children for educational tests or non-participatory observation of public behavior.
Practice Questions & Explanations
Question 1
A researcher wants to evaluate a new third-grade math curriculum by comparing test scores between two classrooms at a local public elementary school. This study qualifies for an exemption under Subpart D because it:
[x] Involves normal educational practices conducted in an established educational setting (Category 1).
[ ] Uses educational tests under Category 2.
[ ] Is funded directly by the Department of Education under PPRA.
[ ] Does not involve identifiable private data.
Explanation: Research on regular and special education instructional strategies or comparisons among instructional techniques in established educational settings qualifies for exemption under Category 1.
Question 2
Under the Protection of Pupil Rights Amendment (PPRA), if a survey asking high school students about their sexual behavior and drug use is directly funded by the U.S. Department of Education, an IRB may:
[ ] Waive parental permission if the survey is anonymous.
[x] Not waive parental permission under any circumstances.
[ ] Approve the study under Exempt Category 2.
[ ] Require only passive parental notification (opt-out).
Explanation: Under PPRA, if a survey covering any of the 8 sensitive topics is directly funded by an ED program, parental permission cannot be waived by the IRB.
Question 3
An outside graduate student who is also employed as a full-time teacher at a public middle school wants to access her students' official standardized test history for a research project. Under FERPA:
[ ] She can freely access the records because she is their teacher.
[x] She does not have automatic access as a researcher and must obtain written parental consent unless an exception applies.
[ ] She only needs verbal approval from the school principal.
[ ] Standardized test scores are considered directory information and require no permission.
Explanation: A teacher's legitimate educational access to student records in their professional capacity does not automatically transfer to their role as an independent researcher. FERPA protections apply, requiring consent or a valid regulatory exception.
International research:
. The Role of Local Research Context
Contextual Factors: Research design, child assent, consent processes, and vulnerability assessments must account for the local socioeconomic, political, and cultural landscape.
Avoid Community Offense: Questions, incentives, or authority structures that seem routine or benign in the U.S. may be culturally insensitive, coercive, or offensive in other regions.
Expertise & Consultation: Researchers and Institutional Review Boards (IRBs) should consult local contacts, stakeholders, community leaders, or external consultants to ensure appropriate subject protections.
2. Institutional "Engagement" in International Research Determining which foreign institutions require formal U.S. regulatory oversight depends on whether they are legally "engaged" in the research project.
Engaged Institutions: An institution is engaged if its employees or agents:
Recruit subjects or secure informed consent.
Perform research-related interventions or procedures.
Share or receive private, identifiable data.
NOT Engaged Institutions: An institution is not engaged if it solely:
Provides space/facilities for U.S. researchers.
Informs prospective subjects about the availability of research without recruiting them.
Releases non-identifiable data or standard educational/medical records.
Federal Assurances: If an engaged foreign collaborating institution is involved in U.S. federally funded research (e.g., NIH), it must provide formal written assurances (such as a Federalwide Assurance [FWA]) complying with Common Rule-equivalent standards or recognized international ethical principles (e.g., Declaration of Helsinki, CIOMS, ICMR).
3. Jurisdiction & Review Requirements
Research Without Foreign Collaborators: Reviewed primarily by the U.S. home institution's IRB. Local or national clearances in the host country may still be required by local law or government policy, even if not mandated by U.S. federal law.
Exempt Research: If a study qualifies for an exemption under federal regulations, foreign review and OHRP "engagement" rules do not apply under U.S. federal law. Home institutional policies determine how international exempt studies are reviewed.
Multi-Layered Approvals: Many host countries mandate national or regional ethics review for all research (including social, behavioral, and humanities studies) independent of U.S. requirements.
4. Tailoring the Informed Consent Process
Community & Head-of-Household Permission: In some cultures, approval from a village chief, community leader, head of household, or spouse is customary before approaching individuals. However, leader approval does not replace individual voluntary consent unless a formal IRB waiver is granted.
Language & Oral Consent: Consent must be provided in the subject's primary or most understandable language. When languages are strictly oral, literacy is low, or signing documents creates distrust/risk, researchers should request an IRB waiver of written documentation to obtain oral consent.
Interpreter Selection: Interpreters must be selected carefully to prevent bias, suppression of information, or undue influence. Children should not serve as interpreters.
Age of Majority & Child Assent: The legal age of consent is determined by the laws and customs of the country where the research takes place, not U.S. state laws.
Local Contact Information: Informed consent materials should include contact details for an accessible local representative or institutional contact who can address participant questions or concerns on-site.
q&a
Question 1
Correct Answer: If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.
Explanation: Under U.S. federal regulations (45 CFR 46), if a research project meets the criteria for exemption, federal rules do not mandate ethics review at the international site. Institutional policies or host country laws may still dictate local requirements, but federal regulations themselves do not.
Question 2
Correct Answer: No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information.
Explanation: According to OHRP guidance, employees or institutions are not "engaged" in human subjects research if their involvement is limited to informing prospective subjects about the availability of a study without recruiting, consenting, or carrying out research interventions/procedures.
Question 3
Correct Answer: In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?
Explanation: In many non-U.S. settings and cultures, community customs require obtaining permission from heads of household, village elders, or community leaders before approaching individual subjects.
Question 4
Correct Answer: Will the researchers have collaborators at the research site abroad?
Explanation: Identifying whether there are foreign collaborating institutions—and whether those collaborators are "engaged" in the research—is the key factor in determining if an international IRB or local ethics committee review is required alongside the home institution's IRB.
Question 5
Correct Answer: Assessing transportation conditions
Explanation: Protecting human research subjects focuses primarily on ethical principles, local customs, risks relative to socio-economic conditions, and community norms. Assessing basic logistical or transportation conditions is least central to human subjects protection.
Online Research:
1. Internet Research Classifications & Federal Definitions
For federal regulations (45 CFR 46 / The Common Rule) to apply, a study must meet both the federal definitions of "Research" and "Human Subject."
Research as a Tool vs. Object of Study:
As a Tool: Using the internet to interact, recruit, or collect data directly from subjects (e.g., Qualtrics surveys, Zoom interviews, MTurk tasks).
As Object of Study: Observing online environments with little to no direct interaction (e.g., analyzing public blog posts, forum activity, or social media trends).
The "Living Individual" & Persona Problem:
Avatars & Virtual Characters: Avatars are user-controlled representations. While some represent fictional identities (e.g., in MMORPGs like World of Warcraft), others reflect real-world individuals. Obtaining consent from an avatar or using its attributes can indirectly identify or affect the human behind it.
Non-Player Characters (NPCs): NPCs are AI-driven computer programs, not human subjects.
Public vs. Private Information:
Access Standard: Material requiring an account, registration, or login leans toward private; open-access web content leans toward public. However, temporary access limits or paywalls complicate this distinction.
Expectation of Privacy: Even in publicly accessible spaces (e.g., open health support groups or public social media feeds), users may still reasonably expect their communications not to be recorded or used for research/marketing purposes.
2. Ethical Principles & Challenges in Online Environments
Respect for Autonomy (Informed Consent)
Documenting Consent Online:
Electronic Signatures: Embedded image signatures, tablet-drawn signatures, or encrypted digital signatures (e.g., DocuSign) satisfy regulatory requirements for documented consent. FDA-regulated studies must meet 21 CFR Part 11.
IRB Waivers of Documentation: Common for minimal-risk online surveys. Uses an active "click-through" button (e.g., "Clicking below indicates I agree to participate") rather than obtaining a formal signature.
Institutional Authentication: Leverages existing organizational logins (e.g., university credentials) to verify identity.
Age Verification & Minors:
Informal checks (asking for birth year or self-reporting age) do not guarantee honesty.
Panels (e.g., Prolific) or specialized Age Verification Services (AVS) add screening layers, though no online verification system is completely foolproof.
Deception & Passive Observation ("Lurking"):
Concealing researcher identity in private groups or observing virtual spaces without consent requires a formal IRB waiver of consent or prospective agreement to deception (where required by exempt categories).
Beneficence & Risk Reduction (Data Security & Confidentiality)
The primary risk in social/behavioral internet research is the loss of confidentiality leading to reputational, social, or legal harm.
Re-identification & Triangulation:
Direct quotes from platforms like X (Twitter) can easily be reverse-searched to find the original account.
Indirect identifiers (e.g., geolocation, demographic subsets, network maps) can be "mined and matched" across datasets to re-identify subjects (e.g., the Taste, Ties, and Time study or the AOL search leak).
IP Addresses:
Classified as direct identifiers under HIPAA and GDPR.
Best practice: Use platform settings (e.g., Qualtrics anonymization) to strip IP addresses prior to data analysis.
Data Storage & Cloud Computing:
Storing unencrypted data on personal devices or unapproved commercial cloud accounts (e.g., personal Google Drive) poses severe security risks.
Data should be encrypted both in transit and at rest, following institutional IT security protocols.
Third-Party Services & Terms of Use:
Researchers must review Third-Party Terms of Service (ToS) for survey platforms, data scraping tools, and AI transcription services.
Watch for clauses regarding indefinite data retention, data ownership, or liability waivers for data leaks.
3. Emerging Issues: Data Integrity & Bots
Automated software scripts (bots) pose a major threat to online research quality, data validity, and financial resources.
Detection & Prevention Strategies:
Simple Measures: CAPTCHA tasks, logic/attention checks, asking identical questions at different points, and requiring open-ended text answers.
Advanced Measures: Tracking completion timestamps, flagging duplicate IP addresses, monitoring for VPN/proxy usage, and analyzing response distributions.
Sophisticated Bot Risk: Modern AI-driven bots can bypass simple checks by synthesizing natural language responses and mimicking human timestamp variances.
Summary Table: Key Internet Research Protections
Area | Major Vulnerability / Challenge | Best Practice / Mitigation |
Consent | Lack of direct face-to-face contact | Use eConsent systems or IRB-approved "click to agree" buttons for minimal risk studies. |
Age Verification | Minors falsely identifying as adults | Utilize platform demographic filters (e.g., Prolific) or explicit age-gate screening. |
Confidentiality | Re-identification via search or data linkage | Strip IP addresses, refrain from publishing direct quotes verbatim, and avoid unencrypted cloud storage. |
Terms of Service | Violating platform policies | Verify that data scraping or observation does not breach the site's ToS agreement. |
Data Integrity | Bot responses corrupting study datasets | Implement CAPTCHAs, timestamp checks, IP verification, and attention-check items. |
Question 1
Correct Answer: Users of social media sites, like Facebook, may not fully understand all of the terms to which they are agreeing to when accepting a sites’ terms of use.
Explanation: The 2014 Facebook study highlighted that accepting a platform's general Terms of Service when creating an account does not mean users fully understand or meaningfully consent to their data or news feeds being manipulated for academic research purposes.
Question 2
Correct Answer: The researcher will ask for a waiver to document informed consent and instead will provide prospective participants with information about the research study and then display a live button that reads, “If you agree to be in this study, click below to begin.”
Explanation: For minimal-risk online studies, IRBs frequently grant a waiver of documentation of consent (meaning no physical/electronic signature is recorded) while still maintaining an active consent process via an informative click-through button.
Question 3
Correct Answer: 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.
Explanation: This study involves living individuals with whom the researcher directly interacts/intervenes to collect identifiable private information. The other options involve deceased individuals, aggregate/de-identified data, or evaluating a website rather than individual humans.
Question 4
Correct Answer: Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
Explanation: Users often share sensitive details on forums, support groups, or social platforms under an assumption of privacy, without realizing the data is publicly visible, persistent, and searchable by third-party researchers.
Question 5
Correct Answer: Researchers cannot guarantee that participants reached the end of the study, and read and understood the debrief.
Explanation: In online settings with minimal direct contact, participants can close their browser at any time, making it difficult for researchers to ensure that subjects receive, read, and understand the debriefing statement designed to correct the misleading information.
Research abd HIPAA oriv oritection
1. Scope & Definitions
Individually Identifiable Health Information: Any form of past, present, or future physical/mental health data, healthcare provision, or payment details tied to an individual (including non-U.S. citizens).
Protected Health Information (PHI): Individually identifiable health information created, received, or maintained by a covered entity.
Research Definition: A systematic investigation designed to develop or contribute to generalizable knowledge.
2. Governance & Enforcement
Compliance is overseen locally by an Institutional Review Board (IRB), a Privacy Board, or a designated Privacy Officer.
Organizations must issue a Privacy Notice explaining how health data is used, along with procedures for filing complaints.
HIPAA requires designated Privacy and Security Officers to enforce data rules and handle breach notifications.
Core Regulatory Pathways
1. Written Authorization (Standard)
Requires explicit consent from the data subject.
Must describe the PHI requested, who will use/receive it, and the specific purpose.
Can expire on a set date, a specific event (e.g., "end of study"), or have no expiration (e.g., repositories/future research).
May be combined with standard Common Rule/FDA informed consent forms.
Subjects may revoke authorization in writing at any time, subject to maintaining study integrity.
2. Exceptions & Waivers to Authorization
Waiver or Alteration (Minimal Risk): Approved by an IRB/Privacy Board if the research involves no more than minimal risk, includes plans to protect/destroy identifiers, and cannot practicably be conducted without the waiver or access to PHI.
Preparatory to Research: Allows browsing data to design a study or recruit subjects, provided PHI does not leave the covered entity.
Decedents' Information: Research solely on deceased individuals' data (requires representation of necessity and proof of death upon request).
Pre-2003 Studies: Pre-existing permissions granted before HIPAA took effect remain valid.
3. Reduced Identification Datasets
De-Identified Data: Not subject to HIPAA restrictions. Achieved via:
Safe Harbor Method: Removal of 18 specific identifying elements.
Expert Determination: Statistical verification that re-identification risk is "very small."
Limited Data Set (LDS): Contains indirect identifiers (e.g., dates, geography) but no direct identifiers. Requires a signed Data Use Agreement (DUA) prohibiting re-identification or contact.
Important Compliance Notes
Minimum Necessary Standard: Un-authorized uses/disclosures (waivers, LDS, preparatory work) must limit PHI to the absolute minimum required for the project. Signed authorizations are exempt from this specific standard, though IRB constraints still apply.
Disclosure Accounting: Subjects have the right to request an accounting of disclosures made to external entities over the prior 6 years.
Exemptions: Disclosure accounting is not required for disclosures authorized by the subject, de-identified data, limited data sets, or internal workforce "uses."
Security & Breach Reporting: The HIPAA Security Rule mandates technical safeguards for electronic PHI. Breaches must be reported to HHS, and security incidents involving 500+ individuals are published publicly on the HHS Breach Portal.
Question 1
Answer: Supplement those of the Common Rule and FDA.
Explanation: HIPAA's data protection rules work alongside (supplement) the existing Common Rule and FDA regulations; they do not replace them or serve as a discretionary substitute. Additionally, HIPAA affects non-covered entities indirectly if they receive PHI from a covered entity source.
Question 2
Answer: Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.
Explanation: HIPAA mandates that authorizations be written in plain, understandable language. They can be revoked in writing by the subject, can be combined with other research permissions (such as Common Rule informed consent), and are required by law rather than left to the investigator's personal discretion.
Question 3
Answer: Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.
Explanation: Retrospective browsing or data mining on identifiable health data for generalizable knowledge meets the formal regulatory definition of "research." Therefore, it requires individual authorization or an approved waiver/exception from an IRB or Privacy Board.
Question 4
Answer: To all human subjects research that uses PHI without an authorization from the data subject.
Explanation: Under HIPAA, the "minimum necessary" standard applies to situations where PHI is accessed or disclosed without explicit authorization (e.g., via waivers, limited data sets, or preparatory work). Research uses based on a signed authorization are exempt from this standard because the subject explicitly granted permission for the specified dataset.
Question 5
Answer: Data that does not cross state lines when disclosed by the covered entity.
Explanation: Geographic boundaries (crossing state lines) do not grant an exemption from HIPAA authorization requirements. The other three options—decedents' data, limited data sets under a Data Use Agreement, and preparatory activities—are all recognized HIPAA pathways that permit accessing or using PHI without individual authorization
research w workers
Executive Summary
Workers and employees represent a distinct vulnerable population in research, primarily due to "paycheck vulnerability"—the economic, social, and professional risks associated with workplace-based studies. While the Common Rule (45 CFR 46) provides overarching human subject protections, it does not explicitly designate workers as a protected subcategory in the same way it does children, prisoners, or pregnant women. Consequently, researchers, employers, and Institutional Review Boards (IRBs) must implement specific safeguards to address power dynamics, coercion, and workplace-specific privacy threats.
Key Concepts & Framework
1. Paycheck Vulnerability & Coercion
Paycheck Vulnerability: Occurs when research is conducted in the workplace or supported by employers/unions, creating subtle or explicit financial and professional pressure on employees.
Coercion Mechanisms:
Employer/Supervisor Pressure: Pressure to participate (or not participate) driven by fears of job restriction, loss of advancement, or credentialing consequences.
Union Pressure: Encouragement to participate based on the expectation that study findings will yield financial "entitlements" or benefits.
Compromised Informed Consent: Workers may feel unable to ask questions, refuse participation, or opt out without risking their livelihood.
2. Workplace-Specific Risks vs. Benefits
┌───────────────────────────────────────────┐
│ WORKPLACE RESEARCH IMPACT BALANCE │
└─────────────────────┬─────────────────────┘
│
┌─────────────────────────┴─────────────────────────┐
▼ ▼
[ WORKPLACE RISKS ] [ WORKPLACE BENEFITS ]
• Threat to job retention / advancement • Improved workplace health & safety
• Loss of mortgage/insurance capability • Expanded educational/training programs
• Financial impact on employer/union • Increased access to new services
• Compromised genetic/health privacy • Higher overall job satisfaction
IRB & Research Plan Requirements
1. IRB Governance & Expertise
Worker Representation: IRBs regularly reviewing workplace studies should include a worker member or consultant knowledgeable in employee issues.
Coercion Evaluation: IRBs must focus specifically on how employment dynamics affect a worker's ability to give truly voluntary informed consent.
Flexible Coordination: Non-biomedical or non-traditional work sites without an existing IRB culture require creative review solutions (e.g., relying on a primary institution's IRB).
2. Defining Research vs. Operational Activities
Research Criteria: Occurs when the primary intent is to gather data contributing to generalizable knowledge, alter conditions for specific worker subsets, or use unapproved experimental diagnostics.
Exclusions under the Revised Common Rule: Quality improvement/assurance (QI/QA), journalism, public health surveillance, public health intelligence, defense, and criminal justice activities are not classified as research.
3. Privacy & Confidentiality Safeguards
Disclosure Limits: Study protocols must clearly define who owns the data, who can access it, and whether results will enter medical or personnel records.
Legal Loopholes:
Privacy Act of 1974: Contains a "routine user" clause allowing access to federally owned occupational health records for research, creating potential privacy gaps.
HIPAA & State Laws: Provide baseline protection, but evolving electronic health records require added diligence.
Genetic Data & Biospecimens: Workplace genetic screening/testing poses high discrimination risks (subject to GINA 2008). Future uses of biological samples and identifiers must be fully disclosed and consented to prior to study commencement.
Core Takeaways for Researchers
Voluntary Sector Compliance: Adherence to the Common Rule is mandatory for federally funded or public sector studies, but voluntary for non-federally funded private sector research unless institutional policy dictates otherwise.
Communication: Multi-stakeholder communication (workers, supervisors, unions, IRBs) is vital from the design phase through protocol completion.
Data Management: Strict separation between research data and employment/personnel records is required to prevent retaliation or career impairment.