E Test 4

Question 1

.What is the definition of Medical research?

Answer 1

Medical research involving human subjects includes research on identifiable human material or identifiable data. The primary purpose of medical research involving human subjects is to improve prophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of disease. Even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility and quality.

Question 2

What is the duty of the physician?

Answer 2

To promote and safeguard the health of the people. The physician’s knowledge and conscience are dedicated to the fulfillment of this duty.

Question 3

What should take precedence in medical research?

Answer 3

Considerations related to the well being of the human subject should take precedence over the interests of science and society.

Question 4

What research populations are considered vulnerable and need special protection?

Answer 4

The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research, and for those for whom the research is combined with care.

Question 5

To whom should the experimental protocol be submitted?

Answer 5

This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed.

Question 6

Who is responsible for the human subject?

Answer 6

The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent. Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person.

Question 7

What is the role of risks and benefits to the subject?

Answer 7

Physicians should abstain from engaging in research projects involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians should cease any investigation if the risks are found to outweigh the potential benefits or if there is conclusive proof of positive and beneficial results.

Question 8

When is medical research justified?

Answer 8

Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.

Question 9

What safeguards must be provided to research subjects?

Answer 9

Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient’s information and to minimize the impact of the study on the subject’s physical and mental integrity and on the personality of the subject.

Question 10

What requirements are there for “informed”?

Answer 10

Each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal.

Question 11

For persons who are unable to give consent, what 2 requirements must be met?

Answer 11

i. The research is necessary to promote the health of the population represented
ii. This research cannot instead be performed on legally competent persons.

Question 12

At the conclusion of the study, what must be assured to every patient?

Answer 12

At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.

Question 13

What was the charge of the commission?

Answer 13

To identify the basic ethical principles that should underlie the conduct of biomedical and behavioural research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.

Question 14

What does “practice” refer to?

Answer 14

Refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success (i.e., practice of accepted therapy). To provide diagnosis, preventative treatment or therapy to particular individuals.

Question 15

What does “research” refer to?

Answer 15

Designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (theories, principles, statements of relationships). Formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

Question 16

How is “experimental” and “research” different?

Answer 16

A procedure is “experimental” in the sense of being new, untested, or different, and therefore cannot be automatically placed in the category of research (i.e., the innovation does not constitute research as it it departs from standard or accepted practice). New procedures should be made the object of formal research at an early stage to determine whether they are safe and effective.

Question 17

What are the three basic ethical principles?

Answer 17

(General judgements that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions)

i. Respect for persons
ii. Beneficence
iii. Justice

Question 18

What are the 2 basic convictions related to respect of persons?

Answer 18

i. Individuals should be treated as autonomous agents (acknowledge autonomy)
ii. Persons with diminished autonomy are entitled to protection (protect those with diminished autonomy)

Question 19

What are 3 examples to show lack of respect?

Answer 19

i. To repudiate that person’s considered judgements
ii. To deny an individual the freedom to act on those considered judgements
iii. To withhold information necessary to make a considered judgement, when there are no compelling reasons to do so

Question 20

What are the 2 general rules of beneficence?

Answer 20

(Cover acts of kindness or charity that go beyond strict obligation)

i. Do not harm
ii. Maximize possible benefits and minimize possible harms

Question 21

What is the principle of justice?

Answer 21

= “fairness of distribution,” or “what is deserved.”
Equals ought to be treated equally
Who is equal and who is unequal?
What considerations justify departure from equal distribution?
Look at distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying differential treatment for certain purposes
-individual and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research

Question 22

What are 5 formulations of the principle of justice?

Answer 22

Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed:

i. To each person an equal share
ii. To each person according to individual need
iii. To each person according to individual effort
iv. To each person according to societal contribution
v. To each person according to merit

Question 23

Why does the selection of research subjects need to be scrutinized?

Answer 23

In order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.

Question 24

What are the information requirements for informed consent?

Answer 24

Specific items for disclosure intended to assure that subjects are given sufficient information: research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and withdraw at any time from the research.

Question 25

What is the question that remains regarding informed consent?

Answer 25

Simple listing of items does not answer the question of what the standard should be for judging how much and what sort of information should be provided.

Question 26

What are the 3 criteria to be met when incomplete disclosure is used?

Answer 26

i. Incomplete disclosure is truly necessary to accomplish the goals of the research
ii. There are no undisclosed risks that are more than minimal
iii. There is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them

Question 27

How does comprehension impact informed consent?

Answer 27

The manner and context in which information is conveyed may adversely affect a subject’s ability to make an informed choice (e.g., presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning).

Question 28

What are conditions in which it is necessary to adapt presentation for informed consent?

Answer 28

When comprehension is severely limited, by conditions of immaturity or mental disability.

Question 29

What are the criteria used to select third parties for informed consent?

Answer 29

Those who are most likely to understand the incompetent subject’s situation and to act in that person’s best interest.

Question 30

What is Voluntariness?

Answer 30

An agreement to participate in research constitutes a valid consent only if voluntarily given.

Question 31

What are the two components of Voluntary consent?

Answer 31

i. Free of coercion (i.e., an overt threat of harm is intentionally presented by one person to another in order to obtain compliance)
ii. Free of undue influence (i.e., an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance)

Question 32

What is meant by the nature and scope of risks and benefits?

Answer 32

The requirement that research be justified on the basis of a favorable risk/benefit assessment bears a close relation to the principle of beneficence, just as the moral requirement that informed consent be obtained is derived primarily from the principle of respect for persons.

Risks and benefits of research may affect the individual subjects, the families of the individual subjects, and society at large (or special groups of subjects in society). Previous codes and Federal regulations have required that risks to subjects be outweighed by the sum of both the anticipated benefit to the subject, if any, and the anticipated benefit to society in the form of knowledge to be gained from the research. In balancing these different elements, the risks and benefits affecting the immediate research subject will normally carry special weight. On the other hand, interests other than those of the subject may on some occasions be sufficient by themselves to justify the risks involved in the research, so long as the subjects’ rights have been protected.

Question 33

What is meant by “risk”?

Answer 33

Refers to a possibility that harm may occur
Small risk/high risk refer to the chance (probability) of experiencing a harm and severity (magnitude) of the envisioned harm

Question 34

What is meant by “benefit”?

Answer 34

Refer to something of positive value related to health or welfare
Risk is contrasted to probability of benefits, benefits are contrasted with harms

Question 35

What types of harm should be considered?

Answer 35

Psychological harm, physical harm, legal harm, social harm, economic harm

Question 36

How does the principle of beneficence apply to risk of harm?

Answer 36

Beneficence requires that we protect against risk of harm to subjects and also that we be concerned about the loss of the substantial benefits that might be gained from research.

Question 37

What is meant by the systematic assessment of risks and benefits?

Answer 37

Benefits and risks must be balanced and shown to be in favourable ratio. This ideal requires that those making decisions about the justifiability of research be thorough in the accumulation and assessment of information about all aspects of the research, and to consider alternatives systematically. This procedure is more rigorous and precise, making communication between review board members and investigators less subject to misinterpretation, and misinformation about conflicting judgements. Thus determine validity of the presuppositions of research, then distinguish the nature, probability, and magnitude of risk.

Question 38

What are the five considerations for the justifiability of research?

Answer 38

i. Brutal or inhumane treatment of human subjects is never morally justified
ii. Risks should be reduced to those necessary to achieve the research objective. I.e., is it necessary to use human subjects at all?
iii. When research involves significant risk of serious impairment, review committees should be insistent on the justification of the risk (i.e., look at the likelihood of benefit to the subject?)
iv. When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated (i.e., nature ad degree of risk, condition of population, nature and level of anticipated benefits)
v. Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process

Question 39

How does the principle of justice impact the selection of subjects?

Answer 39

The principle of justice gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects. Justice is relevant to the selection of subjects at two levels: individual level (fairness in not offering potential beneficial research to only some patients/ selecting undesirable persons for risky research), and social level (distinction should be drawn between classes of subjects that should or should not participate in research).

Question 40

What sources of injustice are there?

Answer 40

Social, racial, sexual, and cultural biases institutionalized by society.

Question 41

What is the definition of vulnerable subjects?

Answer 41

Vulnerable subjects are certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Also, their dependent status, and frequently compromised capacity for free consent.

Question 42

What is the Nuremberg Code and what is its major premise?

Answer 42

The Nuremberg Code was developed following the Nuremberg Military Tribunal, which judged human experimentation conducted by the Nazis. The Code encompasses many of the basic principles governing the ethical conduct of human subjects research today. The Nuremberg Code states that “the voluntary consent of the human subject is absolutely essential” and it further explains the details implied by this requirement: capacity to consent, freedom from coercion, no penalty for withdrawal, and comprehension of the risks and benefits involved.

Question 43

.What were the major contributions of the Declaration of Helsinki?

Answer 43

In 1964, the World Medical Association established recommendations guiding medical doctors in biomedical research involving human subjects. The Declaration governs international research ethics and defines rules for “research combined with clinical care” and “non-therapeutic research.” The Declaration of Helsinki was revised in 1975, 1983, 1989, and 1996, and is the basis for Good Clinical Practices:
• Research with humans should be based on the results from laboratory and animal experimentation
• Research protocols should be reviewed by an independent committee prior to initiation
• Informed consent from research participants is necessary
• Research should be conducted by medically/scientifically qualified individuals
• Risks should not exceed benefits

Question 44

.What is the Common Rule?

Answer 44

In 1981, the Department of Health and Human Services (HHS) codified the Policy for the Protection of Human Subjects (45 CFR 46). Subpart A of these regulations, is also called the “Common Rule,” provides for the basic foundation of the Institutional Review Boards. This Federal Policy has been codified by the federal agencies that conduct, support, or otherwise regulate human subjects research, hence the title “Common Rule.” Additional subparts of 45 CFR 46 provide protections to vulnerable populations such as pregnant women, fetuses, and neonates (Subpart B), prisoners (Subpart C), and children (Subpart D) involved in human subjects research. Many federal agencies and departments have not adopted subparts B, C, and D. Therefore only Subpart A is known as the “Common Rule.”

Question 45

.What are the 3 principles outlined in the Belmont Report?

Answer 45

In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research created The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The Belmont Report sets forth the basic ethical principles required for research involving human subjects. The Belmont Reportencompasses three key principles: respect for persons (autonomy), beneficence, and justice.

Question 46

.What are the requirements for IRB composition?

Answer 46

The IRB is an independent committee comprised of at least five members from relevant academic disciplines or experiences. At least one member must be not affiliated with the institution. The IRB must be diverse in terms of race, gender, cultural backgrounds, and must include at least one member whose primary concern is in a scientific area and one who is not a scientist. The members may include faculty, staff, students, as well as members from the local community. IRB members must have the necessary experience and expertise to evaluate proposed research projects.

Question 47

.What is the responsibility of the IRB?

Answer 47

The IRB functions as a type of “human subjects advocate” whose role is to protect subjects participating in research. The IRB committee reviews research projects submitted by researchers (students, faculty, or staff). The committee has the authority to approve, require changes to the study procedures, or disapprove proposed research projects. Officials at an institution may disapprove an IRB approved project but cannot approve a project that has been disapproved, suspended, or terminated by the IRB. The IRB is charged with reviewing all projects involving human subjects for compliance with institutional policies and state, local, and federal laws, as well as the ethical principles contained in the Belmont Report (that is, respect for persons, beneficence, and justice).

The IRB is part of a bigger system, the Human Research Protection Program (HRPP), in charge of the protection of research subjects. The HRPP may include the Office for the Protection of Research Subjects, the Office of Compliance, the Office of Contracts and Grants, and other Institutional officials and committees (for example, a community outreach program).

The IRB is charged with the responsibility of reviewing and overseeing human subjects research. The IRB review process is designed to protect the rights and welfare of human subjects by ensuring equitable subject selection, assuring adequate informed consent, assessing and minimizing risks, and maintaining privacy and confidentiality. Human subjects research projects cannot be conducted without the approval of the IRB, or exemption by the individual or group identified by the organization or the IRB.

Question 48

What is exempt review?

Answer 48

Exempt research is research with human subjects that generally involves no more than minimal risk. However, it is “exempt” from the provisions stated in 45 CFR 46, Subpart A (Common Rule). An exempt research project does not require ongoing review by the IRB, unless the project is amended in such a way that it no longer meets the exemption criteria.

Question 49

.What are the requirements for a research project to be exempt?

Answer 49

The IRB is required to determine if a research project falls under one of the following six exempt categories listed in the federal regulations (45 CFR 46.101(b)):

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as regular and special education instructional strategies, comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures (of adults), interview procedures (of adults) or observation of public behavior.
3. (a). The human subjects are elected or appointed public officials or candidates for public office. (b). Or the research is conducted for the Department of Justice under Federal statute.
4. Research involving the collection or study of existing data, documents, records, pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate public benefit or service programs, procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies (if FDA approved).
7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
8. Continuing review of research previously approved by the convened IRB as follows: The research is permanently closed to the enrollment of new subjects. All subjects have completed all research-related interventions. And the research remains active only for long-term follow-up of subjects. Or where no subjects have been enrolled and no additional risks have been identified. Or where the remaining research activities are limited to data analysis.
9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

Question 50

.What is an expedited review?

Answer 50

Studies of individual or group behavior, or characteristics of individuals, without manipulating subjects’ behavior and in a manner that does not cause stress to subjects

Question 51

.What are the requirements for a research project to be considered for an expedited review?

Answer 51

No more than minimal risk and the research activities fall within regulatory categories identified as eligible

Question 52

.Who conducts an expedited review?

Answer 52

The expedited review covers the same elements as a full/convened committee review but can be conducted by the IRB chair or a designated experienced reviewer rather than the whole convened committee.

Question 53

.What is the definition of “research”

Answer 53

Federal regulations define research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45CFR46.102(d)). As described in the Belmont Report “…the term ‘research’ designates an activity designed to test a hypothesis [and] permit conclusions to be drawn… Research is usually described in a formal protocol that sets forth an objective and a set of procedures to reach that objective.”

Question 54

..What is the definition of a “human subject”?

Answer 54

A human subject is defined by federal regulations as “a living individual ABOUT whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” (45 CFR 46.102(f)(1),(2))

Question 55

.What is meant by non-engagement in research?

Answer 55

Non-Engagement in Research occurs when an institution’s employees or agents act as consultants on research but at no time obtain, receive, or possess identifiable private information, perform commercial services for the investigators, or inform prospective subjects about the availability of research.

E.g., data collection for internal departmental purposes, information-gathering interviews focusing on things products, or policies, course-related activities specifically for educational or teaching purposes, biography or oral history involving a living individual not generalizable beyond that individual, research involving cadavers, case histories, publicly available data, coded specimens and/or data sets

Question 56

.Who completes the IRB application?

Answer 56

1. Student research preparation: The IRB application is completed under the guidance of the student’s faculty advisor. The student’s advisor is responsible for guiding the student investigator in the development of the research plan as well as the conduct of the research project. The faculty advisor/committee will refine the project and once it is approved by the committee, they should indicate the expected level of review (exempt, expedited, or full board review). (Please note that the final determination of review category will be made by the IRB.) The advisor also assists students in a design to maximize the benefits and minimize the risks involved in the research, and assure the ethical conduct of the project. The Institution’s IRB staff is also available to aid student applicants.
2. Departmental/Faculty review and approval: Depending on the Institution’s policy, the department chair/faculty advisor must review and sign off on the application before it is submitted to the IRB for review. This signoff may address issues of scientific merit, availability of resources, institutional policies, or other issues at the department level.
3. Application submitted to IRB for review: The IRB staff may conduct the initial screening of an application to assist in the future review either for exemption or for further levels of review. The IRB grants the final approval. In some institutions, a designated reviewer/department or school may conduct a pre-review of the application before it is submitted to the IRB for review. If a study is exempt or does not qualify as human subjects research, a designee may determine this and no further approval is required. (The IRB/designee may provide a letter stating that the study qualified as exempt or as not human subject research.)

Question 57

.What are the 4 IRB review outcomes?

Answer 57

The IRB will notify the researcher with one of the following once the application has been reviewed:
• Approval - the application is complete, the risks to subjects are minimal/minimized, and the procedures are appropriate. The IRB gives approval for the research to be conducted.
• Approval with Contingencies/Stipulations - the application is complete but there are issues/changes that must be addressed before the project can begin. Once a satisfactory response to these contingencies is received and approved by the IRB, the review is complete.
• Deferred - applications that are found to have deficiencies (risk to subjects, unclear procedures, serious omissions, ethical issues, or major contingencies) will be deferred. The researcher is sent a memorandum listing the concerns that must be addressed for approval to proceed. The researcher’s response is reviewed by the IRB and will be approved or deferred until all issues are addressed satisfactorily.
• Non-Approval - Applications that are found to have risks that outweigh the potential benefits to subjects and/or society will receive a non-approval and the research will not be allowed to be conducted. Institutional administrative officials may not override this decision.

Question 58

..When do you recruit subjects?

Answer 58

Once the application is approved, the researcher may begin recruiting subjects and conducting study procedures.

Question 59

.When can you implement modifications to your research proposal?

Answer 59

Modifications and Amendments to the approved protocol (changes to the original submitted study must be reviewed and approved by the IRB before they are implemented).

Question 60

.What is an adverse event?

Answer 60

Adverse Events/Effects and Unanticipated Problems involving risks to subjects or others (the IRB must be notified immediately if any undue harms result from the study)

Question 61

.What are the reporting requirements for the researcher?

Answer 61

Modifications and Amendments to the approved protocol (changes to the original submitted study must be reviewed and approved by the IRB before they are implemented)
• Adverse Events/Effects and Unanticipated Problems involving risks to subjects or others (the IRB must be notified immediately if any undue harms result from the study)
• Complaints Regarding Human Subjects Research (the IRB must be notified immediately if any complaints, either from the subjects or the study staff, are made regarding the research study)
• Breach of Confidentiality (If any personal/confidential data has been inappropriately disclosed by any member of the study staff, the IRB must be notified immediately)

Status Report (Renewal or Closeout):
Prior to the expiration of a study, the IRB will require submission of a status report to assess the study's progress or a final report when the study is completed. Either the student or the faculty advisor may submit the final report.

Question 62

.What is PHI?

Answer 62

Protected health information (PHI) is health information transmitted or maintained in any form or medium that includes ALL of the three following characteristics:
•identifies or could be used to identify an individual; and
•is created or received by a healthcare provider, health plan, or healthcare clearinghouse; and
•relates to the past, present, or future physical or mental health or condition of an individual; the provision of healthcare to an individual; or the past, present, or future payment for the provision of healthcare to an individual.
•Examples include: name, social security number, telephone number, etc

Question 63

.What are the general guidelines for writing an informed consent document?

Answer 63

Federal law that generally prohibits health care providers (such as physicians or other health care practitioners, hospitals, nursing facilities and clinics) from using or disclosing “protected health information” (PHI) without written authorization from the patient.

If a student investigator intends to use or release to others (e.g., sponsors, other investigators, collaborators) any identifiable health information in connection with their research, he/she must indicate that in the IRB application.

Question 64

..What are the specific requirements for informed consent?

Answer 64

For human subjects to participate in a research study, they need to have enough information to give a truly voluntary informed consent. Information subjects must be given include:
•Purpose of the research
•Procedures involved in the research
•Alternatives available should a subject decide not to participate in the research
•All foreseeable risks and discomforts to the subject. *Note that these include not only physical injury but also possible psychological, social, or economic harm, discomfort, or inconvenience.
•Benefits of the research to society and possibly to the individual human subject
•Length of time the subject is expected to participate
•Payment for participation (if applicable)
•Person to contact for answers to questions or in the event of a research-related injury or emergency
•Statement that participation is voluntary and that refusal to participate will not result in any consequences or any loss of benefits that the person is otherwise entitled to receive
•Subjects’ right to confidentiality and right to withdraw from the study at any time without any consequences

Question 65

.What is consent and what is assent?

Answer 65

Consent - An adult capable of giving permission to participate in a study can provide consent. In most states, the subject must be 18 years of age and competent to make the decision to participate. Parents/legal guardians of minors can also provide consent to allow their children to participate in a study. Check with your local IRB for your state’s requirement.

Assent - In most states if the subject is under 18 years of age, assent must be obtained. Assent is a child’s affirmative agreement to participate in research. The assent form must include simple language written at the appropriate reading level of the youngest subject in the youth age range. An assent form may also be used if the subject is cognitively impaired. Researchers are advised to contact their local IRB regarding this matter.

Question 66

.What is privacy?

Answer 66

Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

Question 67

.What is confidentiality?

Answer 67

Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission.

• Subjects should be informed of whether the data collected will be retained, and if so, for what purpose, what period of time, or whether and when data will be de-identified or destroyed.
• Care should be taken to explain the mechanisms that have been devised to protect the privacy of the subjects, for example, the use of numbering or code or safely locked files in private offices.

Question 68

What is a risk?

Answer 68

Risk is the probability of harm or injury (physical, psychological, social, or economic) occurring as the result of participation in a research study. Both biomedical and social and behavioral research may entail some level of risk to a person’s health, physical, psychological, or socioeconomic well being.

Student researchers must consider the following risks when conducting their studies:
-Risk Resulting from Study Questions/Surveys
In human subjects research, particularly social and behavioral projects, subjects may feel stress caused by the research questions or procedures.
-Breach of Confidentiality
Reputations or employment may be damaged or jeopardized if confidentiality is not maintained.
Information about subjects’ activities may place them at risk of legal action. The kind and level of risk is determined by context.

Question 69

What is meant by benefit?

Answer 69

Potential benefits for individual subjects may be easy to define in studies offering interventions for behavioral, psychological, or physical problems. However, research is often conducted as part of a faculty member or graduate student investigation into a specialized field of study. The research may provide no direct benefit to the subjects.
Furthermore, it may be many years before the results of the research are publicly known and made useful to society or to groups of people. Vague promises to benefit science or society are not adequate descriptions of benefit in a consent form or a research application. When there is no direct benefit to subjects, they must be told what the researcher is trying to learn and why. (The only exception would be a study in which deception is a necessary, and IRB-approved, element of the design.)
Note that compensation to subjects is not considered a benefit in the risk/benefit analysis, nor is the fact that participants may find it rewarding to be helpful.

Question 70

What is minimal risk?

Answer 70

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. (Note that this definition of minimal risk does not apply to research involving prisoners, which has its own definition of what constitutes minimal risk).

Question 71

What are primary and secondary sources of data?

Answer 71

Primary data collection involves direct contact with, or observation of, one or more people for the purpose of collecting data about them.

Secondary data collection involves accessing information that has already been obtained about humans, either individually or in aggregate form. Secondary data which contains personal identifiers are subject to the requirements set forth under the institution’s research policies. Secondary data, which do not contain personal identifiers, are exempt from these requirements. Secondary data - whether they do or do not contain personal identifiers - may be used only when original consent allows the information to be used in this manner.

Question 72

What is deception?

Answer 72

Deception is the intentional misleading of subjects or the withholding of full information about the nature of the study. Misleading or omitted information might include the purpose of the research, the role of the researcher, or what procedures in the study are actually experimental. Deception increases ethical concerns, because it interferes with the ability of the subject to give informed consent. However, deception is arguably necessary for certain types of behavioral research. Because humans act differently depending on circumstances, full knowledge by the subject might bias the results.

Subjects have the right to full disclosure as soon as possible. In exceptional circumstances, the full or true purpose of the research may not be revealed to the subjects until the completion of data collection. In such cases, subjects should not be exposed to undue stress or embarrassment and must have the right to full disclosure of the purpose of the study as soon as possible after the data have been collected. This process is known as debriefing. Note that techniques of this type are contrary to the policy of full advanced disclosure in the informed consent process and document.

Question 73

What is meant by vulnerable populations?

Answer 73

People who cannot competently understand the information regarding a study and cannot give true consent. Such populations may include individuals with psychiatric, cognitive, or developmental disorders and substance abusers. It is critical that investigators evaluate whether subjects may be vulnerable and whether they are competent to consent.

• Pregnant women, fetuses, and neonates are considered vulnerable because they may be at a greater risk than others. Special protections, however, are geared more toward medical research than social/behavioral research.
• Prisoners are considered to be vulnerable in that they may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and uncoerced decision on whether or not to participate as subjects in research.
• Children are considered vulnerable because they may not be able to completely understand the information presented about a study.

Question 74

What considerations are necessary to involve students in research projects?

Answer 74

Faculty who wish to involve their own students as subjects should be able to provide a good scientific reason, rather than convenience, for selecting those students as research subjects. The research project should be relevant to the topic of the class, and participation should be part of the learning experience for the students.

In instances where investigators can provide a good reason for involving their own students in their research, the IRB generally requires that someone other than the investigator (instructor) obtain informed consent and collect the data. When this is not possible, the IRB will consider other methods for obtaining consent and collecting data that would not reveal to the instructor whether or not a specific student participated in the research project until after final grades have been determined. The students should be informed of what these procedures are in the informed consent form. In addition, it is generally recommended that the investigator/professor provide a recruitment flyer or letter to a student pool, general student population, or both so that the student may be the one who initiates contact with the investigator/researcher.

The researcher may create a written form describing the kind of subjects being recruited and why, which can be:
• Distributed in class (it would be important for the researcher to be absent at the time of distribution to reduce any perception of coercion).
• Posted in a place where potential subjects will see it.
• Distributed via a class e-mail listserv (not using individual student names). If this option is employed, the use of the e-mail listserv should be “at arm’s length.” In other words, the listserv should either list students in the class of a third party or, if the listserv lists students in the researcher’s own class, students should be directed to respond to a third party.
• Students have the right to have class time devoted to classroom activities appropriate to meeting the objectives for the scheduled course. Institutions discourage the use of class time for the investigator’s research activities. If class time is to be used for research, the researcher must make a case to the IRB as to why the research is directly relevant to course content. A student can participate in the research activity without having his or her responses included in publishable data by withholding their consent or saying at the onset that their data may not be used.

Question 75

What are the responsibilities of faculty members?

Answer 75

Faculty members who supervise student research are responsible for the protection of human subjects and are required to:

1. Be familiar with the ethical and regulatory requirements of human subjects research.
2. Determine whether projects require IRB review and assist students with the process. (If the project involves research in a non-US setting, then considerations of local regulations and customs must be understood and satisfied.)
3. Discuss research ethics with the students.
4. Advise students conducting international studies on understanding the local customs and ethics.
5. Monitor student projects, paying special attention to maintaining confidentiality, privacy, level of risk, voluntary participation and withdrawal, and informed consent.
6. Assure that any unexpected or adverse events are reported to the IRB

Question 76

What are elements of the informed consent process?

Answer 76

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 withdraw at any time, decline to answer specific questions, or complete specific tasks at any time during the research.

Question 77

What are the basic elements to be provided in the informed consent process?

Answer 77

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 which are experimental.
•A description of any reasonably foreseeable risks or discomforts to the subject.
•A description of any benefits to the subject or to others, which may reasonably be expected from the research.
•A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
•A 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.

Question 78

What is exculpatory language?

Answer 78

Subjects may not be asked to waive or even appear to waive any of their legal rights. They may not be asked to release a researcher, sponsor, or institution from liability for negligence. Institutions may provide information about how liabilities will be covered.

Question 79

What are the 4 criteria for a waiver of informed consent?

Answer 79

1. The research involves no more than minimal risk to the subjects.
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects.
3. The research could not practicably be carried out without the waiver or alteration. It means that securing consent is not feasible, regardless of cost and time.
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation. This process often is referred to as debriefing.

Question 80

What is deception?

Answer 80

Outright deception can sometimes be justified as essential for investigating a particular phenomenon. For example, subjects may be told that a study is about perception of visual phenomenon, when in fact it is about susceptibility to peer pressure from the researcher’s confederates.

Question 81

How does one ensure comprehension of consent information?

Answer 81

Researchers are required to provide information in a manner understandable to the subjects. This requires preparing material in the subjects’ 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.

Question 82

How does the principle of respect impact informed consent?

Answer 82

The principle of respect for persons requires that participation in research be truly voluntary, free from coercion or undue influence. Even when a study is innocuous, subjects must be informed that they do not have to take part, and they may choose to stop participating at any time.
Federal regulations state that IRBs must ensure that appropriate safeguards are in place to protect the rights and welfare of subjects likely to be vulnerable to coercion or undue influence

Question 83

What are the major issues when using incentives?

Answer 83

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.
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.

Question 84

What are 2 methods for documentation of informed consent?

Answer 84

1. The subject or the subject’s legally authorized representative signs a form containing all the required elements of consent and any additional information necessary to provide complete disclosure. The person who signed the consent form is given a copy as a reference and reminder of the information conveyed.
2. The consent is done orally in language understandable to the subject and is documented by an impartial witness. This process uses two documents: (1) a short- form written consent document stating that the required elements of consent have been presented orally to the subject or the subject’s legally authorized representative, and (2) a written, IRB-approved summary of what will be said to the subject or the subject’s representative. The subject signs the short form. The witness signs both forms. The person actually obtaining consent signs the summary. Copies of the short form and the summary are given to the subject.

Question 85

What is a waiver of documentation of informed consent?

Answer 85

Documentation of the consent process is not always required. Note, however, that waivers of documentation are not waivers of the consent process itself.

Documentation may be waived under two circumstances:

1. The principal risks are those associated with a breach of confidentiality concerning the subject’s participation in the research, and the consent document is the only record linking the subject with the research.
2. Study participation presents minimal risk of harm to the subject and the research involves no procedures requiring consent outside the context of participation in a research study, for example, a telephone survey.

Question 86

What are common categories of harm?

Answer 86

The risks of harm typically associated with social and behavioral research are social, psychological, economic, and legal in nature. However, in rare circumstances, the risks may involve physical harm. For example, those who study victims of domestic violence need to consider that individuals taking part in the study may become the victims of retaliatory violence if the subjects’ involvement in the research is discovered.

Question 87

What are the 3 more common categories of harm in social and behavioral sciences?

Answer 87

nvasion of privacy
• Breach of confidentiality
• Study procedures

Question 88

What is invasion of Privacy?

Answer 88

Invasion of privacy can occur if personal information is accessed or collected without the subjects’ knowledge or consent. For example, if a researcher studying interaction patterns in an online support group joins the group and does not reveal her true identity online, the support group participants could feel that their privacy had been invaded by the researcher, if or when her true identity as a researcher is revealed to the group.

Invasion of privacy also can occur if a subject’s participation in a study is revealed despite assurances that this would not happen. For example, a researcher is studying emotional reactivity in women who have experienced sexual abuse. The research is conducted in a designated university lab on a particular day each week. Another university staff person sees an acquaintance entering the meeting room and therefore discovers that the acquaintance has experienced sexual abuse.

Question 89

What is breach of confidentiality?

Answer 89

Information obtained by researchers could adversely affect subjects if disclosed outside the research setting. Confidentiality can be compromised through an unauthorized release of data, which could have a negative impact on the subjects’ psychological, social, or economic status. For example:
• An unintended disclosure of a subject’s health status could result in the subject’s loss of employment or health insurance coverage.
• Public revelations of data collected about sexual orientation could result in psychological stress.
• Workers asked to share their attitudes about the effectiveness of their managers could lose their jobs or be denied promotions if the information is not adequately protected.
• Information about illegal activities or immigrant status can have serious legal consequences for subjects.

Question 90

How are subjects placed in harm as a result of study procedures?

Answer 90

In some cases, simply taking part in research can put subjects at risk. For example, if a researcher is conducting interviews with individual gang members, it may be necessary to find places to meet where other gang members could not observe the interaction.

Another situation in which merely taking part in research might pose some risk to subjects is when there is a potential for a breach of confidentiality, when data are collected in a group setting such as a focus group. Even though participants typically are cautioned not to share information outside the data collection setting, subjects should be made aware that the researcher cannot guarantee confidentiality.

Often it is assumed that the very nature of the research inquiry can pose risk of harm to subjects, when reviewing research plans that involve asking subjects questions about trauma or abuse, IRB members may be concerned about re-traumatization.

Question 91

What are 2 elements of risk that must be considered?

Answer 91

When assessing risks of harm associated with participation in a research study, there are two distinct elements of risk that must be considered. 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 interaction between these two elements is a crucial factor in determining the level of risk of harm in a study.

Question 92

How does beneficence impact risk?

Answer 92

Federal regulations, based on the ethical principle of beneficence, require that risks of harm associated with research are reasonable in relation to the potential benefits.

The benefits of the research often lie in the importance of the knowledge to be gained, the contributions it makes to science, or the contributions to society in general. There also might be cases in which a specific community, rather than individual subjects, benefits from the research. This should be balanced with the fact that most research in the social and behavioral sciences poses little or no risk of harm to the individual subject.

Federal regulations stipulate that risks of harm must be minimized to the extent possible, consistent with sound research design.
In order to minimize risk, potential research subjects need to be given sufficient information to make a decision about whether they are willing to accept risks and participate in the research. If research questions will be of a sensitive nature, subjects need to be forewarned. Subjects also need to know what steps will be taken to protect confidential information, including disposition of recorded material. Any limits to the extent to which a researcher can protect identifiable personal information should be clearly explained. State and local laws may limit confidentiality, such as reporting requirements for child and elder abuse. Confidentiality cannot be guaranteed for information shared in a focus group.

Question 93

What is a certificate of confidentiality?

Answer 93

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from compelled disclosure.

Certificates of Confidentiality may be obtained for any research, regardless of funding, so long as the research is relevant to the mission of the NIH/HHS.

Certificates of Confidentiality may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation.

A Certificate of Confidentiality will allow the researcher, and others who have access to research records, to be protected from required disclosure of identifying information on research participants in: civil, criminal, administrative, legislative, or other proceedings, whether at the federal, state, or local level.
The kinds of information that can be protected include:
• Substance abuse or other illegal behaviors
• Sexual attitudes, preferences, or practices
• Genetic information
• Psychological health

Question 94

What is privacy?

Answer 94

Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Privacy is related to methods of gathering information from research subjects.

Question 95

What is confidentiality?

Answer 95

Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others, in ways that are inconsistent with the understanding of the original disclosure without permission. Confidentiality refers to the obligations of researchers and institutions to appropriately protect the information disclosed to them.
Confidentiality procedures, as described during the informed consent process, allow subjects to decide what measure of control over their personal information they are willing to relinquish to researchers.

Question 96

What is private information?

Answer 96

Federal regulations (Protection of Human Subjects 2009) define “private information” to mean “information about behavior that occurs in a context in which an individual can reasonably assume that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which he or she can reasonably expect will not be made public (for example, a medical record).

Question 97

What is meant by reasonable assumptions regarding privacy?

Answer 97

“Reasonable assumptions” regarding privacy will vary from culture to culture and setting to setting. For example, in some cultures health information is considered very private, but in others, information about people’s health is part of the community dialog and widely shared.

Reasonable assumptions about privacy may vary among generations. The legal maxim that privacy is the “right to be let alone” (Warren and Brandeis 1890) comes from a world where privacy was seen as threatened by, among other things, the technologies that allowed still photographs to appear in mass-circulated newspapers. Now, through social media, younger generations use images to document their behavior and that of their friends and family, sometimes without restricting public access to the images.

Applying the reasonable assumption standard is not a simple task. It would be unreasonable to assume that behavior on a street corner or a public park is private, but reasonable to assume that behavior in our homes is private. However, given that technology makes it possible to film and record conversations from considerable distances, a third kind of space may be emerging: private spaces in the midst of very public ones. Parents taking their children to a city park might justifiably consider it a violation of privacy if the interactions of their children were audiotaped using long-range recording devices.

Question 98

Can research that uses individually identifiable information be exempt?

Answer 98

In some observational studies, researchers participate in the activities being observed and the subjects know that the researchers have dual roles as both participants and as researchers. However, if subjects are observed and private identifiable information is gathered about them without their knowledge and consent, there is a clear violation of their right to privacy.
Determining whether covert observation can be considered ethically sound depends on answers to questions such as whether the invasion of privacy is justified by the potential benefit of the study and what, if anything, the subjects will be told after the data are collected.

Question 99

What techniques may a researcher apply to protect confidentiality?

Answer 99

The ideal way to protect research data is not to collect information that could identify subjects, that is, neither direct identifiers such as names or email addresses, nor indirect identifiers such as information that could be used to deduce subjects’ identities.

If researchers plan to retain individually identifiable data that if inadvertently disclosed could place participants at risk of harm, researchers need to design procedures to protect the data during collection, storage, analysis, and reporting. These procedures could include creating keys linking subjects’ names to unique numbers associated with the data, storing encrypted data on secure servers, removing identifiers when data collection is completed, reporting data in aggregate, and creating misleading identifiers in articles or presentations.

Consent forms should clearly explain who will have access to identifiable data, both in the present and in the future, and describe any future uses of the data. For example, if researchers want to show video clips of research subjects during conference presentations or use them in a classroom, the subjects must be asked for permission to use their images in those ways.

Question 100

What is FERPA?

Answer 100

The Family Educational Rights and Privacy Act (FERPA) protects the disclosure of educational records, while the Health Insurance Portability and Accountability Act (HIPAA) protects against the dissemination of private health information. For more information about research and HIPAA, refer to the CITI Program module “Research and HIPAA Privacy Protections.”

Question 101

How do state reporting requirements impact confidentiality?

Answer 101

State reporting laws may limit the promises of confidentiality that researchers can offer subjects. Most state laws identify individuals who must report suspected child abuse and neglect. This requirement should be described when child abuse and neglect might be revealed in a research study. Such studies could involve at-risk youth, school-based interventions, or parenting practices, among others. Researchers should consult with the reviewing IRB about the laws in the state or local area where the research will occur.