SBR

Question 1

SBR

Answer 1

refers broadly to research that deals with human attitudes, beliefs, and behaviors. Biomedical and clinical researchers sometimes incorporate SBR questions and methodologies into their physiological research

function
SBR techniques can enhance biomedical research studies by using non-invasive techniques of data collection.

Question 2

what data collection methods are SBR characterized by?

Answer 2

Questionnaires
Interviews
Focus groups
Direct or subject observation
Non-invasive physical measurements

Question 3

5 ways to use these data collection methods in

Answer 3

health histories
Quality of life assessments
family pedigrees
surveillances 
outcomes studies

Question 4

questionnaires

Answer 4

(written questions) or interviews (oral questions, either by phone or in-person).

Question 5

Opinion data and other oral data from key informant interviews, focus groups, or group discussion

Answer 5

these data collection methods to provide qualitative data to enrich or support their physiologic data in testing hypotheses.

Question 6

Direct observation of behavior and interactions

Answer 6

may involve a pre-coded form for noting observations, or recording (audio, video, or other) of actual behavior.

Question 7

Data already collected for other purposes (such as records from education, healthcare, social service programs, employment, and insurance coverage).

Answer 7

These kinds of data are often used by health researchers in outcomes studies and epidemiological studies, or as adjuncts in clinical or basic science research.

Question 8

Non-invasive physiological measurement (such as skin impedance and pupil dilation as reflection of emotional arousal or attention)

Answer 8

Although these are considered physiological measures, they are often used by SBR researchers to document the physiological components of behavior

Question 9

examples of SBR methodologies

Descriptive or exploratory research involving detailed observation, often in the real world, and often of a culture, family, group, or individual. Records-based research that does not involve direct contact with subjects can be included in this category. Examples include:

Answer 9

Collection of family pedigrees for genetic studies
Description (from videotaping of family interactions) of the behavioral effects of drugs, devices, or other physiologic interventions
Epidemiology of farm accidents from an analysis of state workers’ compensation and medical records

Question 10

examples of SBR methodologies

Evaluation of existing programs of care, service, and education. Distinguishing between program evaluation and research can be difficult. If the intent of the data collection is to contribute to “generalizable” knowledge, or if the results are applicable outside of the research setting or population, the activity is usually classified as research. If the results stay entirely in-house and are used for administrative purposes only, many organizations do not consider this to be research. Examples include:

Answer 10

Evaluation of the effect of a computer-generated information sheet given to people picking up asthma medications from a pharmacy
Evaluation of on-call nursing services for the elderly living at home
Assessment of the effectiveness of a manufacturer’s marketing strategies

Question 11

examples of SBR methodologies

Comparison of competing types or programs of information, education, or treatment. These research projects usually randomize subjects between experimental and standard approaches, sometimes with a third control group.

Answer 11

examples include
Massage versus education for lower back pain
Diet only versus diet plus coached exercise for control of diabetes
A new medication versus a standard and widely used medication versus talk therapy for treatment of depression

Question 12

examples of SBR methodologies

Experimental manipulations of belief, attitude, emotion, or behavior, that affect subjects in ways that would not occur in their normal experience outside the research setting. Research of this type typically comes from academic areas (such as psychology, communication, speech and hearing, or education), as well as nursing and medicine. If deception is used, additional consent issues become important and must be addressed. Examples include:

Answer 12

Creating emotional stressors to measure cortisol levels
Using a placebo in clinical drug trials
Evaluating virtual reality as a means for pain management

Question 13

risks unique to SBR

Answer 13

may include psychological stress and discomfort, disruption of personal, and family relationships, economic harms, or political harms when data fall into the wrong hands

Question 14

risk unique to SBR

Answer 14

less predictable, more subjective and variable, and less remediable than physiological harms

Question 15

risks unique to SBR

Answer 15

may be more dependent on socio-cultural factors than physiological harms

Question 16

Managing and Minimizing Risks of Harm from SBR

Answer 16

The federal regulations (45 CFR 46) require that risks to subjects are reasonable in relation to anticipated benefits (Protection of Human Subjects 2018).

Question 17

1st way Managing and Minimizing Risks of Harm from SBR Data management

Answer 17

Many risks of harm from SBR are the result of breaches of confidentiality involving sensitive data. Coding data, securing the master list linking the code to the subject identifier, maintaining the data in a secure environment, or de-linking data from identifiers can minimize risks resulting from breaches of confidentiality.

Question 18

2nd way Managing and Minimizing Risks of Harm from SBR

Answer 18

If distress or deception must be experimentally induced, as in some psychological and physiological measurement research, the research design usually requires withholding certain information from the consent process in order to obtain unbiased results. After subjects have completed participation, it is important to provide this information to subjects from whom it was withheld, and to provide an opportunity for subjects to express their concerns and ask questions about the research. Strategies to accomplish this might include:

Debriefing subjects with a description of what really happened
Explaining why the research could not otherwise be conducted
Issuing an apology

If possible, researchers should debrief the subjects while they still have an opportunity to withdraw their data should they feel offended and not wish to continue participation or have their data excluded.

If deception is used for a benign behavioral intervention, the researcher must inform the subject that they will be deceived before the subject participates in the research

Question 19

3rd way Managing and Minimizing Risks of Harm from SBR

adequate informed consent

Answer 19

Making sure that potentially disturbing experiences and questions are identified during the consent process before the subject agrees to participate can minimize the likelihood that subjects will experience stress and discomfort.

Question 20

6 key points about informed consent

Answer 20

The statement “there are no risks” should not be used. Although some SBR might have no physical risks, it is always necessary to consider whether there is a possibility (even if not a high likelihood) of emotional/psychological risk, loss or breach of confidentiality, or stigmatization.

Describe the content of questions, interview topics, and study procedures, and give specific examples of the most personal, sensitive, or distressing questions that will be asked. Sometimes it is appropriate to reassure subjects that there is no “right” or “wrong” answer.

State that subjects have the right to refuse to answer any question for any reason. This statement should not imply to subjects a specific sensitivity or emotional state (for example, it should not say, “You have the right to skip any questions that make you uncomfortable”).

It may be difficult to advise subjects about emotional distress without increasing the likelihood of experiencing it. This is a judgment call that needs careful consideration in wording of consent forms.

If recordings are used, the consent should state that subjects have the right to review and delete recordings (within a reasonable time period) that the researcher plans to keep indefinitely or share outside of the research team.

If focus groups are used, subjects should be reminded that the identities of fellow subjects and the information exchanged should be kept confidential, but that the researcher cannot assure that subjects will respect the confidentiality of others in the group.