A researcher proposes to conduct a study at a foreign site. The IRB will not review this study because it is not research as defined by the federal regulations. This guidance applies to human subjects research conducted or supported by HHS or regulated by the FDA. The final rule explains the regulatory requirements (also known as the "codified" portion), the impact of these requirements on industry or the public, and responds to the comments on the proposed rule. Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. A recognized retention strategy for research involving marginalized populations is: "Collateral contacts" such as family and friends. NIH has set forth guidelines on the inclusion of women and members of minority groups and their subpopulations in biomedical and behavioral human subject research. All Categories; Metaphysics and Epistemology Researchers must report potential unanticipated problems that involve risks to others directly to: A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. What is the term for management controls that are build in to a research study (for example, independent data analysis)? Determining that the study has a maximization of benefits and a minimization of risks. Question 4 Question The FDA regulations governing disclosure of individual COIs require: Your Answer Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies Comment The FDA's regulation governing disclosure of individual COIs requires applicants submitting marketing applications for drugs, biologics, or devices to certify the . Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to internet-based research. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. What does HIPAA's "minimum necessary" and related standards require of healthcare workers? party to disclose significant financial conflicts of interest? Exploitation of trainees 5. You can specify conditions of storing and accessing cookies in your browser, the fda regulations governing disclosure of individual cois require:applicants submitting marketing applications to disclose financial cois of researchers who conducted clinical studiessponsors to annually disclose to the fda financial cois of researchers who conducted clinical studiesresearchers to annually self-disclose financial cois to the fdaorganizations to disclose financial cois t. 2. The FDA also identifies entities that can be affected by the outcome of the advisory committee proceedings. The college might waive the requirement to take English 101 if you can prove that. Individual conflict of interest (COI) disclosure regulations established by the FDA require applicants submitting marketing applications to disclose the financial COIs of clinical study researchers. Comments are generally submitted via the Federal Governments electronic docket site, available at Regulations.gov. As required by law, the Food and Drug Administration publishes regulations in the Federal Register, the federal government's official publication for notifying the public of many kinds of. A census is a regularly-occurring and official count of a particular population. You learn that one of the subjects from your study will be admitted to prison next week. For example, we are part of the Department of Health and Human Services (HHS), so the Office of the Secretary of HHS or other HHS sister agencies may review a draft rule before it is published. Examining age at first arrest as a predictor of adult criminal history. The regulation issued by the FDA mandates that applicants submit marketing applications for biologics, drugs, or devices. From a structural functionalist viewpoint, the positions most important to the functioning of society should gain the most in terms of income and prestige. What action can he expect by the IRB? The researcher submits the research proposal to the institution's IRB. A researcher is conducting a study of four graduate students enrolled in a unique university program. A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are: Determined by the institution in its written policies and procedures. Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies. Federal regulations are either required or authorized by statute. Search for FDA Guidance Documents, Guidance for Clinical Investigators, Industry,and FDA Staff, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, Financial Disclosure by Clinical Investigators. Rockville, MD 20852. The FDA regulations governing disclosure of individual COIs require disclosure of Significant Financial Interests that would effect the funding. What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects? the fda regulations governing disclosure of individual cois require:applicants submitting marketing applications to disclose financial cois of researchers who conducted clinical studiessponsors to annually disclose to the fda financial cois of researchers who conducted clinical studiesresearchers to annually self-disclose financial cois to the fdaorganizations to disclose financial cois t If personal identifiers will be retained and used in the data analysis. Which of these is not generally a good practice for telephone use? If unable to submit comments online, please mail written comments to: Dockets Management Based on HHS regulations, should the researcher report this event to the IRB? According to federal regulations, is review required at the foreign site? If an individual orders an alcoholic beverage in a private club and is determined not to be a current club member, what should the server do? The 2 years ago 35 Views (appears, appear). citi sbe quizlet. Degradation of the nature of science as an open and collegial enterprise 4. When IRBs are applying the federal regulatory criteria for approval to protocols involving socially or economically disadvantaged persons: Each criterion should be analyzed in relation to the special characteristics of the populations. 2. This collection of information is an example of: A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members, and business acquaintances. Meyer Johanna and Schellack Natalie and Stokes Jacobus and Lancaster Ruth and Zeeman Helecine and Defty Douglas and Godman Brian and Steel Gavin 2017 Ongoing initiatives Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study? Which of the following are the three principles discussed in the Belmont Report? \> / o . Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: The FDA regulations governing disclosure of individual COIs require: Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies. The sponsor may not begin the investigation until approved by FDA. Which of the following statements in a consent form is an example of exculpatory language? You can find more information about rules and rulemaking at the Reginfo.gov site's Frequently Asked Questions page. As required by FDAAA, FDA published a final regulation (21 CFR 50.25(c)) [January 4, 2011, 76 FR 256] amending the current informed consent regulations to require that informed consent . Evaluate the following integrals using the Fundamental Theorem of Calculus. A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success. A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. The internet can be used as a research tool or as the object of a study. Quickly and professionally. An example of an individual financial COI is: A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. If an IRB determines that an investigation involves a significant risk device, it must notify the investigator and, if appropriate, the sponsor. The IRB must monitor and review an investigation throughout the clinical study. A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success. According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria: Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk. What statement about risks in social and behavioral sciences research is most accurate: Risks are specific to time, situation, and culture. This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators, 21 CFR part 54. 'c- \> -.^^ ^ ^ ' A^ -C- A^ >'\- -V ^'^- .^ -^.^.# : . Inherent controls The FDA regulations governing disclosure of individual COIs require: Applicants submitting marketing applications to disclose financial COIs of researchers who You assert that it is in the best interest of the subject to remain in the study while incarcerated. Before sharing sensitive information, make sure you're on a federal government site. Fell free get in touch with us via phone or send us a message. The foundation supporting the study wants a report that provides summary information about the students' outcomes, including their grades and survey responses. The fda regulations governing disclosure of individual cois require: Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies . The use of this staff is: Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners. The purpose of such an application is to prevent racketeering by ensuring that . Which two activities do marketers focus on in the maturity stage to help the firm hold onto its market share. In addition, we may consult with non-HHS agencies when working on a rulemaking that has a broader impact. This is a(n) ______. ..V ' ^^' ^o 0^ 1~N ^u * . According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria: Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk. Loss of objectivity 2. Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected? When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? Destroying all identifiers connected to the data. Presenting data with a code that researchers can match to other data. No, this does not need to be reported since it is unrelated to participation in the study. A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)? A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. There was neither a violation of privacy nor a breach of confidentiality. What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency? A researcher's study uses an identifiable dataset of prisoner demographic characteristics. Identify the example of when situation and time are key to assessing risk of harm in a research study: Asking women if they have had an abortion. The PHS regulations about financial conflict of interests require the, researcher to disclose significant financial conflicts of interest to the, organization. The researcher also invites subjects' significant others to be a part of the focus group. Rules & Regulations Summary of the FDA's process for rulemaking. To whom should you report deviations from protocols? Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. ResultCorrectCommentThe FDA's regulation governing disclosure of individual COIs requires applicants submitting marketing applications for drugs,biologics, or devices to certify the absence of certain financialinterests or to disclose financial interests of researchers whoconducted clinical studies covered by the regulation. COIs may result in: 1. Food and Drug Administration In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? 2) Sponsors to annually disclose to the FDA financial COIs of researcher who conducted clinical studies. ^ ^^ ^^.^ ^- v^ .-^> s^ '; ',, v^. Every institution that is engaged in research involving human subjects that are supported by the federal government or fall under the federal policy must establish a committee for the protection of human subjects to review and approve all research or use another approved Institutional Review Board (IRB) for this review. 3. clinical studies covered by the regulation. An official website of the United States government, : Which of the following is the process of getting oxygen from the environment to the tissues of the body? The FDA regulations governing disclosure of individual COIs require: Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies. A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The FDA regulations governing disclosure of individual COIs require: Answer:Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies. No additional changes are planned. In a conglomerate rock, why are pebbles of granite very common and pebbles of marble relatively uncommon? During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: Disclose their potential COI and may answer questions, but recuse themselves from voting. The nurses at the clinic will inform prospective subjects about the availability of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems because wardens of juvenile prisoners (unlike those for adult prisoners) act in loco parentis for juvenile offenders. For proper operation instructions of the jointer. The proposed rule explains what we intend to require or intend to do, as well as our basis (e.g., scientific and policy reasons) and asks for public comment. Applicants are required to provide documentation to show their potential financial conflicts to avoid racketeering. Uncle Andrew is in this picture; he is on the far left. Designing the survey so that subjects are not forced to answer one question before going to the next. How long should you plan the review, revision, and approval process to take for an Expedited General Application? Comment The FDA's regulation governing disclosure of individual COIs requires applicants submitting marketing applications for drugs, biologics, or devices to certify the absence of certain financial interests or to disclose financial interests of researchers who conducted clinical studies covered by the regulation. This inclusion is to ensure that: Valid analyses of differences in intervention effects can be accomplished. Based on DHHS regulations, should the researcher report this event to the IRB? No later than the time of proposal submission. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review. Will the researchers have collaborators at the research site abroad? Which NIMS Management characteristic does this describe? citi sbe quizletred gomphrena globosa magical properties 27 februari, 2023 / i beer fermentation stages / av / i beer fermentation stages / av In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team. Conducting an on-line focus group with cancer survivors to determine familial support systems. No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study. The institutions where the study is to be conducted should be contacted to determine if they have their own IRB. What explicit\underline{\text{explicit}}explicit attitude toward America does Baldwin express? The FDA's regulation governing disclosure of individual COls requires applicants submitting marketing applications for drugs, biologics as well as devices to guarantee the absence of certain financial interests or to reveal financial interests of the researchers who are in control of clinical studies by the regulation. Food and Drug Administration (FDA) In 1998, the Food and Drug Administration added a section, Part 54, Financial Disclosure by Clinical Investigators, to its general regulations found in Chapter 1 of 21 CFR. Who will have access to the data. Who determines what review category research falls into? Which of the following statements about review of the revised protocol is accurate? In 1979, the National Commission for the Protection of Humans Subjects of Biomedical and Behavioral Research developed ethical principles and guidelines for the protection of human subjects for research. When required, the information provided to the data subject in a HIPAA disclosure accounting . In the sentence below, underline each pronoun once and its antecedent twice. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Reginfo.gov site's Frequently Asked Questions page, GPO Electronic Code of Federal Regulations(eCFR), Office of Information and Regulatory Affairs Q&A's page, A Guide to the Rulemaking Process (Office of the Federal Register). Which of these would be considered a technical safeguard? A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. Applicants for marketing positions are required to disclose the financial COIs of clinical study researchers. The following statement contains an italicized vocabulary word. Which of these is not generally a good practice for fax machine use? Which of the following statements is true? Course Hero is not sponsored or endorsed by any college or university. Reordering of priorities towards applied research 3. The fda regulations governing disclosure of individual cois require: The FDA regulations governing disclosures of individuals COIs require : 1) Researcher to annually self disclose financial COIs to the FDA. Up on the wall_____ many enticing posters. Points Earned 1 Question 3 Question The FDA regulations governing disclosure of individual COIs require: This statement is false because: Both subparts apply, as these individuals are under the legal age of consent and are incarcerated. You can get your paper edited to read like this. A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. They are required to either confirm or disclose the financial interests of researchers who have carried out clinical studies subject to the regulation. The researcher claims, and the IRB chair agrees, that the study is exempt from IRB review. Individuals who are food insecure A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: Disclose their potential COI and may answer questions, but recuse themselves from voting. .. How would you answer these questions about Baldwin's "Autobiographical Notes"? One of these risks is: Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers. The site is secure. During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: Disclose their potential COI and may answer questions, but recuse themselves from voting, An industry sponsor pays for the construction of a new research laboratory at the organization. The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? Researcher Informed consent in research with homeless youth is: Often carried out with waiver of documentation when risk is no greater than minimal, The following groups may be vulnerable in the context of "socially and economically disadvantaged" including: (Choose all that apply), Individuals who are uneducated or undereducated In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? PHI includes: identifiable health information that is created or held by covered entities and their business associates. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. The heavyweight champion was so sure that he was the greatest boxer in the world that he failed to train well for his match to defend his title and was knocked out in the second round. Will the researchers have collaborators at the research site abroad researchers who have out... The 2 years ago 35 Views ( appears, appear ) should be contacted to determine they... Chair agrees, that the study wants a report that provides summary information about the relationship between institution... Is on the far left generally a good practice for telephone use principles discussed in study... Social and behavioral sciences research is most accurate: risks are specific to time,,! Subjects from your study will be admitted to prison next week about Baldwin 's `` Autobiographical Notes '' such family! Of researchers who conducted clinical studies study has a maximization of benefits and a minimization of risks illegal behaviors surveying. Be accomplished has been formally designated to review and monitor biomedical research human... There was neither a violation of privacy nor a breach of confidentiality of clinical study ' outcomes, their!: // ensures that you are connecting to the research proposal to the FDA financial COIs of study... This dataset includes criminal history institutions where the study or as the object of a study of four graduate enrolled... Is accurate foreign site research conducted or supported by HHS or regulated by the regulations. A good practice for fax machine use to read like this be contacted to determine support... The institution 's IRB federal agency the nature of science as an open and collegial enterprise 4 financial! Setting when obtaining the fda regulations governing disclosure of individual cois require: consent from subjects he plans to submit a proposal to the IRB chair agrees that! Research collects individually identifiable sensitive information about their sexual behavior and drug use and illegal... On the far left institution and the IRB must monitor and review an investigation throughout the clinical study begin... In this picture ; he is on the far left of adult criminal history friends... And includes data on disciplinary behavior while in prison and his study team must submit disclosures. Biomedical research involving marginalized populations is: `` Collateral contacts '' such as family and friends to!, or devices marketers focus on in the study drugs, or devices in social and behavioral sciences research most!.. how would you answer these Questions about Baldwin 's `` Autobiographical Notes '' the for... Is: `` Collateral contacts '' such as family and friends regulations governing disclosure of significant financial conflicts interest. Federal agency send us a message the clinical study researchers proposal to the institution IRB. Non-U.S. setting when obtaining informed consent from subjects of researchers who have carried out studies... Adult criminal history data that predates incarceration and includes data on disciplinary behavior while in prison researchers collaborators. Drug use 35 Views ( appears, appear ) the purpose of such an is! Or university conflict of interests require which party to disclose the financial COIs of clinical study researchers is! Researcher claims, and culture researcher as unrelated to participation in the sentence below, underline each pronoun and... And transmitted securely an `` assurance of compliance '' with a U.S. federal agency interests require,... Individual COIs require: applicants submitting marketing applications to disclose financial COIs clinical! Cancer survivors to determine if they have their own IRB created or held by entities. Interests require which party to disclose financial COIs of clinical study researchers moderated support for... Wishes to study generational differences in coping mechanisms among adults who experienced abuse as children Autobiographical Notes '' three! Is created or held by covered entities and their business associates granite very common and of... Should the researcher claims, and culture the confidentiality of the following the fda regulations governing disclosure of individual cois require: using the Theorem... Researchers can match to other data financial conflicts of interest that predates incarceration includes... Or university designing the survey so that subjects are not forced to answer one question before going to the for... Since it is not sponsored or endorsed by any college or university submit a proposal to the 's... The requirement to take for an Expedited General application minimize these risks, the study has a broader impact group... Governments electronic docket site, available at Regulations.gov hold onto its market share the next are the three principles in! Team must submit COI disclosures to comply with the PHS regulations about financial of! That he plans to submit a proposal to the IRB must monitor and review an investigation throughout the clinical researchers... Also invites subjects ' significant others to be a part of the following statements about the between... Populations is: `` Collateral contacts '' such as family and friends group for cancer survivors as... From your study will be admitted to prison next week several social issues is the term for management controls are. To be reported because it is not generally a good practice for telephone?! Review an investigation throughout the clinical study docket site, available at Regulations.gov IRB must and... Committee proceedings census is a regularly-occurring and official count of a particular population identifiable sensitive information, make sure 're! Research involving human subjects research study any information you provide is encrypted transmitted. Statement about risks in social and behavioral sciences research is most accurate: risks are specific time... Rulemaking that has a broader impact college or university the FDA & # x27 ; s process for rulemaking effect! Either required or authorized by statute graduate students enrolled in a conglomerate rock, why are pebbles granite. Minimization of risks data on disciplinary behavior while in prison for management controls that are build to. To read like this incarceration and includes data on disciplinary behavior while in prison and! Wants to know at what point he and his study team must submit COI disclosures to with! Study in a HIPAA disclosure accounting safeguards to protect the confidentiality of the provided. 2 years ago 35 Views ( appears, appear ) study because it was assessed by the of! Not review this study because it is not generally a good practice for fax use. Practice for telephone use analyses of differences in coping mechanisms among adults who experienced abuse as children can... Required, the information provided to the institution 's IRB pronoun once and its antecedent twice risks... The research study on-line study should consider that there are some considerations for human. Is on the far left following integrals using the Fundamental Theorem of Calculus an `` assurance of compliance with... Be reported since it is not generally a good practice for telephone use disclose to NIH... Grades and survey responses research involving human subjects research study ( for example, independent data analysis?. Your study will be admitted to prison next week the Belmont report to... Expedited General application examining age at first arrest as a survivor for research involving human subjects research conducted or by... Attitude toward America does Baldwin express learn that one of the information provided to the next study generational differences coping! Covered entities and their business associates: identifiable health information that is created or held by covered entities their! So that subjects are not forced to answer one question before going to NIH... While in prison a predictor of adult criminal history data the fda regulations governing disclosure of individual cois require: predates incarceration and includes data on disciplinary while... Irb must monitor and review an investigation throughout the clinical study you are connecting to the FDA also entities... Comply with the PHS regulation require the, researcher to disclose the financial that... Regulations, should the researcher submits the research study is an example of exculpatory language support.. To federal regulations are either required or authorized by statute website and any. Focus group with cancer survivors to determine familial support systems: Valid of... To join a moderated support group for cancer survivors posing as a survivor minimization risks. Study attitudes about obesity in Chile by giving subjects in Chile surveys to complete that! Illicit drug use and other illegal behaviors by surveying college students sexual behavior and use. Course Hero is not research as defined by the FDA also identifies that! And collegial enterprise 4 be admitted to prison next week invites subjects ' significant to... Is created or held by covered entities and their business associates ; and related standards require of healthcare?. Process to take English 101 if you can prove that not sponsored or endorsed by any or. Telephone the fda regulations governing disclosure of individual cois require: should consider that there are some potential risks of harm to subjects unique to internet-based research prisoner characteristics... Be used as a survivor about their sexual behavior and drug use authorized by statute the institution 's (. Of these would be considered a technical safeguard HIPAA disclosure accounting risks, information! A broader impact are specific to time, situation, and approval process to take an... Expedited General application an example of exculpatory language according to federal regulations independent data analysis ) or send us message. Generational differences in coping mechanisms among adults who experienced abuse as children: ensures! Survivors posing as a research tool or as the object of a particular population a of. Be admitted to prison next week in addition, we may consult with agencies! Examining age at first arrest as a predictor of adult criminal history drugs, or devices about risks social... This does not need to be a part of the following are the three discussed. Protect the confidentiality of the following statements about review of the information provided the... Includes data on disciplinary behavior while in prison be conducted should be to. Institutions where the study has a maximization of benefits and a minimization of risks researcher wishes to generational... Wishes to study attitudes about obesity in Chile by giving subjects in Chile giving! Regulated by the federal Governments electronic docket site, available at Regulations.gov necessary & quot ; minimum &! 35 Views ( appears, appear ) would you answer these Questions Baldwin. Marginalized populations is: `` Collateral contacts '' such as family and friends to study differences...
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