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Belmont Report (1979) - ansethical principles and guidelines for the protection of human subjects of research. respect for persons - ansindividuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person - ansA person capable of deliberation about personal goals and of acting under the direction of such deliberation Beneficence - ansDo not harm and maximize possible benefits and minimize possible harms Justice - ans1) to each person an equal share 2) to each person according to individual need 3) to each person according to individual effort 4) to each person according to societal contributions 5) to each person according to merit Justice - ans· The selection of research subjects needs to be scrutinized in order to determine whether some classes 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. Justice - ans· Whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research. Three elements of the consent process - ansinformation, comprehension, voluntariness What is an example of how the principle of beneficence can be applied to a study employing human subjects - ansDetermining the study has a maximization of benefits and a minimization of risks What are the three principles discussed in the Belmont Report? - ansRespect for persons, beneficence, justice The Belmont Report's principle of respect for persons incorporates at least 2 ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - ansPersons with diminished autonomy are entitled to protection Nuremberg Code (1947) - ans1) a requirements for voluntary consent 2) the research must have scientific merit 3) The benefits of the research must outweigh the risks 4) Subjects have the ability to terminate participation in the research at any time National Research Act (1974) - ans1) Authorized the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was charged with developing an ethical code and guidelines for researchers 2) Required the establishment of IRBs at organizations receiving PHS support for human subject's research The National Commission (1975- 1978 - ansIssued a series of reports on vulnerable populations (such as fetuses, children, prisoners, and the "mentally infirm") psychosurgery,
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IRBs, and other topics that included recommendations for regulating human subjects' research. These recommendations had significant influence on the development of the federal regulations governing human subject research. 45 CFR 46 - ansAlso known as the Common Rule, this legislation established the role of institutional review boards (IRBs) for research on human rights. Additional protection for these individuals in research - ans1) pregnant women, human fetuses, and neonates 2) children 3) prisoners 21 CFR 50 - ansInformed Consent 21 CFR 56 - ansIRB 21 CFR 812 - ansInvestigational Medical Devices 21 CFR 312 - ansInvestigational Drugs and Biologics Declaration of Helsinki (1964) - ansRecommendations guiding medical doctors in biomedical research involving human subjects WHO Guidelines (1996) Standards and Operational Guidance for Ethics Review of Health- related Research with Human Participants" - ansDocuments designed to serve as international guidelines for the review and conduct of research involving human subjects ICH E6 - ansGuideline for Good Clinical Practice The use of prisoners in research is a concern under the Belmont principle for Justice because:
- ansPrisoners may not be used to conduct research that only benefits the larger society What was the result of the Beecher article? - ansRealization that ethical abuses are not limited to the Nazi regime Issued in 1974, 45 CFR 46 raised to regulatory status: - ansUS Public Health Service Policy What is included in the Nuremberg Code? - ansInformed consent Informed consent is considered an application of which Belmont principle? - ansRespect for persons IRB (Institutional Review Board) - ansA review committee established to help protect the rights and welfare of human research subjects Regulations require: - ansIRB review and approval for research involving human subjects if it is conducted, supported, or regulated by US federal departments and agencies Federal regulations stipulate that an IRB can: - ansApprove research, require modifications, disapprove research, conduct continuing reviews, verify no material changes occurred since previous review, observe, suspend/terminate approval Conveyed committee review - ansFull committee review. Standard type of review described in the federal regulations. Must be used for the initial review of all studies that are not eligible for expedited review or exemption Expedited review - ansCan be used for established categories and minor changes in previously approved research, and for limited IRB review of select exemption categories
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participation in a study 3) Provide the potential study subjects with all information needed to reach a decision on whether or not to participate in a research study Broad consent - ansProspective consent for unspecified future research Legally Authorized Representative(LAR) - ansIndividual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, LAR means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective subjects to the subject's participation in the procedure(s) involved in the research The emphasis of the discussion of informed consent is: - anson subject comprehension and presenting information that a "reasonable person" would want to have in order to make an informed decision to participate, and an opportunity to discuss the information According to 46/116(b), legally appropriate informed consent will include the following elements: - ans1) a statement that the study involves research, an explanation of the research's purpose and the expected duration of the subject's participation, a description of the procedures to be follow, and identification of an procedures that are experimental
- A description of any reasonably foreseeable risks or discomforts to the subject
- A description of any benefits to the subjects or to others that 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 compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
- An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of a research-related injury to the subject.
- A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
- One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
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A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or In addition, if relevant to the research, legally effective informed consent will also include the following elements: - ans1) Statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
- Any additional costs to the subject that may result from participation in the research
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
- A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject · For research that is subject to HHS regulation at 45 CFR 46 (Protection of Human Subjects), the consent form must also include (if appropriate): - ans1) A statements that the subjects biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit
- A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
- For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (that is, sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen) The FDA does require the following statements in the informed consent form: - ans1) Statement that the subjects' records may possibly be inspected by the FDA
- Statement that the clinical trial will be listed in a registry. HHS regulations at 45 CFR 46.116 allow an IRB to waive or alter for informed consent under the following circumstances: - ans1) Government projects
- General waivers and alterations
- Screening, recruiting, or determining eligibility FDA at 21 CFR 50.23 and 50.24 provides exceptions to the requirement for informed consent under the following circumstances: - ans1) In situations where requirements for exception from informed consent are met for emergency research
- In life threatening conditions involving an individual subject where requirements for an exception from informed consent are met and include documentation of all of the following:
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physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later. The ethics of genetic and genomic research have received a great deal of attention due to several factors: - ans1) Genetic testing can reveal a strong predisposition to future disease, making the information psychologically powerful and raising concerns about stigma or discrimination
- Related individuals share many of the same gene sequences in their DNA, meaning that genetic information about one individual provides information about other individuals who may or may not have consented to genetic testing
- Genetic testing can reveal characteristics of recent and distant ancestry that may conflict with peoples' family history, with their social history, or with their religious beliefs
- Historically, genetic concepts and information have sometimes been misused to affect social and political ends genetic determinism - ansThe concept that the control of genes confers great power than can be used or misused As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of research participants in NIH - funded genetic research for broad research use of data and data sharing, even if the cell lines or specimens are: - ansdeidentified When conducting research that involves collecting biological specimens for genetic testing, which of the following issues are the most important for the IRB to consider? - ansEffects of findings on other family memebers Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens? - ansOriginal signed consent documents include provisions for recontacting subjects Which choice best describes the purpose of most pharmacogenomic research? - ansTo evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs Identify which type of discrimination the Genetic Information Non-Discrimination Act protects individuals from: - ansHealth insurance and employment discrimination The Common Rule (45 CFR 46, Subpart A) found at 46.108(a)(4): An IRB shall establish and follow written procedures for ensuring prompt reporting to the IRB; appropriate institutional officials; the department or agency head; and the Office for Human Research Protections, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency of: - ans1) Any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and
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- Any suspension or termination of IRB approval. According to OHRP, it considers unanticipated problems, in general, to include any incident, experience, or outcome that meets ALL OF THE FOLLOWING criteria: - ans1) Unexpected given the research procedures that are described in the research plan-related documents, such as the IRB-approved research plan and informed consent documents and the characteristics of the subject population being studied;
- Related or possibly related to participation in the research; and
- Suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized 21 CFR 312.50 (Investigational New Drug Application 2014) requires sponsors to ensure that FDA and all participating investigators are promptly informed of: - anssignificant new adverse effects or risks with respect to the drug OHRP defines adverse event as: - ansany untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research One of the criteria necessary to qualify as an unanticipated problem is whether the event is related or possibly related to participation in the research. In addition, it must be unanticipated and involve risk to subjects or others. - ansOnly adverse events that are also unanticipated problems need to be reported to the IRB Unanticipated adverse device effects - ansUnanticipated problems in device research 21 CFR 812 - ansAny serious AE on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. For device studies, both the research and sponsor have specific reporting responsibilities: - ans1) In 21 CFR 812. 150(a)(1), the researcher is required to submit reports of unanticipated adverse device effects to the IRB and the sponsor "as soon as possible, but in no later than 10 working days after the investigator first learns of the effect"
- In 21 CFR 812.150(b)(1), the sponsor is required to report unanticipated adverse device effects to the FDA and " to all reviewing IRB's and participating investigators within 10 working days after the sponsor first receives notice of the effect" A Data Safety Monitoring Board report for an investigator-initiated investigational drug study indicates a significantly higher than anticipated rate of an expected AE. This event required revision of the informed consent form to disclose the higher rate. A change in the
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Historically, those who are vulnerable have been subjected to one or more of these four common types of abuses in human research: - ans1) Physical control: physical forced to participate in research. This presents a lack of voluntariness.
- Coercion: The use of a credible threat of harm or force to control another person. This also presents a lack of voluntariness.
- Undue influence: The misuse of a position of confidence or power to lead or influence
- Manipulation: Examples include lying about information, withholding information, or exaggerating information. The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: - anscognitive or communicative, institutional, deferential, medical, economic, and social. Deferential vulnerability - anssimilar to institutional vulnerability but the authority over the prospective subject is due to informal power relationships rather than formal hierarchies HHS 45 CFR 46.111(b) (Protection of Human Subjects 2018) provides the following list of examples of vulnerable subjects: - ans1) Children
- Prisoners
- Individuals with impaired decision-making capacity
- Economically or educationally disadvantaged persons Subjects with a serious illness may be at risk for exploitation because they may be desperate for a possible cure. This is an example of: - ansMedical vulnerability Identify the following groups that are protected in the federal regulations (45 CFR 46) in Subparts B, C, and D with additional protections: - ansPregnant women, prisoners, children According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four? - ansPhysical control, coercion, under influence, and manipulation A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of: - ansEconomic vulnerability Which is an example of a situation where deferential vulnerability might be a factor? - ansA physician recruiting patients to be subjects Investigational New Drug (IND) Application - ansresearch involving a drug or biologic that has not yet reached the marketplace or that studies a new use of the marketed product requires this per 21 CFR 312 This is submitted by the sponsor to the FDA Sponsor - ansthe person who takes responsibility for and initiates a clinical investigation. They develop a research plan for the clinical investigation, which is then evaluated by the FDA. A sponsor can be a drug company, cooperative group, or even an individual physician
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After careful review of the IND application, the FDA will allow human studies to proceed if it determines that the risk of exposure to the drug is reasonable. This determination is based upon: - ans1) Data from prior animal or human testing
- Methods of manufacturing
- Plans for testing and reporting significant toxicities
- A well-developed clinical research plan that minimizes risks to the subjects For research subject to 21 CFR 312, the sponsor cannot begin a clinical investigation until the UND is granted by the FDA and - ansthe IRB approves the study · As noted in the regulations at 312.2(b) the clinical investigation of a marketed drug does not require an IND if all of the following conditions are met: - ans1) The data will not be used to support a new indication, new labeling, or significant change in advertising
- The research does not involve change to the route of administration or dosage level, subject population usage, or other factors that significantly increases the drug product's risks of harm (or decreases the acceptability of the risks)
- The research is conducted in compliance with requirements for promotion and sale at 21 CFR 312. Exemption from IND submission requirements does nor mean exemptions from IRB review and approval or from the requirement to obtain informed consent. - ansThe FDA should be consulted in there are any changes to the research that may affect the IND exemption status Form FDA 1572 - ansStatement of Investigator
- The agreement between the researcher and the sponsor assuring compliance with FDA regulations.
- The document that notifies the FDA of relevant changes in researchers conducting clinical trials under the IND
- only used in clinical investigations of drugs and biologics, not devices Researchers may not participate in an investigation subject to IND regulations until they sign and submit to the sponsor the - ansStatement of the Investigation, Form FDA 1 572 Form FDA 1572 requirements: - ans1) Researchers participating in drug and biologic studies subject to the IND regulations must sign Form FDA 1572
- Form FDA 1572 outlines the commitments that must be made by the researcher(s) regarding the conduct of the study
- Form FDA 1572 must list education, training, and experience of researcher that qualify the researcher to conduct the study
- Form FDA 1572 must list the research sites (names and addresses) and clinical laboratories to be used in the study
- Form FDA 1572 must list sub-investigators
- Form FDA 1572 must list the IRB of record for that study site
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Dental filling materials Menstrual pads or tampons TENS devices Emergency use - ansthe use of an investigational drug or device with a human subject in a life-threatening situation, or in which no standard acceptable treatment is available and there is not sufficient time to obtain IRB approval If an individual subject does not meet the criteria for an existing research plan, or an approved research plan does not exist, the usual procedure is for the physician to: - anscontact the manufacturer and determine if the drug can be made available for an "emergency use" under the company's IND If there is no IND, the FDA per 21 CFR 312.36 may authorize the manufacturer to allow the drug to be used in advance of an IND submission In addition, if the company agrees to provide the product, the physician can contact FDA, explain the situation, and obtain an emergency IND to permit the drug's shipment If there is no IDE, the physician may use the device and notify FDA of it use after the fact. - ansThe physician should obtain both an independent assessment from another physician and informed consent from the subject, before emergency use of the device occurs For emergency use of devices, concurrence of the IRB chair is required before the use takes place IRB review and approval is required in all circumstances if the researcher: - answishes to use the data for research purposes Subsequent use of the investigational product at the organization should have prospective IRB review and approval. If the IRB was not notified before the investigational drug or device was used in an emergency situation: - ansthe IRB should be notified per organizational policy or within 5 working days. The FDA and sponsor should be notified as necessary. Investigator initiated trial (IIT) - ansResearchers who design and conduct their own studies assume responsibility of the researcher and the sponsor Responsibilities of the sponsor include: - ans1) Selecting clinical researchers qualified by training and experience
- Informing and qualifying researchers by obtaining their commitment to supervise the study, follow the research plan, and obtain consent
- Monitoring the study's conduct by auditing documentation and conducting site visits
- Completing regulatory filing related to the IND or IDE, adverse events, amendments or revisions, progress reports, withdrawal of IRB approval, and final reports
- Controlling the distribution, tracking, ad dispensation of the regulated products
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· Researcher Responsibilities: ultimately, investigators are responsible for the conduct of the investigation, as well as: - ans1) Ensuring IRB approval for the study is obtained before any subjects are enrolled
- Ensuring that informed consent is obtained in accordance with FDA regulations
- Ensuring that the investigation is conduced according to the investigational plan and applicable regulations
- Administering the drug or using the device only in subjects under the researcher's supervision or under the supervision of a recognized sub-researcher
- Maintaining adequate records of the dispensation of the drug or device
- Returning unused materials at the end of trial
- Preparing and maintaining adequate case histories and signed informed consent documents
- Maintaining correspondence with the IRB and the sponsor to make sure that both have reviewed research plan amendments, recruiting materials, and Investigator's Brochures
- Retaining records in accordance with regulations
- Provide progress, safety, final, and financial disclosure reports
- Notifying the sponsor if IRB approval is withdrawn
- Complying with International Council for Harmonisation (ICH) guidelines, if applicable · The FDA's Bioresearch Monitoring Program conducts ______ ______ and _____ ______ _____ inspections of IRBs, clinical researchers, and sponsors - ansfor cause & not for cause 21 CFR 11 (Electronic Records; Electronic Signatures) Part 11 - ansIntended to enable the use of electronic documents in the regulatory process for drugs and devices For electronic systems to comply with Part 11, a number of requirements must be met, including: - ans1) Computer systems utilizing electronic records and signatures must ensure accuracy, reliability, and consistent performance. SOPs, audits, testing, and training are required.
- Computer systems must use and maintain secure, computer-generated, time-stamped audit trails independently recording the date and time of entries and actions that create, modify, or delete electronic records
- Computer systems must use system checks ensuring that only those individuals authorized to use the system are allowed access to the system, alter records, and perform operations
- Procedures must be established to ensure that records are retained for a duration of time, in an appropriate format, and to meet FDA requirements at a minimum. A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It is hoped that the new pacemaker will pose fewer risks to individuals when compared to the current commercially available products. How should this device be classified? - ansSignificant risk device
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Senior author - ansNormally the head of the research team, is often the corresponding author, and in some disciplines, the last author. As a result, in some disciplines, it is assumed that the last author position carries significant status whether or not it is the authors' intention. An author's responsibilities include confirming that: - ans1) All relevant work is cited, both confirming and contradictory, in order to provide the reader with a full understanding of how the work relates to the existing literature within the field, and to recognize and acknowledge the work of others in the field
- All data are accurately and clearly presented
- Key underlying assumptions are clearly stated
- The work is described in sufficient detail so that in principle it can be replicated
- Potentially hazardous aspects of the research are clearly identified
- Conflicts of interest that may, consciously or unconsciously, bias the interpretation of the research findings have been disclosed to editors and readers Duplicate publication - ansrepublishing a significant portion of a paper or the paper in its entirety. Republication might be allowed if: - ans1) The work is being translated into another language
- The work is being published in an anthology or similar collection
- The material is rewritten and targeted to a different audience
- The authors are transparent with each respective published about the duplication and have addressed relevant copyright issues Which of the following is the primary criterion for authorship? - ansHaving made a significant intellectual contribution to the work Which of the following represents plagiarism? - ansPresenting someone else's ideas or words and claiming them as one's own Which of the following is a responsibility of each author? - ansConfirming that data have been accurately presented in the paper Which of the following statements is true regarding the International Committee of Medical Journal Editors guidelines? - ansIndividuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgements section Which of the following is true regarding authors who seek to publish the same content in multiple papers? - ansIf the same content is used in multiple papers, it is essential that this information be properly disclosed to journal editors and other relevant entities Collaborative research - ansjoint work on a research project or program that benefits from the knowledge, perspectives, and resources of many individuals, disciplines, or organizations.
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Community partnership - anscollaborations between researchers and community groups, civic associations, non-governmental organizations, and local service agencies that address problems in the community. Multidisciplinary collaboration - ansResearchers work on a problem within their own discipline-based perspectives in parallel with others, fitting their respective results together at the end of a project. nterdisciplinary collaboration - ans· More intentionally collaborative, with researchers working together on a common problem from their respective disciplinary perspectives. Transdisciplinary research - ansan even more collaborative form of work, in which researchers approach a common problem from an integrated conceptual framework, identify discipline-based methods and approaches that they can take together, and redefine both the problem and its solution accordingly. Government funded research - ansSince the passage of the Bayh-Dole Act and the Federal Technology Transfer Act, US academic researchers and universities have been able to patent the results of federally-funded research and license the patented technology to others for commercial development. When academic researchers patent promising research findings, ownership of the patent and the income that it produces are usually divided between the researcher or research team and the university. Many universities have ______________ ___________ ________ that identify research projects with potential for commercialization - ansTechnology Transfer Offices Tech transfer" facilities research collaborations that can make financial profit for institutions and researchers by bringing new findings to market. · Researchers collaborating with industry may be asked to sign a _____ - __________ ___________, promising not to publish results or methods without the sponsor's authorization and agreeing to a period of time in which the sponsor can assess the value of new findings. - ansnon-disclosure agreement Working with community partners with different experiences and perspectives brings both benefits and challenges to academic research: - ans1) Some communities have developed their own research review committees, and insist on reviewing both research proposals that plan to involve their members and the final reports from completed projects
- Communities may seem themselves as the owners of data collected about them, and may seek to control access to research material and the presentation of findings, especially those that may be negative or perceived as stigmatizing
- Community members who contribute to data collection may expect to be listed as authors of any resulting report
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property, responsibilities of authorship, trainees' roles and supervision, and who bears certain financial costs. Collaborations funded by a grant or contract may involve __________________ among the parties that define payment schedules, intellectual property rights and access to data, and the scope of work for each researcher or research team. - anssubcontracts Such subcontracts are usually developed by institutional officials with concern for legal commitments and financial liability. One of the most important steps in establishing a collaboration is to determine who is _____________ for the various components of the project and create a leadership plan that describes processes for making important decisions - ansaccountable Equally important, however, is a shared commitment to values and practices that support the honesty, reliability, and integrity of the research as a whole. What is the most appropriate process for research collaborators to use in determining which journal they should submit their work to? - ansThe research team should discuss the issue early on and while the project is ongoing What is the main function of a Technology Transfer Office with respect to collaborative research? - ansIt helps collaborative researchers to commercialize their work A research collaboration can be enhanced by: - ansDiscussing intellectual property issues while the collaboration is forming In any collaboration, data ownership is typically determined by: - ansThe type and source of funds used to support the project Which of the following statements is true regarding the regulations that govern research? - ansUS funded research collaborations are often governed by US regulations no matter where the research takes place Reliability - ansusually defined in terms of replication, or whether one obtains the same result on repeated measures of the same phenomenon. In other words, it refers to consistency of outcome if the conditions of things being studied have not themselves changed. Validity - ansrefers to the more complex notion of whether operationalized concepts-using the measurement definitions, devices, and methods of the research plan- actually measure what they purport to measure. Methodological Issues - ansThose associated with ensuring that a research study is well- deigned with respect to statistical analysis Methodologic issues include choices about: - anso Population and sample selection o Group assignment o Data collection
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o Data analysis o Data presentation A collection plan should govern the acquisition of data. Issues to consider include: - anso Which data should be collected o By what means should that data be collected in order to ensure reliability and validity o How much data should be collected- for example, how many subjects or events are required for adequate statistical power? o Which collection methods will be used and how will those methods reduce the likelihood of error or bias? o Who will undertake each data-related task? o How will training on the necessary methods and equipment be provided to each research team member? o Who will supervise the work and how will the quality and integrity of the study data be ensured? Planning out a research study may also include the purely technological information technology aspect of data management. It is common to pursue three main goals: - anso Confidentiality: preventing inappropriate users or uses of the data. It is usually discussed within the context of protecting the privacy of research subjects, which is a regulatory and ethical requirement if those subjects are human beings. Confidentiality also involves protecting intellectual property related to the research. o Integrity: The responsibility to record, store, and preserve data appropriately during the full lifecycle of a study, which helps to improve the accuracy of data analysis o Availability: refers to ensuring that the appropriate users have access to data whenever necessary. As with integrity, availability concerns can extend past the formal end of the study, to ensure access by others who wish to replicate the work An increasing number of US funding agencies require an overall _________ ________________plan for projects that they fund. - ansdata management The principles of being a responsible researcher alone impose obligations to stare data with others, provided there are no legal or regulatory constraints that apply to the research. The primary motivation for sharing is the same: o Allows for the replication of research - anso Allows for the replication of research o Enables others to confirm if data support a conclusion o Allows them to build on prior research more easily and accurately In the research context, the term validity most commonly refers to: - ansWhether operationalized terms actually measure what they purport to measure What are the three main goals of data lifecycle management (DLM)? - ansConfidentiality, availability, and integrity
