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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, 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.
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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 Categories for expedited review: - ans1) The research does not involve more than minimal risk
- The entire research project must be consistent with one or more of the federally defined categories (IND/IDE note required) Types of IRB submissions - ans1) Application for initial review
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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: 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
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- 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: The researcher, with the concurrence of another physician, believes the situation necessitates the use of a test article The subject and/or LAR is unable to communicate consent There is insufficient time to obtain consent · No alternative exists that will provide an equal or better chance of saving the subject's life The IRB must be notified within a maximum of _____ days if a test article was used in an emergency situation for one individual are associated with an IRB-approved research study that involves research in emergencies - ans
- An elderly gentleman, whose wife is his LAR since his stroke several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator? - ansSend a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back.
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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
- 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
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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 eligibility criteria of the protocol to reduce the risk was implemented. Current subjects would be reconsented. - ansThis is an unanticipated problem A second study drug is given on Day 7 to counteract the toxicity of Drug 1. Subject #4-706 is given Drug 1 on Day 1. Due to a snowstorm, Subject 4-706 is delayed for several days before returning to the site for Drug 2. Missing the administration of Drug 2 on Day 7 placed the subject at risk of significant toxicity. This event required the subject be notified of the increased risk and required close monitoring of the subject by phone. - ansThis is an unanticipated problem that does not include an adverse event A subject received the wrong study drug resulting in severe nausea and vomiting, and a visit to the emergency room for treatment. The subject notified the study coordinator the day after the emergency room visit. The study coordinator reviewed the subject's study records and discovered the error. The coordinator notified the subject of the study drug error, which caused the nausea and vomiting. The investigator notified the IRB and the IRB approved a revision of the standard pharmacy procedure for administering investigational drugs. - ansThis is an unanticipated problem, which resulted in an adverse event Housekeeping employees of the medical center were recruited for a federally funded study of blood pressure, blood count levels, infectious disease history, and job stress. The interviews and blood tests were conducted in a private location not affiliated with the study center. Follow-up interviews were conducted in the same location. The study coordinator stopped at the cafeteria on her way back to the study office after the second study visit for the last three study subjects and lost the three file folders. Records of one subject indicated he had a history of a STD and another had recently been treated for TB. The subjects were notified of the loss. Following this event, the IRB approved a protocol change requiring that all records be transmitted electronically to the study office using the medical center's secure network. - ansThis is an unanticipated problem and not an adverse event
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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 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
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- 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
- Form FDA 1572 must include protocol information The Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990 provide the regulatory framework for medical device development, testing, approval, and marketing - ans1) Manufacturers who wish to market a new medical device may need to submit a premarket notification to the FDA
- If the device is not exempt for the premarket approval, the FDA at 21 CFR 807.81 (a)(1) (Establishment Registration 2014) determines whether the device is substantially equivalent to similar devices marketed before the 1976 amendment. Those devices are often referred to as 510(k) devices and require a summary to be submitted to the FDA to determine substantial equivalence (21 CFR 807.92)
- If the new medical device is not substantially equivalent, the company may need to demonstrate safety and efficacy in a premarket approval application, which could include clinical trials.
- The FDA regulations at 21 CFR 812 specify how to conduct clinical trials related to investigational devices. The regulations require that devices be classified as: - anssignificant risk or non-significant risk devices · Significant Risk (SR) Devices: As noted in the regulations (21 CFR 812.3), a SR device is one that: - ans1) Is intended to be implanted into a human
- Is used in supporting or sustaining human life
- Is of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise prevents impairment of human health; or
- Otherwise presents serious risk to health, safety, and welfare of a subject For use of a significant risk device in research, the sponsor must submit an IDE application to the FDA per 21 CFR 812.20. - ans1) There is no specific form for this purpose, but the regulations list elements required in the application.
- The trial cannot begin until the FDA grants an IDE and the IRB grants approval for the study. Non-significant Risk (NSR) Devices - ansNSR devices are studied without FDA oversight if the sponsor complies with certain FDA requirements such as monitoring, record keeping, and properly labeling the investigational device. The IRB must agree that the study meets the criteria for NSR. The clinical trial of an NSR device requires IRB approval, informed consent, and proper study monitoring and it must meet all other regulatory compliance requirements. However, an NSR device study does not
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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 An adult with ADHD presents to a physician. To date, no behavioral or drug interventions have proven useful. The physician has just read several reports about a drug that is approved and marketed for another indication, but has shown benefits for ADHD. The physician wants to prescribe this drug, in the labeled marketed dose, for the individual patient. Which of the
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following would be the most appropriate course of action? - ansTreat the patient with the drug based on physician's best medical judgement An investigator proposes to study a marketed product sold to treat high blood pressure in individuals over age 12 using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in younger children. Which of the following is the investigator's most appropriate action? - ansSubmit the research protocol to the IRB for review and submit an IND application the FDA before conduction research The FDAs regulations related to electronic records and electronic signatures (21 CFR Part
- are intended to: - ansa. Allow the use of electronic documents and signatures in the regulatory process for drugs and devices An academic medical center is selecting a new database system for clinical research. The system needs to be "Part 11 compliant" in order to allow: - ansThe medical center to replace the use of paper records with electronic records for its research The International Committee of medical Journal Editors recommends that authorship be based on these criteria - ans1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work
- Drafting the work or revising it critically for important intellectual content
- Final approval of the version to be published
- Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved Iit is the collective responsibility of the research team to determine who qualifies as an author. - ansIdeally, authorship should be discussed when a project begins and while it is ongoing, including when someone joins or leaves the research team. Recognition of the contribution of individuals or groups that does not meet the criteria of authorship is usually given in the form of: - ansan acknowledgement Corresponding author - ansThe individual designated to receive the bulk of a paper's reprints and whom those interested in obtaining a printed or an electronic copy of the paper should contact. This person may or may not be the submitting author, the senior author, the first author, or the last author. 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
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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
- Including community members as researchers on a project may subject them to federal or institutional requirements for formal training and oversight in the protection of human subjects, disclosure of conflict of interest, and research integrity. The content, level of detail, and source of such training may vary significantly from community to community International research collaboration - ansresearchers or sponsors from one country conducting or funding work in another Transnational and global research - ansgrowing important of supranational governmental organizations, such as the European Union, in funding research and setting research policy, and of research on problems that cross national boundaries, such as climate change or infectious disease Factors that can impact international collaborations include: - ans1) The use of animals in research is subject to little oversight in some countries but is highly regulated in others.
- Although the Declaration of Helsinki provides widely recognized international ethical guidelines for biomedical research, national regulations on research with human subjects vary worldwide as do cultural interpretations of vulnerability and protection
- International collaborations may be affected by national export controls that limit or prohibit sharing research data, materials, or training with citizens of countries seen to pose risks to national security.
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- Language barriers may persist even among collaborators who use English in their professional work. In addition to disciplinary jargon, there may be concepts in one culture for which other languages have no word or multiple words with important nuances Although research collaboration itself is not regulated, general research regulations and policies address various aspects of collaboration. These include: - ans1) Sharing of data and materials
- Financial management
- The role of committees for the protection of human subjects and animal welfare
- Financial conflicts of interest The ownership and sharing of data generated in federally-sponsored research is regulated by the _________ _________ - ansgranting agency _____ _________________ typically govern collaborative research funded by US federal agencies wherever the research takes place. - ansUS Regulations A _______________ of understanding may be written broadly to document an open-ended relationship or may detail expectations and commitments on a time-limited project - ansmemorandum A memorandum usually spells out the goals of the collaboration, the contexts and time period in which the research will occur, the people bound by the document, ownership of intellectual 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
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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 Which of the following is true regarding the reporting of research results? - ansClear specification of the methods and procedures used is essential Which of the following is true regarding data analysis? - ansData analysis methods should usually be specified in advance before a study begins Which of the following is most likely to own the data resulting from a research project? - ansThe organization that receives federal funding for a project. Technological Issues - ansPertain to the use of the available tools and processes for managing information throughout a research project's lifecycle and after the project concludes. This is sometimes called data lifecycle management. Its main goals are to ensure data confidentiality, integrity, and availability for as long as the data exists. Achieving such goals requires a combination of measures, which balance prevention, detection, and response to problems. Ethical, Legal-Regulatory, Professional, and Organizational Policy Issues - ansrefer to what is required, recommended, discouraged, or prohibited by governmental entities and other organizations that have oversight over research activities, including an employer's standards Many organizations and governmental agencies look to _____________ to broaden the representation of minorities and women in research professionals, and may programs have been developed to correct the imbalance in mentoring opportunities. - ansmentoring · Organizations can facilitate the creation of productive mentoring relationships by implementing measures such as: - anso Providing rewards to good mentors o Identifying poor mentors and taking steps to improve their behavior o Establishing procedures for reporting grievances or misconduct, and protecting those who report problems o Promoting a diverse, psychologically safe, and nondiscriminatory work environment Facilitating _______________ relationships is one way that organizations can develop a sense of community and mutual respect - ansmentoring
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A Comprehensive ACRP-CP Exam Study
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Which of the following statements most accurately describes the mentoring relationship? - ansMentors teach trainees about aspects of academic life that are not covered in textbooks Which of the following statements best exemplifies that importance of mentoring? - ansA mechanism to transmit values and standards of professional conduct Which of the following most accurately describes good mentoring practice? - ansEncouraging trainees to receive mentoring from a collection of individuals Which of the following is most directly related to successful mentoring? - ansSomeone who is committed to the professional development of the trainee Which of the following is most likely to create a poor relationship between a mentor and a trainee? - ansA mentor is a person who recruits trainees merely for the mentor's own career advancement __________ _______________ is purported to improve the quality of published papers as well as to conserve the amount of space available for the most selective and deserving papers in a given journal. The goal behind the __________ ______________ of grant proposals is to select the highest quality proposals for the limited amount of dollars available. - anspeer review · The most important function of peer review is to serve as a form of __________ _____________. Yet there is some evidence that peer review has a rather limited impact on the quality of publications and might block highly innovative, but unorthodox, work from being published and from receiving grant funding. - ansquality control · Peer reviews can be characterized as open, single-blind, or double-blind - anso Open review: refers to the reviewer knowing the author's identity and the author knowing the reviewer's identity o Single-blind review: refers to the reviewer know the author's identity but the reviewer's identity is confidential and not revealed to the author o Double-blind review: refers to neither the author nor the reviewer knowing each other's identity. Single blind review tends to be more common than double-blind review in many scientific and engineering fields Peer review of manuscripts submitted to professional journals is widespread. Journal editors usually select two or more reviewers, who are supposed to be experts on the paper's subject matter. Reviewers typically pass judgement on the: - anso Appropriateness of the subject as it relates to the journal's focus o Originality and significance of the findings o Validity of the methodology used o Strength of the results and conclusions o Quality of the writing Different US agencies and organizations use different metrics to evaluate grant proposals. In general, a grant proposal submitted to federal agencies will be judged on: - anso Scholarly significance o Methodology
