What Is An Expedited Review?

What Is An Expedited Review
Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The IRB regulations permit, but do not require, an IRB to review certain categories of research through an expedited procedure if the research involves no more than minimal risk.

What qualifies you for expedited review?

In order to qualify for review via expedited procedures, the research must not be greater than minimal risk and fall into at least one of the expedited categories defined by the federal regulations. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal risk.

What is an example of expedited research?

Some examples of expedited research are: studies involving collection of hair, saliva or dental plaque samples. studies of blood samples from healthy volunteers. analyses of voice recordings.

What does expedited processing mean?

Severe Financial Loss to a Person or Company – USCIS may expedite processing on your case if you can prove that a person or company will suffer severe financial loss if USCIS does not give you a decision on your case sooner rather than later. Here’s an example of the sort of situation where USCIS might expedite your case: Imagine that you are joining a nonprofit organization that needs to have you on its board to secure funding with a grant application.

That grant application will expire before you hear back from USCIS.
The organization will not receive the grant without you on its team, and if it doesn’t receive the grant, the nonprofit will be in serious financial trouble.
In this sort of case, expediting your case will prevent harming a U.S.
Company, so USCIS is likely to allow you to expedite.

You will need to prove that you filed your case on time and submitted additional evidence for any Requests for Evidence (RFEs) that USCIS may have issued on your case in a timely manner. Then, USCIS will evaluate the supporting documents that you submitted to show the potential loss to the company or person and conclude whether there will be a severe financial loss to you or a company you’re affiliated with if they don’t give you a decision update as soon as possible.

What is expedited review in Apple?

Expedited reviews You can request the review of your app to be expedited if you face extenuating circumstances, such as fixing a critical bug in your app or releasing your app to coincide with an event you’re directly associated with.

What is the difference between exempt and expedited review?

Expedited level of review Projects not eligible for an exempt review may be eligible for an expedited review. Expedited does not mean that the review is less rigorous or happens more quickly than convened review. It refers, instead, to certain types of research considered to involve minimal risk.

Can an IRB perform an expedited review?

An Expedited review may be performed by the IRB Chair and/or by an experienced IRB member designated by the IRB Chair, based on the member’s area of expertise. In reviewing the research, the reviewer may exercise all of the authorities of the full Committee except to issue disapproval.

What is expedited review 5 IRB?

TC IRB continues the blog series, “Get to Know a Review Category” with Expedited Category 5 – Data Collected for Non-Research Purposes. – Federal regulations stipulate that certain research studies may apply to the Expedited level of review. Expedited review may not be used if the risks related to the invasion of privacy and breach of confidentiality are greater than minimal. Additionally, research that meets the requirements for Exempt review would not be considered under Expedited review categories.

The research constitutes a minor change in a previously approved research project during an approved period; or The research is not greater than minimal risk and falls into one of the categories listed under the new common rule ( 45 CFR 46.110 or 21 CFR 56.110 ). Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). ( U.S. Department of Health and Human Services, 1998)

NOTE: Some research in this category may be exempt from the U.S. Department of Health and Human Services’ regulations for the protection of human subjects ( 45 CFR 46.101(b)(4) ). This refers only to research that is not exempt.

For help determining your review category, please download our guide: Does my human subjects research fall under the expedited review category? Researchers new to the IRB may be unfamiliar with the different activities within each Expedited review category.

This post will provide examples of research that typically falls under Expedited Review type, Category 5, Expedited Category 5 covers research “involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).” Expedited Category 5 research examples include materials collected for “non-research purposes,” but this review category can be used to cover research materials if the investigator’s role is simply to analyze them.

For example: If a researcher receives materials from colleagues with a separate IRB approval to collect them and the materials are handled using sound data security methods, protections for privacy and confidentiality, then the researcher may apply for expedited review for the analysis.

Blood samples collected for other health purposes; Academic exams; Program evaluations

Below are a few scenarios that we will review to see if they meet the requirements for Expedited Category 5. Example A: A team of physical trainers plan to evaluate their program that provides free cardiovascular fitness training to physical education educators on an accredited cardiovascular health care technique.

As part of the typical program, the trainers host sessions; individuals are asked to complete surveys and fitness tests, and track their changes over time using a Fitbit for two hours a day, over the course of two weeks.
As part of their process, the trainers plan to evaluate these measures to gauge the effectiveness of the program and to develop competent cardiovascular fitness training for educators.

The information collected is identifiable, but not sensitive. No minors will participate in these activities. All data will be stored on an encrypted password-protected device. The Physical Fitness Research Lab will collaborate with the physical trainers to evaluate the program’s data.

Is it Expedited Category 5? Yes! This study proposed by the researchers at the Physical Fitness Research Lab meets the requirements for Expedited Category 5 as it is no more than minimal risk and includes information that is collected for non-research purposes. This is a program evaluation, meaning the training program and assessments would occur even if the research did not take place. The IRB would review the program evaluation based on the types of data collected for non-research purposes and the types of identifiable data in the dataset, a core aspect of the Expedited Category 5 (e.g., names, addresses, Fitbit unique identifiers, etc.). The IRB would evaluate the training setting to determine whether the information gathered is not sensitive and data security standards were met. The research team may need to provide each individual in the training program with a data release form describing the data intended to be used for research. The data release form can include a statement that allows the individual to not release their data for research purposes.

Example B: A researcher wants to run a secondary analysis examining existing data on public census data collected by a state-sponsored substance recovery program. The researcher will review the data collected annually by the state on a community’s income, occupation, and education attainment alongside quality of life measures from a state-sponsored substance recovery program that some members of the community received.

The researcher aims to evaluate the participants’ demographic data, time spent in the program, and quality of life survey measures.
The data may include sensitive information (e.g., substance use disorder diagnosis) but will be de-identified by the state before it is shared with the researcher.
The researcher will not interact with any participants nor collect any new data.

All information will be stored on an encrypted password-protected device.

Is it Expedited Category 5? Although the research study includes previous data collected for non-research purposes and possibly sensitive information, this study likely does not meet the requirements for Expedited Category 5. In this case, the data was de-identified before the researcher ever received the data, does not have indirect identifiers, and the researcher will not have contact with participants. Exempt Category 4 review might fit this scenario best because it stipulates; “(ii) The information is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects, the investigator does not contact the subjects and will not re-identify the subjects” ( U.S. Department of Health and Human Services, 2018). The IRB would evaluate research outcomes (e.g., reporting of income, occupation, etc.) and the data-sharing agreement to assess any risk.

Example C: A researcher is interested in cross-examining two datasets to evaluate possible correlated factors between homeownership and education level. The researcher will be requesting datasets from a colleague who conducted similar studies in the past.

The researcher will combine the datasets based on identifiable participant information (e.g., name, home address, etc.). The IRB will review the data-sharing agreement to ensure secure data transfer and security. In the data-sharing agreement, only two members of the research team will have access to the identifiable data.

These two individuals will secure and de-identify the data before sharing it with the rest of the research team. No record of the identifiable data will be maintained. All information will be stored on an encrypted, password-protected device.

Is it Expedited Category 5? Yes, this is an example of an Expedited Category 5 review. The IRB would expect and require a data-sharing agreement and data security plan to ensure the protection of the data and how researchers plan to mitigate risk (e.g., loss of privacy, data breach, etc.).

Research activities may fall into one or more review categories depending on a variety of factors, including the study population, researcher expertise, coinciding events, etc. Researchers can access the Expedited review categories on TC IRB’s website or from the Department of Health and Human Services ( HHS ).

Who is eligible for expedited review by the IRB?

1. An expedited review must be performed by the IRB Chair or by an experienced IRB member designated by the IRB Chair, i.e. a member with demonstrated knowledge and application of research ethics in human subject protections of at least one year.2.

What is the expedited 7 category?

In Spring 2021, TC IRB introduced the blog series, “Get to Know a Review Category.” This Fall, we’ll go through Expedited Categories, starting with Group Characteristics & Behaviors. – Federal regulations permit the Institutional Review Board (IRB) to review and approve proposed research through an Expedited review process if.

Expedited review may not be used if the risks related to the invasion of privacy and breach of confidentiality are greater than minimal. Additionally, research that meets the requirements for Exempt review would not be considered under Expedited review categories.

For help determining your review category, please download our guide: Does my human subjects research fall under the expedited review category? Researchers new to the IRB may be unfamiliar with the different activities within each Expedited review category.
This post will provide examples of research that typically falls under Expedited Review type, Category 7 – Group Characteristics & Behaviors.

Category 7 indicates that protocols may be categorized as Expedited if the research is “on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.” Below are a few scenarios that we will review to see if they meet the requirements for Expedited Category 7.

Example A: A private tutoring center instructor is approached by a researcher who would like to test a new way of teaching grammar with elementary school students. The instructor agrees to split his students into two groups: one group of students will receive the new method of teaching grammar, and the other group will receive the standard method.

Both methods of instruction are considered typical and not deemed to give an unjust advantage to one group of students over another. The researcher will not have any contact with students. The next day, the groups will switch so that all students receive both methods of instruction conducted by the instructor.

Is it Expedited Category 7? Yes, the research method described above is considered a randomized controlled trial (RCT), Although the research involves typical educational practices and the researcher will not make contact with the students (requirements for Exempt Category 1), the introduction of a new method is researcher-designed and that disqualifies the research from being Exempt. In order to ensure fairness in education RCTs, students should receive both methods of instruction as it is not guaranteed that the new instructional method will be effective. The research should also not take away from typical learning or access to resources that the student might otherwise receive. As the research will be with youth under the age of 18, the researcher will need to obtain both parental permission and youth assent, Research with youth may be subject to additional protections and safeguards, as defined by the Office of Human Research Protections (OHRP), Additionally, the researcher should seek a site permission letter signed by the tutoring center’s administrator, once the research has been IRB approved.

Example B: A researcher plans to conduct an online survey using Qualtrics on LGBTQ+ individuals’ beliefs regarding specific laws targeted at trans individuals. Only adults over 18 years of age are eligible to participate in the study. The researcher plans to provide a $10 gift card compensation to participants who successfully complete the survey and meet all attention checks.

Is it Expedited Category 7? So long as the survey questions do not ask about sensitive information (e.g., illegal behaviors, medical records) and the only identifiers collected are the emails, this study would be categorized not as Expedited, but as Exempt. The study activities meet the criteria for Exempt Category 2, which states that recorded information from the survey procedures “cannot readily identify the subject (directly or through identifiers linked to the subjects).” Because participant emails will be recorded separately from the data, there is no way for the recorded information to be linked back to the subjects.

Example C: A researcher plans to interview professional athletes about their thought patterns, daily habits, and sleep schedules before and after a game. She would like to video record the interviews and use them as part of the data analysis and in her published materials.

Is it Expedited Category 7? Yes, this research meets the criteria for Expedited Category 7 as the research activities are not greater than minimal risk. However, the athlete may be identified in the published materials (with their consent) and due to the nature of their profession and fame, the researcher may be unable to guarantee confidentiality. The researcher should disclose to the athlete that she cannot guarantee their anonymity due to the nature of the research, even if the athlete does not consent to their name or direct quotes being used, they may be found out by process of elimination when the findings are published. An IRB may also require that the researcher obtain permission to conduct the study from the athlete’s coach or team administrator and clarify if there are any potential conflicts of interest or copyright issues associated with a professional athlete’s participation in research.

When can a protocol be eligible for expedited review by IRB?

The writers of the federal regulations mandating IRB review recognized that not all research rises to the level of full board review. In some cases, a protocol needs IRB approval but the level of risk in the protocol is considered minimal and the review can be expedited.

One of the key elements to defining an expedited protocol for the Social and Behavioral Sciences is determining if the protocol’s risk level is minimal (aka “minimal risk”). If the protocol meets the definition for minimal risk in addition to the expedited categories defined by OHRP, the Board can expedite a protocol’s review.

Comparing Expedited and Full Board Protocols

No full board review: An expedited protocol does not need full board review; modifications do not need to be reviewed at a full board meeting unless the protocol modifications change the level of risk to participants. Shorter review time: Expedited review time should be shorter, generally two to four weeks depending on the protocol load. A full board protocol is reviewed at the full board as well as any continuations or major modifications (some minor edits can be approved administratively), which can take a month or longer. Continuation review not required: Expedited protocols only need to be reviewed once (unless a protocol needs to be modified or there is an unexpected adverse event). Our office will contact you annually to verify that the protocol is still active; if it is no longer active, please close the study. Submission requirements and pre-review requirements are the same.

Maintaining an Expedited Protocol

Modifications: Your protocol should always reflect your study’s practice and if it doesn’t, you need to modify the protocol, Expedited modifications receive expedited review but please consider grouping modifications into one submission. If you are changing personnel, use the Personnel Management Tool instead of submitting a modification for this change. Update Protocol Status: Expedited protocols do not require an annual continuation review; rather you will be asked on an annual basis to update your protocol’s status (if you haven’t submitted a modification for review over the previous year). You will receive an email notification one month prior to your protocol’s annual notification date with information about how to complete the simple Protocol Status Update form. Failure to complete the form could result in study closure. Unexpected Event Report : Research doesn’t always go according to plan and if that happens, you may need to submit an unexpected event report, Study Closure : Once a study is complete, the protocol needs to be closed,

What does it mean when your manuscript receives a full board review?

Full Board Renewals – Any active protocol that previously received a full board review must come back to the Full Board for its yearly renewal. However, a protocol that previously received Full Board review can go through an Expedited review (Category #8), so long as it meets one of the following three requirements:

the research is permanently closed to the enrollment of new subjects;
all subjects have completed all research-related interventions; and
the research remains active only for long-term follow-up of subjects; or where no subjects have been enrolled and no additional risks have been identified; or where the remaining research activities are limited to data analysis

What is the difference between full board review and delegated review?

Full or Delegated Review? –

Full review at a Research Ethics Board (REB) meeting is the default review process for all human research.The delegated review process, which is conducted by a subcommittee of the board, may be used when the research is determined to be at or below the threshold of ‘minimal risk’.‘Minimal risk’ is defined as the probability and magnitude of possible harms implied by participation in the research can reasonably be expected by participants to be no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research, or during the performance of routine physical or psychological examinations or tests.To evaluate risk for your proposed research, consider the following.

Group Vulnerability Any pre-existing vulnerabilities associated with proposed participant groups, including the following.

E.g., relating to pre-existing physiological or health conditions Cognitive or emotional factors Socio-economic or legal status

Research risk The probability and magnitude of harm participants may experience as a result of the proposed methods to be used and types of data to be collected, including the following.

Physiological or health issues such as clinical diagnoses or side effects Cognitive or emotional factors such as stress or anxiety during data collection Socio-economic or legal ramifications such as stigma, loss of employment, deportation, or criminal investigation (e.g., in the event of duty to report intent to cause serious harm, subpoena, or breach of confidentiality)

The assessments of group vulnerability and research risk (i.e., low, medium, high) can then be used through the Risk Matrix to determine REB process.

Risk Matrix

Group Vulnerability	Research Risk
Low	Medium	High
Low	Delegated	Delegated	Full
Medium	Delegated	Full	Full
High	Full	Full	Full

Using the Risk Matrix can help guide you in determining when to submit your protocol, however, the REB makes the final determination whether a protocol is reviewed through delegated or full board process. Other factors that the REB considers in assigning a protocol to full board may include the following.

Involvement of clinical tests or interventions Use of personal health information (PHI) without participant consent Research complexity Large participant populations or data subjects

Advise in determining the risk level and use of the Risk Matrix Provide information on the full board and delegated review processes

: Determine If a Protocol Qualifies for Delegated Review

Who is eligible for expedited review by the IRB?

When can the expedited review process be used?

Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The IRB regulations permit, but do not require, an IRB to review certain categories of research through an expedited procedure if the research involves no more than minimal risk.

What best describes when a protocol may be eligible for expedited review by the IRB?

According to the U.S. Federal Research Misconduct Policy, fabrication involves: Answer: Making up data or results and recording or reporting them. Which of the following is most likely to be considered plagiarism? Answer: Using materials from a source without proper citation.

Which of the following is the most effective strategy for preventing research misconduct? Answer: Good mentoring Which of the following is true regarding the U.S.
Federal Research Misconduct Policy? Answer: To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.

Which type of research misconduct most likely occurred if someone intentionally removes data points on a graph in order to generate a deceptive conclusion? Answer: Falsification According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct? Answer: Plagiarism In response to a research misconduct allegation, what is the next main phase that takes place after the inquiry if there is sufficient evidence to proceed? Answer: An investigation According to the U.S.

Federal Research Misconduct Policy, falsification involves: Answer: Manipulating research materials, equipment, or processes, or changing or omitting data. What is the primary responsibility of oversight bodies such as an IRB or an IACUC? Answer: To detect compliance with regulatory requirements, including those relating to protecting research subjects.

What are the three main goals of data lifecycle management? Answer: Confidentiality, availability, and integrity In the research context, the term validity most commonly refers to: Answer: Whether operationalized concepts actually measure what they purport to measure.

Which of the following statements is true concerning data selection? Answer: Establishing a data selection strategy prior to collecting data decreases the chance of a biased outcome.
Which of following is most likely to own the data resulting from a research project? Answer: The institution where a federally-funded project takes place.

Which of the following is true regarding data sharing and stewardship? Answer: Agencies that fund research may include data sharing requirements in their funding contracts. Which of the following most accurately describes the practice of ghost authorship? Answer: It is a situation where the individual who wrote the manuscript is not listed as an author.

Which of the following is a responsibility of each author? Answer: Confirming that data have been accurately presented. Which of the following is an example of plagiarism? Answer: Presenting someone else’s ideas or words and claiming them as one’s own. Which of the following is true regarding an acknowledgments section? Answer: The contributions of students and technicians are often listed in the acknowledgments section if they do not meet all of the criteria for authorship.

Which of the following is true regarding publishing the same content in multiple papers? Answer: Using the same content in multiple papers is deceptive if it is not properly disclosed. Which author is normally responsible for sharing reprints of a publication with readers? Answer: The corresponding author.

Which of the following statements is true regarding the International Committee of Medical Journal Editors (ICMJE) guidelines? Answer: Individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgments section.
Which of the following is the primary criterion for authorship? Answer: Having made a significant intellectual contribution to the work.

Which of the following statements is true regarding authorship practices? Answer: Different disciplines have different practices about who should be included as an author. Which of the following statements most accurately describes the review process for grant proposals? Answer: Funding agencies usually have committees, often with external reviewers, that assess the quality of the proposal.

A reviewer’s main responsibility is to: Answer: Be professional and prompt.
The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are: Answer: Intellectual merits and broader impacts.
Which of the following statements is true regarding the responsibilities of a reviewer? Answer: A reviewer’s conflict of interest should be disclosed to the journal editor or grant agency Which of the following is true regarding single-blind and double-blind review: Answer: Under single-blind review, the identity of the author is revealed to the reviewer.

The main reason that grant proposal reviewers with a conflict of interest should remove themselves from the review process is because : Answer: Their removal lessens the chance that bias will affect the review process. Which of the following is most directly related to successful mentoring? Answer: Someone who is committed to the professional development of the trainee.

What is the most appropriate course of action for a trainee who has a problem with a mentor? Answer: After first attempting to communicate directly with the mentor, the trainee should seek the counsel of a trusted senior person in the department or organization.
Which of the following is to be avoided when seeking an effective mentor? Answer: Trainees should assume that whoever is assigned to them as the thesis or research adviser will be their best choice for a mentor.

Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship? Answer: The trainee must take an active role in the relationship and clearly communicate needs and expectations. Which of the following statements most accurately describes the mentoring relationship? Answer: Mentors teach trainees about aspects of academic life that are not covered in textbooks.

Which of the following statements best exemplifies the importance of mentoring? Answer: A mechanism to transmit values and standards of professional conduct. The defining characteristic of a mentor is someone who: Answer: Takes a sincere interest in the growth and development of a trainee. Which of the following is most likely to create a poor relationship between mentor and trainee? Answer: A faculty member searches out trainees merely for that person’s own career advancement.

Which of following is true about the management of conflicts of interest? Answer: Management plans are often created to reduce the impact of conflicts of interest rather than completely eliminating them. If researchers allow their moral or other personal beliefs to influence their objectivity, this is most likely an example of: Answer: A conflict of conscience Which of the following most accurately describes a conflict of commitment? Answer: It occurs when outside activities interfere with obligations to one’s primary employer.

The main focus of NIH’s conflict of interest policy is: Answer: Financial conflicts of interest The entity that normally is supposed to determine whether an academic researcher’s conflict of interest can be managed is: Answer: A conflict of interest committee Which of the following most clearly illustrates an example of an academic conflict of interest? Answer: A researcher becomes overly attached to a specific research outcome.

Which of the following most accurately describes an institutional conflict of interest? Answer: It occurs when an institution’s financial interests could interfere with its research activities. Which of following is true about conflicts of interest? Answer: They increase the likelihood of bias.

if an employer allows a friendship to interfere with a hiring decision, this is typically referred to as: Answer: A personal conflict of interest. Data ownership is typically determined by: Answer: The type and source of funds used to support the project. Which of the following is a key reason why international collaborations can be challenging? Answer: Language barriers and cultural differences among collaborators can complicate communication.

Which of the following is true regarding academic-industry collaborations? Answer: The industry sponsor typically owns the data from research that it funds. What is the most appropriate process for determining which journal a collaborative research team should submit their work to? It should be discussed early on in the collaboration by the members of the research team.

Which of the following is true regarding industry-sponsored research? Answer: Industry sponsors of research may place restrictions on the disclosure of research results. What is the main function of the Bayh-Dole Act of 1980 as it relates academic institutions? Answer: It allows institutions to have control over the intellectual property from federally-funded research.

What is the main function of a Technology Transfer Office? Answer: It helps researchers to commercialize their work. A research collaboration can be enhanced by: Answer: Discussing intellectual property issues while the collaboration is forming. Which of the following is true regarding the use of animals in research? Answer: The attending veterinarian must be allowed to have access to all research animals at all times.

Which of the following is the main reason why proper training in euthanasia techniques is important? Answer: Improper techniques can cause unnecessary pain and distress in animals.
Which of the following is empowered by the U.S.
Federal government to review and approve research activities involving vertebrate animals? Answer: The Institutional Animal Care and Use Committee (IACUC) Prior to implementing any significant change in the use of animals, what is the most important thing that the research team must do? Answer: Obtain IACUC approval for the change.

Which of the following most accurately describes the process that must occur when working with research animals covered by U.S. federal regulations? Answer: The research team must obtain IACUC approval for the proposed research procedures prior to starting the work.

Which entity is responsible for monitoring institutional compliance with PHS Policy? Answer: The Office of Laboratory Animal Welfare (OLAW) What is the primary purpose of the “3Rs” concept from Russell and Burch? Answer: To decrease the use of animals in research and to minimize pain and distress caused by animal experiments.

Which of the following is the general guideline that IACUCs use to evaluate the potential pain of a procedure conducted with animals? Answer: Any procedure that causes pain or distress in human beings may cause pain or distress in other animals. Which statement best describes information that must be included in a consent form: Answer: A description of the research’s potential benefits and risks.

Which of the following best describes when a protocol may be eligible for expedited review by the IRB: Answer: The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified by the federal government. Which of the following statements most clearly illustrates the principle of beneficence: Answer: Determining whether the benefits of a study outweigh the risks.

Which statement best describes the role of an IRB: Answer: a committee that reviews different types of human subjects research, Which of the following studies most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report: Answer: The Tuskegee Study.

The three ethical principles discussed in the Belmont Report are: Answer: Respect for Persons, Beneficence, Justice. As a first step, what must be done before enrolling a young child in a research protocol: Answer: the risks and benefits must be explained to the child’s parents or legally authorized representative.

Which statement most accurately describes the process leading to the development of the Nuremberg Code: Answer: it was created in response to the harms caused by Nazi researchers around the time of the Second World War. Which of the following protocols most likely requires IRB review: Answer: A study to evaluate a newly designed wheelchair by asking elderly individuals to use it.

Which statement best describes what an IRB is responsible for reviewing: Answer: Any form of research involving a human subject.
Who Should Consider Taking RCR? Answer: RCR is suitable for any person involved in research, ranging from upper-level undergraduates to established faculty.
Particular emphasis is given to the educational needs of graduate students and postdoctoral researchers.

Which Disciplines Or Fields Does It Cover? Answer: It covers essential topic areas such as authorship, data management, and research misconduct that are relevant to researchers from any field or discipline. It also includes content more specifically tailored to a subset of research fields, including “Research Involving Human Subjects” and “Using Animal Subjects in Research.” Does It Satisfy The NSF Or NIH RCR Training Mandate? Answer: The RCR policy from the National Science Foundation (NSF) allows organizations to make an internal determination about the type of training, CITI Program or otherwise, that satisfy the RCR training requirement.