Which Type Of Review May Be Conducted To Follow Up On Previous Findings Of Noncompliance?

Which Type Of Review May Be Conducted To Follow Up On Previous Findings Of Noncompliance?
If a researcher becomes aware of any noncompliance with respect to a specific study, then a post-approval report must be made to the IRB, preferably through the Principal Investigator, to the IRB.

What is non compliance in research?

Updated July 14, 2021 Research studies may result in the implementation of unapproved changes to IRB-approved research plans or failure to comply with established regulations, policies, and procedures. Any action or activity associated with the conduct or oversight of research involving human participants that fails to comply with the research plan as approved by a designated IRB, or federal regulations or institutional policies governing such research constitutes noncompliance.

Noncompliance may range from minor to serious, be unintentional or willful, and may occur once or several times. Noncompliance includes deviations to the protocol made in the interest of a single participant such as to coordinate study visits. Noncompliance may result from the action of a participant, investigator or staff and may or may not impact the rights and welfare of research participants or others, or the integrity of the study.

Complaints or reports of noncompliance from someone other than the research investigator are handled as allegations of noncompliance until such time that the allegation is validated or found to be invalid and dismissed. This policy addresses noncompliance as it pertains to the conduct of research involving human participants.

What is a full committee review and expedited review?

Types of Reviews – Institutional Review Board Information regarding the types of reviews are guidelines. Special considerations such as the Health Insurance Portability and Accountability Act (HIPAA), Federal regulations, or other applicable law or local policies must be taken into consideration and included regarding IRB review.

Items 1 – 4 refer to IRB applications for initial review.
Brief overview of review categories: 1.
IRB review not required : The IRB may determine that the research proposal does not meet the qualifications for IRB review 2.
Exempt review : An “exempt” IRB review is selected when the research falls into one of the six approved categories of exempt research (45 CFR 46.101 ) and is not applicable to research in a covered research category (e.g., FDA regulation – 21 CFR 50.20).

Often anonymous survey research with adults in a non protected class that is minimal risk (i.e. does not ask invasive/sensitive questions) is classified as exempt.3. Expedited review: If the research does not meet the exempt review criteria, but involves no more than minimal risk, it typically classified as expedited.4.

Full review: Research that does not meet the criteria of the previous review categories (typically involves more than minimal risk) is classified as a full review. This means that a quorum (aka majority) of IRB committee members must meet, discuss, and have a majority vote on the research proposal.5.

Amendments or Modification Review : Any changes that affect the subjects in any way after initial IRB approval must be submitted to the IRB for review before the implementation of that change. This can include minor changes (i.e. changing the wording on a survey question), or major changes (i.e.

studies approved through an expedited mechanism
studies approved by the full board once subject interaction is completed

DEFINITIONS:
Research: means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human subject: means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

Minimal Risk: Minimal risk means that the probability and magnitude of harm or discomfort anticipated are not greater in and of themselves than those encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(i)).

Explanations & examples of review categories: 1. IRB review not required. If the research application is determined to not meet the requirement of human subjects research, it is not required to be reviewed by the IRB. University policies and ethical guidelines regarding research are still applicable to the research project.

The IRB chair, or their designee, will contact the researcher in writing with this decision. Typically this determination will take 5-7 business days, however, it may take longer if clarification from the researcher is needed.2. EXEMPT review: Submissions that meet the criteria for exempt review are reviewed at minimum by the IRB chair or their designee.

Typically turnaround time for IRB exempt review decisions is two weeks or less, however, it may take longer if clarification from the researcher is needed.
Exempt review criteria: An “exempt” IRB review is selected when the research falls into one of the six approved categories of exempt research (45 CFR 46.101 ) and is not applicable to research in a covered research category (e.g., FDA regulation – 21 CFR 50.20).

Exempt Category 1: Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.

A study evaluating the effectiveness of a commonly accepted science curriculum. For the study, researchers will observe classroom instruction and collect quizzes and class evaluations that are part of the curriculum and classroom practices.
A study comparing two curricula that are currently being implemented in a school. Researchers will observe classrooms as well as interview instructors about their experiences implementing the instructional materials (but not about specific students).
A study comparing driver’s education curricula offered by area driving schools. The researcher will observe classes and compare group driving test scores at the end of the courses.

Note: If the researcher is also the teacher/instructor and is part of the interaction with the participants it DOES NOT qualify under this exemption.
Exempt Category 2:
Research that only includes interactions involving

educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures*, or
observation of public behavior (including visual or auditory recording)** if at least one of the following criteria is met:

(i) The information obtained 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; (ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7)*.

*Not applied for use with children.
**Can only be applied for use with children when the investigators do not participate in the activities being observed
Examples of research exempt under Category 2:

A study involving an anonymous survey regarding workplace satisfaction at area firms.
An observational study of pedestrians crossing a street; the researcher takes notes of what occurs, recording sex, race, and type of clothing of pedestrians, but does not interact with subjects.
A study involving interviews with college seniors (age 18 and older) about their plans after graduation. The answers to questions asked would present no risks to subjects if divulged outside the research.
A study involving focus groups with expectant mothers regarding their perceptions of parenting education.

Exempt Category 3:
Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
(A) The information obtained 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;
(B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or

(C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.

Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
Examples of research exempt under Category 3:
Exempt Category 4:
Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
(i) The identifiable private information or identifiable biospecimens are publicly available;
(ii) Information, which may include information about biospecimens, 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 the investigator will not re-identify subjects;

(iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C.3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C.552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C.3501 et seq.

A research study of treatment outcomes for a certain drug that involves the review of patient charts at a medical facility. The researcher records patient age, sex, diagnosis, and treatment outcome in such a way that the information cannot be linked back to the patient.
A graduate student has access to coded data from a study previously conducted by her faculty advisor and records the information she needs for her research without the code, so that the data being analyzed for the research can in no way be traced back to individual subjects.

Exempt Category 5: Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.

Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

Note: Exemption Category 5 only applies to research on public benefit programs (such as Social Security) conducted by the federal government and therefore is rarely, if ever, applied to research at WLU. Research and demonstration projects in general (e.g., state or city funded public service programs) do not fit under this exempt category.

Exempt Category 6: Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S.

Department of Agriculture. Examples of research exempt under Category 6:

A taste-test on different varieties of a fruit to determine consumer preference, when the fruits do not have any additives and subjects are asked to indicate which fruit they prefer.
A study that involves taste-testing of various beef products from cattle that have been given feed with a chemical additive. If the researcher can document that the amount of the additive was at or below the levels approved by the USDA, the research may qualify for an exemption.

3. EXPEDITED review: Submissions that meet the criteria for expedited review are reviewed by the IRB chair or their designee, and at least one other IRB member. Typically turnaround time for IRB decision is two weeks or less, however, it may take longer if clarification from the researcher is needed, or it is determined that a full review is warranted.

Expedited review criteria: An “expedited” IRB review is selected when the research does not meet the criteria for exempt status but involves no more than minimal risk to subjects OR is being reviewed strictly for minor changes to previously approved protocols in the research project.
Minimal risk means “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests”
Expedited Category 1 – Clinical studies of drugs and medical devices only when (a) the research is on drugs for which an investigational new drug application (21 CFR 312) is not required or (b) the research is on medical devices for which (i) an investigational device exemption application (21 CFR 812) is not required or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Expedited Category 2 – Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from (a) healthy, non-pregnant adults who weigh at least 110 pounds for whom (i) the amounts drawn do not exceed 550 ml in an 8 week period and (ii) collection does not occur more frequently than 2 times per week or (b) other adults and children, for whom, considering the age, weight, and health of the subjects, and the collection procedures, (i) the amount of blood to be collected does not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and (ii) collection does not occur more frequently than 2 times per week.

(Note: Children are defined as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.”) Expedited Category 3 – Prospective collection of biological specimens for research purposes by noninvasive means.

Expedited Category 4 – Collection of data through non-invasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. (Note: Where medical devices are employed, they must be cleared/approved for marketing.)

Expedited Category 5 – 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. (This listing refers only to research that is not exempt )
Expedited Category 6 – Collection of data from voice, video, digital, or image recordings made for research purposes.
*Expedited Category 7 – Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

*According to the Federal regulations and Category 7, most survey research that is not otherwise exempt is eligible for expedited review. However, 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.” (63 FR 60364, November 9, 1998) Expedited Category 8 (continuing review) Continuing review of research previously approved by the convened IRB: (a) where

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

(b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.
Expedited Category 9 (continuing review)
Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

4. Full review: Submissions that meet the criteria for full review are typically reviewed by a quorum (aka majority) of IRB members which must include at least one member whose primary concern is in a nonscientific area. Full review criteria: A “full” IRB review is required when the research is defined as (a) a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (38 CFR 16.102d); (b) that involves human subjects (i.e., a living person about whom a researcher collects either identifiable private information OR data through an intervention or interaction); and (c) involves greater than minimal risk to those human subjects.

A full review is required for any study that does not meet the requirements for an exempt or expedited review. In order to approve research, the IRB must determine that all of the requirements specified in 45 CFR 46.111 (and if applicable, 21 CFR 56.111) are satisfied.5. Amendments or Modification Review: Changes that affect the subjects in any way cannot be made to approved studies, including informed consent documents, without prior IRB review and approval.

An exception to this is any changes necessary to immediately protect subjects safety as noted in 21 CFR 56.108(a)(4) and 56.115(a)(1). The amendment or modification review may fall under a “full” or “expedited” category, depending on the magnitude of the change and the affect of the change on the risks/benefits ratio.

Amendment or Modification procedure: The Amendment or Modification form and information is accessible on the IRB website.
This form is completed online by the P.I.
And is forwarded to the IRB chair.
The IRB chair, or their designee, determines if the form has been appropriately completed and contacts the researcher regarding any necessary clarifications regarding the submission.

The IRB chair, or their designee, then determines the appropriate level of IRB review. See above for descriptions of expedited and full reviews.6. Continuing review: The IRB must re-review studies at minimum of once every year. The IRB may require review more frequently depending on the IRB’s assessment of the study’s risk/benefit ratio and provisions provided by federal guidance (i.e.

final rule HHS 2018). The frequency of review is indicated in the IRB notification of decision document. The continuing review may be a full or expedited review. Continuing review procedure: The Continuing review form and information is accessible on the IRB website. This form is completed online by the P.I.

and is forwarded to the IRB chair. The IRB chair, or their designee, determines if the form has been appropriately completed and contacts the researcher regarding any necessary clarifications regarding the submission. The IRB chair, or their designee, then determines the appropriate level of IRB review.

What are the levels of review?

The Three Types of IRB Review IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full.

Research, conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

The information obtained 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; Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

The identifiable private information or identifiable biospecimens are publicly available; Information, which may include information about biospecimens, 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 the investigator will not re-identify subjects; The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under HIPAA as “health care operations,” “research” or “public health”; or The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities and the information is subject to federal privacy standards and other requirements specified in the exemption

Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.

Taste and food quality evaluation and consumer acceptance studies.
Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use.
The exemption can only be used when there is broad consent from the subjects for the storage, maintenance, and secondary research use of their identifiable materials.

Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

Broad consent is obtained from the subjects for the secondary research use of their identifiable materials, Documentation or waiver of documentation of informed consent is obtained, An IRB conducts a limited review to make certain determinations relating to privacy and confidentiality protections and broad consent, and The investigator does not include returning individual research results to subjects as part of the study plan.

What are the different types of review?

Types of Reviews

Label	Search
State-of-the-art review	Aims for comprehensive searching of current literature
Systematic review	Aims for exhaustive, comprehensive searching
Systematic search and review	Aims for exhaustive, comprehensive searching
Systematized review	May or may not include comprehensive searching

How do I report non compliance to the IRB?

Incidences of serious noncompliance should be reported to the Office of Research Compliance, Integrity and Safety within five business days of becoming aware that it has occurred. Such reports may be submitted via email or in writing to the IRB administrator. They may also be presented verbally to the IRB.3.

What is non compliance assessment?

Non-Compliance Risk Assessment Tool – CLASP Robust compliance activities protect national markets from non-compliant products and safeguard benefits of adopted energy efficiency and quality policies. Although compliance plays a key role in policy implementation, it is often overlooked or delayed.

Governments, funders, and development partners perceive the efforts and resources required to design and enforce strong compliance frameworks to be inhibitory. Challenges also arise in evaluating the associated impacts. There is currently no clear methodology to estimate the benefits of compliance, such as measuring the reduced number of non-compliant products on the market, to provide a compelling reasoning for the investment in compliance-related initiatives.

Testing a large number of products from the market to assess non-compliance rate is cost-prohibitive for many. Recognizing the challenges that governments face in measuring market non-compliance rates, CLASP developed the Non-Compliance Risk Assessment Tool (NC-RAT) to underscore compliance’s importance.

Assess national compliance processes for product energy efficiency and quality programs, and associated market non-compliance risk Advance policy compliance and enforcement by identifying specific gaps, prioritize investment in compliance processes with greatest impact to strengthening them Build a case for investment in policy compliance and enforcement initiatives Track progress/improvement of compliance efforts, e.g., conduct initial assessment to set the benchmark and assess the compliance program regularly, i.e., on an annual basis.

NC-RAT is an easy-to-use tool that is based on a qualitative assessment of national compliance programs and organized under five Indicators: Regulation, Resources, Certification & Registration, Market Surveillance & Enforcement, and Compliance Communication.

Each Indicator includes relevant questions for the user to respond to, based on which, the Tool calculates scores for 1) each Indicator and 2) a corresponding overall score for market non-compliance risk.
The tool also provides initial recommendations for how policymakers can strengthen compliance programs, based on individual user responses To learn more about how to use the NC-RAT, for a step-by-step tutorial.

For questions and inquiries on the NC-RAT, suggestions for improvement, sharing country’s assessment results, etc. please contact Lina Kelpsaite at lkelpsait[email protected]. : Non-Compliance Risk Assessment Tool – CLASP

What does IRB review mean?

Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

This group review serves an important role in the protection of the rights and welfare of human research subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

Regulations: Good Clinical Practice and Clinical Trials, Comprehensive list of regulations governing human subject protection and the conduct of clinical trials. Guidance for Institutional Review Boards and Clinical Investigators, A series of Information Sheets providing the Agency’s current guidance on the protection of people who are subjects of research. Topics include Institutional Review Boards and Sponsor-Investigator-IRB interrelationships, FDA clinical investigator inspections and sanctions, clinical trials protocols, informed consent, and documents necessary for the conduct of clinical trials. Information for Health Professionals, Additional links to information on subject protection from FDA and other government agencies. Clinical Safety Data Management (PDF – 49KB), Provides the definitions and terminology associated with clinical safety experience and the standards for expedited reporting of adverse drug reactions that occur during clinical trials. FDA Compliance Program 7348.809 – BIMO for Institutional Review Boards (PDF – 1050MB). FDA Compliance Program 7348.811 – Bioresearch Monitoring: Clinical Investigators.

Institutional Review Board Questions: Contact the Office of Good Clinical Practice, 301-796-8340, or [email protected]

When can expedited review be used?

Expedited Review The expedited review category is used for certain types of research involving no more than minimal risk and minor changes to research previously approved by the full committee, during the period for which approval has been authorized. Research eligible for expedited review is reviewed by a subcommittee of the IRB. Expedited review of continuing reviews where the protocol is unchanged from the previous year or minimal risk amendments/modifications may be conducted by a single designated reviewer. Agreement of all reviewers is needed for approval. Reviewers may refer the proposal to the full committee. The principal investigator will be informed in writing whether the proposed research has been approved or referred for full committee review. The IRB will be notified of all research activities that have been approved by expedited review. The following types of research may qualify for expedited review: 1. Clinical studies of drugs when an IND is not required, or; clinical studies of medical devices when an IDE is not required, or the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, non-pregnant adults who weight >110 pounds where the amount drawn is <500 ml/8 week period and collection occurs at most 2 times/week, or; collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected (at most 50 ml or 3 ml/kg/8 week period), and the frequency with which it will be collected (at most 2 times/week.) 3. Prospective collection of biological specimens for research purposes by noninvasive means.4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.5. Research involving materials (data, documents, records, or specimens) that have been, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (Note: some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt) 6. Collection of data from voice, video, digital, or image recordings made for research purposes.7. Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.8. Continuing review of research previously approved by the convened IRB where: i. the research is permanently closed to the enrollment of new subjects; ii. all subjects have completed all research-related interventions; and iii. the research remains active only for long-term follow-up of subjects, or; Continuing review of research previously approved by the convened IRB where no subjects have ever been enrolled at a particular site and neither the investigator nor the IRB at a particular site has identified any additional risks from any site or any other relevant source, or; Continuing review of research previously approved by the convened IRB where the remaining research activities are limited to data analysis. (For a multi-center protocol, and expedited review procedure may be used by the IRB at a particular site whenever these conditions are satisfied for that site.) 9. Continuing review of research, not included under an investigational new drug application or investigational device exemption where categories (2) through (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than Minimal Risk and no additional risks have been identified. Related resources: Policy: Expedited Reviews

What are the two types of review?

Scoping reviews – Scoping reviews are exploratory and they typically address a broad question, compared to a systematic review that typically has a more targeted question. Researchers conduct scoping reviews to assess the extent of the available evidence, to organize it into groups and to highlight gaps.

What is a Level 1 review?

Level I: Evidence from a systematic review of all relevant randomized controlled trials.

What is better than a systematic review?

Results – Researchers may conduct scoping reviews instead of systematic reviews where the purpose of the review is to identify knowledge gaps, scope a body of literature, clarify concepts or to investigate research conduct. While useful in their own right, scoping reviews may also be helpful precursors to systematic reviews and can be used to confirm the relevance of inclusion criteria and potential questions.

What are review techniques?

What Is a Review Strategy? Review strategies are techniques for reengaging with information that you have already learned, so that it stays fresh in your mind. They’re particularly valuable when you’re learning for a specific purpose – for instance, revising for an assessment or exam.

What is the difference between systematic review and traditional review?

5 differences between a systematic review and other types of literature review There are many types of reviews of the medical and public health evidence, each with its own benefits and challenges. In this blog post, we detail five key differences between a systematic review and other types of reviews, including narrative and comprehensive reviews.

First, we must define some terms. “Literature review” is a general term that describes a summary of the evidence on a certain topic. Literature reviews can be very simple or highly complex, and they can use a variety of methods for finding, assessing, and presenting evidence. A “systematic review” is a specific type of review that uses rigorous and transparent methods in an effort to summarize all of the available evidence with little to no bias.

A good systematic review adheres to the international standards set forth in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 27-item checklist.1 Reviews that are less rigorous are often called “narrative,” “comprehensive,” or simply “literature reviews.” So, what are the 5 key differences between a systematic review and other types of review? 1.

The goal of the review The goal of a literature review can be broad and descriptive (example: ” Describe the available treatments for sleep apnea “) or it can be to answer a specific question (example: ” What is the efficacy of CPAP for people with sleep apnea? “).
The goal of a systematic review is to answer a specific and focused question (example: ” Which treatment for sleep apnea reduces the apnea-hypopnea index more: CPAP or mandibular advancement device? “).

People seeking to make evidence-based decisions look to systematic reviews due to their completeness and reduced risk of bias.2. Searching for evidence Where and how one searches for evidence is an important difference. While literature reviews require only one database or source, systematic reviews require more comprehensive efforts to locate evidence.

Multiple databases are searched, each with a specifically tailored search strategy (usually designed and implemented by a specialist librarian).
In addition, systematic reviews often include attempts to find data beyond typical databases.
Systematic reviewers might search conference abstracts or the web sites of professional associations or pharmaceutical companies, and they may contact study authors to obtain additional or unpublished data.

All of these extra steps reflect an attempt to minimize bias in the summary of the evidence.3. Assessing search results In a systematic review, the parameters for inclusion are established at the start of the project and applied consistently to search results.

Usually, such parameters take the form of PICOs (population, intervention, comparison, outcomes). Reviewers hold search results against strict criteria based on the PICOs to determine appropriateness for inclusion. Another key component of a systematic review is dual independent review of search results; each search result is reviewed by at least two people independently.

In many other literature reviews, there is only a single reviewer. This can result in bias (even if it is unintentional) and missed studies.4. Summary of findings In a systematic review, an effort is usually made to assess the quality of the evidence, often using risk of bias assessment, at the study level and often across studies.

Other literature reviews rarely assess and report any formal quality assessment by individual study.
Risk of bias assessment is important to a thorough summary of the evidence, since conclusions based on biased results can be incorrect (and dangerous, at worst).
Results from a systematic review can sometimes be pooled quantitatively (e.g., in a meta-analysis) to provide numeric estimates of treatment effects, for example.5.

Utility of results Due to the rigor and transparency applied to a systematic review, it is not surprising that the results are usually of higher quality and at lower risk of bias than results from other types of literature review. Literature reviews can be useful to inform background sections of papers and reports and to give the reader an overview of a topic.

Systematic reviews are used by professional associations and government agencies to issue guidelines and recommendations; such important activities are rarely based on a non-systematic review.
Clinicians may also rely on high quality systematic reviews to make evidence-based decisions about patient care.

Each type of review has a place in the scientific literature. For narrow, specific research questions, a systematic review can provide a thorough summary and assessment of all of the available evidence. For broader research questions, other types of literature review can summarize the best available evidence using targeted search strategies.

Ultimately, the choice of methodology depends on the research question and the goal of the review.
Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009).
Preferred Reporting Items for Systematic Reviews and Meta-Analyse s: The PRISMA Statement.
PLoS Med 6(7): e1000097.
Doi:10.1371/journal.pmed1000097.

: 5 differences between a systematic review and other types of literature review

What is a descriptive review?

9.3.2. Descriptive or Mapping Reviews – The primary goal of a descriptive review is to determine the extent to which a body of knowledge in a particular research topic reveals any interpretable pattern or trend with respect to pre-existing propositions, theories, methodologies or findings ( King & He, 2005 ; Paré et al., 2015 ).

In contrast with narrative reviews, descriptive reviews follow a systematic and transparent procedure, including searching, screening and classifying studies ( Petersen, Vakkalanka, & Kuzniarz, 2015 ).
Indeed, structured search methods are used to form a representative sample of a larger group of published works ( Paré et al., 2015 ).

Further, authors of descriptive reviews extract from each study certain characteristics of interest, such as publication year, research methods, data collection techniques, and direction or strength of research outcomes (e.g., positive, negative, or non-significant) in the form of frequency analysis to produce quantitative results ( Sylvester et al., 2013 ).

In essence, each study included in a descriptive review is treated as the unit of analysis and the published literature as a whole provides a database from which the authors attempt to identify any interpretable trends or draw overall conclusions about the merits of existing conceptualizations, propositions, methods or findings ( Paré et al., 2015 ).

In doing so, a descriptive review may claim that its findings represent the state of the art in a particular domain ( King & He, 2005 ). In the fields of health sciences and medical informatics, reviews that focus on examining the range, nature and evolution of a topic area are described by Anderson, Allen, Peckham, and Goodwin (2008) as mapping reviews,

Like descriptive reviews, the research questions are generic and usually relate to publication patterns and trends. There is no preconceived plan to systematically review all of the literature although this can be done. Instead, researchers often present studies that are representative of most works published in a particular area and they consider a specific time frame to be mapped.

An example of this approach in the eHealth domain is offered by DeShazo, Lavallie, and Wolf (2009). The purpose of this descriptive or mapping review was to characterize publication trends in the medical informatics literature over a 20-year period (1987 to 2006).

To achieve this ambitious objective, the authors performed a bibliometric analysis of medical informatics citations indexed in medline using publication trends, journal frequencies, impact factors, Medical Subject Headings (MeSH) term frequencies, and characteristics of citations.
Findings revealed that there were over 77,000 medical informatics articles published during the covered period in numerous journals and that the average annual growth rate was 12%.

The MeSH term analysis also suggested a strong interdisciplinary trend. Finally, average impact scores increased over time with two notable growth periods. Overall, patterns in research outputs that seem to characterize the historic trends and current components of the field of medical informatics suggest it may be a maturing discipline (DeShazo et al., 2009).

What are the two different types of IRBs?

Local and Central IRBs/IECs – There are two types of IRBs/IECs: local and central. Local IRBs/IECs are functions of the academic institutions that conduct research and review only their trials, while central IRBs/IECs provide review services for multiple entities.

What are the different types of ethics review?

Research ethics review is a process of initial and ongoing review and monitoring of research involving human participants. The process requires the evaluation of all proposed research by an independent committee (REB) of experts which examines the research study through the lens of prospective participants.

The REB’s assessment of a proposed study’s ethical acceptability is guided by the core principles of research ethics (i.e., respect for persons, concern for welfare, and justice). The underlying value of research ethics review is respect for human dignity. The review process ensures that research involving humans is sensitive to the inherent worth of all human beings and the respect and consideration they are due.

There are two categories of research ethics review (Behavioural and Clinical), each with different application processes. The difference between Clinical and Behavioural studies is not always clear. The final decision about which type of REB will review your study is at the discretion of the Boards.

Please reach out to your REB if you have any questions about which study type should be selected in Box 4.1. Behavioural and social sciences projects study the relationship between people and their surroundings, including how people interact with each other, their communities, and institutional systems.

They include psychological phenomena such as emotions, biases, and motivations. Psychological therapy and counselling studies fall under behavioural research. Emergent design and community-based studies are considered social science and behavioural research unless a clinical intervention is involved.

Common methods include, but are not limited to, interviews, focus groups, surveys, questionnaires, behavioural therapy workshops, experimental coaching, observations, and secondary use of data. Behavioural and social sciences studies can be about health and include health care providers and patients, where the goal is not to modify direct patient clinical care (i.e., do not involve diagnosis, medication, or treatment).

When clinical charts are being accessed for a behavioural study, full patient consent is required. Retrospective medical chart review projects should be submitted using the Clinical application form. Clinical research evaluates the effects of one or more health-related interventions on health outcomes.

Investigations include, but are not restricted to, drug administration, surgical procedures, radiologic procedures, devices, genetic therapies, cells and other biological products, radiopharmaceuticals, natural health products (NHPs), process-of-care changes, preventive care, manual therapies, and psychotherapies.

Health Canada and US FDA regulated research, research evaluating human anatomy, physiological outcomes and processes, medical chart reviews, secondary analysis of clinical data, biobanks and clinical data registries should be submitted as a Clinical application.

A clinical research project that also includes questionnaires or interviews as part of its methodology should be submitted to a Clinical Research Ethics Board.
Find out more A Combined Metrics Report for all UBC Affiliated REBs is created annually to reflect review trends.
The reports started in 2015 (which covers 2012 – 2015).

September 2021 (covering 2019-2020) December 2019 December 2018 December 2017 November 2016 September 2015

What are the stages of IRB review?

Levels of IRB Review – Penn IRB Which Type Of Review May Be Conducted To Follow Up On Previous Findings Of Noncompliance? There are three levels of IRB review for human subjects’ research: exempt, expedited, and convened. Institutional policy requires IRB review of all human subjects’ research that falls into an exempt or expedited review category. Human subjects’ research not falling into one of these categories requires convened board review.

Exempt and expedited reviews are delegated reviews, which are screened by IRB staff and undergo final review by 1-2 IRB members.
The three levels of IRB review are explained here.
Please note that the IRB does not expect researchers to be experts in levels of review and categories of exempt and expedited review.

Final determination of level of review and review categories resides with the IRB’s expertise.

“Exempt” refers to categories of minimal risk human research outlined in the regulations. Exempt does not mean that the research doesn’t have to be submitted to the IRB. “Limited Review” refers to select categories of exempt research under the Revised Common Rule that require ongoing modification submissions to the IRB. Projects not eligible for an exempt or limited review may be eligible for an expedited review. “Expedited” refers to categories of minimal risk research outlined in the regulations that require ongoing submissions to the IRB. In general, research may qualify for expedited review if 1) it falls into one of the expedited categories, 2) the risks are minimal, and 3) it does not include sensitive populations or topics. Projects not eligible for an exempt or expedited review undergo review by a convened board, even if the study may be minimal risk. The Penn IRB office supports 7 biomedical committees, 1 social behavioral committee, and 1 executive committee. Each committee is supported by a Chair, IRB Director-level regulatory representative, Administrator, and Coordinator.

Which Type Of Review May Be Conducted To Follow Up On Previous Findings Of Noncompliance? IRBs are tasked with determining both the degree and likelihood of risk in the research. This is done by categorizing research as either minimal risk (MR) or greater than minimal risk (GTMR). The regulatory definition of minimal risk: “The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” Which Type Of Review May Be Conducted To Follow Up On Previous Findings Of Noncompliance? The risk of the study determines the need for ongoing reviews.

What are the different types of research papers review?

This article is part of a Series Which Type Of Review May Be Conducted To Follow Up On Previous Findings Of Noncompliance? This article is part of a Series Key takeaways:

Scholarly journals publish content in different formats, not just original research articles. Some forms of scholarly literature require original research (primary literature) and some are based on other published work (secondary literature). Consider options like review articles or perspective/opinion pieces to start off your publication journey.

The field of research requires persistence and most researchers devote many a sleepless night towards conducting research and documenting results. In the competitive world of academia, you are expected to start publishing early in your career, and many early-career researchers are faced with the looming worry of how to publish a journal article.

Although original research sometimes takes years to complete, it does not mean you cannot have any publications to your credit till the time you complete your research. There are different types of scholarly literature, some of which require original research (categorized as primary literature) and some that are based on other published work (secondary literature).

It is important to have a clear idea about the different types of articles that you can publish in journals. This will help you understand the ways in which you can disseminate your work and identify what kind of article would be suitable for your study.

The types of publications are different in different fields. For instance, a clinical trial is possible only in the field of medicine, while an empirical study is more common in the field of social sciences. It is important to remember that not all journals publish every kind of article. Therefore, most journal publishers provide prospective authors with accurate and specific guidelines for the different articles they publish.

Specifications about the types of articles published can be found under the guidelines to authors section on a journal’s website. If you have a target journal in mind, you should check whether it publishes the kind of manuscript you are planning to write.

Some of the possible types of scientific publications are: 1.
Original research: These are detailed studies reporting original research and are classified as primary literature.
They include hypothesis, background study, methods, results, interpretation of findings, and a discussion of possible implications.

Original research articles are long, with the word limit ranging from 3000 to 6000, 2,3 and can even go up to 12,000 words for some journals.1 These require a significant investment of time.2. Review article: Review articles provide a critical and constructive analysis of existing published literature in a field, through summary, analysis, and comparison, often identifying specific gaps or problems and providing recommendations for future research.1,6 These are considered as secondary literature since they generally do not present new data from the author’s experimental work.

Review articles can be of three types, broadly speaking: literature reviews, systematic reviews, and meta-analyses.
Review articles can be of varying lengths depending upon the journal and subject area.
For narrative reviews or literature reviews, the length could range anywhere between 8000 to 40,000 6 words while systematic reviews are usually less than 10,000 words long.6 However, some journals also publish shorter reviews, around 3000-5000 words long.1-3 To submit a publication ready manuscript without errors and mistakes that commonly go unnoticed by authors, check out Editage’s professional editing services,3.

Clinical case study: Clinical case studies present the details of real patient cases from medical or clinical practice. The cases presented are usually those that contribute significantly to the existing knowledge on the field. The study is expected to discuss the signs, symptoms, diagnosis, and treatment of a disease.1,5 These are considered primary literature and usually have a word count similar to that of an original article.

Clinical case studies require a lot of practical experience and may not be a suitable publication format for early career researchers.5 4. Clinical trial: Once again, specific to the field of medicine, clinical trials describe the methodology, implementation, and results of controlled studies, usually undertaken with large patient groups.1,5 Clinical trial articles are also long, usually of about the same length as an original research article.

Clinical trials also require practical work experience, as well as, high standards of ethics and reliability.5 So this format is more useful for experienced researchers.5. Perspective, opinion, and commentary: Perspective pieces are scholarly reviews of fundamental concepts or prevalent ideas in a field.

These are usually essays that present a personal point of view critiquing widespread notions pertaining to a field.1-3 A perspective piece can be a review of a single concept or a few related concepts.
These are considered as secondary literature and are usually short articles, around 2000 words.2 Opinion articles present the author’s viewpoint on the interpretation, analysis, or methods used in a particular study.

It allows the author to comment on the strength and weakness of a theory or hypothesis. Opinion articles are usually based on constructive criticism and should be backed by evidence.1 Such articles promote discussion on current issues concerning science.

These are also relatively short articles. Commentaries are short articles usually around 1000-1,500 words long that draw attention to or present a criticism of a previously published article, book, or report, explaining why it interested them and how it might be illuminating for readers.6. Book review: Book reviews are published in most academic journals.

The aim of a book review is to provide insight and opinion on recently published scholarly books. Book reviews are also relatively short articles and less time-consuming. Book reviews are a good publication option for early – career researchers as it allows the researcher to stay abreast of new literature in the field, while at the same time, adding to his publication list.5 Related reading:

A young researcher’s guide to writing an original research article A young researcher’s guide to writing a literature review A young researcher’s guide to a systematic review A young researcher’s guide to writing a clinical case report A young researcher’s guide to a clinical trial A young researcher’s guide to perspective, commentary, and opinion articles What is the difference between a research paper and a review paper? Which is easier to publish – an original research article or a review article?

Bibliography: 1. Frontiers in group. Frontiers in Neuroscience Available from http://www.frontiersin.org/Neuroscience/articletype 2. Sage Publications. Manuscript Submission Guidelines Available from http://www.uk.sagepub.com/msg/hsr.htm#ARTICLETYPES 3. Nature Publications.

Author Resources Avaialable from http://www.nature.com/authors/author_resources/article_types.html 4.
AcademyHealth.
Writing Articles for Peer-review Publications: A Quick Reference Guide Available from http://www.academyhealth.org/files/HIT/writingguide.pdf 5.
University of Colorado Libraries.
Publish, Not Perish: The Art & Craft of Publishing in Scholarly Journals, Module 1, Overview of Scholarly Publishing Available from 6.

Zurich-Basel Plant Science Center. Guidelines for writing a review article. Available from http://ueberfachliche-kompetenzen.ethz.ch/dopraedi/pdfs/Mayer/guidelines_review_article.pdf Published on: Feb 20, 2015