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What Type Of Irb Review Requires A Determination?

What Type Of Irb Review Requires A Determination
Exempt Research – Although the category is called “exempt,” this type of research does require IRB review and the determination of exemption must be made by the IRB. The exempt determination process is much less rigorous than an expedited or full-committee review.

To qualify, research must fall into one or more of eight federally defined exempt categories. These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous or public data, or conduct of the least potentially harmful research experiments.

Some examples of exempt research are:

anonymous surveys or interviews passive observation of public behavior without collection of subject identifiers retrospective chart reviews analyses of discarded pathological specimens without patient identifiers

Research involving minor children may be exempt only as it applies to categories 1, 4, 5, 6, 7 and 8. Research involving minors which falls under category 2 may be exempt for educational tests and observation (when the investigator does not participate in the activities being observed).

What type of IRB review does not require an IRB approval?

Research Exemptions from IRB Review – “Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.

Exempt projects are not subject to continuing review Amendments are required only if changes to the project could alter the exempt determination An exempt determination does not lessen the investigator’s ethical obligations, including the completion of human subjects protections training (NIH or CITI) Review the Common Rule on exempt research: 45 CFR 46.104

What determines type of IRB review?

Types of IRB Review – The basic types of IRB Review are: Comprehensive, Exempt, and Not Regulated, The type of IRB review and the associated review process (e.g., full board, expedited, limited IRB review, system-generated ) are determined by the:

  • Level of risk to research participants
  • Type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)
  • Sensitivity of the research questions or complexity of the research design
  • Involvement of vulnerable populations as research participants
  • Use of identifiable information or indentifiable biospecimens
  • Applicability of one or more of the criteria for exempt or expedited review

What are the different types of IRB determination?

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:

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.

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.

  1. Taste and food quality evaluation and consumer acceptance studies.
  2. Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use.
  3. 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 type of research is exempt from IRB review?

Exempt Review: Institutional Review Board (IRB) Office Exempt human subjects research is a specific sub-set of “research involving human subjects” that does not require ongoing IRB oversight. Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal IRB regulations.

Studies that qualify for exemption must be submitted to the IRB for review before starting the research. Pursuant to NU policy, investigators do not make their own determination as to whether a research study qualifies for an exemption — the IRB issues exemption determinations. There is not a separate IRB application form for studies that could qualify for exemption – the appropriate protocol template for human subjects research should be filled out and submitted to the IRB in the eIRB+ system.

Although the HHS IRB regulations list eight exemption categories, NU has opted to implement six of those categories at this time (see the list below). Of the six exemption categories listed below, only exemption category 6 (for taste and food quality evaluation and consumer acceptance studies) applies to studies that are FDA-regulated.

  1. The Belmont principle of Respect for Persons generally requires that subjects be given the opportunity to choose whether or not to participate in research.
  2. For this reason, voluntary informed consent should be obtained from participants for any exempt research where the investigator will be collecting data through interaction with participants.
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For exempt research studies that will collect data through interaction with participants, the NU IRB expects that researchers provide participants with consent information that includes, at a minimum:

  1. An explanation that they are being asked to participate in a research study.
  2. The identity and affiliation of the researcher.
  3. A clear description of the study procedures and how data will be used in the future.
  4. A statement that participation in the research is voluntary.
  5. Contact information for questions and concerns about the research.

Studies that qualify for an exemption do not undergo continuing review. Modifications do not need to be submitted for exempt studies so long as the research remains minimal risk and stays within the boundaries of the exemption categories that the IRB found were applicable to the research, If your study has received an exemption from the IRB, please contact the IRB if you are planning to:

  • add procedures that could affect risks to participants; or
  • add procedures that do not fit within the exemption categories; or
  • add new types of participants to your study that include vulnerable populations (e.g., adding children, individuals with cognitive impairments, prisoners, etc.)
  • change of Principal Investigator

Examples of changes that would likely require IRB review:

  • Removal of the consent process, or use of deception or incomplete disclosure.
  • Significant changes to the recruitment procedures.
  • Adding sensitive questions to a survey or interview process (e.g. questions regarding illegal activities; traumatic events such as childhood, sexual, or domestic abuse; suicide; or other probing questions that could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation).
  • Collection of new or additional identifiable information.
  • Changes to the data storage plan which may affect confidentiality.

Exempt studies may also be subject to the HIPAA Privacy Rule. For instance, a study involving medical record review to gather a dataset that would be eligible for Exemption Category 4 involves access to Protected Health Information (PHI) and should request a waiver of HIPAA authorization.

  • Exemption 2(iii) and Exemption 3 do not apply to research with children.
  • Exemptions other than Exemption Category 6 do not apply to FDA-regulated research.
  • OHRP Exempt Categories 45 CFR 46.104 – (HRP-312)
  • 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.

  • Evaluating the use of accepted or revised standardized tests
  • Testing or comparing a curriculum or lesson
  • A program evaluation of pharmacy continuing education

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:

  1. The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects cannot be readily ascertained, directly or indirectly through identifiers linked to the subjects; OR
  2. Any disclosure of 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
  3. The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects can be readily ascertained, directly or indirectly through identifiers linked to the subjects, AND an IRB conducts limited IRB review. (See “WORKSHEET: Limited IRB Review (HRP-319).”)

Examples:

  • Surveying teachers, nurses, or doctors about a technique or an outcome
  • Interviewing managers about a management style or best practice
  • Conducting a focus group about an experience or an opinion of a community program

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:

  1. 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 indirectly, through identifiers linked to the subjects; OR
  2. 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
  3. The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects can be readily ascertained, directly or indirectly through identifiers linked to the subjects, AND an IRB conducts limited IRB review. (See “WORKSHEET: Limited IRB Review (HRP-319).”)

(i) 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.

(ii) 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.

Healthy adult subjects are asked to take part in two two-hour-long assessments of memory, attention and information processing speed before and after 1 hour of cognitive enhancement exercise using specially designed computer software. The procedures are conducted during a single visit, and subjects are encouraged to take breaks when desired.

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:

  1. The identifiable private information or identifiable biospecimens are publicly available; OR
  2. 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; OR
  3. 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 (HIPAA), 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
  4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research 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.

Note: Exemption Category 4 only applies to the re-use of data and specimens that were or will be collected for non-research purposes or from research studies other than the proposed research study. The research materials typically will be publicly available materials, medical records, or existing repositories of clinical specimens.

A researcher is given two datasets that contain private, identifiable information. The researcher uses the identifiers to merge the two datasets but strips the resulting (merged) data of identifiers immediately after the merge and before conducting data analysis. The resulting data used for the analysis is completely de-identified with no link to identifiers.

Category 5 Research and demonstration projects which 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 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.

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I) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision.

The research or demonstration project must be published on this list prior to commencing the research involving human subjects. 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 Dept.

How do you determine if an IRB is required?

Research Requiring IRB Review – The IRB must review and approve all research involving live humans before any such research activities may begin. What Type Of Irb Review Requires A Determination Research involving human subjects must receive IRB approval in accordance with federal regulations set forth by the U.S. Department of Health and Human Services (HHS) (known as the “Common Rule”) and the U.S. Food and Drug Administration (FDA). A project may be subject to one or both sets of regulations depending on whether the project meets the definition for Human Subjects Research (HHS) and/or Clinical Investigation (FDA).

  • HHS Definition of Research (Common Rule)
  • “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
  • In general activities that contribute to generalizable knowledge are those that:
  • attempt to make comparisons or draw conclusions based on the data;
  • seek underlying principles that have predictive value and can be applied to other circumstances;
  • identify general explanations or themes that a reader can extrapolate to another situation.

Although publication is often viewed as evidence of research status, it is not the only criterion. In fact, “systematic investigations” often result in published information, yet they do not qualify as research because they were not designed to contribute to generalizable knowledge.

  1. HHS Definition of a Human Subject (Common Rule)
  2. Human subject – A living individual about whom an investigator (whether professional or student) conducting research:
  3. (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;
  4. or
  5. (2) Obtains, uses, studies, analyzes, or generates identifiable private information or biospecimens.

Intervention includes both physical procedures by which data are gathered (e.g. venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, as well as information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g. a medical record). Identifiable information means that the identity of the subject is, or may be readily ascertained (directly or indirectly) by the investigator (or others) or associated with the information.

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FDA Definition of a Clinical Investigation “Any experiment that involves a test article and one or more human subjects that is either subject to requirements for prior submission to the Food and Drug Administration under section 505(i), or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted to, or held for inspection by the Food and Drug Administration as part of an application for a research or marketing permit.” The term does not include experiments that are subject to the provision of 21 CFR 58, regarding nonclinical laboratory studies. Under FDA regulations, the terms “research” and “clinical investigation” are synonymous. A test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug and Cosmetic Act, FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements), FDA Definition of a Human Subject FDA Human subject – an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.

Is IRB Approval Required?

Does the IRB review all research?

What is the Institutional Review Board (IRB)? – The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

  • The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants.
  • The IRB is concerned with protecting the welfare, rights, and privacy of human subjects.
  • The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.

The IRB shall have at least five members of varying backgrounds in order to provide complete and adequate review of human research and its institutional, legal, scientific, and social implications. The Board will also include at least one member who is not affiliated with the institution and one member who is not a scientist.

What is Category 2 Limited IRB review?

TC IRB continues the blog series, “Get to know a Review Category.” This article will cover examples of research that meet requirements for Exempt Category 2. – Federal regulations stipulate that certain research activities may be considered exempt from regulatory requirements under the Common Rule (45 CFR 46), if approved by the IRB and confirmed in writing to the Principal Investigator (PI).

  • These activities must fall into one of the eight predefined Exempt categories set forth by the Office of Human Research Protections (OHRP).
  • Researchers may believe that “exempt” review means that they do not need to submit a protocol to the IRB.
  • However, studies that are categorized as “exempt” are only exempt from federal regulations stipulated in the Common Rule (45 CFR 46).

In other words, this type of research is still subject to state, city, and institutional policies. At Teachers College (TC), all human subjects research must be submitted to the IRB for review. Researchers new to the Institutional Review Board (IRB) may be unfamiliar with the different activities within each Exempt category.

This post will provide examples of research that typically falls under Exempt Review – Category 2. Category 2 indicates that protocols may be exempt from IRB review if the research “only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording).” However, not all research that meets this description can be considered Exempt, as exemption may depend on the types of identifiers included with the data.

Identifiers can be both direct identifiers (e.g., name, address, social security number, patient ID) or indirect identifiers (e.g., a code that links data back to the subject, a combination of non-direct identifiers that can be used to deduce a participant’s identity).

  1. Recorded information cannot readily identify the subject (directly or indirect identifiers linked to the subjects); OR
  2. Any disclosure of the human subjects’ responses outside of the research would NOT reasonably place subjects at risk of criminal or civil liability, or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; OR
  3. The information is obtained 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 a determination.

“Interactions involving educational tests.survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording)” – Exempt Review, Category 2 Below are a few scenarios that may be exempt from review based on Category 2.

  1. Example A: A researcher stands on a public street and asks adult pedestrians to participate in a five-minute interview about their thoughts on a public works project.
  2. He takes an audio-recording of the interview but does not record any identifying information about the participants.
  3. He plans to transcribe the interviews for analysis by computer-assisted qualitative data analysis software.

Once transcriptions are complete, the researcher plans to destroy the audio recordings of the interviews, leaving only the transcription texts for analysis.

Is it Exempt Category 2? Yes, the researcher’s data collection only involves interview procedures. Additionally, the audio recordings meet the criteria that “recorded information cannot readily identify the subject,” as the researcher does not plan to collect identifiers.

Example B: A student researcher plans to conduct individual interviews with professors and then administer surveys to the professors at different points during the year. During the interview, she will collect participants’ perceptions of the COVID-19 pandemic’s impact on their students’ ability to participate in class.

  • Is it Exempt Category 2? As the researcher will not be recording or collecting identifying information during the individual interview process, the interviews would meet criteria for exempt Category 2. In order to conduct a follow-up survey with these same individuals, the researcher may have to create a coding system to link the surveys together. So long as the information collected in the surveys does not pose significant detrimental consequences to the study participants, the surveys may still be categorized as Exempt Category 2. These study activities are reviewed on a case-by-case basis by the IRB.
  • Exceptions: Any collection of students’ grades or educational records may be protected by Family Education Rights and Privacy Act (FERPA), and thus does not fall under Exempt Category 2.

Example C: In a now infamous study known as the Tearoom Trade Study, a researcher collected data on anonymous male sexual behavior in public restrooms. He also interviewed some of the men who participated in these activities, including gathering their demographic information.

Is it Exempt Category 2? This study is regarded as a textbook example of researcher ethical violations, Though the study confronted assumptions and stereotypes of the day (the 1960s), the sexual acts recorded were illegal; in many cases, disclosure of these acts would have been harmful to the subjects’ social standing and put them at risk of criminal liability. The parameters of the study do not meet the requirement that the “disclosure of the human subjects’ responses outside of the research would NOT reasonably place subjects at risk of criminal or civil liability, or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.” Additionally, the study included a number of ethically concerning elements, such as the deception, contested nature of public bathrooms as “public spaces,” and lack of informed consent.

Research activities may fall into one or more Exempt categories depending on a variety of factors, including the study population, researcher expertise, coinciding events, etc. TC IRB administrators will always review research on a case-by-case basis. Published Tuesday, Mar 2, 2021

What is the difference between single IRB and central IRB?

What is the difference between a central IRB and a single IRB? Both are designed to help streamline IRB review, and the terms are sometimes used interchangeably. In general: A Central IRB is the IRB of record that provides the ethical review for all sites participating in more than one multi-site study.

What is the difference between local IRB and central IRB?

Introduction – In the scientific research community, there are two types of independent review boards (IRBs) : local IRBs and central IRBs. These independent organizations review human subject research in order to ensure that studies are conducted with ethical care as the priority for subjects.

What are IRB requirements?

Criteria for IRB Approval of a Human Research Study Risks to subjects are minimized. Procedures are consistent with sound research design and do not unnecessarily expose subjects to risk. Study utilizes procedures already performed for diagnosis/treatment – when appropriate.

What is a limited IRB review?

What is limited IRB review? Limited IRB review is a process that is required only for certain exemptions, and does not require an IRB to consider all of the IRB approval criteria in §46.111. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations, are met.

Do all research studies require ethical approval?

All studies which will involve people as participants need a research ethics committee (REC) review. The principal investigator (or lead researcher on the study) is responsible for seeking this review. RECs are there to protect the rights, safety, dignity and wellbeing of research participants.

So they will consider things such as fairness of the study population, burden to participants and duty of confidence. In the UK, ethical review is usually sought from the lead researcher’s university or from one of the Health Research Authority’s (HRA) NHS RECs, NHS REC review is a requirement for certain types of research.

In addition to ethical approval, you may need other approvals or permissions in place before your research can begin. Exactly what you will need will depend on your research and what will be involved in your investigation. You may also need a sponsor. Learn more about ‘sponsorship’ in your local research office,

Does secondary data analysis require IRB approval?

Other types of secondary data analyses do meet the definition of human subjects research and must be submitted to the IRB for either an Exempt determination, or IRB review (either Expedited or Full Board). Secondary data analysis requires IRB review when the data is identifiable.

Can you do research without IRB approval?

Research Requiring IRB Review – The IRB must review and approve all research involving live humans before any such research activities may begin. What Type Of Irb Review Requires A Determination Research involving human subjects must receive IRB approval in accordance with federal regulations set forth by the U.S. Department of Health and Human Services (HHS) (known as the “Common Rule”) and the U.S. Food and Drug Administration (FDA). A project may be subject to one or both sets of regulations depending on whether the project meets the definition for Human Subjects Research (HHS) and/or Clinical Investigation (FDA).

  • HHS Definition of Research (Common Rule)
  • “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
  • In general activities that contribute to generalizable knowledge are those that:
  • attempt to make comparisons or draw conclusions based on the data;
  • seek underlying principles that have predictive value and can be applied to other circumstances;
  • identify general explanations or themes that a reader can extrapolate to another situation.

Although publication is often viewed as evidence of research status, it is not the only criterion. In fact, “systematic investigations” often result in published information, yet they do not qualify as research because they were not designed to contribute to generalizable knowledge.

  1. HHS Definition of a Human Subject (Common Rule)
  2. Human subject – A living individual about whom an investigator (whether professional or student) conducting research:
  3. (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;
  4. or
  5. (2) Obtains, uses, studies, analyzes, or generates identifiable private information or biospecimens.

Intervention includes both physical procedures by which data are gathered (e.g. venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, as well as information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g. a medical record). Identifiable information means that the identity of the subject is, or may be readily ascertained (directly or indirectly) by the investigator (or others) or associated with the information.

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FDA Definition of a Clinical Investigation “Any experiment that involves a test article and one or more human subjects that is either subject to requirements for prior submission to the Food and Drug Administration under section 505(i), or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted to, or held for inspection by the Food and Drug Administration as part of an application for a research or marketing permit.” The term does not include experiments that are subject to the provision of 21 CFR 58, regarding nonclinical laboratory studies. Under FDA regulations, the terms “research” and “clinical investigation” are synonymous. A test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug and Cosmetic Act, FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements), FDA Definition of a Human Subject FDA Human subject – an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.

Is IRB Approval Required?