Exempt Research: Federal Regulations and Best Practices for Human Subjects, Schemes and Mind Maps of Marketing

Download Exempt Research: Federal Regulations and Best Practices for Human Subjects and more Schemes and Mind Maps Marketing in PDF only on Docsity! Information About Exempt Research 1/19/2021 1 Information about Exempt Research Background Federal regulations designate certain types of research involving humans as being exempt from many of the regulatory requirements governing human subjects research, and thus subject to fewer IRB review requirements. It is important to note that exempt research requires submission to the IRB office for review by IRB staff for formal determination of exemption. Some exempt research is also subject to “limited IRB review” by an IRB member to assess privacy and confidentiality protections. In all cases, human subjects research activities may not commence until a formal written determination of exemption is received by the principal investigator. This document outlines:  Eligibility for Exempt Review under both the new 2018 Common Rule and the pre-2018 Common Rule,  Submission Requirements for Exempt Research,  Limited IRB Review, and  Key Ethical Responsibilities of investigators (e.g., informed consent, promoting voluntariness, protecting privacy and confidentiality. Exempt Research Defined Eligibility for Exempt Review To be eligible for exempt review, research must meet all of the following conditions: 1. Research presents little to no risk of harm to participants; AND 2. All research procedures fit into one or more of the regulatory exemption categories (described in the table below); AND 3. Confidentiality of participants will be protected when results are disseminated (no deductive disclosure or re- identification concerns); AND 4. The research does not include prisoners. Research with prisoners reviewed under the 2018 Common Rule may be exempt if the research is intended to involve a broader population, and only incidentally includes prisoners. Submission Requirements for Exempt Research Principal investigators (PIs) may request exemption by answering relevant questions in the IRB Application in IRBManager. There is not a separate application for exempt studies; rather, the IRB Application in IRBManager is conditioned to show questions related to exempt status. If the IRB staff determines that the project does not qualify for exempt status, the application will be returned to the PI for completion of questions applicable to non-exempt research. In most instances, submission of data collection, recruitment, and consent materials is not required. Limited IRB Review Limited IRB review is a new process required by the 2018 Common Rule for certain exemptions. It requires review by an IRB member to assure that privacy and confidentiality protections are adequate for research where the primary risks to subjects relate to harm from disclosure of their information. Investigators are routinely asked to provide information about privacy and confidentiality protections in IRB applications for exempt research. Thus, the Limited Information About Exempt Research 1/19/2021 2 IRB Review process should not affect investigators. When Limited IRB Review is required, IRB staff route applications for exempt research to an IRB member for final approval. Key Ethical Responsibilities To facilitate streamlined review, IRB applications for exempt research are intended to collect only the information necessary to determine that exemption is allowable. Researchers are not required to provide extensive detail about recruitment or informed consent processes. However, all ISU research—even that which eligible for exemption— must adhere to basic ethical standards that protect and respect research subjects. Essentially, research participation must be informed, voluntary, and at the lowest-risk possible. Promoting Voluntariness Participation in research MUST ALWAYS be voluntary. Voluntariness is compromised when prospective subjects feel pressure to participate, even when such pressure is inadvertent. This is particularly an issue when researchers hold a position of power over prospective subjects (e.g., as their teacher, supervisor, etc.). It can also occur when participants feel that participation in research is required to receive services or other benefits (e.g., medical treatment, financial support, etc.). Researchers must design recruitment and informed consent processes that mitigate pressure to participate. Participants must be explicitly informed that participation is voluntary; when applicable, they should also be told that participation is not required to access services or treatment, receive a specific grade, etc. See IRB Guidance on Participant Recruitment for additional information on ethical considerations related to recruitment. Informed Consent for Exempt Studies Informed consent is a cornerstone principal of ethical human subjects research. Researchers must ensure prospective participants receive information about the study, sufficiently detailed to facilitate a truly informed choice. This ethical obligation exists for all research—exempt and non-exempt. Federal regulations outline formal informed consent requirements for non-exempt research. Research confirmed as meeting the criteria for exempt review (i.e. “exempt research”) is not subject to those formal requirements, allowing PIs flexibility in how informed consent is obtained. While the use of a formal informed consent form containing all the elements of consent is not required for exempt research, the Iowa State University IRB expects researchers to provide information about the research to prospective participants (and their parent/legal guardian, when applicable) prior to their enrollment in the study. At minimum, this information should include:  a statement that the project involves research;  a general description of study procedures and time commitment;  any potential discomfort or risk related to participation (e.g., discomfort responding to sensitive or personal questions, privacy concerns, disclosure risks);  indication that participation is voluntary and that they may skip any questions they do not feel comfortable answering in an interview or survey;  how their privacy and confidentiality will be protected;  an outline of plans for data-sharing or future research use of their information. When applicable, PIs should also describe: Information About Exempt Research 1/19/2021 5 2018 Exemption 2 – (effective 1/21/2019) Surveys, interviews, educational tests, observation Pre-2018 Exemption 2 Surveys, interviews, educational tests, observation 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 [determine there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of the data]. Exemption 2 Guidance  Exemption 2 applies to surveys or interviews with adults when information is: o Gathered anonymously; OR o Not sensitive or risky to subjects if disclosed; OR o Identifiable, but adequate privacy and confidentiality provisions are in place (determined through limited IRB review).  “Survey” refers to information collected through questionnaires or similar procedures, including asking subjects to provide verbal or written Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:  information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and  any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. Exemption 2 Guidance  Applies to surveys or interviews with adults where information is: o Gathered anonymously; OR o Not sensitive or risky to subjects if disclosed.  Audio and video recording of the interactions is allowable under Exemption 2, with adequate privacy and confidentiality protections.  Does not apply to research involving ANY intervention (e.g., physical data collection procedures or manipulations of the subjects’ environment, such as manipulating room temperature or interviewer gender, measuring height or weight, etc.).  Does not apply when significant risk or discomfort to subjects is inherent in the data collection procedure (e.g., asking detailed questions about traumatic experiences).  Surveys and interviews with children are not eligible exemption. Information About Exempt Research 1/19/2021 6 responses to scenarios, vignettes, or other similarly presented information. It does not include any collection of biospecimens.  Audio and video recording of the surveys, interviews, or public behavior is allowable, with adequate privacy and confidentiality protections.  Exemption 2 may not be granted when: o Research involves ANY intervention (e.g., physical data collection procedures or manipulations of the subjects’ environment such as manipulating room temperature or interviewer gender, measuring height or weight, asking subjects to manipulate objects or play a game, etc.). o Significant risk or discomfort to subjects is inherent in the data collection procedure (e.g., asking detailed questions about traumatic experiences).  Limitations for research with children: o Surveys and interviews with children are not eligible for Exemption 2. o Observation of public behavior of children may be granted exemption only if the investigator(s) do not participate in the activities being observed. o Research involving educational testing with children may not be granted exemption if information is sensitive and identifiers are collected with responses. Information About Exempt Research 1/19/2021 7 2018 Exemption 3 (effective 1/21/2019) Benign Behavioral Interventions Pre-2018 Exemption 3 Surveys, interviews, observation of public officials 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 [determine that there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of the data]. Benign behavioral interventions are  brief in duration,  harmless and 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 Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under Exemption 2, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Exemption 3 Guidance This exemption has rarely applied to research at ISU. Additional guidance is not provided because the exemption category has been eliminated in the 2018 Common Rule. Information About Exempt Research 1/19/2021 10 2018 Exemption 4 (effective 1/21/2019) Secondary use of information or biospecimens Pre-2018 Exemption 4 Secondary use of information or biospecimens 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 (iii) 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. Exemption 4 Guidance  Exemption 4 is limited to secondary use of information or biospecimens that have been or will be collected or generated for non-research Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if:  these sources are publicly available or  if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Exemption 4 Guidance  Exemption 4 applies largely to accessing identifiable information that is routinely gathered for non-research purposes. Common examples include information from student records, medical records, biospecimens collected for clinical care, etc.  Information gathered must be existing at the time the research is proposed; Exemption 4 does not apply to information yet-to-be gathered (even for non-research purposes).  Information must be immediately recorded by the investigator in a manner that subjects cannot be identified.  Secondary use of information about children may be granted exemption when all applicable conditions for exemption are met.  Exemption 4 does not apply to research using existing information or biospecimens that include any identifiers, such as: o Names, addresses, email addresses, phone numbers, social security numbers, IP addresses; o Identifying numbers, such as social security numbers, license numbers, account numbers, etc. o ID codes, if any member of the research team can connect the ID codes with subjects’ identities; Information About Exempt Research 1/19/2021 11 2018 Exemption 4 (effective 1/21/2019) Secondary use of information or biospecimens Pre-2018 Exemption 4 Secondary use of information or biospecimens purposes or from research studies other than the proposed study when the information is: 1. Publicly available  From public library archives,  From government /institutional records or commercial entity where public access is provided upon request or the only requirement is paying a user fee or registering as a visitor 2. De-identified  Information is recorded by the investigator such that the identity of subjects cannot be readily ascertained  Research does not involve any contact between the investigator(s) and subjects. Thus, this exemption does not apply if the research also involves components where subjects will be contacted (e.g., surveys, interviews, etc.).  Subjects will not be re-identified 3. Subject to HIPAA Privacy Rule protections, including  Authorization from individuals for research use of their protected health information; or  Waiver of authorization from a Privacy Board or IRB;  Sufficient data security measures 4. Conducted by a government agency using government data obtained for non-research purposes and adheres to federal privacy standards.  Secondary use of information about children may be granted exemption when all applicable conditions for exemption are met. o Inherent identifiers (e.g., video recordings or photographs of people); o Demographic information when it can be used in combination to re-identify individuals. Information About Exempt Research 1/19/2021 12 2018 Exemption 4 (effective 1/21/2019) Secondary use of information or biospecimens Pre-2018 Exemption 4 Secondary use of information or biospecimens  When information was collected from a different study, the investigator’s use must align with what subjects were told during the informed consent process for the original study.  Exemption 4 does not apply to secondary research using information or biospecimens that include any identifiers, such as: o Names, addresses, email addresses, phone numbers, social security numbers, IP addresses; o Identifying numbers, such as social security numbers, license numbers, account numbers, etc. o ID codes, if any member of the research team can connect the ID codes with subjects’ identities; o Inherent identifiers (e.g., video recordings or photographs of people); o Demographic information when it can be used in combination to re-identify individuals. Information About Exempt Research 1/19/2021 15 2018 Exemption 6 (effective 1/21/2019) Taste tests & food quality evaluation Pre-2018 Exemption 6 Taste tests & food quality evaluation 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. Exemption 6 Guidance  Generally, applies to taste tests of typical foods that persons may routinely consume in daily life;  May be applied to research with children when appropriate; parent consent is required;  Exemption 6 does not apply to research involving o Investigational products, or research intended to support applications to the FDA for marketing of a food additive; o Alcohol consumption; o Vitamins, dietary supplements; o Food with risks of serious physical harm (serious allergic reaction, vitamin or nutrient deficiency, etc.). 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. Exemption 6 Guidance  Generally applies to taste tests of typical foods that persons may routinely consume in daily life;  May be applied to research with children when appropriate; parent consent is required;  Exemption 6 does not apply to research involving o Investigational products, or research intended to support applications to the FDA for marketing of a food additive; o Alcohol consumption; o Vitamins, dietary supplements; o Food with risks of serious physical harm (serious allergic reaction, vitamin or nutrient deficiency, etc.). Information About Exempt Research 1/19/2021 16 Exempt Categories—FDA Regulations Research subject to FDA oversight is exempt only under very specific conditions as follows: 1. Any investigation which commenced before July 27, 1981, and was subject to requirements for IRB review under FDA regulations before that date, provided that the investigation remains subject to review of an IRB which meets the FDA requirements in effect before July 27, 1981. 2. Any investigation commenced before July 27, 1981, and was not otherwise subject to requirements for IRB review under FDA regulations before that date. 3. Emergency use of a test article, provided that such emergency use is reported to the IRB within five working days. Any subsequent use of the test article at the institution is subject to IRB review. 4. Taste and food quality evaluations and consumer acceptance studies if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level found to be safe by the FDA or approved by the EPA or the FSIS/USDA. For FDA-regulated studies, research involving children may not be deemed exempt. When both Common Rule and FDA regulations apply to research involving human subjects, the IRB applies the most restrictive regulations from each to the research being conducted to ensure the protection of the rights and welfare of the human participants and compliance with federal requirements Document History Created: 11/2/2011 Revised: 3/16/2018 Revised: 1/21/2019 Revised: 10/18/2019