IRB Glossary of Terms and Acronyms - Fred Hutch Glossary of Terms and Acronyms 050IRBform_Glossary

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  • 050IRBform_Glossary / Version 10.00 / 09-02-2019 / Page 1 of 35

    A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

    A AAHRPP Association for the Accreditation of Human Research Protection Programs Adverse Event (AE) Any harm or untoward medical occurrence in a research participant administered a medical product, medical treatment or procedure even if it does not necessarily have a causal relationship with the product, treatment, or procedure. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medical product, medical treatment or procedure whether or not considered to be related. [FDA: 21 CFR 312.32] Adverse Reaction (AR), Adverse Drug Reaction (ADR)

    Pre-Approval Clinical Use of a Product All noxious and unintended responses to a medicinal product related to any dose. Marketed Medicinal Product A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.

    [FDA: Guideline for Industry, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting] Affiliated IRB members are considered affiliated if they, their spouse, domestic partner, or dependent children are an employee, contractor, student, board member, or have any other similar affiliation with Fred Hutch, UW, SCCA, or Seattle Children's. Allegation of Noncompliance An assertion that noncompliance has or may have occurred that requires further investigation to determine whether noncompliance has in fact occurred. Alteration of HIPAA A request to change or omit one or more of the research-related HIPAA requirements. The most common use of an alteration is to omit the HIPAA signature requirement. Demonstrating that the "research could not practicably be conducted without the waiver or alteration" is the main obstacle to approving an alteration. If the participant is physically present, it is usually practicable to obtain written HIPAA Authorization. 45 CFR 164.512(i)(2)(ii)

    Glossary of Terms and Acronyms

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    Assent Affirmative agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. Assurance See Federalwide Assurance. Attachment A The internal routing and approval form submitted along with a proposal for an activity to be performed at Fred Hutch under a grant, contract or other sponsored agreement. Attachment B The internal routing and approval form submitted along with a funding proposal for an activity to be performed at Fred Hutch funded by Center funds, discretionary funds, royalties, or other non-sponsored funding source. Attachment C The internal routing and approval form for commercial and non-commercial research agreements. Authorized Institutional Official An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research. Autonomy Personal capacity to consider alternatives, make choices, and act without undo influence or interference of others. B Belmont Report The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical Behavioral Research is a statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978. Beneficence An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm. Benefit A valued or desired outcome; an advantage. Broad Consent Under the 2018 requirements of the Common Rule, a type of informed consent that allows for the storage, maintenance, and secondary research uses of identifiable private information and

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    identifiable biospecimens. Broad consent is less specific than consent for each use, but narrower than open-ended permission without any limitations. C Cancer Consortium A research partnership between the institutions of Fred Hutch, the University of Washington, Seattle Cancer Care Alliance, and Seattle Children’s Hospital. Also called the Fred Hutch/University of Washington Cancer Consortium. Children 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. [HHS: 45 CFR 46.402(a)] In most states, including Washington state, the legal age at which a person is able to consent to participate in research is 18 years. Investigators should check appropriate State laws and regulations before conducting research to determine the definition of a child for the purposes of participation in research studies. In the case of research studies conducted outside the United States, the relevant laws and regulations of the research participants’ country of residence should be applied. CITI Collaborative Institutional Training Initiative (www.citiprogram.org), an online provider of research ethics, compliance, and professional development education. Fred Hutch, University of Washington, and SCCA have subscriptions for a number of CITI courses available to researchers, including Human Subjects and Good Clinical Practice training. Clinical Investigation Any experiment that involves a test article and one or more human subjects and that is either subject to requirements for prior submission to the FDA, or is not subject to requirements for prior submission but the results are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit. [FDA: 21 CFR 50.3(c)] This term is used by the FDA to describe research that is subject to FDA regulations relating to informed consent and review by an IRB. Additional information regarding FDA clinical investigation definitions for drug or device studies is found at 21 CFR 312.3(b) and 21 CFR 812.3(h), respectively. Clinical Research Support (CRS) The Fred Hutch Office that promotes, supports, and facilitates research trials within the Cancer Consortium. CRS supports the Cancer Consortium Data and Safety Monitoring Committee and the Scientific Review Committee. (See: Data and Safety Monitoring Committee and Scientific Review Committee.) Clinical Trial A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. [HHS 2018: 45 CFR 46.102(b); NIH Policy: Notice of Revised NIH Definition of “Clinical Trial”]

    http://www.citiprogram.org/

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    Clinical Trial Staff Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator. [NIH Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-Funded Clinical Trials] Closure A study is closed when accrual of research participants is complete and all research activities have ceased. This means no interaction/intervention is planned for the purpose of research with research participants and no long-term follow-up. Data collection and analysis are complete. Coded When identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code) AND a key to decipher the code exists, enabling linkage of the identifying to the private information or specimens. [OHRP Guidance: Coded Private Information or Specimens Use in Research] Cohort A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences. Common Rule See Federal Policy. Confidentiality The treatment that must be afforded to individually identifiable information about research participants or potential research participants. Confidential treatment of information in the conte