NOHSP Definitions - A

A glossary of terms and concepts found in the Nemours HSP policies and procedures. References and resources are located in the policy noted by HSP### after each definition.

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Administrative approval: Nemours terminology for final approval by the IRB Chair, or designee, of a research study subsequent to the investigator’s satisfactory response to stipulations. (HSP#037)

Adult: A person who has attained the legal status for consent to treatments or procedures involved in research (clinical investigations), under the applicable law of the jurisdiction in which the research will be conducted. Unless otherwise specified, an individual who is 18 years of age and older is an adult. (HSP-052)

Adverse event: An untoward response to the use of a test article or research procedure by a participant in a clinical investigation. Any unfavorable and unintended sign including an abnormal laboratory result, vital sign, symptom; or disease temporally (occurring in a time period) associated with the research. (HSP#067)

Advertisement: An announcement to the public using a printed notice or voice or data broadcast that describes a research study and includes contact information. Used for recruitment purposes for a research study. (HSP#045)

Direct advertising includes, but is not necessarily limited to: internet or e-mailed announcements, newspaper, radio, TV, bulletin boards, posters, and flyers that are intended for prospective subjects. Not included are: (1) communications intended to be seen or heard by health professionals, such as "dear doctor" letters and doctor-to-doctor letters (even when soliciting for study subjects), (2) news stories and (3) publicity intended for other audiences. (HSP#057)

Advocate: An individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the childs participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization. One individual may serve as advocate for more than one child. This includes ensuring that to the extent possible, the child understands what will be required of him or her during the research, and that if capable, the child provides his or her assent to participate. Acting in the best interests of the child could include evaluating the ongoing impact of the research study on the child. The advocate should represent the individual child subject’s interests throughout the child’s participation in the research. This added protection is intended to ensure that the ward, who is particularly vulnerable, is not exploited, coerced, or subjected to undue influence or harm in the course of the research. (HSP#071)

Affiliated: An employee or agent of Nemours or a member of that person’s immediate family. Affiliated IRB members include, but are not limited to: part-time employees; current students; board members, paid or unpaid consultants; healthcare providers holding credentials to practice at the institution; and volunteers working at the institution on business unrelated to the IRB. Unaffiliated members include people whose only association with the institution is that of a patient, subject, or former student. Paying an unaffiliated IRB member a reasonable market value for their services does not make the member otherwise affiliated or cause the member to have a conflicting interest. (HSP#009)

Alternate: A member designated to replace a specific predetermined reular voting member, or a specified group of members with expertise, when needed (HSP#009)

Amendment: A proposed change in a protocol as approved by the IRB. (HSP#042)

(IRB) Authorization Agreement: A legal agreement prescribed by OHRP that describes the obligations of both parties when one relies upon the other for IRB review services. (The OHRP template for this Agreement is found here: http://www.hhs.gov/ohrp/humansubjects/assurance/iprotsup.rtf. (HSP#002)

Assent: A child’s affirmative agreement to participate in research. Mere failure to object will not, absent affirmative agreement, be construed as assent. (HSP#027)