assentrequired elements of informed consent - Wilkes University：所需的知情同意的元素-威尔克斯大学

REQUIRED ELEMENTSOF INFORMEDCONSENT

• The form should have a clear title. (ex: “Informed Consent Form for researchbeing conducted under the auspices of the[insertdepartm” entordivisionand col lege orschool]at Wilkes University Wilkes-Barre,PA)

• Write in language that is appropriate for the educational level of prospectiveparticipants.

• Identifythe principal investigator (PI) ,al l Co-PIs,and the facultysponsor, ifappl icable,with contact information.

• Identify the sponsoring/funding organization, if appl icable.

• I“nclude a statement regarding age restrictions,”if appropriate. Forexample,participants must be 18years of age orolder. NOTE: If your researchinvolves minors,you must prepare an assent form and a parent/legalguardian permission form that arewritten in language that is appropriate forthe educational level of prospective participants.

• Describe the general purpose of the study.

• Detail the main features of the study.Whatwil l participants experience orberequired to do?

• Estimate the time required(duration of participation) .

• Note any possible risks (discomfort) to and benefits for participants.

• Explain howanonymityorconfidential itywil l be maintained throughout thestudy ornote any l imits to assurances.

• Note physical orpsychological harms, if any, that might result fromparticipating in the research.

• Note any benefits that might accrue directlyto participants and/orsociety.

• Provide the name and contact information for the investigators (and facultysponsor, if appl icable) towhom questions about the research must bedirected.

• Provide contact information for the Wilkes University Institutional Re’viewBoard Office(570-408-4241 ) to which questions about participants rightsmust be directed.

• Indicate that participation is voluntary.

• Indicate that the participantcan discontinue participation atanytime.

• Note anycompensation,course credit,or treatment that’is available toparticipants, if any. If appl icable,note how a participant swithdrawal fromthe study mightaffectsuch compensation orcourse credit.

• Include a statementabout medical services not being provided, ifappl icable.

• Indicate that refusal to participate or to continue to participatewil l not resultin a penaltyor loss of benefits.

• N“ote if parti”cipants are to be videotaped, filmed,oraudio taped. If so,checkoffs must be provided so thatsubjects mayactivelyconsent tobeing videotaped, filmed,oraudio taped.Please explain the disposition ofthe tapes. Indicate if the tapes wil l be erased ordestroyed after transcription.Explain to prospective subjects whatwil l become of the tapes.

• Indicate thatsubjects do notwaive their legal rights bysigning an informedconsent form.

NOTE:Subjects should always receive a copy of the informed consent form.