Human/animal use considerations. Protection of Human Subjects Basic principles Basic principles...

Human/animal use Human/animal use considerationsconsiderations

Protection of Human Protection of Human SubjectsSubjects

Basic principlesBasic principles– Clinical trials should be conducted in Clinical trials should be conducted in

accordance with generally accepted ethical accordance with generally accepted ethical principlesprinciples

– Before a trial is initiated, foreseeable risks and Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the inconveniences should be weighed against the anticipated benefit for the individual trial anticipated benefit for the individual trial subject and societysubject and society

– A trial should only be initiated and continued if A trial should only be initiated and continued if the anticipated benefits justify the risksthe anticipated benefits justify the risks


Basic principlesBasic principles– The rights, safety and well being of trial The rights, safety and well being of trial

subjects are the most important subjects are the most important considerations and should prevail over considerations and should prevail over interests of science and societyinterests of science and society

– The available nonclinical and clinical The available nonclinical and clinical information on an investigational product information on an investigational product should be adequate to support the proposed should be adequate to support the proposed clinical trialclinical trial

– Clinical trials should be scientifically sound Clinical trials should be scientifically sound and described in a clear, detailed protocoland described in a clear, detailed protocol


Basic principlesBasic principles– A trial should be conducted in compliance with A trial should be conducted in compliance with

the protocol that has received prior IRB approvalthe protocol that has received prior IRB approval– The medical care given to, and medical The medical care given to, and medical

decisions made on behalf of, subjects should decisions made on behalf of, subjects should always be the responsibility of a qualified always be the responsibility of a qualified physicianphysician

– Each individual involved in conducting a trial Each individual involved in conducting a trial should be qualified by education, training and should be qualified by education, training and experience to perform their respective tasksexperience to perform their respective tasks

– Freely given informed consent should be Freely given informed consent should be obtained from every subject prior to clinical trial obtained from every subject prior to clinical trial participationparticipation

Protection of Human Protection of Human SubjectsSubjects Basic principlesBasic principles

– All clinical trial information should be recorded, All clinical trial information should be recorded, handled and stored in a way that allows its handled and stored in a way that allows its accurate reporting, interpretation and verificationaccurate reporting, interpretation and verification

– The confidentiality of records that could identify The confidentiality of records that could identify subjects should be protectedsubjects should be protected

– Investigational products should be manufactured, Investigational products should be manufactured, handled and stored in accordance with good handled and stored in accordance with good manufacturing practice and used with the manufacturing practice and used with the approved protocolapproved protocol

– Systems with procedures that assure the quality Systems with procedures that assure the quality of every aspect of the trial should be of every aspect of the trial should be implementedimplemented


Study needsStudy needs– PurposePurpose– BackgroundBackground– LocationLocation– DurationDuration– Research planResearch plan– Economic considerationsEconomic considerations– Justification of subject populationJustification of subject population– Inclusion / exclusion criteriaInclusion / exclusion criteria


Relevant issues to be addressed:Relevant issues to be addressed:– The need for the trialThe need for the trial

1) What is the problem to be addressed?1) What is the problem to be addressed? 2) What are the principle research questions 2) What are the principle research questions

to be addressed?to be addressed? 3) Why is a trial needed now?3) Why is a trial needed now? 4) Give references to any systematic review 4) Give references to any systematic review

and discuss the need for a trial in this lightand discuss the need for a trial in this light 5) How will the results of this trial be used?5) How will the results of this trial be used?


Relevant issues to be addressedRelevant issues to be addressed– The proposed trialThe proposed trial

1) What is the proposed trial design1) What is the proposed trial design 2) What are the planned trial 2) What are the planned trial

interventionsinterventions 3) What are the proposed practical 3) What are the proposed practical

arrangements for allocating participants arrangements for allocating participants to trial groupsto trial groups

4) What are the proposed methods for 4) What are the proposed methods for protecting against sources of bias?protecting against sources of bias?

5) What are the planned inclusion / 5) What are the planned inclusion / exclusion criteria?exclusion criteria?



6) What is the proposed duration of 6) What is the proposed duration of treatment period?treatment period?

7) What is the proposed frequency and 7) What is the proposed frequency and duration of follow-up?duration of follow-up?

8) What are the primary and secondary 8) What are the primary and secondary outcome measures?outcome measures?

9) How will the outcome measures be 9) How will the outcome measures be measured at follow-up?measured at follow-up?

10) What is the proposed sample size?10) What is the proposed sample size? 11)What is the planned recruitment rate?11)What is the planned recruitment rate?



12) Are there likely to be any problems with 12) Are there likely to be any problems with compliance?compliance?

13) What is the likely rate of loss to follow-up?13) What is the likely rate of loss to follow-up? 14) Give details of the planned analyses14) Give details of the planned analyses 15) Are there any planned subgroup analyses?15) Are there any planned subgroup analyses? 16) What is the proposed frequency of analyses?16) What is the proposed frequency of analyses? 17) Will the trial address any economic issues?17) Will the trial address any economic issues? 18) What is the estimated cost and duration of the 18) What is the estimated cost and duration of the

trial?trial? 19) What are the details of the trial team?19) What are the details of the trial team?


Subject populationSubject population– Must describe and justify:Must describe and justify:

Number of subjectsNumber of subjects AgesAges GenderGender Inclusion of minoritiesInclusion of minorities ChildrenChildren Vulnerable groupsVulnerable groups


Information required when using human Information required when using human subjects:subjects:

1) A description of all persons who will be involved in 1) A description of all persons who will be involved in the research, including their roles and qualificationsthe research, including their roles and qualifications

2) Information regarding who will have access to the 2) Information regarding who will have access to the personal health informationpersonal health information

3) A description of the anticipated public or scientific 3) A description of the anticipated public or scientific benefit of the studybenefit of the study

4) A description of all personal health information to 4) A description of all personal health information to be collected and how it will be usedbe collected and how it will be used

5) Justification of why research can not be 5) Justification of why research can not be accomplished without using personal health accomplished without using personal health informationinformation

Protection of Human Protection of Human SubjectsSubjects Information required when using Information required when using

human subjects:human subjects: 6) A description of how personal health 6) A description of how personal health

information is to be linked to other information is to be linked to other informationinformation

7) A description of how long personal 7) A description of how long personal information will be retained and then information will be retained and then disposed ofdisposed of

8) A description of foreseeable risks and 8) A description of foreseeable risks and harms and how these will be addressedharms and how these will be addressed

9) A description of any conflicts of interest9) A description of any conflicts of interest

Informed ConsentInformed Consent

A process by which a subject A process by which a subject voluntarily confirms his or her voluntarily confirms his or her willingness to participate in a clinical willingness to participate in a clinical trialtrial

Informed of all aspects of the trial that Informed of all aspects of the trial that are relevant to their decision to are relevant to their decision to participateparticipate

Documented by means of a written, Documented by means of a written, signed and dated consent formsigned and dated consent form


Key componentsKey components– ProcessProcess– VoluntaryVoluntary– Informed of all aspectsInformed of all aspects– DecisionDecision– DocumentationDocumentation


Process of obtaining consentProcess of obtaining consent– Provide ample time and opportunity Provide ample time and opportunity

to:to: Inquire about details of trialInquire about details of trial Discuss and interactDiscuss and interact Decide whether or not to participateDecide whether or not to participate Have all questions answered to Have all questions answered to

subject’s satisfactionsubject’s satisfaction


Essential requirementsEssential requirements– Information about the consent Information about the consent

procedureprocedure– Information about study and treatmentInformation about study and treatment– Information about risks/benefitsInformation about risks/benefits– Other essential informationOther essential information– SignatoriesSignatories– ReadabilityReadability

Informed consentInformed consent

Information about the consent Information about the consent procedureprocedure– Consent to be given under subject’s Consent to be given under subject’s

free willfree will– Right to withdraw at any time Right to withdraw at any time

without prejudice or consequenceswithout prejudice or consequences– Adequate time allowed for subjects Adequate time allowed for subjects

to decide on participation in study to decide on participation in study and to ask questionsand to ask questions


Information about the consent Information about the consent procedureprocedure– Explanation that participation is Explanation that participation is

confidential, but records will be confidential, but records will be reviewed and may be disclosed to a reviewed and may be disclosed to a regulatory authorityregulatory authority

– Description of circumstances under Description of circumstances under which participation will be terminatedwhich participation will be terminated

– Ethics committee approval obtainedEthics committee approval obtained– Name of contact person on ECName of contact person on EC


Information about study and Information about study and treatmenttreatment– Name of sponsor or sources of Name of sponsor or sources of

fundingfunding– Explanation that study is a research Explanation that study is a research

procedureprocedure– Research aims, purpose or objectivesResearch aims, purpose or objectives– Description of medication or devicesDescription of medication or devices


Information about study and Information about study and treatmenttreatment– Procedures to be followedProcedures to be followed– Experimental proceduresExperimental procedures– Randomization proceduresRandomization procedures


Information about study and treatmentInformation about study and treatment– Comparator treatment (including placebo Comparator treatment (including placebo

where no other treatment exists)where no other treatment exists)– Expected duration of participation in studyExpected duration of participation in study– Number of other subjects participatingNumber of other subjects participating– Reasons for selection of suitable subjectsReasons for selection of suitable subjects– Access to best proven treatment at Access to best proven treatment at

conclusion of studyconclusion of study


Information about risks/benefitsInformation about risks/benefits– Refusal to participate would involve no Refusal to participate would involve no

penalties or loss of usual benefitspenalties or loss of usual benefits– Foreseeable risks, discomforts, side Foreseeable risks, discomforts, side

effects, inconvenienceseffects, inconveniences– Issues related to embryo, fetus or nursing Issues related to embryo, fetus or nursing

infantinfant– Known therapeutic benefits, if anyKnown therapeutic benefits, if any– Availability of alternative therapiesAvailability of alternative therapies– Financial remuneration, if anyFinancial remuneration, if any


Information about risks/benefitsInformation about risks/benefits– Any new findings which might Any new findings which might

adversely affect safety of subject adversely affect safety of subject would be disclosed to subjectwould be disclosed to subject

– Any additional costs to subject that Any additional costs to subject that may result from study participationmay result from study participation


Information about risks/benefitsInformation about risks/benefits– Assurance of compensation, if any, Assurance of compensation, if any,

for medicine induced injuryfor medicine induced injury– Measures to be taken in the event of Measures to be taken in the event of

an adverse event or therapeutic an adverse event or therapeutic failurefailure


Other informationOther information– Information (name, address, 24-hour Information (name, address, 24-hour

telephone number) about contact telephone number) about contact person at study site for emergencyperson at study site for emergency

– Requirements to disclose use (and Requirements to disclose use (and any change in use) of any medicines any change in use) of any medicines (or alcohol, tobacco/other drugs)(or alcohol, tobacco/other drugs)

– Requirement to disclose details of Requirement to disclose details of medical historymedical history


Other informationOther information– Requirement to disclose Requirement to disclose

participation in other studiesparticipation in other studies– Primary care physician to be Primary care physician to be

informed of study participation and informed of study participation and significant problems during studysignificant problems during study


Other informationOther information– Medical records to clearly indicate Medical records to clearly indicate

study participationstudy participation– Conditions as applicable to women Conditions as applicable to women

of child bearing potentialof child bearing potential– Any possible conflicts of interest and Any possible conflicts of interest and

institutional affiliations of the institutional affiliations of the investigatorinvestigator


SignatoriesSignatories– Date and time of providing Date and time of providing

information and obtaining consent information and obtaining consent must be documented in writingmust be documented in writing

– All signatories must date their own All signatories must date their own signaturessignatures


SignatoriesSignatories– Consent form should be signed and Consent form should be signed and

dated by:dated by: Study subject or, where appropriate, a Study subject or, where appropriate, a

legally authorized representativelegally authorized representative Investigator who provided information, Investigator who provided information,

obtained consent and assured that obtained consent and assured that subject understood informationsubject understood information


SignatoriesSignatories– Other personnel (eg study site co-Other personnel (eg study site co-

ordinator who assist in consent ordinator who assist in consent procedureprocedure

– Witness or patient advocateWitness or patient advocate


ReadabilityReadability– 44thth – 6 – 6thth grade grade

““You don’t have to be in this research study. You can You don’t have to be in this research study. You can agree to be in the study now and change your mind agree to be in the study now and change your mind later. Your decision will not affect your regular care. later. Your decision will not affect your regular care. Your doctor’s attitude toward you will not change”Your doctor’s attitude toward you will not change”

– CollegeCollege ““You voluntarily consent to participate in this research You voluntarily consent to participate in this research

investigation. You may refuse to participate in this investigation. You may refuse to participate in this investigation or withdraw your consent and investigation or withdraw your consent and discontinue participation in this study without penalty discontinue participation in this study without penalty and without affecting your future care or your ability to and without affecting your future care or your ability to receive alternate medical treatment at the University.”receive alternate medical treatment at the University.”


Consent form: ComponentsConsent form: Components 1) Title: Consent to participate in a 1) Title: Consent to participate in a

research studyresearch study 2) Title of research study2) Title of research study 3) Investigators3) Investigators 4) Study sponsor4) Study sponsor 5) Purpose of the research5) Purpose of the research 6) Description of the research6) Description of the research 7) Potential harms7) Potential harms 8) Women as research subjects8) Women as research subjects


Consent form: ComponentsConsent form: Components 9) Potential Benefits9) Potential Benefits 10) Treatment options10) Treatment options 11) Confidentiality and privacy11) Confidentiality and privacy 12) Publication of results12) Publication of results 13) Reimbursement13) Reimbursement 14) Compensation for injury14) Compensation for injury 15) Participation and withdrawal15) Participation and withdrawal 16) Research ethics board contact16) Research ethics board contact 17) Consent17) Consent

Surrogate consentSurrogate consent

CriteriaCriteria– The research protocol has scientific meritThe research protocol has scientific merit– It would not be feasible to carry out the It would not be feasible to carry out the

research relying on subjects who are research relying on subjects who are capable to give free and informed consentcapable to give free and informed consent

– Any imposition on the individual is clearly Any imposition on the individual is clearly outweighed by the potential benefit of the outweighed by the potential benefit of the research to the group sharing the conditionresearch to the group sharing the condition

– The research is limited to the investigation The research is limited to the investigation of those conditions or aspects of behaviour of those conditions or aspects of behaviour which are directly relatedwhich are directly related

Surrogate ConsentSurrogate Consent

The procedures proposed by the The procedures proposed by the research protocol involve no research protocol involve no significant risk of either harm or significant risk of either harm or more than trivial discomfort to the more than trivial discomfort to the subject and would not be regarded subject and would not be regarded by a reasonable person of full by a reasonable person of full capacity as involving capacity as involving embarrassment or indignity or embarrassment or indignity or breach of confidentialitybreach of confidentiality

DocumentationDocumentation

Requirements for Ethics Requirements for Ethics Committee/IRBCommittee/IRB– Investigator name, qualifications and Investigator name, qualifications and

site addresssite address– Full protocol including case report Full protocol including case report

formsforms– Subject information sheet and consent Subject information sheet and consent

formform– Investigator brochureInvestigator brochure– Insurance/compensation for subjectsInsurance/compensation for subjects

DocumentationDocumentation

Requirements for Ethics Requirements for Ethics Committee/IRBCommittee/IRB– Indemnity for investigator/instituteIndemnity for investigator/institute– Financial agreements, if anyFinancial agreements, if any– AdvertisementsAdvertisements– Regulatory submission and/or Regulatory submission and/or

approval documentsapproval documents

Investigator Investigator responsibilitiesresponsibilities 13 main obligations for the 13 main obligations for the

investigatorinvestigator 1) Qualifications and agreements1) Qualifications and agreements 2) Adequate resources2) Adequate resources 3) Medical care of trial subjects3) Medical care of trial subjects 4) Communication with IRB4) Communication with IRB 5) Compliance with protocol5) Compliance with protocol 6) Investigational product6) Investigational product

Investigator Investigator responsibilitiesresponsibilities

7) Randomization procedures and 7) Randomization procedures and unblindingunblinding

8) Informed consent of subject8) Informed consent of subject 9) Records and reports9) Records and reports 10) Progress reports10) Progress reports 11) Safety reports11) Safety reports 12) Procedure termination or 12) Procedure termination or

supervision of trialsupervision of trial 13) Final report by investigator13) Final report by investigator

Animal welfareAnimal welfare

Oversight by Animal Care and Use Oversight by Animal Care and Use CommitteeCommittee

Need a complete description of Need a complete description of research planresearch plan

Special considerationsSpecial considerations– Species, age, gender, numbers of animals, Species, age, gender, numbers of animals,

anaesthesia (terminal and survival anaesthesia (terminal and survival experiments), discomfort, hazards experiments), discomfort, hazards (infectious, chemical, physical, infectious (infectious, chemical, physical, infectious agentsagents

– Must justify use of animals vs in vitro Must justify use of animals vs in vitro techniques, analytical models, humanstechniques, analytical models, humans

– Must justify speciesMust justify species


Veterinary care must be outlinedVeterinary care must be outlined– Minimization of discomfortMinimization of discomfort– AnaesthesiaAnaesthesia– AnalgesicsAnalgesics– AntibioticsAntibiotics– Methods of euthanasiaMethods of euthanasia– Must use an accredited facilityMust use an accredited facility


Common pitfallsCommon pitfalls– Reasons for rejection of proposalReasons for rejection of proposal

Poor justification of animal numbersPoor justification of animal numbers Unclear animal care endpointsUnclear animal care endpoints

– When morbidity is expected, the severity, When morbidity is expected, the severity, monitoring frequency and provisions for monitoring frequency and provisions for unexpected complications should be statedunexpected complications should be stated

– Death and animal moribundity should be Death and animal moribundity should be avoidedavoided

Budgets/JustificationBudgets/Justification

Budgets/JustificationBudgets/Justification

Preparing the Budget: Defining “Real” Preparing the Budget: Defining “Real” CostsCosts– Common fixed costs: lab, xray etcCommon fixed costs: lab, xray etc– Related costs: phlebotomy fees, supplies, Related costs: phlebotomy fees, supplies,

specimen processing feesspecimen processing fees– Drug costs: investigational drug Drug costs: investigational drug

management/dispensing, alternate or management/dispensing, alternate or adjunct drugsadjunct drugs

– Subject costs: travel, parking, time Subject costs: travel, parking, time compensation compensation

Budgets/justificationBudgets/justification Preparing the Budget: Defining “Real” Preparing the Budget: Defining “Real”

Costs Costs – Ancillary costs: travel, pager/phone, Ancillary costs: travel, pager/phone,

administrative (copying, long distance phone)administrative (copying, long distance phone)– Marketing costs: radio, newspaper ads etcMarketing costs: radio, newspaper ads etc– Study personnel: research nurse/coordinator, Study personnel: research nurse/coordinator,

investigator, technicianinvestigator, technician Budget by time estimate or milestoneBudget by time estimate or milestone Use actual salary valuesUse actual salary values Use significant detail in describing dutiesUse significant detail in describing duties Ensure there is someone to perform all needed tasksEnsure there is someone to perform all needed tasks

– Institutional feesInstitutional fees IRB, Contracting, Overhead or indirect costsIRB, Contracting, Overhead or indirect costs

– Record retention feesRecord retention fees

Budget/justificationBudget/justification

Preparing the Budget: Defining Preparing the Budget: Defining “Real” Costs “Real” Costs – Equipment feesEquipment fees

Budget early and justify wellBudget early and justify well

– SuppliesSupplies Ask for enough money to buy what you Ask for enough money to buy what you

needneed For animal research justify expenses: For animal research justify expenses:

purchase costs, surgery costs, housing purchase costs, surgery costs, housing per diem; what are costs over timeper diem; what are costs over time

Budgets/justificationBudgets/justification Preparing the Budget: Defining “Real” Preparing the Budget: Defining “Real”

CostsCosts– ““Hidden costs”Hidden costs”

Time/cost to obtain special reportsTime/cost to obtain special reports Copy cost for xrays, MRIsCopy cost for xrays, MRIs Cost increases for studies that go on later than Cost increases for studies that go on later than

one yearone year– Inflation, health system price increases etcInflation, health system price increases etc

Personnel costsPersonnel costs– Screening, training of staff, failed enrollment etcScreening, training of staff, failed enrollment etc

Cost of starting enrollment lateCost of starting enrollment late Publication costsPublication costs Disposal costsDisposal costs Service contracts / lab maintenanceService contracts / lab maintenance

Budgets/justificationBudgets/justification

Common elements of a study budgetCommon elements of a study budget– 1)Administrative fees1)Administrative fees

Start-up: protocol review, consent preparation, Start-up: protocol review, consent preparation, budget review, regulatory requirements, budget review, regulatory requirements, meetings, staff training, site activation, clerical meetings, staff training, site activation, clerical supportsupport

Pharmacy feesPharmacy fees REB feesREB fees Patient advertisingPatient advertising Overhead: use of utilities, telephone, fax, Overhead: use of utilities, telephone, fax,

internet, photocopying, use of maintenance staff, internet, photocopying, use of maintenance staff, general administrative work, institutional opening general administrative work, institutional opening and maintenance of a file, keeping records etcand maintenance of a file, keeping records etc

Budgets/justificationBudgets/justification Common elements of a study budgetCommon elements of a study budget

– 1)Administrative fees1)Administrative fees Overhead: exclude start-up fees, pharmacy Overhead: exclude start-up fees, pharmacy

fees, REB fees, maintenance fees, close-out fees, REB fees, maintenance fees, close-out fees, storage fees patient advertising, fees, storage fees patient advertising, screen failures, per patient fees, screen failures, per patient fees, investigator feesinvestigator fees

Maintenance fees: audits, storage costs, Maintenance fees: audits, storage costs, submission of protocol amendments, submission of protocol amendments, implementation of revisions, reporting etcimplementation of revisions, reporting etc

Close out feesClose out fees Storage /archiving feesStorage /archiving fees


Common elements of a study budgetCommon elements of a study budget– 2) Screen failures2) Screen failures

NB to review the complete process required to NB to review the complete process required to assess whether a patient is eligibleassess whether a patient is eligible

Assess ratio of screened patients required to Assess ratio of screened patients required to find each eligible patientfind each eligible patient

Include cost of consentInclude cost of consent– 3) Per patient fees3) Per patient fees

Entry: consent process, registration, Entry: consent process, registration, randomization, preparing timelines for randomization, preparing timelines for treatment, patient education, documentation, treatment, patient education, documentation, sample submission, suppliessample submission, supplies

TreatmentTreatment Follow-upFollow-up


Common elements of a study Common elements of a study budgetbudget– 4) Taxes / currency4) Taxes / currency– 5) Termination: all startup payments 5) Termination: all startup payments

should be non-refundableshould be non-refundable– 6) Payee6) Payee

All payments should run through an All payments should run through an institutional accountinstitutional account


IssuesIssues– Define study costs vs standard of Define study costs vs standard of

carecare A priori determination works bestA priori determination works best

– Specify major study costs in consent Specify major study costs in consent formform If grant will not support, notify subject If grant will not support, notify subject

they are responsiblethey are responsible


IssuesIssues– Clinical trial budgets are usually fixedClinical trial budgets are usually fixed

Usually broken into “per subjects” Usually broken into “per subjects” paymentspayments

Payments prorated based on subject Payments prorated based on subject completioncompletion

Overhead / indirect costs may be included Overhead / indirect costs may be included in fixed budgetin fixed budget

– Study costs increase over the time the Study costs increase over the time the study is underwaystudy is underway


ChallengesChallenges– Accounting for subjects screening costsAccounting for subjects screening costs

May be unpredictableMay be unpredictable Screening failuresScreening failures

– Reimburse as a ratio of enrolled subjectsReimburse as a ratio of enrolled subjects– Reimburse only a fixed numberReimburse only a fixed number

– ?Payments for partial or nonevaluable ?Payments for partial or nonevaluable subjectssubjects

– Study delaysStudy delays Study on holdStudy on hold

– Accounting for residual dollarsAccounting for residual dollars


StrategiesStrategies– Budget development processBudget development process

Understand costs at siteUnderstand costs at site– Use standardized templatesUse standardized templates– Define “research costs” for proceduresDefine “research costs” for procedures

Know “break even” pointKnow “break even” point– How long can you go without enrolling 1How long can you go without enrolling 1stst

subject ie cost of co-ordinatorsubject ie cost of co-ordinator Get insight from experienced clinical Get insight from experienced clinical

research staffresearch staff


StrategiesStrategies– ?Budget cost per subject?Budget cost per subject– Overhead or indirect costs included?Overhead or indirect costs included?– Understand “one time” costsUnderstand “one time” costs

IRB fee etc.IRB fee etc.

– Have flexibility to cover prn costsHave flexibility to cover prn costs ie follow-up imagingie follow-up imaging

– Consider start-up costsConsider start-up costs– Have a payment scheduleHave a payment schedule


SummarySummary– Identify all study-related costs a prioriIdentify all study-related costs a priori– Address the issues that are specific to your Address the issues that are specific to your

site that may result in hidden costssite that may result in hidden costs– Work with experienced people in designing Work with experienced people in designing

budgetbudget– Make sure the budget matches the work Make sure the budget matches the work

planplan– Ask for what you need, not too little and Ask for what you need, not too little and

not too muchnot too much

Human/animal use considerations. Protection of Human Subjects Basic principles Basic principles...

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