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Evaluating Risk

IRB CELT Presentation 2014-2015

Colleen Donaldson – IRB AdministratorJulie Wilkens – IRB Coordinator

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Evaluating Risk

Federal and state laws require review of all research involving human subjects. College policy ensures that the rights and welfare of human participants are adequately protected in research conducted under its

auspices:

The IRB will review all research involving human participants. The IRB has the responsibility and authority to review, approve,

disapprove or require changes in and monitor research activities involving human participants.

The IRB focuses on whether participants are found to be at risk, at which time the risk/benefit ratio of the project will be evaluated.

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Evaluating Risk

The review of human participants research is confined solely to procedures affecting the rights and welfare of human participants.

Review of protocol focuses on issues of:Risk/Benefit RatioRecruitment and Equitable Selection of ParticipantsInformed Consent ProcessPrivacy and Confidentiality

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Evaluating Risk

Risk Benefit Ratio The IRB will examine study design or scientific merit only within the context of its risk/benefit analysis.

Risks to participants are minimized by using procedures which are consistent with sound research design and do not unnecessarily expose participants to risk.

Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result from the research.

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Evaluating Risk

Recruitment and Equitable Selection of Participants

The IRB ensures that the recruitment of participants is equitable and free of coercion.

Selection criteria should consider all populations that might potentially benefit from the research, not just those readily available.

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Evaluating Risk

Informed ConsentInformed consent will be sought from each prospective participant or the participant’s legally authorized representative and will be appropriately documented in accordance with 45 CFR 46.116 and 46.117 (Code of Federal Regulations).

The reviewers will look for the process used to obtain informed consent, not just the informed consent document.

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Evaluating Risk

Informed Consent

Reviewers must be convinced that all information regarding the study that would be relevant to participants’ ability to make an informed decision to participate has been provided.

A written signature is documentation of consent and is required for all Category 3 proposals

Proposals that fall into an exempt (Category 1) or expedited (Category 2) category do not require signed informed consent

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Evaluating Risk

Basic Elements of Informed Consent

Researcher and institutional affiliation Description/purpose of the projectExpectations for participantsLength of time required for participationLocation of studyIndicates that participation is voluntary and subject can withdraw at

any time without penalty

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Evaluating Risk

Basic Elements of Informed Consent:

Indicates confidentiality will be protected and explains how data will be disseminated

Risks/benefits statement Disclosure about video- and/or audiotaping (if applicable), including

storage and disposalInformation about paying participants (if applicable)Participant or person giving consent is over 18Contact information for investigator and/or faculty advisor, including

phone number and email.

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Evaluating Risk

Privacy and Confidentiality

The IRB will determine that adequate provisions have been taken to protect the privacy of participants and for ensuring confidentiality of participants and of study data as appropriate.

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Evaluating Risk

Compliant Proposals Include:

Clear and concise objectives, methods and proceduresRecruitment procedures and recruitment script, letter or emailCopies of all questionnaires, testing instruments or interview

questionsSpecific steps to safeguard privacy & confidentialityInformed consent document(s)Letter from participating institution or organization

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Evaluating Risk

Resources

Contact information:

Colleen Donaldson 395-5118 or cdonalds@brockport.eduJulie Wilkens 395-2779 or jwilkens@brockport.eduKim Remley 395-2523 or kremley@brockport.edu

Protecting Human Subjects – three instructional films

IRB Website: www.brockport.edu/irb

References: www.brockport.edu/irb