Evaluating Risk 1 IRB CELT Presentation Colleen Donaldson – IRB Administrator Julie Wilkens – IRB Coordinator

Evaluating Risk 2 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.

Evaluating Risk 3 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 Ratio Recruitment and Equitable Selection of Participants Informed Consent Process Privacy and Confidentiality

Evaluating Risk 4 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.

Evaluating Risk 5 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.

Evaluating Risk 6 Informed Consent Informed 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 and (Code of Federal Regulations). The reviewers will look for the process used to obtain informed consent, not just the informed consent document.

Evaluating Risk 7 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

Evaluating Risk 8 Basic Elements of Informed Consent Researcher and institutional affiliation Description/purpose of the project Expectations for participants Length of time required for participation Location of study Indicates that participation is voluntary and subject can withdraw at any time without penalty

Evaluating Risk 9 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 disposal Information about paying participants (if applicable) Participant or person giving consent is over 18 Contact information for investigator and/or faculty advisor, including phone number and .

Evaluating Risk 10 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.

Evaluating Risk 11 Compliant Proposals Include: Clear and concise objectives, methods and procedures Recruitment procedures and recruitment script, letter or Copies of all questionnaires, testing instruments or interview questions Specific steps to safeguard privacy & confidentiality Informed consent document(s) Letter from participating institution or organization

Evaluating Risk 12 Resources Contact information: Colleen Donaldson or Julie Wilkens or Kim Remley or Protecting Human Subjects – three instructional films IRB Website: References: