Initial Review Worksheet

KPNC IRB Initial Review Worksheet

Study Short Title: / Reviewer Signature:
Agenda Item # / Meeting Date:Expedited Review Date:
Section 1Primary Reviewer Conflict of Interest
Y N / Do you, the primary reviewer, have any conflict of interest in the study you are reviewing? If yes, do not proceed with this review, and notify the IRB Administrator ASAP.
Section 2Core Materials Reviewed
Research Application / Grant application, if federally funded / Study protocol

Section 3 Primary Reviewer Recommendation(s)

The Study
(check one) / Informed Consent
(check all that apply) / Privacy Rule (PR) Authorization
(check all that apply)
Approve study / Approve CF / Approve PR Authorization
waive for recruitment
Approve study, subject to
(describe): / Approve CF as revised
(describe): / Approve PR Authorization as revised waive for recruitment
Defer action pending
(describe): / Waive consent / (describe):
Disapprove study
(give reasons): / Waive consent documentation / Waive PR Authorization for entire study
Cede review authority to:
(stop – review complete) / Other: / Other:

If recommending study approval, recommended duration: 1 year (max) Other:

In addition, primary reviewer recommends approval/acceptance of:

Y N / Survey Instrument(s) / Y N / Telephone script(s)
Y N / Participant contact letter(s) / Y N / Recruitment document(s)
Y N / Physician contact letter(s) / Y N / Accept IB
Y N / Reply postcard(s) / Y N / Accept Safety Reports
Y N / Other:

Section 4 Expedited Review Eligibility

Complete this section only if conducting an expedited review

Y N / Is the studyeligible for expedited review as outlined in SOP KPNC-030? [See triage sheet]
Section 5Required IRB Determinations
Y N /
  1. Does the research qualify as minimal risk? Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.[See Section E, Q10A and Section F, Q 8-13]
If no, assess the study as:
Greater than minimal risk, but low risk (if yes, consider whether benefits outweigh the risks)
Moderate risk (if yes, consider whether benefits outweigh the risks)
High risk (If yes, consider whether benefits outweigh the risks & approval period of <1 year)
Y N /
  1. Are the risks to participants minimized? [See Section E, Q10B and Section F, Q 8-13]
  1. Procedures are consistent with sound research design and do not unnecessarily expose participants to risk, AND
  2. When appropriate, uses procedures already being performed on the participants for diagnostic or treatment purposes.

Scientific Design
Y N Is the research design likely to produce valid findings?
Y N Are the research design and methods adequately described and justified?
Y N Are the research design and methods adequate to answer the research question(s)?
Y N Are the research objectives likely to be achievable within the projected time frame?
Y N /
  1. Are the physical, psychological, social, and economic risks to participants reasonable in relation to anticipated benefits to participants and/or society? [See Section E, Q3 and 10]

Risk Assessment Questions
Y N Are there reasonably anticipated potentially serious consequences to the safety or welfare of study participants such as a prolonged in-patient hospitalization, a life threatening event, long-term disability or functional impairment, congenital anomaly or birth defect, or death?
Y N Are there reasonably anticipated potentially serious breaches of privacy or confidentiality of participant medical information that could lead to loss of employment, health insurance, relationships, or reputation for study participants?
Y N Is it reasonably possible that the study could lead to unintended termination of a pregnancy or loss of fertility?
Y N Is it reasonably possible that a study-related revelation of a genetic predisposition or diagnosis could have significant consequences for participants or their families?
Y N Can it be reasonably anticipated that the public disclosure of a study-related event could damage the reputation of KP or place KP at a competitive disadvantage or at risk of litigation?
Y N Is it possible that the anticipated knowledge can be gained by means other than this study as currently designed, with significantly lower risk to the participants?
If any of the above risks are identified, the IRB will not approve the study unless offsetting benefit(s) to study participants or to society can be reasonably anticipated and are supported by scientifically valid data from prior studies. What is/are the benefit(s)?
Y N
N/A /
  1. Does the research plan make adequate provisions for monitoring the data collected to ensure the safety of participants? When the protocol does not have a procedure or intervention where safety is an issue, this is N/A. [Section E, Q10C]

Y N
N/A /
  1. Are there adequate provisions to protect the privacy of participants and to maintain the confidentiality of data? [See Section E, Q5 and Section F, Q8-13]

Does the study collect data from participants that are of a sensitive nature?
No Yes If yes, consider requiring a Certificate of Confidentiality?
Will individuals or organizations not affiliated with KP have access to confidential or proprietary information? No Yes If yes, consider requiring a confidentiality agreement.
If yes,are risks properly mitigated according to the RAMP tool and attestation? [See Section G]
No Yes
Y N /
  1. Is the selection of participants equitable, meaning that no particular group or category is excluded arbitrarily or unnecessarily? [See Section E, Q6C]

Considerations for Recruitment and Obtaining Consent
Who (position, organizational affiliation, and relationship to participants and study) will contact potential research participants?
How, when and where will participants be contacted?
How much time will potential participants be given to consider participation?
Is the consent process free of coercion (e.g., payment appropriate)?
Are the consent form and other participant materials appropriate for the population being recruited?
  1. Check all that apply. Note: If more than one box checked, indicate for which study component the consenting process or waiver is intended. [See Section E, Q8]

Waive the requirement to obtain informed consent from participants
Complete box 7.1
Waive the requirement to obtain written informed consent from participants
Completebothboxes 7.2 and 7.3
Requirewritten informed consent
Complete box 7.3
Box 7.1: In order for the IRB to waive/alter informed consent for any part of the study, all four of the following determinations must be made regarding that part/those parts:
True /
  1. The research involves no more than minimal risk to the participants;

True /
  1. The waiver or alteration will not adversely affect the rights and welfare of the participants; and,

True /
  1. The research could not reasonably be carried out without the waiver or alteration.

Y N /
  1. Is it appropriate for PI to provide participants with a summary of research findings?

Box 7.2: To waive the requirement to obtain writtenconsent for any part of the study, at least one of the two following must be met regarding that part/those parts:
  1. The only record linking the participant and the research would be the consent document and the primary risk would be potential harm resulting from a breach of confidentiality;
OR
  1. The research involves no more than minimal risk to the participants and involves no procedures for which written consent is normally required outside of the research context.

Box 7.3: For studies that require informed consent, all required elements of informed consent must be present.
Does the informed consent document contain the following required basic elements and is each element adequate?
  1. A statement that the study involves research.

  1. An explanation of the purposes of the research.

  1. The expected duration of the participant’s participation.

  1. A description of the procedures to be followed.

  1. Identification of any procedures that are experimental.

  1. A description of any reasonably foreseeable risks or discomforts to the participant.

  1. A description of any benefits to the participant or to others which may be expected from the research.

  1. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.

  1. A statement describing the extent to which confidentiality of records identifying the participant will be maintained.

  1. For research involving more than minimal risk, an explanation as to whether any compensation will be provided and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.

  1. An explanation of whom to contact for answers to pertinent questions about the research and research participant’s rights, and whom to contact in the event of a research-related injury to the participant.

  1. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.

  1. The participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.

Does the consent form contain the following additional elements, when relevant to this study?
  1. A statement that the particular treatment or procedure may involve risks to the participant (or embryo or fetus) which are currently unforeseeable.

  1. Anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent.

  1. Any additional costs to the participant that may result from participation in the research.

  1. Consequences of a participant’s decision to withdraw from the research and procedures for orderly termination of participation by the participant.

  1. A statement that significant new findings discovered during the course of the research which may relate to the participant’s willingness to continue participation willl be provided to the participant.

  1. The approximate number of participants involved in the study.

Y N /
  1. Does the HIPAA Privacy Rule apply?
 If no, skip to Section 6
9. Check all that apply[See Section F, Q2]
Waive the requirement to obtain Privacy Rule authorization for the purposes of recruitment or for some other part of the study. If other part, indicate part:
Require written Privacy Rule authorization for the remainder of the study
Complete box 9.1
Waive the requirement to obtain Privacy Rule authorization for the entire study
Complete box 9.1
No waiver of the requirement to obtain Privacy Rule authorization for any part of the study (including recruitment)
Skip to Section 6
Box9.1: In order for the requirement to obtain written HIPAA Privacy Rule authorization to be waived for any part of the study, including recruitment, the following determinations must be true for that part/those parts:
True /
  1. The use or disclosure of PHI involves no more than a minimal risk to the privacy of the individuals [See Section F, Q2C] to include at least the presence of the following elements:
  • An adequate plan to protect the identifiers from improper use or disclosure[See Section F, Q2D];
  • An adequate plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research (unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law) [See Section F, Q2E]; and
  • Adequate written reassurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law [See Section F, Q14].

True /
  1. The research could not be practicably conducted without the waiver or alteration [See Section F, Q2B]; and

True /
  1. The research could not be practicablyconducted without access to and use of the PHI [See Section F, Q2A]; and

True /
  1. Only the minimum necessary PHI will be used or disclosed under the research [See Section F, Q2F].

Section 6Other IRB Considerations
Y N /
  1. Are the investigators and sub-investigators appropriately qualified and trained to conduct this research project? [see the investigators’ CV]

Y N /
  1. As stated in the Research Application, are the researchers free of personal conflicts of interest with this study? [See IRB staff if any questions]

Y N
NA /
  1. If this study is being done as part of satisfying an academic degree, is the letter from the faculty advisor included? [See Section D, Q22]

Y N /
  1. Does the application clearly state at which KPNC facilities this study will be conducted? Has the PI obtained all required approval signatures? [See Section E, Q16A]

Y NNA /
  1. If the study included an investigational drug or device, has an IND or IDE been obtained?[See Section D, Q14, 15 and 16]

Y NNA /
  1. If the study invovles an investigational device, is it a significant risk device?[See Section D, Q16]

Section 7Children
Does the protocol specifically exclude children?
Yes – skip to Section 8
No – indicate the level of risk (check one):
Research not involving greater than minimal risk
Research involving greater than minimal risk but prospect of direct benefit to participant
Research involving greater than minimal risk and NO prospect of direct benefit to participant, but likely to yield generalizable knowledge.
Other determinations regarding children:
The risks are justified by the anticipated benefits and the relation of the anticipated benefits to the risks is at least as favorable as that for alternative approaches based on the following considerations:

If 7 years of age or older, adequate provisions* will be made to solicit documentation of assent taking into account (when appropriate) the age, maturity, and psychological state of the children.
Adequate provisions* are made to obtain consent from one parent for the first two risk levels in the box above. Both parents required for higher risk levels unless one is deceased, unknown, incompetent, not reasonally available, or only one parent has legal responsibility.
* Adequate provisions for assent and/or parental or guardian permission may include granting a waiver or determining that assent/permission is not a necessary condition to proceed with the study.
Section 8Other Vulnerable Populations – If none, skip this section
PREGNANT WOMEN AND FETUSES
If pregnant women or fetuses specifically targeted in this research, are all the following conditions met?
  1. Where scientifically appropriate, pre-clinical studies (including studies on pregnant animals, and clinical studies, including studies on non-pregnant women) have been conducted and provide data for assessing the potential risks to pregnant women or fetuses.

  1. Any riskis the least possible for achieving the objectives of the research.

  1. Any risk to the fetus that is greater than minimal is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus.

  1. The woman’s consent or the consent of her legally authorized representative is obtained (or waived) in accord with the federal regulations on informed consent.

  1. In the case where the research may directly benefit the fetus only, the father’s consent or the consent of his legally authorized representative is obtained (or waived) in accord with the federal regulations on informed consent.

  1. Each person providing consentis fully informed regarding the reasonably foreseeable impact of the research on the fetus or resultant child.

  1. For minors who are pregnant, assent is obtained in accord with subpart D of DHHS regulations.

  1. The study does not offer inducements, monetary or otherwise, to terminate a pregnancy.

  1. The individuals engaged in the research do not have any part in decisions as to the timing, method or procedures used to terminate a pregnancy.

  1. The individuals engaged in the research do not have any part in determining the viability of a fetus.

THE DECISIONALLY IMPAIRED
If the decisionally impaired are specifically targeted in this research, are adequate safeguards in place to protect their rights and welfare?
Y N
N/A /
  1. For participants with memory impairment, should the IRB require the PI to explain the research to the participant on multiple occasions and/or at each study visit?

Y N
N/A /
  1. For participants with a progressive dementia, should the PI consider the capacities of potential participants at various stages of the disease?

Y N
N/A /
  1. If a legal representative is signing the consent form on behalf of the decisionally impaired participant, does the consent form indicate that the signature is of the legal representative?

Y N
N/A /
  1. Should a separate line be included on the consent form for the decisionally impaired participant to sign?

Y N
N/A /
  1. Should the IRB require assessment, independent of the PI, of the decisionally impaired participant’s capacity to understand the consent process for the study?

Y N
N/A /
  1. Should the IRB require alternate methods of communication to enable the participant to most effectively communicate whether he/she wishes to participate in the study?

OTHER VULNERABLE POPULATIONS
If the following vulnerable populationsare specifically targetted in this research, are adequate safeguards in place to protect their rights and welfare?
Y N N/A / Economically disadvantaged
Y N N/A / Educationally disadvantaged
Y N N/A / Non-English speaking populations
Y N N/A / KP Employees
Comments regarding this application:

Please turn in this completed worksheet to the IRB Administratorat the IRB meeting.

v. 06/08/2011 Page 1 of 7