WSIRB Review Worksheet

(Online template:

Reviewer Name:Project #: Board Meeting Date:

Application

  • Is the application complete (including the appropriate appendices)?

Yes

No Points for discussion on application:

Investigator(s)
  • Are the investigators appropriately trained and qualified to conduct/manage this research?

Yes

No Points for discussion on investigator(s):

  • Are study activities, staff, and subjects able to be appropriately supervised?

Yes

No Points for discussion:

Funding

  • Is the funding source clear?

Yes

No Points for discussion on funding:

Conflict of Interest

Is there a potential conflict of interest?

No

Yes Points for discussion on conflict of interest:

Study Design and Analysis
  • Is the purpose of the research clear, and the study design sound enough to produce valid results related to the research objectives?

Yes

No

  • Are study procedures and instruments clearly described and appropriate for the aims of the study? (Who, what, when, where, how?)

Yes

No

  • Is there a clear differentiation between research procedures and standard/routine care?

Yes

No

  • Is the proposed data analysis sufficient to address the research questions and/or hypothesis?

Yes

No

Points for discussion on study design and analysis:

Study Population

  • Are the inclusion/exclusion criteria clearly specified?

Yes

No

  • Are the inclusion/exclusion criteria appropriate for the goals of the study?

Yes

No

  • Is the selection of subjects equitable?

Yes

No

  • Does the research include vulnerable populations?

No

Yes Identify vulnerable population(s):

Is inclusion of vulnerable population(s) justified? Yes

No

Are the proposed protections adequate? Yes

No

Complete sections below, if applicable.

Subpart B, Pregnant women/fetuses:Subpart C, Prisoners:

Meets criteria in section 46 Meets criteria in section 46.306(a)(2):

.204 .205 .207 (i) (ii) (iii) (iv)

Does not meet criteria Meets criteria for epi waiver of special protections

Does not meet criteria

Subpart D, Children:

Meets criteria in section 46

.404 .405 .406 .407

Does not meet criteria

Parent permission:Assent required:

One parent Yes

Two parents No

Meets criteria for waiver

Points for discussion on study population:

Recruitment Not Applicable

  • Are the methods, documents, and individuals responsible for recruitment clear and appropriate?

Yes No NA (waiver requested)

Points for discussion on recruitment:

Consent Not Applicable

  • Are the procedures, setting, timing, and individuals responsible for obtaining consent clear and appropriate?

Yes No NA (waiver requested)

  • Do consent/assent and/or authorization documents contain all required elements and are they written at appropriate reading levels and in appropriate language(s)?

Yes No NA (waiver requested)

Points for discussion on consent procedures and documents:

Waivers of Consent, Partental Permission,Authorization Not Applicable

Waiver of documentation of consent/assent for

Does the waiver meet the criteria in Appendix I, Section 1?

Yes, approve waiver No, disapprove waiver

Waiver of consent/assent, or elements of consent/assent for

Does the waiver meet the criteria in Appendix I, Section 2?

Yes, approve full waiver No, disapprove waiver

Yes,waive some elements of informed consent/assent:

Waiver of parental/guardian permission for study participation of

Does the waiver meet the criteria in Appendix I, Section 3?

Yes, approve waiver No, disapprove waiver

Waiver of HIPAA authorization for release of records/PHI for

Does the HIPAA waiver meet the criteria in Appendix I, Section 4?

Yes, approve waiver No, disapprove waiver

Points for discussion on waivers:

Privacy/Confidentiality

  • Are there adequate provisions to protect the privacy of subjects?

Yes

No Points for discussion on privacy:

  • Are there adequate provisions to protect the confidentiality of study data and confidential records?

Yes

No Points for discussion on confidentiality:

Requests for Confidential Records and/or Agency Resources Not Applicable

  • Is it clear what confidential record information and/or agency resources are being requested?

Yes

No Points for discussion on recordsand resources requests:

  • Has the responsible agency administrator signed Appendix G and/or Appendix H?

Yes

No Points for discussion on recordsand resources requests:

Risk/Benefit Assessment

  • Are the risks to subjects adequately identified, described and evaluated?

Yes

NoComments:

  • Is the research designed to minimize risks to subjects?

Yes

NoComments:

  • Are the anticipated benefits to subjects and/or society adequately identified, described and evaluated ?

Yes

NoComments:

  • Are the risks to subjects reasonable in relation toanticipated benefits to subjects or society?

Yes

Approve

Conditional Approval

No

If no, can the risks be further reduced or the anticipated benefits increased to produce a favorable risk/benefit ratio?

Yes No

Approve Deferral

Conditional Approval Disapproval

Points for discussion on risk/benefit assessment:

Presentation Elements to Cover in Board/Review Summary:

Regulatory Determinations and Disposition Recommendation

(Copy and distribute at Board meeting)

Reviewer Name:Project #: Board Meeting Date:

1.Type of study (check all that apply):

A.SBER (regulated by HHS)

B.Drug/device (regulated by FDA). Also complete drug/device checklist.

2.Is the research

Minimal Risk

Greater than Minimal Risk

3.Is there a potential conflict of interest?YES/NO

4.Vulnerable populations included?

Children (Subpart D)

Prisoners (Subpart C)

Wards

Neonates

Pregnant Women (Subpart B)

Adults Lacking Capacity

Other vulnerable categories (income, disease, limited or nonreaders)

5.If a vulnerable class is included, please make a finding for each class as follows:

A.Did the protocol include this population? YES/NO

B.Is the Board allowing this population? YES/NO

C.Although they are included, in the context of this research, does the Board find them vulnerable? YES/NO

D.If they are vulnerable – are their adequate protections? YES/NO

6. If children enrolled also make the following findings:

A.Component analysis necessary? YES/NO If yes, determine for each arm of the study.

Description

B.Assent required? YES/NO

  1. If yes, written or verbal?
  2. If yes, what ages?

Comments

7.For Adults Lacking Capacity:

A.Assent required? YES/NO

  1. If yes, written or verbal?
  2. Reason for including/excluding?

8.Consent/assent process will be:

Waived

45 CFR 46.116(d)

(i) no more than minimal risk

(ii) won’t adversely affect subjects’ rights/welfare

(iii) research would be impracticable w/out waiver

(iv) when app, subjects provided w/ add’l info after study

If yes, will a CA be required in accordance with RCW 42.48YES/NO

Waiver of Documentation of Consent

45 CFR 46.117(c)(1) - only record linking subject to research is consent doc and principal risk is harm resulting from breach of confidentiality

45 CFR 46.117(c)(2) / 21 CFR 56.109(c)(1) - min risk and involves no procedure for which consent is normally required outside research context

Taken in accordance with all criteria in the consent checklist

Comments

9.HIPAA AuthorizationYES/NO

10.Approve other study documents as submitted? Any documents require changes?

A.Advertisements

B.Recruitment materials

C.Subject materials

D.Translations/short forms

E.Other

Comments

11.Determinations

A.Wards

B.Neonates

C.Non-viable neonates

D.Unexpected incarceration

Comments

Disposition Recommendation:

Approve

Recommended approval period: (1 year maximum)

Conditional approval

Recommended approval period: (1 year maximum)

Approval Conditions:

Deferral

Review issues:

Disapprove project

Review issues:

1

(Rev. 02/05/2018)