Tip Sheets

Tip Sheets are designed to help Organizations write Human Research Protection Program policies, procedures, and other supporting documents that help them meet the Accreditation Standards.

The Tip Sheets are based on the Evaluation Instrument for Accreditation and have been updated to reference the Standards and Elements of the AAHRPP Accreditation Standards.

The Tip Sheets are most useful when used alongside the Evaluation Instrument for Accreditation. The formats for policies and procedures described in the Tip Sheets are flexible. As long as you provide the required content, the format of your Organization's policies and procedures could differ from the Tip Sheets.

Before using a Tip Sheet, review the Evaluation Instrument for Accreditation and consider your Organization's current practice, taking into account organizational issues that might affect the current practice. Then use the Tip Sheets below to help you write or revise policies, procedures, or other supporting documents that fit your Organization.

Tip Sheet #                 Keywords                                                              AAHRPP Standard

1                                  Criteria for Approval                                                      II-2, II-3, II-4
2                                 Defining Research Involving Human Participants          I.1.A., II.1.A.
3                                  Documenting Discussions and Decisions                     II.5.B.            
4                                  Confidentiality of Data                                                   II.3.E.
5                                  Privacy Protections                                                        II.3.D.
6                                  Monitoring Data and Safety                                           II.3.B.
7                                  Evaluation of IRB Members, Staff                                  II.1.B.
8                                  Exemptions: Criteria - See Evaluation Instrument         II.2.A.
9                                  Exemptions: Process                                                     II.2.A.
10                                Financial Conflict of Interest: Researchers                    I.6.B., III.1.B.
11                                ICH-GCP (E6)                                                                I.1.D., I.1.F., I-2     12                                IRB Authority and Independence                                   I.1.C.
13                                Conflict of Interest: IRB Member                                    II.1.D.
14                                Non-compliance                                                             I.5.D., II.2.H.
15                                Unanticipated Problems                                                 I.5.D., II-2, III.2.C.
16                                Convened IRB Review                                                   II.2.D., II.2.E.
17                                Expedited Review                                                           II.2.F.
18                                Prisoners                                                                        II-1, II-2, II-4
19                                State and Local Law                                                       I.1.G.
20                                Criteria for Approval                                                       II-3, II-4
21                                Suspensions                                                                   I.5.D., II.2.G, II.2.H.
22                                IRB Member Roster                                                        II.1.A.
23                                Unanticipated Problems                                                  II.2.G.
24                                Single IRB or EC Review                                                I-9   
25                                Contracts: Required Provisions                                       I-8
26                                Diminished Capacity                                                       II.4.A., II.4.B.
27                                Equivalent Protections                                                    I-1, I-3, II-2, II-3, II-4
28                                Counting the Number of Studies                                     I-2

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