Our HRPP Standard Operating Procedures have been Updated!

Our HRPP Standard Operating Procedures have been Updated!

For the past year, we have been preparing for our second re-accreditation with the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and as a result, our SOPs have been extensively reviewed and updated.

We have posted them at this time as a single pdf here: Human Subjects Standard Operating Procedures but will create a more user-friendly format to allow for easy navigating in the near future. Please refer to these SOPs often to ensure the compliant conduct of your research activities.

Some of the more substantive changes you will notice:

1. Revisions to reflect the changes in FDA and NIH regulations over the past few years (and sent to you via this mailing and/or in Research News) including, e.g., the NIH GCP training requirement, allowance of FDA waiver of consent for minimal risk research, NIH single IRB requirement, etc.)

2. Revisions to reflect the (impending) move from IRBNet to Click as our IRB electronic management system.

3. Detailed SOPs on IRB reliance arrangements in Multi-site Research (see, in particular, Section 17.16)

4. Section (‘Recruitment of Subjects’) identifies that SBU participates in ResearchMatch (see new section 17.13) and confirms that, when recruiting patients as potential subjects, first contact must be made by someone who has a relationship (e.g., treatment etc.) with the patient; This policy protects the patient’s right to privacy.

5. Section 5.2 (‘Definitions’ within the ‘Obtaining Informed Consent’ section) provides greater detail, per the NYS Family Health Care Decisions Act, regarding the definition of a legally authorized representative who can give permission as a surrogate (in instances where an adult cannot consent for themselves).

6. Section 5.7 (‘Documentation of Informed Consent’) adds that, when using the short form procedure: In addition to receiving a copy of the (English) summary and a copy of the short form at the time of consenting, the subject must receive a copy of the summary, translated into their native language, as soon as possible after their enrollment into the study.

7. Extensive revision to Section 7.5 (‘Responsibilities for FDA-regulated Research’) to be clear regarding responsibilities of FDA regulated Clinical Investigators as well as responsibilities of those investigators who are also sponsors of INDs and IDE’s: see in particular Section (‘Additional Responsibilities When the Clinical Investigator is also the Sponsor of the IND or IDE [“Sponsor-Investigator”]’) and support services now available for Sponsor-Investigators (Section

8. Section 14 (Conflicts of Interest in Research) was revised to reflect the new annual disclosure process utilizing the electronic myResearch program.

9. Section 17.4 (‘Registration of Clinical Trials’) clarifies which research activities are subject to the clinicaltrials.gov registration requirement.

10. New Special Topics for:

a. Genomic Data Sharing (GDS) for NIH Grant Submissions (Section 17.12);

b. ResearchMatch as a Recruitment Tool (Section 17.13);

c. Conducting Research in a Clinical Setting (e.g., University Hospital): Special Considerations (Section 17.14);

d. Additional Requirements for Studies Funded by the Department of Defense (Section 17.15);

e. IRB Reliance/Single IRB (sIRB) Review (Section 17.16)

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