K.1.6 Protection of Human Subjects

Initiated by: Manager of Sponsored Programs
Approved by: MBL Director/CEO
Date: July 3, 2006
Revision:
Distribution: MBL Community

1.0 Policy Statement:
The Marine Biological Laboratory (MBL) is dedicated to protecting the rights and welfare of human participants engaged in its research endeavors. The institution is guided by the ethical principles regarding all research involving human subjects, as set forth in The Belmont Report – Ethical Principles and Guidelines for the Protection of Human Subjects of Research (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, National Institutes of Health, April 18, 1979) and the ethical standards adopted through the Common Rule.

2.0 Applicability
This policy and the principles of The Belmont Report and the Common Rule are applicable to all research involving human subjects regardless of whether the research is subject to Federal regulation or with whom it is conducted or the source of support (i.e., agency or other sponsorship).

3.0 Adherence to Federal and Other Regulations:
The MBL shall adhere to The Common Rule such as the regulations of the Department of Health and Human Services (DHHS) as published in the Code of Federal Regulations (CFR), Title 45 Part 46 Protection of Human Subjects, June 23, 2005, or as codified for other Federal agencies under their respective Titles of the CFR. In addition, the MBL will comply with all other applicable federal, state, local, or institutional laws, regulations and policies.

4.0 Federalwide Assurance:
The MBL shall maintain a DHHS-approved Federalwide Assurance (FWA) for the Protection of Human Subjects. The MBL’s Manager of Sponsored Programs will serve as Human Protections Administrator. The Chief Academic and Scientific Officer will be the Signatory Official for the MBL.

5.0 Institutional Review Board:
The MBL will delegate Institutional Review Board (IRB) functions to extramural review boards with whom the MBL has on file, an Authorization Agreement signed by both parties. The MBL shall verify that the extramural IRBs have currently-approved IRB Registrations. The MBL will ensure that the extramural IRBs designated under the FWA have established written procedures for IRB functions and will maintain copies of said procedures on file.

6.0 Reporting Incidents to Office for Human Research Protections (OHRP, DHHS)
The delegated IRB and the Office of Sponsored Programs shall jointly be responsible for reporting incidents to the OHRP. The procedures outlined in Guidance on Reporting Incidents to OHRP (May 27, 2005) http://www.hhs.gov/ohrp/policy/incidreport_ohrp.html will be followed.

7.0 Responsibilities of the Investigator
In order for any investigator to begin their research involving humans as participants, the investigator will:

• acknowledge and accept their responsibility for protecting the rights and welfare of human research participants and
• ensure compliance with all applicable provisions of the federal awarding agency and all policies and procedures of the designated Institutional Review Board;
• be responsible for ensuring that all personnel have been adequately trained in the conduct of human participant research; and that all appropriate key personnel involved in human participant research involving National Institutes of Health funding have successfully completed an educational program;
• ensure that only procedures in the IRB approved protocol are conducted (including the consent process are performed and/or supervised by the listed investigator or other authorized personnel); and that no research (including modifications to approved protocols) will be initiated until IRB approval is received;
• provide the IRB with the appropriate information on the research protocol including initial information, notification of subsequent modifications, terminations, and adverse reactions, etc.,
• provide a copy of the IRB approved informed consent document to each research participant at the time of consent and after signing by the research participant, unless the IRB has specifically waived this requirement. All signed consent documents are to be retained.
• promptly submit proposed changes in previously approved human subject research activities to the IRB. The proposed changes will not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the participants;
• report the progress of approved research via the Office of Sponsored Programs (OSP) to the federal agency as required by the agency
• promptly report in writing to the IRB and the OSP any injuries, adverse events, or other unanticipated problems involving risks to subjects or others arising during the conduct of an IRB-approved protocol;
• promptly report to the IRB and the OSP any significant findings that become known in the course of the research that might affect the willingness of a research participant to participate in the study or, once enrolled, to continue to take part;
• ensure the timely completion, submission and approval by the IRB of the continuing review report prior to the protocol expiration date;
• maintain confidentiality of all records;
• notify the IRB when the study has been completed.

It is the responsibility of the investigator to insure that copies of IRB letters are distributed to appropriate individuals (e.g. Office of Sponsored Programs, department administrators, granting agencies or other sponsors, participants, etc.).

8.0 Policy Clarification and Updates:
Policy clarification and updates are available from the office of Sponsored Programs office or Chief Academic and Scientific Officer.