The Compliance Protocol Submission Process

A “how to” guide to protocol submission using the Protocol and Compliance Management System

Updated October 15, 2013Cindy Corbett

Every road has a beginning…

What do you want to research?

Determine what your research will entail…

** Human subjects- to what does this apply?Code of Federal RegulationsTITLE 45, PUBLIC WELFAREDEPARTMENT OF HEALTH AND HUMAN SERVICES, PART 46 PROTECTION OF HUMAN SUBJECTS, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101

**Animal subjects

**Recombinant DNA

**Radiation

Review Committee InformationView Compliance Committee informationhttp://www.wm.edu/offices/sponsoredprograms/preaward/policies/compliancereqs/index.php

By accessing the information here, you will find additional resources about each committee including policies and useful links.

IACUC (Institutional Animal Care and Use Committee)

PHSC (Protection of Human Subjects Committee)

IRSC (Institutional Radiation Safety Committee)

IBC (Institutional Biohazard Committee)

EDIRC (School of Education Internal Review Committee)

Speak with your Advisor

• As a student, you must have a faculty member listed as PI (Principal Investigator) on your protocol submission in order for the protocol to be considered for review.

• Usually, but not always, this is your faculty advisor.

• In cases where a faculty advisor may be unavailable for an extended period of time, you may need to speak with the department Chair who should be able to help you find an alternative.

• In order to facilitate a speedy review, the named PI should assist you in developing the protocol, informed consent, questionnaire and other components of study.

• The PI should thoroughly review the protocol prior to endorsing it in the Protocol and Compliance Management system.

Training• For human subjects protocols, you

need to access CITI training modules https://www.citiprogram.org/

* PHSC rules mandate all researchers

must be properly trained in Human Subjects rules and regulations.

• You should indicate in the body of the protocol that you have completed human subjects training

• CITI: 

Collaborative

Institutional

Training Initiative

is a subscription

service providing

research ethics

education

Training

• Animal research modules are available directly for you through CITI training.

• You and your PI of record are responsible for maintaining copies of your training records and should be able to produce them upon request.

• The course meets the federal (USDA, OLAW) requirements for basic training in the humane care and use of animals in research and teaching.

Once you have completed your training, you are ready to start your protocol submission

Log in to the Protocol and Compliance Management system here: https://www.wm.edu/offices/sponsoredprograms/preaward/policies/compliancereqs/index.php

• Select the committee to which you wish to submit your protocol:

StudentIRB (for Charles Center programs only)PHSC (for human subjects projects which are not

sponsored by the Charles Center or not “Exempt” researchEDIRC-School of Education IACUC-Institutional Animal Care and Use CommitteeIBC-Institutional Biosafety CommitteeRAD-Radiation (not functional at this time, contact Chair)

Why reinvent the wheel?

• Often, one of the most misunderstood components of the Human Subjects Protocol is the Informed Consent.

Did you know there is a sample Informed Consent form under PHSC Information?

All you need to do is tweak the sample Informed Consent as necessaryfor your needs….please be sure to indicate the entire approved protocol

number on the Informed Consent form prior to giving it to research subjects, e.g., PHSC-2013-08-03-7013-XXXX

Sample Informed ConsentThe College of William & Mary

• The general nature of this study entitled " ____ (title here) ___ " conducted by ____ (investigators names here) _________ has been explained to me. I understand that I will be asked to _______ (specific procedures regarding the subject participation here, including any potential risks) ________. My participation in this study should take a total of about _________ hours/minutes. I understand that my responses will be confidential or that anonymity will be preserved (include appropriate term; “confidential” indicates that subjects’ identities and responses will be known to investigator but will not be divulged; “anonymity” indicates that subjects’ identities will not be known or connected to responses) and that my name will not be associated with any results of this study. I know that I may refuse to answer any question asked and that I may discontinue participation at any time. I also understand that any grade, payment, or credit (include one of these situations, if applicable) for participation will not be affected by my responses or by my exercising any of my rights. Potential risks resulting from my participation in this project have been described to me. I am aware that I may report dissatisfactions with any aspect of this experiment to the Chair of the StudentIRB, Dr. Monica Griffin, 757-221-2495 or mdgrif@wm.edu. I am aware that I must be at least 18 years of age to participate. My signature below signifies my voluntary participation in this project, and that I have received a copy of this consent form.  

• _________________________                         ____________________________                Date                                                                          Signature

•                                                                            ____________________________                                                                                               Print Name

• Once the project is determined to be EXEMPT FROM FORMAL REVIEW under 45 CFR 46.101(b), please insert this statement in the footer of the informed consent form:

• THIS PROJECT WAS FOUND TO COMPLY WITH THE APPROPRIATE ETHICAL STANDARDS AND WAS EXEMPTED FROM THE NEED FOR FORMAL REVIEW BY THE COLLEGE OF WILLIAM AND MARY PROTECTION OF HUMAN SUBJECTS COMMITTEE (Phone: 757-221-3966) ON [INSERT DATE].

•   • If study subject has any questions in regard to this project, please contact the Principal Researcher directly:

(name, contact information).

• NOTE: Additional procedures concerning informed consent, along with additional sample consent forms, can be found in the Guidebook of Policies and Procedures for Research Involving Human Subjects on the Protection of Human Subjects Committee web site.Revised 9/15/08

Just answer the questions….

* Answer questions in a succinct manner

* If a question doesn’t apply, indicate N/A so the reviewer knows you just didn’t omit a response.

• Be sure to include any questionnaires to be used in the proposal. This may be accomplished by adding as an attachment or embedding questions within the Methods section of the protocol form. Protocols submitted without the questionnaire will be ruled “REVISIONS REQUIRED” and returned for subsequent submission with the survey document.

* If you have any questions when completing the protocol, you can stop and save your submission. You may come back and edit as many times as you wish.

* Keep it simple, write as though you are addressing a lay audience

• REMEMBER to SAVE your work….

What happens after you submit your protocol?

• Don’t be surprised when you receive a warning telling you that you don’t have sufficient permissions to submit a protocol.

• If you have been attentive, you know you should name a faculty member as a PI of record.

• The named faculty member will receive an email informing them they have been named as a PI on a protocol. The faculty member must agree to serve in this capacity in order for the protocol to move forward to committee for consideration.

• Please note: the faculty member will receive cc emails on all correspondence associated with your protocol.

It will look like this….• View Email• From:

compli@wm.edu

• To:apsmit@wm.edu, jmjone@wm.edu,

• Cc:

• Date Sent:2013-08-03 15:19:59

• Subject:Your response needed for protocol StudentIRB-2013-08-03-8829-apsmit set to contingent

• ______________________• PI / STATUS• ______________________

• Smith, Anne (apsmit) Status: accept• Jones, Josephine (jmjone) Status: awaiting

• This is to notify you that you have been named as a Principal Investigator (PI) for protocol StudentIRB-2013-08-03-8829-apsmit titled Charles Center Summer Research:XXXX. This protocol will be submitted for committee review upon acceptance by all PIs. Work on this protocol shall not begin until all named PIs have accepted this role and you have received notice of committee approval. For your reference, the current status of each named PI is listed at the top of this email.

• To respond to this request, you will need to access the Protocol and Compliance Management application (https://compliance.wm.edu).

• In order for this protocol to move forward through the compliance system, you will need to log in to the Protocol and Compliance Management system and endorse your role.

Once PI and student have agreed to serve on protocol, the submission is

complete and will forward to committeeAn email will be sent to both the PI and the student with a copy of the successful submission. This is your record the protocol has progressed to the committee for review.

•Allow sufficient time for review/revisions (3-4 weeks)…not just a day or two.

•StudentIRB turn around time is approximately 3-4 weeks. Additional time will be necessary if revisions are required.

•Do not begin your research without a written approval from the compliance committee chair.

•Any questionnaires or survey results from implementation of research study prior to written committee approval will not be publishable material.

Sample email…

• This is to notify you on behalf of the Protection of Human Subjects Committee (PHSC) that protocol StudentIRB-2013-08-03-8829-apsmit titled Charles Center Summer Research: XXXXXX has been EXEMPTED from formal review because it falls under the following category(ies) defined by DHHS Federal Regulations: 45CFR46.101.b.1, 45CFR46.101.b.2.

Work on this protocol may begin on 2013-09-27 and must be discontinued on 2014-09-27. Should there be any changes to this protocol, please submit these changes to the committee for determination of continuing exemption using the Protocol and Compliance Management application ( https://compliance.wm.edu ).

Please add the following statement to the footer of all consent forms, cover letters, etc.:

THIS PROJECT WAS FOUND TO COMPLY WITH APPROPRIATE ETHICAL STANDARDS AND WAS EXEMPTED FROM THE NEED FOR FORMAL REVIEW BY THE COLLEGE OF WILLIAM AND MARY PROTECTION OF HUMAN SUBJECTS COMMITTEE (Phone 757-221-3966) ON 2013-09-27 AND EXPIRES ON 2014-09-27.

You are required to notify Dr. Monica Griffin, Chair of the StudentIRB, at 757-221-2495 (mdgrif@wm.edu) if any issues arise with participants during this study.

Good luck with your study.

After going to committee…

• The protocol will undergo thorough review.

• If revisions are necessary, you will receive notice via the automated Protocol and Compliance Management system. Please note: both you and the PI (faculty member) will receive copies of all compliance related information .

• Be sure to check your WM email regularly.

• If you are told to revise your protocol, the committee Chair will indicate the nature of the revisions required.

Revisions required?

• After receiving notice of Revisions required, you will need to go in to myWM and “revise” your protocol.

• This entails opening the protocol awaiting revisions in your queue (ruled “Revisions required”)

• Make changes necessary as indicated by Chair.

• Save and submit protocol again…

• Then the process starts all over….

Revisions required email will look like this…

• View Email• From:

compli@wm.edu

• To:apsmit@wm.edu, jsjones@wm.edu, phsc-l@wm.edu,

• Date Sent:2013-09-30 10:59:50

• Subject:Status of protocol PHSC-2013-08--03-8829-apsmit set to revise

• Message:This is to notify you that protocol PHSC-2013-03-03-8829 - apsmit Charles Center Summer Research: XXXXXX requires revisions in order to be approved.

YOU SHOULD NOT BEGIN WORK ON THIS PROTOCOL UNTIL IT HAS BEEN APPROVED.

You will need to access the Protocol and Compliance Management to submit your revisions. If revisions are not received within six months of this date, this protocol will become void.

If you have questions about this action, please contact the Office of Sponsored Programs at (757) 221-3966.

-------------------------COMMENTS-------------------------2013-09-30- 10:59:39 (Griffin, Monica)Dear Prof and students,The Protection of Human Subjects Committee has reviewed your recently submitted proposal entitled “Charles Center Summer Research:XXX...". Accordingly the committee wishes the following changes/amendments to be made before submitting a revised proposal for further review.

You may start your research, upon notice of an “Active” protocol. In the case of Charles Center human subjects, your protocol will be

ruled “Exempt.” All research protocols for Charles Center Student submissions must fall under the

“Exempt” review category.

How can I be sure…• You will receive explicit notice the

protocol has been approved and you may begin your research.

• When in doubt, ask.

** Do not begin your research without a written approval from the appropriate compliance committee . If you conduct research before you receive notice of protocol approval, research results may not be publishable.

• If at any time during this process you need help, remember the resources which are available to you:

• Your Advisor (or Co-PI on protocol).

• The Office of Sponsored Programs compliance liaison:• Cindy Corbett, cacorb@wm.edu

• The Compliance committee webpages have information on regulations, training, and sample documents.