Human Research Protection Program

HITECH Act

Getting Started

 

Jean Larson, Education Manager, HRPP

"Getting Started as a Principal Investigator" (Click Image for Video)

 

If you are doing research that involves human subjects you will need to obtain IRB approval or an IRB determination of exemption prior to beginning the project.

Is your project research and does it include human subjects?

Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (45CFR46.102(d)).

A human subject is defined as a “living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) obtains identifiable private information” (45CFR46.102(f)).

For a project to require IRB review and approval, or IRB determination of exemption, the project must qualify as “research” and involve “human subjects” as defined above. For additional guidance as to whether or not you are doing research involving human subjects, see IRB policies:

100: IRB Review of Research Protocol

100 GD1: Humanities Projects and IRB Review

100 GD5: Quality Assurance/Quality Improvement Guidance

For additional information, view the OHRP decision tree, Chart I. Also, the reference staff of the Harvey Cushing / John Hay Whitney Medical Library can provide expert advice in literature searching as you develop a protocol. Please consult the Medical Library Liaison Program Web page to identify the librarian assigned to your department. Occasionally, the HIC reviewing your protocol will suggest a consultation with the Medical Library to gather additional information to support your proposal. The Medical Library reference staff can also teach time-saving techniques to monitor emerging literature related to proposed and approved protocols.

Have you completed the required training?

You and every person listed on your protocol who will be interacting with research participants or their identifiable data or samples must complete the human subjects protection training before IRB approval can be given. HIPAA training is also required for studies involving personnel or facilities of YSM, YSN, the Psychology clinics, Yale Health Services, or agencies or institutions external to Yale that are subject to the HIPAA Privacy Rule. Yale Human Subject Protection and HIPAA Privacy training are available at the Training and Certification website.

Do you meet the Yale faculty handbook requirements to be a Principal Investigator?

The University sets out guidelines for who may act as Principal Investigator for research studies. See IRB policy 100, IRB Review of Research Protocols, Section 100.3. If you do not meet the requirements and would like to serve as a Principal Investigator then you must complete the Request for Permission to Serve as Principal Investigator form. Upload the completed document with your submission to the IRB. If you are a student, fellow or post-doc, this form is not applicable. Instead, you must have a faculty sponsor sign your protocol application.

Do you or any members of the research team have any financial or non-financial relationships with the proposed research that may pose a conflict of interest?

External financial or non financial interests related to the research that are held by Principal Investigators, co-investigators, persons obtaining consent or members of their immediate family have or may the potential to affect the protection of individuals volunteering for the research. Such interests must be disclosed to the Principal Investigator and the IRB and may need to be managed, minimized or reduced. For more information about research team members who need to disclose and the types of interests that must be disclosed see the Disclosures and Management of Personal Interests In Human Research policy.

Selecting the right application

You’ll need to determine what kind of protocol application fits your study. Please visit our Forms page.

A. Is my protocol exempt?

Research may qualify for exemption when the only involvement of human subjects in the research falls into certain categories. See Guidance 100 GD9: Exemption from Committee Review. If your study meets the criteria you may submit a Request for Exemption from Committee Review form.

B. Does my protocol qualify as non-human subjects research?

Research projects may be classified as “not involving human subjects” if they involve obtaining, collecting and/or using coded, non-identifiable, or anonymous private information or human biologic specimens or if they do not collect information about an identified living individual. Research projects may be classified as not constituting research if the study isn’t designed to develop generalizable knowledge (see IRB policies: 100: IRB Review of Research Protocols, 100GD1: Humanities Projects and IRB Review and 100 GD5: Quality Assurance & Improvement Guidance). If your study meets the criteria of Non-Human Research and you would like an IRB concurrence of this determination, submit the Not Human Subjects Research Form.

C. What if my research project is limited to the review of medical records?

If your study solely involves the review of medical records, submit the Medical Record Review form.

D. What if my study is human research and doesn’t fall into any of these categories?

If your study does not meet the criteria above, it requires that the full IRB application be completed. Here are the steps to follow:

  1. You will need to read the instructions for and complete the IRB Protocol Application form. For electronic submissions see the COEUS online IRB Submissions at Yale website. For paper submissions (available through July 2010) view the Biomedical instuctions on our Biomedical Forms & Templates page, and view the Arts and Sciences instructions at the Social, Bahvioral, & Educational For,s & Templates page. If you will be using electronic submission, review the information on training and authorization for electronic submission at the COEUS website.
  2. After submission, an IRB staff member may contact you to clarify the information in your protocol application.
  3. Depending on the risks to research participants and the interventions of the study, your protocol will either be scheduled for review at one of the meetings of the fully convened IRBs or reviewed by IRB reviewers designated by the Chair to perform expedited review. Generally protocols that are reviewed by the full committee are scheduled for the next meeting of the IRB, provided that the application is received at least nine days prior to the meeting date. View the IRB meeting schedule. For HSC IRB submission information, contact human.subjects@yale.edu.
  4. Protocols that do not require full committee review are generally processed within three to four weeks of receipt by the IRB.
  5. After review, you’ll be notified of approval or any revisions that are required for approval. You’ll also be notified of the IRB contact person for your protocol.

Protocol Preparation Steps:

Step

Action

1.

Review the IRB protocol application instructions and forms prior to developing the protocol. Utilize the prompts provided within the application form template to assist in the protocol development.

2.

Complete the IRB protocol application form, the informed consent or compound authorization form(s) and other related documents needed to support the protocol.

3.

Ensure that research personnel have completed the required training.

4.

Determine whether or not research team members have a real or potential protocol-related COI and modify the study design or documents to reduce, eliminate or manage the interest. Ensure that research team members have submitted or updated their COI forms, if applicable.

5.

If using a paper submission, obtain requisite departmental and research team member sign-off and submit the protocol application and support documents to the required pre-IRB review committees. (Note: Electronic submissions will automatically obtain the appropriate signatures and approvals.)

6.

When the application and all pre-reviews are complete, submit the paper submission to the IRB. (Electronic submissions are sent automatically once all requisite pre-reviews are complete.) IRB staff may contact you with questions, revisions or clarifications prior to formal IRB review.

7.

Once the formal IRB review is complete, you will receive either notification of approval or a request for revisions that must be re-submitted to the IRB before approval is granted by the IRB.

8.

Submit the revisions requested by the IRB to the coordinator identified in the request. Revisions should be submitted within 60 days of the IRB request for revisions.

Studies may not start until the approval process (which may include revisions), is complete, so always allow adequate time for review of your protocol.

Where Should I Submit My Application?

Social and behavioral questions should be directed to the Human Subjects Committee: human.subjects@yale.edu; biomedical questions should be directed to the Human Investigation Committee:hrpp@yale.edu.

How Long Does This Process Take?

It’s difficult to predict a general length of time for protocol development and approval. Protocol development time is unique to each study and varies depending on the complexity of the research and the number of pre-reviews that must be obtained, e.g., YCCI, MRRC, etc. Once a protocol is received by the IRB, you should allow at least four weeks for IRB review, and a maximum of another 60 days for you to submit back to the IRB any requested changes that are needed to receive protocol approval.

What if I’m working with sites other than Yale?

A) Working with the VA

Yale University and the West Haven VA (WHVA) work closely together and Yale researchers frequently conduct studies at the WHVA.

As separate institutions, Yale and the WHVA each maintain an IRB. If you are conducting research at the WHVA, approval of their IRB must be granted as well as approval of the HIC.

What if I am conducting research at Yale AND at the West Haven VA?

You must complete BOTH Yale and VA forms and all attachments for new applications, renewals and amendments. No research can begin, continue or change until approval of both IRBs has been given.

What if I am conducting research ONLY at the VA?

For new applications, complete the VA forms and all attachments. When VA approval has been given, submit the VA forms and a copy of the VA approval letter to the appropriate Yale IRB. No Yale forms are required. For renewals, submit the Yale request, along with the VA approval letter, the current VA IRB approved consent form, and the VA Conflict of Interest Disclosure, if applicable. For amendments of VA only protocols the Yale request must be submitted, along with a copy of the VA approval and any relevant supporting documents.

No research can begin, continue or change until approval of both IRBs has been given.

How Do I contact the IRB?

  • Contact the VA IRB: call (203) 937-3830
  • contact the HIC: email ysmhic@yale.edu or call (203) 785-4688

B) Working with Researchers from Other Universities/Institution

What if I plan to include colleagues from other universities or institutions in my research?

Approval by the collaborating researcher’s institutional IRB may be required. Generally documentation of IRB approval must be provided when employees or agents of that university or institution, as part of the research, obtain (1) data about the research subjects through intervention or interaction with them or (2) identifiable private information about the subjects. Such documentation must be received by the IRB prior to such colleagues taking part in the research.

What documentation is required?

Researchers from other institutions must submit a copy of their institution’s IRB approval or other determination to the Yale principal investigator, who is responsible for ensuring that it is submitted to the Yale IRB.

What if the institution doesn’t have an IRB?

Other agreements are necessary. Some institutions have filed Assurances with federal authorities permitting them to designate one or more of the Yale IRBs as their “IRB of record”. This means that the Yale IRB review, conducted on behalf of the Yale investigator, will also satisfy the IRB approval required of researchers from these external institutions. For more information contact the Yale IRB office at hrpp@yale.edu.

When Yale investigators collaborate with colleagues from an external institution without a local IRB or an agreement with Yale, it may be necessary for that institution/organization to file as Assurance with federal authorities and designate an IRB to review and approve the research. Typically, an institution that is routinely involved in the conduct of human research would be required to do so. Other arrangements may be made if the institution does not plan to regularly take part in human research (see question below). See Research Affiliates, or contact the IRB office for more information. The review of the research by an IRB representing the external institution/organization must take place prior to such representatives participating in the research.

What if my research colleague and/or other institution does not plan to regularly take part in human research?

The research colleague who plans to work on the research project with a full time Yale faculty member can apply for Collaborating Investigator status to satisfy the IRB approval requirement. See the Request for Permission to Serve as a Collaborating Investigator Form.

C) What If My Research Takes Place in a Community Agency?

Research conducted within a community agency requires a letter of support from the agency. The letter must indicate that permission is granted to the investigator to conduct the research at the site and/or with their clients. This letter must be submitted to the IRB before the research can begin.

The agency may also require that other conditions be met before the research can begin. These conditions should be considered when planning the research, as time is required to obtain the necessary permissions.

What If I’ll Be Using Community Agency Staff in My Research Project?

If you plan to engage the community agency in your research by having its staff, as part of the research, obtain (1) data about the research participants through intervention or interaction with them or (2) identifiable private information about the research subjects, arrangements must be made in one of the following ways:

  • If the community agency has its own IRB, or is affiliated with an IRB, that IRB must review the research for the agency’s participation. A copy of the IRB approval must be provided to the Yale IRB. Alternatively, the agency’s IRB may request that a Yale IRB review the research on its behalf.
  • If the community agency plans to routinely engage in other research and does not have an IRB, it may be necessary for that institution/organization to designate an IRB (or a Yale IRB) to review its research. This may require the agency to file a formal agreement with a federal agency and the organization funding the IRB. If the collaborating institution/organization wishes to designate a Yale IRB and become a Research Affiliate, they should review the Research Affiliates section of this website. The review of the research by an IRB representing the external institution/organization must take place prior to the institutional/organizational representatives taking part in the research.
  • If the community agency a) does not plan to regularly take part in other research projects and b) is only interested in taking part in the research being proposed by a Yale faculty member, the agency staff working on the research can enter into an agreement with Yale whereby the Yale IRB review covers their participation. This agreement is known as a Collaborating Institutional Investigator Agreement. For instructions and to request forms please see Research Affiliates page.
 

What if I'm conducting human research abroad?

All human research conducted outside the United States must receive approval from the Yale Institutional Review Board (IRB) and the IRB used by the international site (or justification for why the international IRB approval cannot be obtained) before researchers initiate work under the protocol. Researchers should anticipate the time that obtaining local review and approval will require. This varies from country to country, and can take several months. To ensure review and approval by Yale IRBs, protocols should be submitted two months prior to leaving the country. The Yale IRB is responsible for ensuring that human research conducted outside the United States conforms to the same ethical and regulatory standards to which research conducted in the United States is held. International human research must be conducted in accordance with applicable Yale policies for the conduct and review of human research, including informed consent and use of vulnerable populations.

Human research conducted outside the United States must comply with the relevant laws of the host country. If an international institution or site is considered engaged in research, and if the research is supported by federal funding, special requirements must be met. See IRB Policy 450: International Research, and Guidance 450 GD1: International Research: Required Documents and Additional Considerations. You may also contact the Yale IRB that will be reviewing your protocol for assistance. Social and behavioral questions should be directed to the Human Subjects Committee: human.subjects@yale.edu; biomedical questions should be directed to the Human Investigation Committee: hrpp@yale.edu.

What if my Research is Supported by the Department of Defense?

If you are conducting a study with any of the Department of Defense branches—Army, Navy, Air Force, Marine Corps or Coast Guard—additional requirements apply.

See Yale IRB Procedure 100 PR.4 Department of Defense Supported Research (http://www.yale.edu/hrpp/policies/index.html) and the Application Supplement: Department of Defense (DoD) Supported Protocols FR 16 (http://www.yale.edu/hrpp/forms-templates/index.html) for information on DoD and Yale requirements.

Are There Special Requirements for Research Supported by the Department of Justice (DOJ)?

Additional requirements for protocols involving research supported by the DOJ, including the Bureau of Prisons are described IRB Policy 320 IRB Review and Approval of the Participation of Prisoners in Research. 

In addition, note the following:

For DOJ research a copy of all data must be de-identified and sent to the National Archive of Criminal Justice Data, including copies of the informed consent document, data collection instruments, surveys, or other relevant research materials.

For research conducted with the Bureau of Prisons:

  • At least once a year, the researcher shall provide the chief, Office of Research and Evaluation, with a report on the progress of the research.
  • At least 12 working days before any report of findings is to be released, the researcher shall distribute one copy of the report to each of the following: the chairperson of the Bureau Research Review Board, the regional director, and the warden of each institution that provided data or assistance. The researcher shall include an abstract in the report of findings.
  • In any publication of results, the researcher shall acknowledge the Bureau's participation in the research project.
  • The researcher shall expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the Bureau.
  • Prior to submitting for publication the results of a research project conducted under this subpart, the researcher shall provide two copies of the material, for informational purposes only, to the Chief, Office of Research and Evaluation, Central Office, Bureau of Prisons.

What Additional Requirements are Applicable to Research Supported by the U.S. Department of Energy (DOE)?

The DOE has additional requirements related to maintaining confidentiality of personally identifiable information as described in IRB Policy 400:  Privacy and Confidentiality of Human Research Information, including a requirement to immediately report (e.g. upon discovery) to the DOE Program Manager any compromise of personally identifiable information. 

DOE also has stringent reporting requirements including the requirement to report to the DOE within 30 days:

  • Any significant adverse events, unanticipated risks, and complaints about the research, with a description of any corrective actions taken.
  • Any suspension or termination of IRB approved research
  • Any significant non-compliance with HRPP procedures or other requirements

What if I have questions?

For Biomedical Research

Call us at (203) 785-4688. Or email us at hrpp@yale.edu.

For Social Science, Behavioral, or Educational Research

Call us at (203) 436-3650. Or email us at human.subjects@yale.edu.

For Nursing Research

Call us at (203) 737-2420 Or visit us at the Nursing School website.