Skip to main content

Search
Institutional Review Board

Frequently Asked Questions About Research at Seattle Children's

|

This FAQ is applicable until August 31, 2010. Please see the new FAQ (DOC) for the new processes and forms that go into effect September 1.

Is my project research?

Research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge.

In the clinical setting, it is important to make a distinction between research and practice. They are frequently carried out together. This is the case when a clinical research activity evaluates the safety and efficacy of a treatment.

Practice includes interventions that can reasonably be expected to enhance the well-being of a person through diagnosis or treatment. In contrast, research involves testing a hypothesis and drawing conclusions. Usually the research activity is described in a formal plan (protocol) that identifies the objectives and procedures to reach the objectives.

In addition to clinical research, other types of research are also conducted at Children's. One is survey research, which involves interacting with individuals to gather information using questionnaires or interviews.

Another involves the collection of data from identifiable private information sources, e.g., medical records, so that analysis of the data will yield conclusions. Yet another involves bench or laboratory research, e.g., the use of surgical and laboratory specimens that would otherwise be discarded.

Your project is most likely research if it contains any of the elements described above.

back to top

Does my research require IRB approval?

All research projects involving human subjects require IRB review and approval.

A human subject is any individual, living or deceased, about whom the investigator collects data through direct intervention or interaction, or from sources such as medical records, clinical databases, billing records and pathologic or diagnostic tissue specimens. Data from these sources is called identifiable private information.

At Children's, human subjects are patients, families or other individuals, e.g., the patient's classmates, who are asked to participate in a project. Staff members may also be subjects. 

back to top

Do case reports require IRB approval?

The IRB is responsible for the review of research. Research is defined as a “systematic investigation…designed to develop or contribute to generalizable knowledge.” Most case reports do not meet this definition of research because there is no systematic investigation, i.e., no data analysis.

Therefore, most case reports do not require IRB review. However, it is important for investigators to recognize that the federal privacy rule HIPAA applies to case reports. Therefore, authors of case reports must be sure that all information conveyed in the report has been de-identified as required by HIPAA's privacy regulations. 

back to top

What is the IRB's authority?

The IRB has the authority under federal regulation and institutional policy to approve, require the modification of or disapprove research activities being conducted at Seattle Children's, being conducted with Children's patients or being done with funds awarded to Children's.

It also has the authority to suspend or terminate research that was previously approved in which unforeseen harm to subjects occurs, or that is not being conducted as approved by the IRB. 

back to top

How long does IRB review take?

We recommend that you allow 60 days for review.

A well-prepared application will hasten the process. Many projects can be approved in less than 60 days if the application is complete and comprehensive.

back to top

What can I do to help the IRB process move quickly?

Researchers can help move the IRB process quickly by preparing applications that are complete. There is a checklist at the back of the IRB-SAC application form that details the submission standards for new studies.

Use the checklist to ensure that the application you submit to the IRB is complete. As shown in the checklist, the IRB requests that consent forms be written at 8th grade reading level or lower and use Children's consent form template.

Assent forms (for 7 to 13 year olds) should be written at a second-to-third-grade reading level and use Children's assent form template.

When your application is complete, send one electronic copy of the application with all attachments and the completed checklist to the IRB office.

When a new study is submitted it will be screened for completeness. If complete, the PI will be notified the application is complete and pre-review will begin. If the application is not complete, the PI will be notified of what items are needed to complete the application.

The PI has two weeks to provide the remaining items to the IRB office. After two weeks, if the items are not submitted, the application will be returned. It can be submitted once the items are available.

All new IRB applications receive a preliminary review (pre-review) by IRB staff before the application is sent for IRB review.

Pre-review is done to facilitate the review of new IRB applications. It helps the researcher provide the information the IRB needs to make a determination about the new research project.

The IRB staff will send the principal investigator pre-review comments. All efforts are made to send pre-review comments within one week after a complete application is received.

Researchers can help move the IRB process more quickly by addressing items identified in prereview.

It is common that the researcher will make additions or changes to the application or provide additional documentation based on the information they receive during prereview.

The researcher can help move the process by responding quickly to pre-review and submitting the final version of the application. The IRB requests one electronic copy be sent to the IRB.

In addition to IRB pre-review, the Office of Biostatistical Services is available to provide pre-review and consultation regarding study design and methods. To find out more, read the next question. 

back to top

What statistical and data management support is available?

Children’s Core for Biomedical Statistics (CCBS) provides an array of biostatistical and data management support to physicians and researchers at Seattle Children's. Research projects often benefit from expert biostatistical and data management input prior to study initiation regarding: 

  • Study design, including refinement of study hypotheses, selection of outcome measures and evaluation of sample size requirements
  • Protocol development, including development of a data analysis plan
  • Data management planning, including considerations for database selection as well as best practices for database design and data collection 

Through a partnership with the Institute of Translational Health Sciences (ITHS), CCBS is able to offer researchers throughout the region access to a broad network of research expertise. The ITHS covers the cost of up to two hours of biostatistical and data management consultation for ITHS members.

To request a consultation with a CCBS biostatistician or data specialist, please complete a brief online request form. Additional information is available on the CCBS website.

back to top

What happens after I submit my IRB application?

Please refer to the IRB new application process.

back to top

May I recruit participants for my study before IRB approval?

No.

Research subjects are not to be approached until the IRB has given final approval to the application.

back to top

May I advertise to recruit participants for my study?

The IRB must review and approve any materials you plan to use to recruit research participants before you begin contacting individuals.

This includes advertisements that appear in the newspaper or on radio, television or the Internet. Flyers, letters of approach and telephone scripts must also be approved.

Recruiting materials should provide basic information about the study, including the time involved; the primary purpose of the research, e.g., testing an experimental drug; and an overview of procedures and testing.

The materials should also describe potential benefits to participants and compensation when applicable.

For more information about advertising, see Advertising for Research Subjects or IRB Policy 24, Recruiting Potential Research Participants (PDF 271KB). 

back to top

May I pay study participants?

Whether or not individuals and families are paid for participating in research can depend on a number of factors, including availability of funds and the extent of effort on the part of study participants.

The IRB's primary consideration in looking at remuneration plans involves the effect that coercion or undue inducement could have on a prospective participant's ability to make an informed, voluntary choice about taking part in research.

This is especially important when participation may include significant discomfort or the assumption of risk, and when involving children in a study.

In some instances researchers choose to offer non-monetary incentives, like gift certificates for toys or meals at a fast-food restaurant. If expenses for travel, lodging or meals are incurred the IRB recommends that participants be reimbursed for such expenses.

If compensation or the use of incentives is to be part of your study, it is important to include specific information in the IRB application and to provide detailed information about payment, including terms, in the informed consent document.

Procedures for payment or distribution of incentives should be established before the first participant is recruited.

back to top

What if there are changes to my study after I receive IRB approval?

You are required to obtain IRB approval before implementing any changes to an approved study.

The only exception to this requirement is when an immediate change is made to eliminate a risk or hazard to a subject. In such a case the change must be submitted to the IRB as soon as possible for review.

Minor changes to a study not involving greater than minimal risk usually undergo an expedited review by a subcommittee of the IRB. Major changes to a study require full IRB review.

A member of the IRB staff can answer your questions about modifications.You may also view Modifications (PDF) for additional information. 

back to top

What if adverse events occur among participants in my study?

Under federal regulations, the IRB is responsible for receiving and reviewing information about adverse events experienced by research participants. In general, there are two types of adverse events: expected and unexpected.

Unexpected adverse events are those that are not expected to occur, are more serious than anticipated when they do occur or occur more frequently than reasonably anticipated.

Unexpected adverse events must be reported to the IRB by the researcher in a timely manner. Unexpected adverse events that occur in research participants enrolled under Children's IRB approval must be reported on Children's Adverse Event Report Form.

For more information about the specifics of reporting adverse events, please view the Adverse Events Reporting Guidelines (DOC).

Those events that can be expected to occur are reported to the IRB at the time the study is being renewed. Expected adverse events must be described in the consent form that participants read and sign.

If the frequency or the severity of expected events is greater than anticipated, these events should be reported to the IRB as unexpected. 

back to top

How do I renew or close a study?

Federal regulations require that the IRB review all ongoing studies at least yearly.

In some instances, based on factors such as the vulnerability of the participants, the risks of the research or difficulties in implementing the project, the IRB may review a study more frequently.

About 10 weeks before the end of the study approval period, the IRB sends a notice to the investigator asking if the study should be renewed or closed.

If a study is to be renewed, it is important for the researcher to respond in a timely manner so the review can be completed before the expiration date.

The IRB is not allowed to renew studies that have expired. Please view Renewing or Closing a Study (PDF) for more information. 

back to top

What is emergency use?

Emergency use, sometimes called “compassionate use,” is the use of an investigational drug or device for a single subject in a life-threatening situation.

No standard acceptable treatment is available in such an instance, and there is not sufficient time to obtain full IRB approval. Children's policy is that the researcher must call the IRB chair, Dr. Douglas Diekema, to obtain verbal approval prior to use.

Further use of the same drug or device for the same indication requires prospective review by the full IRB. Please refer to Emergency Use of an Investigational New Drug (PDF) for more information.  

back to top

My project uses only medical records to collect data. Will I need IRB approval?

Yes. The use of medical records, clinical databases (paper, electronic or any form) for research purposes requires IRB review.

This is in accordance with the federal regulations for the protection of human research subjects, Washington state law pertaining to health care records and the federal privacy rule known as HIPAA.

Generally, if you will be gathering information from sources that already exist (retrospective review) and need to collect identifiers like patient names and medical record numbers so the data can be linked to individuals, your project qualifies for expedited review.

Please use the IRB Expedited Review Application – For Existing and Confidential Data, Records or Specimens (DOC).

Additional information regarding the use of private or protected health information for research can be found in the Federal Privacy Rule: HIPAA and Research (PDF).  

back to top

What if my research involves other sites besides Children's, many with their own IRB?

If the project includes Children's patients, families or staff as research participants; or involves Children's facilities; or the funding for the research is based at Children's, Children's IRB review is required.

The only exception is for research studies at Children's involving pediatric bone marrow or stem cell transplant patients. For those research studies, the review is done by the IRB at the Fred Hutchinson Cancer Research Center.

Children's and the University of Washington have an agreement whereby if the research involves patients from the University of Washington and Children's, Children's IRB reviews the research.

The University will accept the review of Children's IRB for those projects.For other studies involving sites with their own IRBs, dual IRB review will likely be required.  

back to top

What is a cooperative agreement?

A cooperative agreement is an agreement reached between Children's and another research institution to delineate the responsibilities of each institution with regard to IRB activities.

Children's has entered into cooperative agreements with the University of Washington, Fred Hutchinson Cancer Research Center, Group Health Cooperative and Multicare Health System (Mary Bridge Children's Hospital).

View further information about Children's Cooperative Review Agreements

back to top

What is an FWA?

A Federalwide Assurance (FWA) is an agreement between Children's and the Office for Human Research Protections (OHRP), which acts on behalf of the Secretary of the U.S. Department of Health and Human Services.

The agreement provides written assurance that the hospital will comply with the basic ethical principles and the federal laws and regulations as well as state and local laws regarding the protection of human subjects in research. The hospital's FWA number is FWA00002443.

View Children's FWA

back to top

What is the link between the grant proposal and the IRB application for funded projects?

The funding agency expects the IRB to review and approve the use of human subjects as described in the funding proposal. Before funds are awarded, the agency requires certification of approval from the IRB.

If the funding agency requires IRB approval before the funding proposal will be reviewed by the agency, then an IRB application must be submitted and pending approval in the IRB office before the funding proposal is mailed to the funding agency. 

back to top

What is different about proposals going to the NIH?

The National Institutes of Health (NIH) uses a just-in-time policy. IRB approval is not required before NIH peer review.

Following peer review, if the proposal is likely to be funded based on the score received, the principal investigator needs to proceed with IRB review and approval. No NIH funding award will be made without IRB approval for the human subjects research activities described in the funding proposal.

If you submit a funding proposal to the NIH for research that will be based at Children's and involves human subjects, you will receive a letter from the Office of Research Administration.

It will notify you that, if the score received during peer review indicates it will likely be funded, you will need to proceed with the IRB approval process.The IRB application will be due in the IRB Office no less than 60 days before the NIH requires IRB certification.

There may be circumstances when the NIH requires, or you think it is desirable, to submit an IRB application before NIH peer review takes place.

For example:

  • The research involves multiple sites
  • The research is controversial
  • You anticipate the IRB process will be extensive or lengthy
  • IRB certification is required by the NIH before peer review because of timing or funding considerations

back to top

What is minimal risk?

The federal regulations define minimal risk as follows: The probability and magnitude of harm or discomfort anticipated by participating in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Procedures that may involve a small degree of risk for a healthy child may involve a higher risk to a child with an illness or a condition. For example, obtaining blood samples from a hemophiliac child may involve higher risk than venipuncture involving a child without such a condition.

On the other hand, the risk or fear of an invasive procedure such as blood drawing in a child with a chronic illness may be much less than in a healthy child who has not had much exposure to medical care.

The definition of minimal risk is an important criterion used in approving research with children.

Please see Regulations for Research with Children (PDF) for more information.  

back to top

What is informed consent and when is it needed?

In almost all cases, consent must be obtained from the research participants or their legally authorized representatives (parents or guardians) before participation in research begins.

The informed consent process is a basic ethical obligation for researchers.

It consists of providing adequate information to the subject about the study, giving the subject the opportunity to consider options, responding to questions the subject may have and ensuring that the subject or the legal representative (parent or guardian) understands the information.

In addition, the process includes obtaining the subject's voluntary agreement to participate in the research, indicated by the participant's or their parent's signature on the written consent document. Consent is a process that does not stop after a signature is obtained.

During the conduct of the entire study, researchers want to check with participants and their parents to be sure they understand what will happen during the study and agree to continue in the research.

The IRB may approve a waiver of consent in limited circumstances. Consent may be waived if the IRB determines that:

  • No more than minimal risk to research participants would be involved
  • The rights or welfare of participants would not be adversely affected
  • The research could not be practicably conducted without a waiver

For further information about informed consent, view the Consent Form Preparation (PDF). 

back to top

What is assent and when is it needed?

Because children have not yet attained legal age, the parent or legal guardian is asked to give permission for participation whenever a child is asked to take part in research.

Federal regulations require, however, that children be asked to provide assent, or agreement to participate in the research, whenever they are capable of doing so. Age, maturity and psychological state need to be taken into account when determining whether to ask for assent.

Out of respect for developing persons, it is important to involve children in the decision-making process whenever possible. Though they may not be able to give legal consent, they have the ability to assent or to dissent.

It is important to keep in mind that a child's failure to object to participation should not automatically be construed as assent. Assent implies the affirmative agreement of the child.

Usually children who are age 7 and older are asked to sign an assent form, which is written in language appropriate to the ages and conditions of study participants.

The assent form should include a description of the study and describe the inconveniences and discomforts subjects may experience.

The IRB generally asks for a simple written assent form for children ages 7 to 13, to be written at a second-to-third-grade reading level. For further information, view Assent Form Preparation (PDF).

Generally, adolescents age 14 and older are asked to read and sign the consent form if it is written at a reading level that is appropriate to the adolescent.

In these cases, the parents co-sign the same consent form signed by their adolescent. 

back to top

Looking for a Researcher?

Looking for a researcher?

Name: