IRB 101 for Students Kristen Kenny, BFA Research Compliance Specialist, IRB, IACUC and IBC Administrator Office of Research and Sponsored Programs

The IRB at UMB ▸Protects human subjects ▸Does not act as a scientific review committee – unless “the science” of a study creates unnecessary and inappropriate risk or burden to subjects ▸10 regular members, 1 meeting/month

It is the Institutional Review Board’s job to: 1) Determine and certify that all projects reviewed by the IRB conform to the regulations and policies set forth by DHHS regarding health, welfare, safety, rights and privileges of human subjects; 2) assist the investigator in complying with federal and state regulations.

Protection of human subjects in research today 5 Important Issues to Consider:  Consistency throughout the submission  Consent  Understanding the subject population  Understanding the risk/benefit ratio  Compensation of research subjects  Justification of everything being done

Get acquainted with the IRB Website On the IRB website you can find: ▸All forms, including application, protocol format, consent/assent form format, modification/amendment forms, final report forms ▸Review categories from the Department of Health and Human Services (DHHS) ▸UMB Policies

1 st thing to do: Complete the required Humans Subjects Protections training before sending in your submission. · Biomedical Research/Social Behavioral (Human subjects) · Animal Care and Use · Responsible Conduct of Research · Export Control Students: your advisor must do this too! (This training must be renewed every 3 years from the date first completed.)

Is it Research? “Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”

Does the research involve human subjects? Human subject means 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)Identifiable private information.

The Life of an IRB Submission Protocol is submitted to the IRB office Protocols are reviewed on a first come first serve basis The Administrator reviews the submission for completeness and will contact the PI to make changes if necessary. Submission is entered into the database The submission gets sent to the Chair or Vice Chair for review, or put on the agenda for review at the next IRB meeting Once reviewed, submission is returned to Administrator. The comments and final decision are entered into the database and a letter is created and mailed to the PI If approved, approval is for 1 year. Submissions requiring revision must return to the Administrator, and the process starts again

Into which review category does your study fall ? Full Board Review ▸Greater than minimal risk to subjects ▸Depending on the research studies involving children, prisoners and intellectually disabled, pregnant women, students, employees Expedited Review ▸Not involving vulnerable populations, and no more than minimal risk to subjects ▸(7): Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies Exempt  Research involving normal educational practices, some interviews, surveys, or observation of public behavior, collection of existing data, evaluations of public benefit or service programs ▸Does not mean the project is exempt from review – it will just be exempt from further review

Include in your submission to the IRB: ▸The application ▸The protocol (study summary) ▸Recruitment materials ▸Consent documents ▸Other approval/permission letters ▸Measures, surveys, questionnaires

The Application  Principal Investigator (PI) information, completion of training, staff  Purpose of study  Start/end date  Vulnerable populations  Funding  Type of Review  HIPPA and Protected Health Information  Signatures: PI, Faculty Advisor, Department Head/Chair  Submission Checklist

In the PROTOCOL: ▸Describe your study procedures in detail. ▸How many subjects are you recruiting? ▸How are you recruiting them? ▸Where are you recruiting them from? ▸What are the risks? ▸Justify everything your are doing. ▸Ensure consistency throughout the protocol.

For Example… ▸The research question should be clearly stated in the beginning of the protocol. ▸When conducting focus group discussions and distributing questionnaires, ensure the protocol and consent forms both reflect this. ▸Specify when the study will take place and where it will happen. Especially if there are multiple centers. When conducting focus group discussions and distributing questionnaires, ensure the protocol and consent forms both reflect this.

Understanding the subject population ▸Is the population “vulnerable”? ▸Children ▸prisoners ▸mentally disabled persons ▸non-native English speakers ▸homeless ▸students and employees ▸What protections does your population need?

Risk/Benefit Ratio ▸Research with human subjects can involve risk (physical, emotional, social or economic) ▸Risk must be outweighed by, or in proportion to, the benefits ▸Benefits can be to subjects themselves or future populations ▸If risk is significant, protocol must contain adequate justification

Compensation of Research Subjects ▸Must be justified based on the risk level, the study procedure, the population ▸Must inform subjects about compensation in consent form ▸The same information must be included in IRB protocol ▸Cash ▸Lottery tickets ▸Gift cards ▸Small token items such as journals or books ▸Entry into a drawing for a larger “prize” ▸Reimbursement for expenses * Compensation is NOT a benefit!

Consent and Assent ▸The process by which an individual is fully informed about a research study and decides whether to participate or not ▸Only individuals over age 18 provide consent ▸Minors (under 18), among others, provide assent – which is not legally binding

Elements of the Consent Form ▸Should be written in clear, simple language ▸Must describe the study clearly ▸Include the purpose of the research, the procedures involved, how long a subject will be involved ▸Risks or benefits to the subject ▸How information will be kept confidential ▸How subjects can withdraw from the study ▸Include contact information for the PI and the IRB office

Assent ▸A child's affirmative agreement to participate in research. Failure to object should not be construed as assent ▸UMB IRB requires description of assent process for minors or others who cannot consent to research procedures ▸Protocol should discuss what will be done to ensure these subjects understand the study and are comfortable with participating

Waiver of Consent ▸Only if research involves no greater than minimal risk ▸Waiver will not adversely affect rights of research subject ▸Research could not practicably be carried out without waiver ▸Subjects will receive all necessary information about the study ▸Its use must be justified in the protocol

When is verbal consent appropriate? ▸For some very low risk studies ▸When population is not in a position to read and sign a form, i.e. some phone interviews (if study is low risk) ▸When it may be necessary for protection of participants’ identities, i.e. the consent form is the only link between participants and the study, in which case the committee will ask to see a script to evaluate the consent process

Also included in submission: ▸ Surveys ▸ Interview Questions ▸Phone interview text ▸Screening questions ▸Questionnaires

Online Surveys ▸Must identify the online survey service used, e.g. Survey Monkey, Psychedata, Survata, Surveygizmo…. ▸In the protocol explain how the service works, and how data will be kept confidential ▸If names, addresses, or other potentially identifying information are transmitted at any point for any reason, explain how program will keep it separate from data

Online vs. Paper Surveys ▸Participants should be able to skip questions using either method ▸Participants should be able to change their responses using either method ▸No advantage to either – a matter of preference & consideration of type of study

Recruitment Tools ▸Flyers, brochures, information sheets, letters, newspaper ads, online media, blast, must be reviewed, and approved before being used ▸Must say participation is voluntary ▸All recruitment materials must say that the project is for research purposes ▸Must say that research is conducted through UMB and must include your contact information

After Receiving IRB Approval… ▸You will receive an approval letter in the mail, with consent/assents and recruitment materials that have received the IRB approval stamp. ▸IRB approval valid for maximum one year ▸Must submit continuing review report at least on annual basis ▸Make no changes/modifications without submitting them to IRB first

Continuing Review ▸Unless your study has been approved as EXEMPT, all research must be reviewed on an annual basis. ▸Reminders go out from the IRB office 90, 60 and 30 days before your study expires. ▸Studies that went to the full board will return there for their annual review; studies that were expedited will be expedited for their annual review. Compliance is Key

Modifications  Submit formal modification form with justification for the change  Do not wait for annual review to report a change ▸Exempt Review ▸Depending on the modification the study’s review category may change if the risk to the subjects increases ▸Expedited Review ▸For studies reviewed via expedited review, when changes do not increase risk to participants ▸If previously a full review study, and changes are “minor” ▸Full Review ▸For studies reviewed via full review, when changes are substantial

Remember! ▸ Keep your files together. From the original submission, continuing reviews to amendments and final report. ▸Only assent/consent forms and recruitment materials with the IRB approval stamp may be copied and distributed.

Final Report ▸When your research is done a Final Report must be submitted to the IRB office with a study summary. ▸Your study will then be closed out in the IRB database. ▸Without this Final Report, your study will expire and be out of compliance.

Contact Information ▸Office of Research and Sponsored Programs, Quinn Admin. Bldg., 2 nd Floor or (617) ▸IRB and all documents on the web: s/research_compliance/institutional_review_boar d_irb