Institutional Review Board

All faculty, staff, or students conducting human research, training, or related studies at Maria college must follow federal, state, and institutional laws, guidelines, and procedures.

Federal and State Regulations and Guidance

• Belmont Report
• Federal Regulations (Code of) 45 CFR 46, Title 45, Part 46
• Revised Common Rule
• Revised Common Rule Q& A
• OHRP Decision Flow Charts 
• New York State Department of Health Research Participant Information

Institutional Policies and Procedures

• Maria College Consent Guidelines
• Maria College Handbook
• Conflict of Interest statement for IRB

Conflicts of Interest

The IRB Committee shall have no member participate in the IRB’s initial or continuing review of any study in which the member has a conflicting interest, except to provide information requested by the IRB.  

Any IRB member must disclose conflicting interest in a proposal. This member cannot serve as a reviewer of the proposal and must leave the room during discussion and voting, except if the IRB member is providing information at the IRB’s request.  

A conflict of interest exists if any of the following occur:  

• IRB member is listed as an investigator or is a member of the research team;  
• IRB member is a professional supervisor of an investigator;  
• IRB member is a family member or has a close personal relationship with an investigator;  
• Any other reason for which the IRB member believes he or she has a conflicting interest in the research proposal.  

If an IRB member becomes aware of a conflict of interest, the member will immediately identify the conflict to the committee. The minutes of any meeting in which conflicting interests are discussed and/or voted on will document the recusal of the IRB member.  

If the chair cannot serve as reviewer due to a conflict, another committee member will serve as chair for all duties involving the disclosed conflict of interest.

For the IRB to have adequate information on which to base its review of the proposed research, investigators must submit the Maria College IRB application, which requires the specification of the following:

• The purpose and significance of the study, including a statement of hypotheses to be tested, along with an indication of the theoretical, biomedical, and/or social significance of potential findings.
• A description of the population of human subjects that will be used, and a description of the procedures that will be used for recruiting subjects, for obtaining informed consent (a copy of the proposed informed consent form must be attached), for assuring the confidentiality of subjects’ data, and for debriefing them upon conclusion of the study.
• A description of the materials to which subjects will be exposed during the course of the study, procedures for conducting the study, and a description of the independent and dependent variables being used.
• Assurance that the Principal Investigator will take all necessary steps to protect the safety and security of data collected, along with a description of those steps.

The principal investigator who plans to conduct studies or activities involving human subjects should be aware of the following process:

Step 1 – Electronically Submit Application

• Complete acceptable IRB training and submit verification of certification with your IRB application.
• Complete the Maria College IRB application, available here (LINK), a minimum of three weeks before the anticipated start of research.
• Submit the completed form to the IRB

Step 2 – Review of Application by Chair

• The Chair reviews all applications upon submission makes an institutional determination within two weeks of receipt, whether the research protocols qualify for:

1. 1. 1. exemption from review;
      2. expedited review; or
      3. full IRB review.

• If exempt, the Chair will work with at least one other committee member to evaluate the proposal and confirm that determination. If the determination is disputed, the proposal is presented to the full committee.
• The researcher may be asked to make revisions in the protocol to make it acceptable.
• If an exempt or expedited status is determined, the full IRB committee will be notified of this result.
• At this point, the principal investigator for approved exempt and expedited applications will receive a letter from the IRB chair verifying this status and granting approval for beginning the research study.

Step 3 – IRB Review

• If the chair determines full IRB review is required, the IRB will meet and review the protocol within two weeks of submission OR at the next scheduled IRB meeting.
• Approval requires a majority of those present at the meeting.
• The IRB makes decisions based on the following requirements:

1. 1. 1. Risks to subjects are minimized;
      2. Risks to subjects are reasonable in relation to anticipated benefits and knowledge that may be expected to result;
      3. Recruitment of subjects is equitable and free of coercion;
      4. Informed consent will be obtained from each subject or his/her representative;
      5. Informed consent will be appropriately documented.
      6. Collected data will be monitored to ensure the safety of subjects; and
      7. Privacy of subjects and confidentiality of data are maintained.

• The full IRB may act on a protocol in one of four ways:

1. 1. 1. The protocol may be approved.
      2. The protocol may be approved pending modifications (the modified protocol may or may not need to be re-reviewed by the full IRB);
      3. The protocol may be deferred, needing substantial revisions or clarifications (such protocols always need to be re-reviewed by the full IRB);
      4. The protocol may be disapproved (in this case, the study may be re-written to address all concerns, and re-submitted for full IRB review).

• The principal investigator will receive a letter from the IRB chair granting approval for beginning the research process.

Amending an approved study

Researchers may not implement any changes to an already approved study without prior approval from the IRB. For studies that have been approved as exempt, this amendment procedure is only necessary for changes that would impact or alter the initial determination of it’s exempt status. For expediated or full board review studies an amendment must be approved for any changes to study team members, protocol, procedures, or documentations. (including informed consent, recruitment materials, or measurement instruments).

The exact process of the amendment procedure depends on the nature and quantity of the changes to the study. Major changes, especially those that change the risk or harm to the study subjects, would likely require a full board approval. Minor changes, such as addition or removal of a team member, changes in procedures that will not impact the risk to the subjects, or additional recruitment, will likely follow an exempt or expediated approval process.

1. What types of studies must be reviewed by the IRB?

The human subjects review process applies to all research involving the use of human subjects.  This applies to research that is funded or unfunded; research that is undertaken by faculty, staff, or students at Maria College; research done on the property of or using the facilities of Maria College, and/or research using Maria college personnel or students as subjects.

2. What types of course activities do not require IRB approval, and can I make that decision?

Course activities that use human subjects (including individuals outside the classroom setting) are exempt from review as long as the purpose is purely pedagogical and the results are intended solely for use within the university community.  If the results have the potential for public dissemination, IRB approval must be obtained.  Anonymous classroom assessment techniques of students for the purpose of improving classroom instruction would be considered exempt from IRB review.  If the activities clearly fall within these criteria, then the instructor/investigator could make this determination.  If the instructor/investigator is not clear on the status of the study or would prefer that the IRB decide such status of the study, the instructor/investigator can submit the proposal to the IRB for review.

3. Do students undertaking a study as part of a class assignment require IRB approval?

Certain types of survey research, conducted as a portion of a specific course, do not require IRB approval.  This includes research where the responses of subjects are not identifiable by name or description, and where the survey is seeking opinions about various topics.  In cases where the subject is not asked to reveal personal experiences or behaviors, IRB approval is not necessary. 

When survey research is conducted as a portion of a class where a subject is asked to disclose identifying information, IRB approval is required.  Further, survey research that seeks to identify subjects only within a specialized population or investigates a variety of sensitive requires approval.  

For all student research conducted as a part of a course, the protocol must be reviewed and approved by the course instructor, department chair/head, and college dean or representative. 

All other research conducted with human subjects as part of a course will require normal IRB approval. 

4. My study involves a community partner. Do I need Maria College IRB approval?

Partnering with a community member in no way alters the Maria College employee’s responsibility to participate in the IRB review process. All policies regarding the review and safeguards for research subjects must be maintained in accordance with standard policy. 

In some cases, a community partner may have their own institutional review board.  In these cases, the community partner may require adherence to policies that are more protective of a subject’s rights than Maria College policy, and Maria College employees and students would be expected to comply with those policies.  If an outside review board sets a policy that is less stringent than Maria College’s policy, all employees will be required to adhere to the policy of Maria College. 

5. Does exempt mean that I do not need IRB review?

No, an exempt study is not required to meet certain federal regulations, as it has been determined to have no more than minimal risk for the subjects and fits into specific federal categories.

6. Who determines that a study is exempt?

Final determination as to whether a research study is exempt from IRB review is made during the IRB review process following initial submission.

7. What happens if my IRB application is not approved or given back to me with required revisions?

When the IRB review process is complete, you will receive written notification that your proposal has been approved, approved contingent on modifications, or denied.  If approved, contingent upon modifications, you are not authorized to start your study, but you may resubmit a revised proposal that incorporates the required revisions. If your proposal is denied, you may also resubmit a revised proposal.

8. What happens if I do not agree with the committee?

You may reapply with recommended changes. 

9. I have a sponsored study for an outside organization that must be done within a tight time constraint. Do I need approval, and if so, how long will it take?  Will the review force me to reject the funding?

Sponsored studies are treated as any other research studies.  How long it takes depends on which level of review is required.    The normal review process on a complete application may take three to six weeks; modifications to the application will extend this process.  Please contact an IRB representative at Maria College for more information.

Unless your proposal/application is approved, funding may have to be rejected. 

10. I submitted a protocol for review because it was part of an externally sponsored study. The external sponsor did not fund my study.  What do I do? 

If you decide not to conduct the research, you should inform the IRB in writing, and the IRB file will be closed. 

Many agencies provide investigators with feedback about grant applications that are not funded.  If you incorporate any of the suggested modifications into your research protocol, it will be necessary to obtain IRB approval on the new research protocol.  Reapproval would be necessary with any change in the subject-informed consent form. 

11. I intend to use some standardized intelligence test (attitudinal or aptitude tests) in class for research purposes; do I need approval?

A protocol would need to be submitted to the IRB.

12. My potential subjects do not speak English in the home; how do I ensure they understand informed consent?

To obtain Informed Consent from a non-English speaker to participate in research, the subject should be asked in his or her own language for consent/assent to participate.  The Informed Consent form should be written in the subject’s home language, OR you may receive consent from a guardian who speaks the subject’s language and understands the subject’s linguistic culture.  This is needed for any non-English speaker because the subject is not capable of giving fully informed consent.  Assent of a non-English speaker who is a minor may be obtained verbally; however, if assent of the subject is to be obtained verbally, the submission should include a description of how the investigator will ask for assent from the minor subject.