I. Justification and Statement of Policy

Franklin & Marshall College is committed to ensuring that research involving human subjects is consistent with sound ethical principles and that it is in compliance with all applicable federal, state, and local regulations. F&M’s policy and procedures derive from the ethical principles that were first articulated in the Belmont Report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. The procedures for review adhere to the regulations of the Department of Health and Human Services (Title 45 CFR 46), and to the Federal Wide Assurances filed by the College. 

Human Subjects Research in all forms is handled by two main entities on campus: 

• the Institutional Review Board (IRB) charged with reviewing Human Subjects Research proposals before the research begins to assure that the procedures align with ethical principles

• the Office of Institutional Research (IR) responsible for providing reliable, consistent, and comprehensive data and analyses to support the College's strategic initiatives and decision-making.

II. Scope

F&M’s Human Subjects Research Policy applies to any Human Subjects Research activities conducted by F&M students, faculty, or staff for academic or non-academic but College-related purposes. 

III. Definitions

Franklin & Marshall College adheres to the following definitions:

1. 1. Human Subjects Research: Federal guidelines define research as "a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." If a project fits this definition of research and includes live human participants/respondents, it requires IRB review.

   2. Systematic Investigation: A predetermined method for studying a specific topic, answering a specific question, testing a specific hypothesis, or developing theory.  In other words, any scientific or scholarly activity involving qualitative or quantitative data collection and data analysis that sets forth an objective and a set of procedures intended to reach the objective.

   3. Generalizable Knowledge: Any activity where the results of the systematic human subjects investigation is intended to be applicable to a wider audience. Additionally, F&M's IRB requires that researchers submit Human Subjects Research proposals for any Systematic Investigation from which findings may be shared beyond the College. This sharing of information may take the form of a presentation/talk, publication (book/research article), internet posting, or any other display made available to individuals outside of the College community.

   4. Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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. Additionally, a study is of more than Minimal Risk if, in the event of a confidentiality breach, the results could harm or significantly impact the everyday functioning, reputation, criminal record, financial standing, insurability, college standing, or future career trajectory of any participants in the study.

   5. Survey: Any organized attempt to gather information (views, beliefs, or experiences) from individuals to inform research, assessment, reporting, or decision-making. A Survey may be quantitative or qualitative in nature and may be conducted via paper, electronic, or in-person interview format. 

 IV. Policy

All research involving human subjects, whether federally funded or not, must be reviewed by the Institutional Review Board. Research involving Survey methodology within the F&M community may also need to be reviewed by the Office of Institutional Research.

1. 1. F&M Institutional Review Board (IRB): The function of the IRB is to protect the safety, welfare, rights, and privacy of all participants in Human Subjects Research that occurs under the guidance of F&M faculty, staff, and students. The IRB is charged with reviewing Human Subjects Research proposals before the research begins. For specific information on the IRB application process and procedures, please refer to the IRB website (F&M login required) or contact the IRB at irb@fandm.edu.
      
      To determine if IRB submission is required, answer the following questions and/or refer to the decision tree on the IRB website:

      1. 1. Does the project meet the definition of a Systematic Investigation with human participants as outlined above?
                     If yes, then continue to the following questions.
                     If no, then no IRB review is needed.

         2. Does the project result in the creation of Generalizable Knowledge as outlined above? 
                     If yes, then IRB submission is required. 
                     If no, then continue to the following question.

         3. Is there any possibility of you sharing the findings from this project outside the F&M community in any way (conference, website, journal article, etc.)?
                     If yes, then IRB submission is required. 
                     If no, then continue to the following question.

         4. Do you plan on using any external participants (individuals outside of the F&M community)? 
                     If yes, then IRB submission is required.
                     If no, then continue to the following question.

         5. Does the project pose more than Minimal Risk to the research participants (as defined by the F&M IRB)? 
                     If yes, then IRB submission is required.
                     If no, then IRB submission is not required. 

      2. In cases where IRB submission is not required, individuals are still expected to adhere to their discipline’s best practices for conducting research in a manner that aligns with ethical principles. This might include procedures akin to informed consent, data confidentiality processes, etc.  

   2. F&M Office of Institutional Research (IR):  The Office of IR is charged with providing reliable, consistent, and comprehensive data and analyses to support the College's strategic initiatives and decision-making. As such, one function of IR is to ensure that all institutional Survey efforts aimed at compiling data from/about the College community are coordinated, purposeful, and meet Survey data collection best practices. For questions, contact institutional-research@fandm.edu.

      To determine if IR submission is required:
      
      Is the primary purpose of your Survey academic research?

               If yes and you plan to survey within the F&M community, you may survey up to 200 individuals (students, faculty, or professional staff). IR submission is not required. If you require a random sample of up to 200 community members' email addresses/ contact information, you will need to request a random sample from IR.
               If yes and you plan to survey only outside the F&M community, IR submission is not required.
               If no, continue to the following question.

      Is the primary purpose of your Survey to inform institutional decision-making or assessment? 

               If yes and you plan to survey a large population of F&M community members (more than 200 individuals), IR submission is required.
               If yes and you will be surveying no more than 200 individuals. IR submission is not required. If you require a random sample of up to 200 community members' email addresses/contact information, you will need to request a random sample from IR.
               If no, continue to the following statement.

      If the primary purpose of your Survey is something other than academic research, institutional decision-making, or assessment, please contact IR for further guidance.

      In cases where IR submission is not required, individuals are still expected to adhere to best practices in data collection, analysis, and use. This includes determining whether data exist elsewhere before making additional requests for data, working to collaborate with other individuals/groups on campus when possible, sharing results with internal constituents as appropriate, etc. 

      In order for Survey data to be considered as part of any College decision-making process, data provided must be from Surveys that adhere to the requirements outlined in this policy.  Data presented from Surveys that do not adhere to this policy’s requirements will be subject to review by IR before determining their impact in the context of institutional decision-making. Any member of the F&M community may at any time request information on whether a Survey has been reviewed/approved by IR.

   3. Exceptions
      Activities not requiring review according to the federal government 45 CFR 4.102 definitions

      • Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

      • Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in disease). Note that this does not apply to all Surveys that involve public health-related questions.

      • Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

      • Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

      
      In addition to the above federal suggestions, the F&M IRB notes that certain activities such as program evaluation and quality assurance checks may not require IRB review as they are often (though not always) not systematic or generalizable in a way that deems them Human Subjects Research. Please contact the IRB for  guidelines on the difference between these activities and Human Subjects Research. Decisions concerning what is or is not Human Subjects Research should be made in concert with the IRB.

      Activities deemed “not a Survey” according to F&M: 

      Administrative requests:

      • Forms collecting data solely to inform scheduling or day-to-day operations.

      • Forms collecting data solely to gather registration or nomination information.

      • Forms collecting data solely to facilitate the work of an institutional shared governance committee.

      • Faculty teaching evaluations.

      Casual questions:

      • Questions posed to a class as part of a faculty member’s instruction of students currently enrolled in their class(es) – e.g., asking students in a class to list their name, major, and class year.

      • Questions posed to a group as a straw poll or other informal collection of opinion purely for use in conversation or other unofficial/casual capacity – e.g., “How many of you had turkey for Thanksgiving?”

   4. Noncompliance

Issues of noncompliance must be reported promptly (within a week) to one or more members of F&M’s IRB or IR Office (as relevant). Should any such concerns occur, members of the IRB and/or IR Office will recommend an appropriate intervention and dialogue with the responsible researcher(s) regarding a solution so as to ensure that this policy is followed.

V. Related Documents and Forms

Institutional Review Board Website
Institutional Research Website
IRB and IR Approval Decision Trees

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Policy Maintained by: The Office of the Provost
Original Effective Date: November 11, 2005
Last Revised: May 5, 2025