91大神

Conducting Research Outside 91大神

The 91大神 IRB permits research studies to include participants from outside 91大神.  For instance, the researchers can study behavioral or educational practices of non-91大神 students, study or survey patients from hospitals, minors attending schools, and etc.  There are several components that determine the level of IRB oversight when enrolling participants from outside 91大神. The 91大神 researchers will have to consider the following criteria or steps (not limited to) before considering to enroll non-91大神 participants.  

General Considerations

Rationale

The plan to recruit non-91大神 participants should include sound scientific logic and the purpose to seek outside volunteers must be clear.  For instance, projects that attempt a comparison of instructional practices between 91大神 and Vanderbilt University courses may require participants being enrolled from both institutions.  Also, studies that evaluate medical practices in hospitals, child development and other types of studies cannot be done with 91大神 population but recruitment of external participants may be essential.  Moreover, researchers often find themselves needing to recruit participants beyond the 91大神 population in a previously reviewed and approved protocol in order to reliably test their hypothesis.  In such circumstances, requesting a new protocol may not be necessary; a simple amendment to an existing protocol by expanding the participant pool would be sufficient, as long as the target population fits the approval criteria.   For instance, a study that focuses on 91大神 LGBT community can be simply expanded to state-wide or beyond by merely requesting an amendment.  However, researchers must be aware that there may be other requirements and restrictions by the external entities where participants are recruited from.  These restrictions or requirements may not imposed by 91大神. 

Participant recruitment strategy

Since the study will be conducted at a non-91大神 site, the investigators must provide a clear strategy for how the subjects will be recruited.  Whether using bulk emails, posting flyers within the site’s premises, advertise in local magazine/journal, use of social media, etc., must be clearly described.  If using bulk emails, the investigators must also explain how they got access to the emails in the first place.  If recruitment will be done face to face, a script to be used must also be presented to the IRB for review. Recruitment of participants at events such as conferences and others must also be explained in detail.

Plan to obtain informed consent

 Irrespective of how the research will be conducted, the administration of informed consent is the most crucial step for any IRB-approved study.  It is unlikely that the 91大神 IRB will approve a consent waiver on studies carried out with participants outside 91大神 unless it is proven by the investigators that the informed consent process would expose the participants to unforeseen adversities.  Studies that use online surveys must obtain informed consent prior to the start of the questionnaire.  

Level of Risk

The investigators must plan their research to minimize any potential risk for the participants.  The research strategy must be designed to avoid potential harms.  Any potential risk that the participants may face should be comparable to what an 91大神 person would have experienced.  The researchers should pay attention to the environment of the participants before designing their study.  For instance, a survey that would imply no risk to an 91大神 student may expose a non-91大神 participant to potential risks depending on the situation and environment that person may experience.  Therefore, it is essential that the investigators recognize such situations while making their research plan.  If and when possible, the investigators are strongly encouraged to avoid recording any information that may potentially land the volunteers in unforeseen harms.  

Participant Pool (Target Population) – General Adults versus Others

Studies that target a general population within the age group 18 to 65 may have the least oversight restrictions.  When targeting specific populations, the researchers must apply higher ethical reasoning.  Regardless if the study population is specifically selected, or the research recruits a general population, it is critical that the researchers clearly analyze their research goals to avoid situations where a study group may be inadvertently targeted in a negative sense.  For instance, a behavioral study conducted on a certain ethnic population may inadvertently reveal the potential high risk for cancer among that population.  Although the finding may be important for the target population, it must be also noted that people of that ethnicity may be exposed to discrimination by health insurance providers.  Therefore, it is important that the investigators have a clear understanding of the potential harm to the target population and consider recruiting general adults when seeking participants from non-91大神 entities.  

Permission Requirement

Researchers may be asked to provide permission letters when enrolling participants such as school students, prisoners, hospitalized patients, and etc., from the school administration, prison superintendent or hospital’s dean, respectively.  The letter of support must clearly indicate that the approving authority has knowledge of the activities and the external agency would provide adequate protection to the participants in case of unforeseen adverse events.  Depending on the type of research and target population, the IRB may mandate, recommend or waive the permission letter requirement.  Please note that a waiver from 91大神 IRB to produce a permission letter merely means that no human subject compliance is observed but the IRB may not have the authority to allow researchers to use an external facility.  That facility would reserve the right to permit 91大神 researchers or not. Click here for more.

Type of Study – Social/Behavioral, Psychological, Physical, Educational, etc.

Almost all educational studies and most of simple social/behavioral studies would be approved with similar oversight requirements as the ones done at 91大神.  When the studies involve special populations or if the investigation involves measurements using sensitive information, the oversight requirements are elevated.  In addition, studies involving physical or psychological interventions would be scrutinized more stringently.  The investigators must demonstrate that they are capable of carrying out the proposed task through their prior experience, expertise and knowledge in the methods to be used, professional training and other aspects of the methodology critical to the proposed protocol.  The investigators must develop a thorough data storage and transportation of research materials such that confidentiality is protected.  The protocol must also recognize any additional restraints imposed by the external agency and provide detailed plans on how the investigators plan to implement them.  

Plan to Protect Confidentiality

The IRB recognizes that research records will be collected outside 91大神 and the data may include sensitive participant information, voice records, videos and information of such kind.  The data must be secured so the participant confidentiality can be enhanced.  Based on the study and prior training of the researchers, the IRB may allow certain exceptions to permit short-term storage of sensitive research data at an off-campus location.  Even in such circumstances, the storage of data at student residences and dorm rooms will be highly discouraged.  All long-term storage of data must be done only within a secure location at 91大神 unless allowed by the IRB.  

Institutional Authorization Agreement (IAA)

IAA is a mutual agreement executed between 91大神 and an external institution to allow researchers to freely conduct studies involving human subjects between the multiple researchers.  IAA can be executed specifically for a research study or for a bulk of studies.  They also have options to allow shared oversight or oversight reliance depending on a protocol. Click here for more. 

If you are an 91大神 researcher conducting a study off-campus or an external researcher conducting a study at 91大神 or with 91大神 personnel, please email [email protected] to explore your options.