Harvard Irb Forms
The IRB`s estrif system library and website list the forms and templates required to complete an IRB application. Additional documents are available in the ESTR system and contain the regulatory information required for a study. The simplest approach is to follow the forms one by one, answer the questions, and click Next to save your information and move on to the next form. When you reach the end of the form series, click the Save and Finish button. You may need to prepare one or more forms to submit with your application. These forms can be downloaded from the ESTR library. All submissions and exams are processed by ESTR, our electronic bid tracking and reporting system, which automates the IRB review process for Harvard CISRs (Harvard University region and Harvard Longwood campus). You will complete a SmartForm and be asked to attach additional documents if necessary (see below for more information on forms and templates). For multi-site or collaborative projects that are in progress, revisions and updates to the study reviewed by the registered IRB may be recorded: you can request the Harvard IRB to rely on the review of another IRB (called an external IRB or assigned review).
This type of presentation may be appropriate if a study is conducted at two or more different institutions, and instead of obtaining separate approval from each institution`s IRB, it is agreed that one institution will conduct the examination and that the other institution or institutions will rely on the IRB review. According to federal human subject protection regulations, “informed consent is documented using a written consent form approved by the IRB and signed by the subject or his or her legally authorized representative (including in electronic form). A written copy is given to the person signing the declaration of consent. (45 CFR 46,117) IRB COUNCIL! Take the “In a Perfect World” approach. If you don`t know you need a full-board exam, don`t worry about the exam category or deadlines. Consider the ethical regulations and concerns you learned during your ethics training and design the study as you envision it. If revisions are required, your IRB administrator will notify you and assign the level of verification accordingly. For individual site projects that are in an external IRB status, revisions and updates to the study reviewed by the registered IRB may be recorded under Update Study Details to provide Harvard with an update on the general status or content of the study and to provide a copy of the registered IRB`s letter of approval. Although we are used to thinking that consent documentation is a personal signature, there are many alternatives that meet these requirements.
The options selected here indicate additional features in other areas of the system. Click on HLS, HKS or Department of Psychology to schedule office hours Example: Interventions with physical or emotional illnesses Since the above guidelines show the flexibility of what counts as valid documented consent, some regulations require strict safety requirements. As a IRB, we found that, for this reason, certain types of studies require a personal and coloured signature as the only acceptable method of documentation. These include FDA-regulated studies that fall under 21 CFR 312 (Drugs and Biologics) and 21 CFR 812 (Devices) and therefore require Compliance with Part 11, as well as studies that are hipaa-regulated and require individual approval for the use/disclosure of research (45 CFR 164). Investigator`s Manual (IM) – This is your complete guide. In addition to the topics discussed here on our website, the IM covers many others, such as .B. reports on financial interests, consent considerations, conflicts of interest, data management and security, research in schools, secondary data analysis, deception and incomplete disclosure, topic groupings, additional requirements for government-funded research, HIPAA confidentiality rule, principal investigator responsibilities and statement of assurance, provost review, and more Access the single IRB? on the CUHS main page to learn more about this process. .
Harvard University`s Human Research Protection Program (HRPP) Plan – This is the “30,000 Feet View” document that connects all parts of our program. It defines the roles and mission and provides a comprehensive overview of the regulatory requirements to be met. More information can also be found on the HRPP overview page. . 1. External IRB: Click Select to specify which institution is to serve as the reference IRB. If the verification institution is not listed, select Other. 2. External Study ID: If available, the study number provided by the external IRB.3. Indicate why the study should be reviewed by an external IRB: Write the rationale for the request to Harvard to rely on another institution.
While the federal regulations of 45 CFR 46 (again the “Common Rule”) do not specify a retention period for research records, other federal regulations such as the FDA and hipAA do. In addition, Massachusetts law and Harvard policy require a retention period for these records. Example: Search with anonymized datasets; Anonymous Surveys Student Researchers Who Need an IRB Exam – Where to Start On the next page, you will need to enter information about the external IRB that serves as the reference IRB for the study. Use of technologies that support an electronic signature. When using an electronic signature, things get a little more complicated. Some regulations require strict compliance with certain requirements, such as .B. for FDA-regulated research (see 21 CFR 11,100(b)). Other laws suggest using a password or other security tool to ensure that the people who sign electronically are the people named in the document.
Under the Massachusetts Uniform Electronic Transactions Act (“UETA”; see M.G.L.c. 110G § 9), the “effectiveness of a security procedure” used in the electronic signature process may be used to prove that a record was attributable to the person who signed it. TIPS> Do not list the IP on this page. > For studies with a non-faculty principal investigator and if required by the IRB (academic field only based on applicability), register the faculty sponsor on this page. > Each person appointed as a member of the study team must complete training on a human subject (see your IRB website for information on training requirements). Our most commonly used set of rules is aware that it is not always possible to verify that the person signing the consent form is the study participant, and therefore favours a risk-based approach to considering the identity of the subject. For example, for some surveys, if the consent form (by mail, email, fax, etc.) was sent directly to the individual, it may be sufficient to verify whether the signed consent form is returned to the study team using the same method. Important! IRB external submissions completed before October 2015 cannot be processed by amendment.
Contact the IRB office to determine if an update is required. If such a requirement is required, the submission must be recreated under new requirements and processes. Harvard`s institutional guidelines require that all persons involved in research involving human subjects undergo training in the ethical conduct of human research. These include: The project does not meet the federal definition of “research”. A virtual meeting or conference call where the study team sees the study participant sign the consent form. Some study teams have found that virtually performing the consent process or by conference call is an effective way not only to ensure the understanding of study participants, but also to verify the identity of the person signing the form. If a consent process takes place in person, it is easy to verify the identity of the individual, but what if the consent process takes place remotely? Here are some ideas: ORARC offers tip sheets on various topics that are not otherwise described in detail in the HRPP or Toolkit. .
