"Importance of Medical Records in Clinical Research"
Part D: Guidelines for Special Types of Research 1. FDA-Regulated Products Clinical investigations involving a test article that is subject to regulation by the Food and Drug Administration must comply with FDA informed consent and IRB review regulations (21 CFR, parts 50, 56). As defined in 21 CFR 56.102: (c) Clinical investigation means any experiment that involves a test article and one or more human subjects… (l) Test article means any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under section 351 or 354-360F of the Public Health Service Act. Research involving investigational drugs. An investigational drug may be defined by one of the following: a. a drug in any of the clinical stages of evaluation (Phase I, II, III) which has not been released by the FDA for general use or cleared for sale in interstate commerce; b. any commercially available drug proposed for a new use; c. any commercially available drug to be used in a new dosage, form, or method of administration; d. any commercially available drug which contains a new component such as an excipient, coating, or menstruum; e. a new combination of two or more commercially available drugs; f. a combination of commercially available drugs in new proportions; g. any commercially available drug involved in a post-marketing surveillance. Good medical practice and patient interests require that physicians be free to use commercially available drugs according to their best knowledge and judgment. If a physician uses a drug for an indication not in the approved labeling, he or she has the responsibility to be well informed about the drug and to base its use on a firm scientific rationale and on sound medical evidence, and to maintain records of the drug‟s use and effects. Use of a drug in this manner as part of the “practice of medicine” does not require review by the IRB or FDA notification despite the fact that the drug is technically classified as investigational. The investigational use of an approved, marketed product differs from the situation described above. “Investigational use” suggests the use of an approved product in the context of a clinical research study protocol. When the principal intent of the investigational use of a drug is to develop information about its safety or efficacy, IRB review and approval is required. When a marketed drug is shipped in interstate commerce for the purpose of conducting a clinical trial on the drug for an unapproved use, at an unapproved dosage, by an unapproved route of administration, or in an altered dosage form, the submission of an Investigational New Drug permit (IND) is required. As described in the FDA regulations at 21 CFR 312.2(b)(1), the clinical investigation of a marketed drug or biologic does not require submission of an IND if ALL six of the following conditions are met: NDSU IRB Guidelines Page 1 of 10 Revision Date June 2009 Section I Part D Guidelines for Special Types of Research (i) it is not intended to be reported to FDA in support of a new indication for use or to support any other significant change in the labeling for the drug; (ii) it is not intended to support a significant change in the advertising for the product; (iii) it does not involve a route of administration or dosage level, use in a subject population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product; (iv) it is conducted in compliance with the requirements for IRB review and informed consent [21 CFR parts 56 and 50, respectively]; (v) it is conducted in compliance with the requirements concerning the promotion and sale of drugs [21 CFR 312.7]; and (vi) it does not intend to invoke 21 CFR 50.24. Even though the law may not require an IND in all investigational situations,the FDA believes that it is in the interests of the investigator and the public for one to be submitted. It is possible that the FDA may have safety data that are not available to the investigator. Furthermore, information obtained from such a clinical trial might expedite either approval of this new use or a decision regarding its abandonment if similar trials showed adverse results or lack of efficacy. When a marketed drug is shipped in interstate commerce for the purpose of routine clinical use and is subsequently proposed for use in a manner as defined by “investigational drugs,” an IND is not legally required, but IRB review and approval must be obtained. Research involving medical devices. The Center for Devices and Radiological Health, Food and Drug Administration, provides a definition of a ‘medical device’: If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing and postmarketing regulatory controls. A device is: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: o recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, o intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or o intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes." Medical devices include, among other things, surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. Medical devices also include diagnostic aids such as reagents and test kits for in vitro diagnosis (IVD) of disease and other medical conditions such as pregnancy. More information about medical devices is provided on the FDA website. Investigational devices are medical devices that are the object of clinical research determining their safety or effectiveness. Studies done to develop safe and effective data for medical devices involving human participants require IRB review and approval, and must be conducted according to the requirements of the Investigational Device Exemption (IDE) regulations (21 CFR 812). NDSU IRB Guidelines Page 2 of 10 Revision Date June 2009 Section I Part D Guidelines for Special Types of Research Investigational devices are determined to be either significant risk or non-significant risk devices. Examples of non-significant risk devices are: most daily wear contact lenses, lens solutions, heel cups, anti-bacterial surgical garments, incontinent devices, oral training splints, ultrasonic tooth cleaners, and Foley catheters. Investigations of non-significant risk devices must meet the abbreviated IDE requirements. Unless otherwise notified by FDA, an investigation of a non-significant risk device is considered to have an approved IDE if the sponsor fulfills the abbreviated requirements of the IDE regulations. These regulations require, in part, that IRB approval be obtained and maintained throughout the investigation and that informed consent be obtained and documented. A significant risk device is defined in the FDA regulations at 21 CFR 812(m): Significant risk device means an investigational device that: (1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject; (3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or (4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. Examples of significant risk devices are pacemakers, IUDs, some laser systems, and some hemodialyses systems. Investigations involving significant risk devices must meet the full IDE requirements (21 CFR 812) including the submission of an IDE application to the FDA, and FDA approval of the investigation. In addition to determining whether a study should be approved, the IRB will also determine whether the device presents significant or non-significant risk. The determination that a device presents non-significant or significant risk is initially made by the sponsor. The proposed study is then submitted to the IRB for review. The IRB may ask for and obtain certain information prior to determining the risk status of the device. A risk assessment determination and the rationale of the sponsor‟s decision should be provided by the sponsor. The IRB may ask the sponsor whether other IRBs have reviewed the proposed study and what determination was made. The sponsor should notify the IRB of the FDA‟s assessment of the device‟s risk if such an assessment has been made. The IRB may also consult the FDA for its opinion. In deciding if a device presents significant or non-significant risks, the IRB will consider the device‟s total risks, not as compared with the risks of alternative devices or procedures. If the device is used in conjunction with a procedure involving risk, the IRB will consider the risks of the procedure in conjunction with the risk of the device. The IRB may choose to agree or disagree with the sponsor‟s initial determination of degree or risk. Sponsors must notify the FDA when an IRB determines that a device, judged by the sponsor not to present a significant risk, should be categorized as a significant risk device. Once a decision on the degree of risk is reached, the IRB will consider whether the study should be approved or not. Some studies involving non-significant devices may also be considered minimal risk studies and thus may be reviewed through the expedited review procedure established by the IRB. The FDA considers studies of all significant risk devices to present more than minimal risk; thus, full IRB review for all studies involving significant risk devices is necessary. NDSU IRB Guidelines Page 3 of 10 Revision Date June 2009 Section I Part D Guidelines for Special Types of Research In considering whether a study should be approved, the IRB will use the same criteria it would use in considering approval of any research involving a FDA regulated product. In considering the risks of the device as they pertain to IRB approval (as opposed to whether or not the FDA should approve the IDE), the IRB will not simply judge the increase in risk over standard treatment, but rather the risk of the procedure as a whole. The risks and benefits of a medical device compared to the risks and benefits of alternative devices or procedures will be considered by the IRB in deciding the approvability of a study involving a medical device. Clinical investigations of intraocular lenses (IOLs) differ from other medical device investigations and are subject to s specific regulation (21 CFR 813). 2. Prospective/Retrospective Studies of Confidential Records Replaced by SOP 11.1 Use of Confidential Records 7/11/2008: Although the researcher may not directly interact with subjects, research involving the study of confidential records (e.g., school, university, or medical records) does involve human participants and does require IRB review or certification of exempt status. It is understood that such records are collected solely for non-research purposes. However, if an investigator knows at the time a person‟s record is obtained that it may be used for research purposes, the investigator should apply for IRB review, and afford that person, as a potential research subject, the opportunity to provide informed consent for the research use of his/her records. Research studies limited to review of existing records may be eligible for exemption (category #4) providing the investigator records the data in such a manner that participants cannot be identified directly or through identifiers linked to the participant, and the records were in existence prior to initiation of the research project. Please note that in order to qualify for this exemption, the recorded data must be completely de-identified and a linked code to identifiers must not be maintained by, or accessible to, the research team. In other words, it must not be possible for the research team to trace a data record back to an individual. Obvious identifiers are name, social security number, student, or medical record numbers. Other information, sometimes in combination with related datasets, may also be sufficient to identify an individual, particularly when the sample size is small, and/or the subject pool is named (i.e, students enrolled in a specified course at a certain time, members of a certain club, etc.). Research involving the study of confidential records must be reviewed by the IRB using expedited or full review methods if the investigator plans to record the data in such a manner that participants will be identified directly or through identifiers linked to the participant, or if information will be obtained from the record in a prospective fashion. In some instances, the requirement to obtain informed consent from participants may be waived, as long as the applicable provisions are met (see Section II). However, use of some types of records may require informed consent or authorization from the participant before the investigator‟s access to the record is granted. If an investigator wishes to utilize confidential records to identify potential participants for a prospective study, any initial contact with participants must be made by an individual with legitimate access to the records (e.g., subject‟s dentist, pharmacist, nurse, lawyer, social worker, NDSU IRB Guidelines Page 4 of 10 Revision Date June 2009 Section I Part D Guidelines for Special Types of Research etc.). The researcher may not obtain any information from the records prior to IRB review. Such projects would require review by expedited or full board methods. Additional requirements apply to use of academic records subject to the Family Educational Rights and Privacy Act (FERPA). The researcher is responsible for complying with these provisions, and the NDSU General Counsel should be consulted with any questions about the use of NDSU educational records for research. In many instances, a signature is required from the student or parent to access or release identifiable academic records; there is no provision for waiver of this requirement. If the academic records to be used are from an entity unaffiliated with NDSU, a permission/cooperation letter from that entity addressing FERPA compliance should be included in the submission to the IRB. Additional requirements also apply to research use of medical records (Protected Health Information, PHI) subject to the Health Insurance Portability & Accountability Act (HIPAA); consult the NDSU Privacy Officer for any questions regarding use of NDSU medical records for research. In order to use such PHI for research, the investigator must: 1) obtain written authorization from participants/patients, or 2) access only information de-identified in accordance with HIPAA policy, or 3) receive a waiver of authorization approved by an IRB or Privacy Board to access only the minimum necessary PHI, or 4) use a limited data set under a data use agreement. If the medical records to be studied are held by NDSU, the researcher is responsible for complying with the NDSU HIPAA Privacy Policies and Procedures, and the NDSU Privacy Officer should be consulted with any questions. If the medical records to be studied are held by an unaffiliated entity, a protocol is to be submitted to the NDSU IRB, however the outside entity would be responsible for compliance with HIPAA. The IRB protocol submission should include the patient authorization form to be used, or documented approval of a waiver from the outside entity. Requests for a waiver of authorization must be reviewed by a Privacy Board or IRB using the following criteria: 1) the use of PHI involves no more than minimal risk to the privacy of individuals, 2) the research could not practicably be conducted without the waiver, and 3) the research could not practicably be conducted without access to and use of the PHI. Reference information on research use of personal health information can be found on the National Institutes of Health‟s website at: http://privacyruleandresearch.nih.gov. Research records containing PHI must be held in strict confidence, using both physical and electronic safeguarding procedures. The NDSU IT Security Officer should be consulted for appropriate electronic security measures. 3. Human Pathological or Diagnostic Specimens Replaced by SOP 11.2 Human Biological Specimens 7/11/2008: In most instances, use of biological specimens, tissues, or bodily fluid samples of human origin for research purposes requires IRB review and approval, or certification of exempt status. The only exception to this is when biological specimens are obtained from a commercial source, and no identifiable information is associated with the sample, or available to the researcher. NDSU IRB Guidelines Page 5 of 10 Revision Date June 2009 Section I Part D Guidelines for Special Types of Research Research involving use of existing human specimens may be eligible for exemption, category #4, as long as the specimens were already „on the shelf‟ at the time the research was proposed, subjects cannot be identified by the research team either directly or through linkages, and the specimens were collected for a purpose other than the proposed research. However, if an investigator knows at the time a person‟s specimen is obtained that it may be used for research purposes, the investigator should apply for IRB review, and afford that person, as a potential research subject, the opportunity to provide informed consent for the research use of his/her specimen. In order to qualify for this exemption, the specimens must be completely de-identified and a linked code must not be maintained by, or accessible to, the research team. In other words, it must not be possible for the research team to trace a specimen record back to an individual. Obvious identifiers are name; social security, student, or medical record numbers. Other information, sometimes in combination with related information, may be sufficient to identify an individual, particularly when the sample size is small, and/or the subject pool is named or specifically described. All other uses of human specimens for research, including prospective collection of specimens, require IRB review by expedited or full board methods, and informed consent from the individual donors. Waivers of informed consent may be requested; the IRB will determine if a waiver would be approvable, in accordance with applicable provisions (see Section II). 4. Secondary Analysis of Existing Data Replaced by SOP 11.3 Secondary Analysis of Existing Data 7/11/2008: If existing data contains information about living individuals, use of the data for research purposes requires IRB review and approval, or certification of exempt status. In some cases, such a study may be eligible for exempt status (category #4) as long as the data exists prior to initiation of the research project, and was collected for a purpose other than the proposed research. In addition, the data must either be 1) publicly available, or 2) recorded by the investigator so that individuals cannot be identified, directly or through linkages maintained by, or accessible to, the research team. Examples would include public use, or other de-identified datasets. Please note that in order to qualify for this exemption, the recorded data must be completely de-identified and a linked code must not be maintained by, or accessible to, the research team. In other words, it must not be possible for the research team to trace a data record back to an individual. Obvious identifiers are name; social security, student, or medical record numbers. Other information, sometimes in combination with related datasets, also may be sufficient to identify an individual, particularly when the sample size is small, and/or the subject pool is named (ie, students enrolled in a specified course at a certain time, members of a certain club, residents of a dorm, etc.). The IRB application must provide a complete description of the data to be used, a description of the original collection (if known), including purpose, dates, etc. and any security provisions or confidentiality agreements required by the owner organization. If available, the agreement or consent under which the information was originally obtained from individuals should be provided in order to determine whether or not the proposed secondary use is consistent with their understanding of use of their information. The IRB may require that individuals be re-contacted (by someone with legitimate access to their information) for permission for secondary use of their information, if feasible. NDSU IRB Guidelines Page 6 of 10 Revision Date June 2009 Section I Part D Guidelines for Special Types of Research If an investigator requests to utilize an existing dataset (not originally collected under IRB approval) for research, a justification must be provided as to why IRB review was not sought or applicable at the time of original collection. It is important to note that, if at any time prior to the original collection of such data, it is intended that at least one of the purposes may be for „research‟, the investigator should apply for IRB review, and afford each person, as a potential research subject, the opportunity to provide informed consent for the research use of his/her information. Collection of data with the intention of avoiding IRB review or fully informing participants will be considered noncompliance. If existing data is not publicly available, or contains any identifiers or a linkage to identifiers, it must be reviewed by the expedited or full board method. Informed consent will be required from participants, unless a waiver of this requirement is approvable. Replaced by SOP 9.3 Waiver or Alteration of Informed Consent 9/11/2009: 5. Deception/Incomplete Information North Dakota State University subscribes to the guidelines of the American Psychological Association (APA) in the use of deception in research studies. Ethical Principle 9 E, as stated in the APA brochure titled, Ethical Principles in the Conduct of Research with Human Participants, 2002, is as follows: Methodological requirements of a study may make the use of concealment or deception necessary. Before conducting such a study, the investigator has a special responsibility to: (i) determine whether the use of such techniques is justified by the study’s prospective scientific, educational, or applied value; (ii) determine whether alternative procedures are available that do not use concealment or deception; (iii) ensure that the participants are provided with sufficient explanation as soon as possible. A special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to impair the validity of the research. Information about risks should never be withheld for the purpose of eliciting the cooperation of participants, and truthful answers should always be given to direct questions about the research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator. When reviewing research involving deception, the IRB must find, and document the basis for approving this waiver of some, or all of the elements of informed consent, as outlined in Section II, ‘Requirements of Informed Consent’. 6. Biomedical and Behavioral Research involving Women and Minorities. In March 1994, the National Institutes of Health (NIH) published guidelines requiring the use of women and minorities in all clinical research conducted or funded by the NIH. The guidelines were originally published in the Monday, March 28, 1994 issue of the Federal Register, vol. 59, no. 59, pp 14508-14513 and updated October 2, 2000 and October 2001. These guidelines are available as a hyperlink in the appendix. NDSU IRB Guidelines Page 7 of 10 Revision Date June 2009 Section I Part D Guidelines for Special Types of Research As stated in the guidelines: It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH-funded clinical research, unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant Institute/Center Director that inclusion is inappropriate with respect to the health of subjects or the purpose of the research. The inclusion of both women and men and of minorities in research is important, both to ensure that they receive an appropriate share of the benefits of research and that they do not bear a disproportionate burden. To the extent that participation in research offers direct benefits to the participants, under representation of men, women, or minorities denies them the opportunity to benefit. Moreover, for purposes of generalizing research results, investigators must include the widest possible range of population groups. IRBs are empowered to approve, request modification of, or disapprove research to be submitted for NIH funding, based on their review and assessment of the extent to which the analysis criteria specified in the NIH Guidelines will be met in the proposed research. Accordingly, it is NDSU policy that the NDSU IRB will comply with the above guidelines in the review of research projects to be submitted to NIH for funding. Further, it is expected that all federal agencies that fund biomedical or behavioral research to make an effort so far as is practical to include women, men, and minorities in their research designs, regardless of the anticipated funding source. In deliberation about appropriate selection of research participants, NDSU and the NDSU IRB have the following responsibilities: To help ensure that investigators understand the importance of inclusion of both genders and minorities in research and clearly delineate the expectations for the design and conduct of such research. They should assist in providing investigators with written guidance and educational opportunities for clarification. To specify that, when scientifically appropriate, investigators cite evidence or lack of evidence if a health situation or intervention in the proposed research addresses that evidence. Investigators should be prepared to describe how the proposed research may affect one gender or minority group differently and describe how the proposed research addresses that evidence. Investigators should be prepared to describe the extent to which both genders and persons of various ethnic and racial backgrounds are or have been involved in similar research. To help create guidelines for investigators to facilitate recruitment and retention of participants to ensure representation and sufficient involvement of targeted populations from different To help create guidelines for investigators to facilitate recruitment and retention of participants to ensure representation and sufficient involvement of targeted populations. The extent to which investigators are collaborating with those at other institutions that can involve increased numbers of men or women or populations from different minority groups must be a part of the information the IRB reviews, particularly with regard to Phase III clinical trials. To ensure that any special vulnerabilities of participants (e.g., educational level, socioeconomic status) are accounted for and handled appropriately. The IRB should carefully consider if reimbursements (cash or material provisions) are appropriate to the context of the proposed research, with special attention that these reimbursements do not promote coercion or undue influence to participate or remain in a study. NDSU IRB Guidelines Page 8 of 10 Revision Date June 2009 Section I Part D Guidelines for Special Types of Research To safeguard the consent process and promote open and free communication between the researcher and the participants. Investigators and IRBs must seek to understand cultural nuances and types of foreign languages inherent in the populations to be enrolled. The possibility of illiteracy of a potential research participant must also be considered and assurances given that adequate provision has been made for appropriate translations of the consent documents or the availability of translators. To arrange for inclusion of women and members of minority groups on the IRB, especially if the nature and volume of the research to be conducted at the institution routinely includes these populations. IRBs should also consider consulting ad hoc advisors who could help with understanding the perspectives of various groups. Also, institutions and IRBs can encourage investigators to seek out such perspectives during planning of research protocols. To specify that investigators of federally-funded research provide details of the proposed involvement of humans in the research, including the characteristics of the subject population, anticipated numbers, age ranges, and health statuses. The proposed research should specify the gender and racial/ethnic composition of the participant population, as well as criteria for inclusion or exclusion of any subpopulation. If ethnic, racial, and gender estimates and continuing review are not included in the background data for a protocol, the investigators must provide a clear rationale for the exclusion of this information. 7. Oral History Activities In some cases, projects involving oral history interviews do not require review (or certification of exemption) by the IRB. In evaluating the applicability of IRB purview to a project, the following working definitions will be used: “Oral history”: …collects spoken memories and personal commentaries of historical significance through recorded interviews. (D. Ritchie, “Doing Oral History”, New York: Twayne Publishers) An oral history interview is generally an open-ended exchange with the interviewer, and places importance on the identity of specific individuals, rather than recording anonymous members of a particular group. Oral history tapes are made available to the public in archives or libraries. “Research”: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (Dept. of Health & Human Services, 45 CFR 46.102(d). Oral history activities that are designed solely to create a record of specific historical events, or persons (ie, a biography), and do not intend to use the information to draw generalizable conclusions would not fall under the HHS definition of “research”, and would not come under the purview of the IRB. However, an oral history project would come under the purview of the IRB if the researcher intends to develop or contribute to generalizable knowledge. Such projects are required to be submitted to the IRB for review (or certification of exempt status), and are subject to the standard policies and procedures. NDSU IRB Guidelines Page 9 of 10 Revision Date June 2009 Section I Part D Guidelines for Special Types of Research Several examples of oral history projects are provided by the Office of Human Research Protections (OHRP) for guidance: 1. Oral history activities, such as open ended interviews, that ONLY document a specific historical event or the experiences of individuals without an intent to draw conclusions or generalize findings would NOT constitute “research” as defined by HHS regulations 45 CFR 46. >> No submission to IRB; follow ethical principles of American Historical Association. Example: An oral history video recording of interviews with holocaust survivors is created for viewing in the Holocaust Museum. The creation of the video tape does NOT intend to draw conclusions, inform policy, or generalize findings. The sole purpose is to create a historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their stories. 2. Systematic investigations involving open-ended interviews that are designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions, inform policy, or generalize findings) WOULD constitute “research” as defined by HHS regulations at 45 CFR 46. >>Submit protocol to IRB. Example: An open-ended interview of surviving Gulf War veterans to document their experiences and to draw conclusions about their experiences, inform policy, or generalize findings. 3. Oral historians and qualitative investigators may want to create archives for the purpose of providing a resource for others to do research. Since the intent of the archive is to create a repository of information for other investigators to conduct research as defined by 45 CFR 46, the creation of such an archive WOULD constitute “research” under 45 CFR 46. >>Submit protocol to IRB. Example: Open ended interviews are conducted with surviving Negro League Baseball players in order to create an archive for future research. The creation of such an archive would constitute “research” under 45 CFR 46 since the intent is to collect data for future research. The investigator and their department/unit will be responsible for conducting any oral history activities in accordance with the ethical principles of the American Historical Association, whether or not these activities are under the purview of the IRB. If at any time prior to the original collection of an oral history, it is intended that it may also be used for future research purposes, the investigator should apply for IRB review, and afford that person, as a potential research subject, the opportunity to provide their consent for the research use of his/her information. Collection of oral histories with the intention of avoiding IRB review or fully informing participants will be considered noncompliance. NDSU IRB Guidelines Page 10 of 10 Revision Date June 2009 Section I Part D Guidelines for Special Types of Research